Company Information This section presents fundamental company information, covering board structure, banking, H share registrar, stock code, and website [Board of Directors](index=3&type=section&id=Board%20of%20Directors) The company's Board of Directors is led by Mr. Liu Gexin, Chairman and Non-executive Director, and includes Executive Director Dr. Ge Junyou, several Non-executive Directors, and Independent Non-executive Directors, with Audit, Remuneration, and Nomination Committees all established and chaired by Independent Non-executive Directors - Chairman and Non-executive Director: **Mr. Liu Gexin**[5](index=5&type=chunk) - Executive Director: **Dr. Ge Junyou**[5](index=5&type=chunk) - Chairman of the Audit Committee: **Dr. Li Yedong** (Independent Non-executive Director)[5](index=5&type=chunk) - Auditor: **KPMG**[5](index=5&type=chunk) [Principal Banks](index=4&type=section&id=Principal%20Banks) The company maintains relationships with several principal banks in China, including Bank of China, Industrial Bank, CITIC Bank, and China Merchants Bank - Principal banks include **Bank of China, Industrial Bank, CITIC Bank, and China Merchants Bank**[6](index=6&type=chunk) [H Share Registrar](index=4&type=section&id=H%20Share%20Registrar) The company's H share registrar is Hong Kong Central Share Registrar Limited, located in Wan Chai, Hong Kong - H Share Registrar: **Hong Kong Central Share Registrar Limited**[6](index=6&type=chunk) [Stock Code](index=4&type=section&id=Stock%20Code) The company's H share stock code is 06990 - H Share Stock Code: **06990**[6](index=6&type=chunk) [Company Website](index=4&type=section&id=Company%20Website) The company's official website is https://kelun-biotech.com - Company Website: **https://kelun-biotech.com**[6](index=6&type=chunk) Financial and Business Highlights This section summarizes the company's financial performance and key business achievements, including revenue, profit/loss, and significant progress in drug development and commercialization [Financial Highlights](index=5&type=section&id=Financial%20Highlights) For the six months ended June 30, 2025, the company's revenue decreased by 31.3% year-on-year to RMB 950.4 million, with a loss of RMB 145.2 million for the period, compared to a profit of RMB 310.2 million in the prior year, while cash and financial assets and total equity both saw significant growth Financial Highlights for the Six Months Ended June 30, 2025 | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | Period Change | | :--- | :--- | :--- | :--- | | Revenue | 950,445 | 1,382,791 | -31.3% | | R&D Expenses | (611,539) | (652,337) | -6.3% | | (Loss)/Profit for the Period | (145,175) | 310,226 | -146.8% | | Adjusted (Loss)/Profit for the Period | (69,398) | 385,636 | -118.0% | | **As of June 30, 2025** | **As of December 31, 2024** | | | | Cash and Financial Assets | 4,527,814 | 3,075,651 | 47.2% | | Total Equity | 5,014,290 | 3,308,661 | 51.6% | [Business Highlights](index=5&type=section&id=Business%20Highlights) The company achieved encouraging progress in both ADC and novel conjugate drug assets and non-conjugate drug assets, with multiple core products receiving marketing approval or entering the NDA stage, actively advancing commercialization and global collaborations, and achieving total commercial sales of RMB 309.8 million in the first half, with sac-TMT (Aitaiwei®) contributing 97.6% - Since early 2025, the company's business has achieved **encouraging progress**[10](index=10&type=chunk) - Total commercial sales reached **RMB 309.8 million** in the first half of 2025, with sac-TMT (Aitaiwei®) sales accounting for **97.6%**[33](index=33&type=chunk) [Key Developments in ADC and Novel Conjugate Drug Assets](index=5&type=section&id=Key%20Developments%20in%20ADC%20and%20Novel%20Conjugate%20Drug%20Assets) The company made several key advancements in ADC and novel conjugate drug assets, with core product sac-TMT (Aitaiwei®) approved for TNBC and EGFR-mutated NSCLC, and multiple global Phase 3 clinical studies underway, while bodotuximab (Shutaiwei®) NDA has been accepted, and other novel ADC drugs are in clinical trials - Possesses **over 10 ADC and novel conjugate drug assets** in clinical or later stages[10](index=10&type=chunk) - sac-TMT (Aitaiwei®) has received **two marketing approvals**, and bodotuximab (Shutaiwei®) has reached the **NDA stage**[10](index=10&type=chunk) [Key Developments in Non-Conjugate Drug Assets](index=10&type=section&id=Key%20Developments%20in%20Non-Conjugate%20Drug%20Assets) The company also made significant progress in non-conjugate drug assets, with tagolimab (Ketaiwei®) approved for first-line and second-line treatment of nasopharyngeal carcinoma, and cetuximab N01 (Daitaiwei®) approved for first-line treatment of RAS wild-type metastatic colorectal cancer, while A400/EP0031 showed good efficacy in advanced RET-mutated MTC patients and received FDA Fast Track designation - Tagolimab (Ketaiwei®) has been approved by the NMPA for the treatment of recurrent or metastatic NPC patients and in combination with chemotherapy for first-line treatment[30](index=30&type=chunk) - Cetuximab N01 (Daitaiwei®) has been approved by the NMPA in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type metastatic colorectal cancer[30](index=30&type=chunk) - Phase I study results of A400 in advanced RET-mutated MTC patients showed an overall confirmed ORR of **63.0%** and a DCR of **100%**[32](index=32&type=chunk) [Commercialization](index=11&type=section&id=Commercialization) The company has successfully commercialized sac-TMT (Aitaiwei®), tagolimab (Ketaiwei®), and cetuximab N01 (Daitaiwei®), and expects to launch bodotuximab (Shutaiwei®) and submit NDA for A400 in the second half of 2025, with a commercial network covering 30 provinces and over 2,000 hospitals, actively promoting product inclusion in national medical insurance and provincial/municipal inclusive insurance - Marketing approvals for sac-TMT (Aitaiwei®), tagolimab (Ketaiwei®), and cetuximab N01 (Daitaiwei®) have been obtained, and commercialization has commenced[34](index=34&type=chunk) - Expected to launch bodotuximab (Shutaiwei®) in the Chinese market and submit an NDA for A400 in the **second half of 2025**[34](index=34&type=chunk) - Business has covered **30 provinces, over 300 prefecture-level cities, and over 2,000 hospitals**, with sales revenue achieved in over 1,000 hospitals[35](index=35&type=chunk) - Aitaiwei® has completed listing in **29 provinces**, Ketaiwei® in **25 provinces**, and Daitaiwei® in **15 provinces**[36](index=36&type=chunk) - All launched products (Aitaiwei®, Ketaiwei®, and Daitaiwei®) have passed the preliminary formal review for the National Medical Insurance Drug Catalogue[36](index=36&type=chunk) [Licensing and Collaboration Arrangement Highlights](index=13&type=section&id=Licensing%20and%20Collaboration%20Arrangement%20Highlights) The company has established multiple strategic collaborations with Merck, Ellipses Pharma, and Windward Bio, with the Merck collaboration covering global development and commercialization of sac-TMT and other ADC assets, Ellipses Pharma advancing global clinical development of A400 with FDA Fast Track designation, and Windward Bio collaborating on SKB378/WIN378, having received upfront payment and equity - Entered into a licensing and collaboration agreement with Merck for the development of multiple ADC assets for cancer treatment, with exclusive rights for sac-TMT outside Greater China granted to Merck[37](index=37&type=chunk) - Merck is advancing **14 global multi-center Phase 3 clinical studies** for sac-TMT across multiple cancer types[20](index=20&type=chunk) - Collaborating with Ellipses Pharma on the development of A400/EP0031, which has received **FDA Fast Track designation** and approval to enter Phase 2 clinical development[43](index=43&type=chunk) - Entered into an exclusive licensing agreement with Windward Bio, granting them rights for the development, manufacturing, and commercialization of SKB378/WIN378 globally (excluding Greater China and certain Southeast Asian and West Asian countries)[43](index=43&type=chunk) - The company and Harbour BioMed are eligible to receive a combined maximum of **USD 970 million** in upfront and milestone payments, plus tiered royalties ranging from single-digit to double-digit percentages based on net sales of SKB378/WIN378[42](index=42&type=chunk) [Environmental, Social and Governance](index=15&type=section&id=Environmental%2C%20Social%20and%20Governance) The company has established a comprehensive three-tier ESG governance framework, with the Board of Directors as the highest decision-making body, and received the "Best ESG" award from Extel in May 2025 - A comprehensive three-tier ESG governance framework has been established, consisting of the **Board of Directors, ESG Working Group, and ESG Executive Body**[44](index=44&type=chunk) - Awarded "**Best ESG**" by Extel (formerly "Institutional Investor") in **May 2025**[44](index=44&type=chunk) [Placement of New H Shares](index=15&type=section&id=Placement%20of%20New%20H%20Shares) The company completed the placement of 5,918,000 H shares on June 12, 2025, at a placement price of HKD 331.80 per share, raising net proceeds of approximately HKD 1,943.0 million - On **June 12, 2025**, completed the placement of **5,918,000 H shares** to no less than six placees at a placement price of **HKD 331.80 per share**[44](index=44&type=chunk) - Net proceeds from the placement amounted to approximately **HKD 1,943.0 million**[44](index=44&type=chunk) Management Discussion and Analysis This section provides an in-depth review of the company's business operations, financial performance, and future outlook, highlighting strategic initiatives and key achievements [I. Business Review](index=16&type=section&id=I.%20Business%20Review) The company is a biopharmaceutical firm focused on innovative drug R&D, manufacturing, and commercialization in oncology, immunology, and other therapeutic areas, with core products sac-TMT and bodotuximab achieving significant progress, and continuously expanding its diversified pipeline and commercialization infrastructure through three major technology platforms and global strategic partnerships - The company is a biopharmaceutical company dedicated to the R&D, manufacturing, and commercialization of innovative drugs in oncology, immunology, and other therapeutic areas[45](index=45&type=chunk) - Possesses two core ADC drugs: **sac-TMT (TROP2 ADC)** and **bodotuximab (HER2 ADC)**[45](index=45&type=chunk) - Has a pipeline of **over 30 drug candidates** under development, with **more than 10** in clinical stages[45](index=45&type=chunk) - Licensing and collaboration agreements with partners such as Merck, Ellipses Pharma, and Windward Bio demonstrate R&D and business development capabilities[47](index=47&type=chunk) [Overview](index=16&type=section&id=Overview) The company is a biopharmaceutical firm focused on innovative drug R&D, manufacturing, and commercialization in oncology, immunology, and other therapeutic areas, with core products sac-TMT and bodotuximab, a pipeline of over 30 drug candidates, and development driven by internal technology platforms and global strategic partnerships - The company is one of the **pioneers in ADC development**, accumulating **over a decade of experience** in ADC development[46](index=46&type=chunk) - Is one of the first biopharmaceutical companies in China and among a few globally to establish an in-house developed ADC and novel conjugate drug platform, **OptiDC™**[46](index=46&type=chunk) [Our Pipeline](index=16&type=section&id=Our%20Pipeline) The company's pipeline includes over thirty drug candidates, with more than ten in clinical stages, primarily targeting prevalent or refractory cancers such as breast cancer, non-small cell lung cancer, gastrointestinal cancers, and gynecological tumors, as well as non-oncology diseases like autoimmune and metabolic disorders, with core products sac-TMT and bodotuximab showing significant progress, and multiple novel ADC and non-conjugate drugs achieving important clinical data and regulatory approvals - The pipeline targets prevalent or refractory cancers worldwide, such as **BC, NSCLC, GI cancers, and gynecological tumors**, as well as non-oncology diseases and conditions with large patient populations and unmet medical needs[48](index=48&type=chunk) - A robust pipeline has been established, comprising **over thirty drug candidates**, including **more than ten clinical-stage candidates**[48](index=48&type=chunk) [Our Oncology Pipeline](index=17&type=section&id=Our%20Oncology%20Pipeline) The oncology pipeline features diverse therapeutic options and differentiated mechanisms, comprehensively covering prevalent or refractory cancers domestically and internationally, with core product sac-TMT approved for TNBC and EGFR-mutated NSCLC and advancing multiple global Phase 3 clinical trials, bodotuximab NDA accepted, and multiple novel ADCs (e.g., SKB315, SKB410) and immunotherapy/targeted therapy drugs (e.g., tagolimab, cetuximab N01, A400) also making significant progress - Sac-TMT (Aitaiwei®) has been approved by the NMPA for marketing in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have previously received at least two systemic therapies[53](index=53&type=chunk) - Sac-TMT is the **first domestically developed ADC with global intellectual property rights** to receive full marketing approval in China[53](index=53&type=chunk) - The NDA for bodotuximab (Shutaiwei®) has been accepted by the NMPA's CDE for the treatment of adult patients with HER2+ unresectable or metastatic BC who have previously received at least one anti-HER2 therapy[66](index=66&type=chunk) - Tagolimab (Ketaiwei®) is the **world's first PD-L1 monoclonal antibody** approved for first-line treatment of nasopharyngeal carcinoma[75](index=75&type=chunk) [Non-Oncology Pipeline](index=24&type=section&id=Non-Oncology%20Pipeline) The non-oncology pipeline primarily focuses on immune-mediated diseases such as moderate-to-severe asthma and thromboembolic diseases, with SKB378 (TSLP mAb) having completed Phase 1 clinical trials in China and received IND approval for COPD, and partner Windward Bio initiating the Phase 2 POLARIS trial, while SKB336 (FXI/FXIa mAb) has completed Phase 1 clinical trials in China - SKB378 (TSLP mAb) is expected to be one of the **first independently developed anti-TSLP monoclonal antibodies in China** for the treatment of patients with moderate-to-severe asthma[88](index=88&type=chunk) - The IND application for SKB378 for the treatment of COPD was approved by the NMPA in **January 2025**[89](index=89&type=chunk) - SKB336 (FXI/FXIa mAb) has completed Phase 1 trials in China, aiming to serve as an anticoagulant for the prevention and treatment of thromboembolic diseases[91](index=91&type=chunk) [Our Technology Platforms](index=25&type=section&id=Our%20Technology%20Platforms) The company has established three core technology platforms focusing on ADC and novel conjugate drugs, biologics, and small molecules, supporting the discovery and development of innovative drugs, with the OptiDC™ platform accumulating a decade of experience in ADC development, possessing expertise in conjugate drug design, development, and a core component library, while the biologics platform utilizes advanced technologies to accelerate antibody discovery, and the small molecule platform is driven by medicinal chemistry and AIDD technologies - Three core platforms have been established, focusing on **ADC and novel conjugate drugs, biologics, and small molecules**, respectively[93](index=93&type=chunk) - The ADC and novel conjugate drug platform, **OptiDC™**, is supported by deep understanding of biological targets and diseases, tested and validated expertise in conjugate drug design and development, and a library of conjugate drug core components[94](index=94&type=chunk) - The biologics platform accelerates the generation of innovative antibodies by integrating a **monoclonal B-cell screening platform, next-generation sequencing, and high-throughput screening and analysis**[99](index=99&type=chunk) - The small molecule platform is driven by integrated **medicinal chemistry, computer-aided drug design (CADD), and AIDD technologies**[99](index=99&type=chunk) [Research and Development](index=27&type=section&id=Research%20and%20Development) The company possesses a comprehensive in-house R&D engine covering drug discovery, translational medicine, process development, and clinical research, staffed by experienced industry veterans, utilizing AI technology to enhance efficiency and ensure the quality and efficiency of drug development at all stages - In-house R&D capabilities allow the company to flexibly control and supervise the R&D process, reduce reliance on CROs, and ensure the quality and efficiency of drug development projects[98](index=98&type=chunk) - AI has been introduced into multiple R&D processes to further enhance R&D efficiency, such as **AI-assisted antibody sequence prediction and binding site prediction**[102](index=102&type=chunk) [Our Licensing and Collaboration Arrangements](index=28&type=section&id=Our%20Licensing%20and%20Collaboration%20Arrangements) The company actively seeks external collaborations to generate synergies, partnering with Merck for the development of multiple ADC assets, with exclusive rights for sac-TMT outside Greater China granted to Merck, and 14 global Phase 3 clinical studies underway, collaborating with Ellipses Pharma for A400, which has received FDA Fast Track designation, and with Windward Bio for SKB378/WIN378, having received upfront payment and equity - Collaboration with Merck: Granted Merck exclusive license to develop, use, manufacture, and commercialize sac-TMT outside Greater China, with Merck initiating **14 global Phase 3 clinical studies**[105](index=105&type=chunk) - Collaboration with Ellipses Pharma: Granted exclusive license for A400 outside Greater China and certain Asian countries, with A400/EP0031 receiving **FDA Fast Track designation**[111](index=111&type=chunk) - Collaboration with Windward Bio: Granted exclusive license for SKB378/WIN378 globally (excluding Greater China and certain Southeast Asian and West Asian countries), having received upfront payment and equity in Windward Bio's parent company[109](index=109&type=chunk) [Manufacturing and Quality Management](index=31&type=section&id=Manufacturing%20and%20Quality%20Management) The company possesses cGMP-compliant end-to-end manufacturing facilities covering the entire lifecycle of ADC development, continuously improving its integrated quality management system, and bodotuximab has been approved by the NMPA to conduct a cross-provincial segmented production pilot program - The main manufacturing base in Chengdu is one of the few cGMP-compliant facilities in China with **end-to-end capabilities for ADC development**[116](index=116&type=chunk) - Bodotuximab (Shutaiwei®) received formal approval from the NMPA to conduct a **cross-provincial segmented production pilot program**[116](index=116&type=chunk) [Commercialization](index=31&type=section&id=Commercialization) The company has successfully commercialized sac-TMT (Aitaiwei®), tagolimab (Ketaiwei®), and cetuximab N01 (Daitaiwei®), and expects to launch bodotuximab (Shutaiwei®) and submit NDA for A400 in the second half of 2025, with a commercial network covering 30 provinces and over 2,000 hospitals, actively promoting product inclusion in national medical insurance and provincial/municipal inclusive insurance - Total commercial sales reached **RMB 309.8 million** in the first half of 2025, with sac-TMT (Aitaiwei®) sales accounting for **97.6%**[115](index=115&type=chunk) - A mature marketing team of **over 350 people** has been established, dedicated to the marketing and commercialization of strategic products[117](index=117&type=chunk) - Aitaiwei® has completed listing in **29 provinces**, Ketaiwei® in **25 provinces**, and Daitaiwei® in **15 provinces**[118](index=118&type=chunk) - All launched products have passed the preliminary formal review for the National Medical Insurance Drug Catalogue, and Aitaiwei® has been included in inclusive insurance schemes in **over 7 provinces and more than 20 cities**[118](index=118&type=chunk) [Awards and Recognition](index=33&type=section&id=Awards%20and%20Recognition) The company received multiple industry awards in 2025, including "Asia's Best Company" from FinanceAsia, "Most Honored Company" and "Best ESG" from Extel, as well as "Tianma Award for Investor Relations Management of Chinese Listed Companies" from Securities Times and "China Pharmaceutical Emerging Innovation Power Award" from China Pharmaceutical Industry Information Center - In **May 2025**, awarded "**Asia's Best Company**" by FinanceAsia[119](index=119&type=chunk) - In **May 2025**, awarded a series of industry awards by Extel, including "**Most Honored Company**," "**Best Board of Directors**," "**Best CEO**," "**Best CFO**," and "**Best ESG**"[119](index=119&type=chunk)[122](index=122&type=chunk) - In **July 2025**, awarded "**China Pharmaceutical Emerging Innovation Power Award**" by China Pharmaceutical Industry Information Center[121](index=121&type=chunk) [Environmental, Social and Governance](index=33&type=section&id=Environmental%2C%20Social%20and%20Governance) The company has established a comprehensive three-tier ESG governance framework, with the Board of Directors serving as the highest body for responsibility and decision-making, guiding and supervising ESG development, and received the "Best ESG" award from Extel in May 2025 - A comprehensive three-tier ESG governance framework has been established, consisting of the **Board of Directors, ESG Working Group, and ESG Executive Body**[122](index=122&type=chunk) - The Board of Directors serves as the **highest body for ESG management and information disclosure**[122](index=122&type=chunk) [II. Financial Review](index=33&type=section&id=II.%20Financial%20Review) For the six months ended June 30, 2025, the company's revenue decreased by 31.3% to RMB 950.4 million, primarily due to reduced milestone payments from licensing and collaboration agreements, resulting in a loss of RMB 145.2 million for the period, while selling and distribution expenses significantly increased by 334.8% reflecting an expanded commercialization team and increased marketing activities, and the company maintained strong liquidity with a substantial increase in cash and financial assets, mainly driven by the H share placement - For the six months ended June 30, 2025, revenue was **RMB 950.4 million**, a **31.3% decrease** from the prior year[125](index=125&type=chunk) - Loss for the period was **RMB 145.2 million**, compared to a profit of **RMB 310.2 million** in the prior year[148](index=148&type=chunk) - Selling and distribution expenses increased by **334.8% to RMB 178.9 million**, primarily due to an expanded commercialization team and increased marketing activities[137](index=137&type=chunk) - Cash and cash equivalents increased to **RMB 3,102.8 million**, mainly reflecting the net proceeds from the placement in June 2025[150](index=150&type=chunk) [Revenue](index=33&type=section&id=Revenue) For the six months ended June 30, 2025, the company's revenue was RMB 950.4 million, a 31.3% year-on-year decrease, primarily due to reduced milestone payments from licensing and collaboration agreements, with drug sales contributing RMB 309.8 million Revenue Components (For the six months ended June 30) | Revenue Source | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Revenue from licensing and collaboration agreements | 628,015 | 1,377,978 | | Revenue from providing R&D services | 12,674 | 4,813 | | Revenue from drug sales | 309,756 | – | | **Total** | **950,445** | **1,382,791** | - Revenue decreased by **31.3%**, primarily due to lower milestone payments from licensing and collaboration agreements compared to the first half of 2024[125](index=125&type=chunk) - In the first half of 2025, drug sales contributed **RMB 309.8 million** in revenue[125](index=125&type=chunk) [Cost of Sales](index=34&type=section&id=Cost%20of%20Sales) For the six months ended June 30, 2025, cost of sales was RMB 290.5 million, a 5.1% year-on-year decrease, primarily attributable to reduced employee costs for collaborative projects Cost of Sales Details (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Employee costs | 29,123 | 46,030 | | Trial and testing expenses | 227,006 | 225,976 | | Others | 34,328 | 34,095 | | **Total** | **290,457** | **306,101** | - Cost of sales decreased by **5.1%**, primarily attributable to reduced employee costs for collaborative projects in the first half of 2025[128](index=128&type=chunk) [Gross Profit and Gross Margin](index=34&type=section&id=Gross%20Profit%20and%20Gross%20Margin) For the six months ended June 30, 2025, gross profit was RMB 660.0 million, a 38.7% year-on-year decrease, with gross margin declining from 77.9% in the prior year to 69.4% Gross Profit and Gross Margin (For the six months ended June 30) | Indicator | 2025 | 2024 | | :--- | :--- | :--- | | Gross Profit (RMB million) | 660.0 | 1,076.7 | | Gross Margin | 69.4% | 77.9% | - Gross profit decreased by **38.7%**, and gross margin decreased by **8.5 percentage points**[129](index=129&type=chunk) [Other Net Income](index=35&type=section&id=Other%20Net%20Income) For the six months ended June 30, 2025, other net income was RMB 31.8 million, a decrease of RMB 62.6 million from RMB 94.4 million in the prior year, primarily due to reduced government grants Other Net Income Details (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Interest income from bank deposits | 8,238 | 12,509 | | Interest income from financial assets measured at amortized cost | 4,464 | 5,155 | | Net realized and unrealized gains from financial assets measured at fair value through profit or loss | 13,028 | 7,265 | | Net foreign exchange (loss)/gain | (1,636) | 19,040 | | Government grants | 12,555 | 50,909 | | Net loss on disposal of property, plant and equipment | (33) | (46) | | Others | (4,829) | (437) | | **Total** | **31,787** | **94,395** | - Other net income decreased by **RMB 62.6 million**, primarily due to reduced government grants[131](index=131&type=chunk) [Administrative Expenses](index=35&type=section&id=Administrative%20Expenses) For the six months ended June 30, 2025, administrative expenses were RMB 73.8 million, a 12.2% year-on-year increase, primarily due to higher employee costs Administrative Expenses Details (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Employee costs | 60,799 | 50,638 | | Consulting service fees | 3,727 | 2,043 | | Office and travel expenses | 1,643 | 3,189 | | Others | 7,675 | 9,969 | | **Total** | **73,844** | **65,839** | - Administrative expenses increased by **12.2%**, primarily due to higher employee costs[134](index=134&type=chunk) [Selling and Distribution Expenses](index=36&type=section&id=Selling%20and%20Distribution%20Expenses) For the six months ended June 30, 2025, selling and distribution expenses were RMB 178.9 million, a significant 334.8% year-on-year increase, primarily due to the expansion of the commercialization team and increased costs related to product marketing activities Selling and Distribution Expenses Details (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Employee costs | 94,753 | 33,797 | | Conference, marketing, administrative expenses and others | 84,172 | 7,354 | | **Total** | **178,925** | **41,151** | - Selling and distribution expenses increased by **334.8%**, primarily due to the continuous expansion of the commercialization team and increased costs and expenses related to product marketing activities[137](index=137&type=chunk) [Research and Development Expenses](index=36&type=section&id=Research%20and%20Development%20Expenses) For the six months ended June 30, 2025, R&D expenses were RMB 611.5 million, a 6.3% year-on-year decrease, primarily due to reduced raw material usage R&D Expenses Details (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Employee costs | 201,672 | 200,857 | | Trial and testing expenses | 289,511 | 298,119 | | Raw materials | 53,298 | 85,278 | | Others | 67,058 | 68,083 | | **Total** | **611,539** | **652,337** | - R&D expenses decreased by **6.3%**, primarily due to reduced raw material usage[142](index=142&type=chunk) [Finance Costs](index=37&type=section&id=Finance%20Costs) For the six months ended June 30, 2025, finance costs were RMB 3.0 million, a 20.5% year-on-year increase, primarily attributable to higher interest expenses on lease liabilities Finance Costs Details (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Interest expense on lease liabilities | 3,022 | 1,140 | | Interest expense on bills payable | – | 1,367 | | **Total** | **3,022** | **2,507** | - Finance costs increased by **20.5%**, primarily attributable to higher interest expenses on lease liabilities[143](index=143&type=chunk) [Income Tax](index=37&type=section&id=Income%20Tax) For the six months ended June 30, 2025, the company recorded an income tax refund of RMB 30.4 million, compared to an income tax expense of RMB 99.0 million in the prior year, primarily benefiting from a USD 6.5 million withholding tax refund from the US IRS Income Tax (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Current tax | | | | －China corporate income tax | – | – | | －Withholding tax | 16,335 | 99,025 | | －Withholding tax refund | (46,715) | – | | **Total** | **(30,380)** | **99,025** | - The company recorded an income tax refund of **RMB 30.4 million** in 2025, compared to an income tax expense of **RMB 99.0 million** in 2024[144](index=144&type=chunk) - In 2025, the US IRS refunded withholding tax of **USD 6.5 million** (equivalent to RMB 46,715 thousand)[146](index=146&type=chunk) [Profit/(Loss) for the Period](index=38&type=section&id=Profit%2F%28Loss%29%20for%20the%20Period) For the six months ended June 30, 2025, the company recorded a loss of RMB 145.2 million, a 146.8% decrease from a profit of RMB 310.2 million in the prior year Profit/(Loss) for the Period (For the six months ended June 30) | Indicator | 2025 (RMB million) | 2024 (RMB million) | Period Change | | :--- | :--- | :--- | :--- | | Profit/(Loss) for the Period | (145.2) | 310.2 | -146.8% | [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) The company completed an H share placement on June 12, 2025, raising net proceeds of approximately HKD 1,943.0 million, significantly increasing cash and cash equivalents to RMB 3,102.8 million, with net current assets also growing substantially by 64.1% to RMB 4,402.3 million - On **June 12, 2025**, completed the placement of **5,918,000 new H shares**, with net proceeds of approximately **HKD 1,943.0 million** (equivalent to RMB 1,777.4 million)[150](index=150&type=chunk) Cash and Financial Assets (Period-end) | Indicator | As of June 30, 2025 (RMB million) | As of December 31, 2024 (RMB million) | | :--- | :--- | :--- | | Cash and cash equivalents | 3,102.8 | 1,336.5 | | Financial assets measured at fair value through profit or loss | 852.3 | 1,448.3 | | Financial assets measured at amortized cost | 488.3 | 284.0 | - Net current assets were **RMB 4,402.3 million**, an increase of **64.1%** compared to net current assets of RMB 2,683.0 million as of December 31, 2024, primarily due to the net proceeds from the placement[155](index=155&type=chunk) [Net Cash Used in Operating Activities](index=39&type=section&id=Net%20Cash%20Used%20in%20Operating%20Activities) For the six months ended June 30, 2025, net cash used in operating activities was RMB 373.2 million, a significant increase from RMB 68.9 million in the prior year, primarily due to reduced payments received from Merck under the collaboration in the first half of 2025 Net Cash Used in Operating Activities (For the six months ended June 30) | Indicator | 2025 (RMB million) | 2024 (RMB million) | | :--- | :--- | :--- | | Net cash used in operating activities | (373.2) | (68.9) | - The increase in cash used was primarily due to reduced payments received from Merck under the collaboration in the first half of 2025[153](index=153&type=chunk) [Employees and Remuneration Policy](index=40&type=section&id=Employees%20and%20Remuneration%20Policy) As of June 30, 2025, the company had 1,870 employees, with remuneration packages including salaries, bonuses, and equity incentives determined by qualifications, performance, and seniority, aimed at motivating employees and fostering long-term company growth - As of **June 30, 2025**, the company had a total of **1,870 employees**[162](index=162&type=chunk) - Employee remuneration packages include **salaries and bonuses**, and provide **equity incentives and promotion opportunities**[162](index=162&type=chunk) [III. Outlook](index=40&type=section&id=III.%20Outlook) The company will continue to deepen R&D innovation, focus on its strengths, strengthen external collaborations, and leverage big data and artificial intelligence to improve R&D success rates, with future development strategies including advancing a differentiated drug pipeline, innovating conjugate drug design, enhancing end-to-end R&D and commercialization capabilities, expanding global presence and deepening strategic partnerships, and optimizing operating systems, aiming to become a globally leading biopharmaceutical company - Continue to deepen R&D innovation reforms, focus on inherent strengths, strive to improve efficiency, and strengthen external collaborations[163](index=163&type=chunk) - Utilize big data and artificial intelligence applications to enhance research capabilities in biology/small molecules and translational medicine, thereby improving the success rate of innovative drug R&D[163](index=163&type=chunk) - Plans to implement five major development strategies: advancing a differentiated drug pipeline, innovating conjugate drug design, enhancing end-to-end R&D and commercialization capabilities, expanding global presence and deepening strategic partnerships, and optimizing operating systems[163](index=163&type=chunk) [Advance an Indication-Oriented Differentiated Drug Pipeline Addressing Significant Medical Needs](index=40&type=section&id=Advance%20an%20Indication-Oriented%20Differentiated%20Drug%20Pipeline%20Addressing%20Significant%20Medical%20Needs) The company plans to advance a pipeline of over 10 clinical-stage drug candidates in the second half of 2025, accelerate clinical development, continue to strengthen its ADC and novel conjugate drug pipeline, and promote joint management with partners to target high-prevalence and unmet medical need cancer indications and non-oncology diseases - Key objective for the **second half of 2025** is to advance a pipeline of **over 10 clinical-stage drug candidates** and accelerate the clinical development process[164](index=164&type=chunk) - Continue to strengthen the ADC and novel conjugate drug pipeline, promote joint management of collaborative projects with partners, and secure further milestone payments[164](index=164&type=chunk) [Innovate and Optimize Payload-Linker Strategies, Novel Conjugate Drug Design and Structures, and Expand Applications in Non-Oncology Diseases](index=41&type=section&id=Innovate%20and%20Optimize%20Payload-Linker%20Strategies%2C%20Novel%20Conjugate%20Drug%20Design%20and%20Structures%2C%20and%20Expand%20Applications%20in%20Non-Oncology%20Diseases) The company will further expand its OptiDC™ portfolio through a multi-pronged strategy, including developing ADCs for new targets and target combinations, expanding payloads beyond common cytotoxic molecules, optimizing conjugation technologies for precise DAR control, exploring novel conjugate drugs like RDC, iADC, DAC, and applying ADCs to non-oncology diseases - Develop ADCs targeting new targets and target combinations, including **bispecific antibodies (bsAb) and TAA-IO bsAbs**[170](index=170&type=chunk) - Expand payloads beyond common cytotoxic molecules and develop **DNA damaging agents and other novel cytotoxic molecules and their combinations (dual-payload ADCs)**[170](index=170&type=chunk) - Optimize conjugation technologies to achieve precise control over payload conjugation sites and numbers, and develop **site-specific conjugation technologies**[170](index=170&type=chunk) - Develop novel conjugate drugs with multiple mechanisms of action beyond cytotoxic mechanisms, such as **RDC, iADC, and DAC**[168](index=168&type=chunk) - Develop ADCs equipped with various novel non-cytotoxic payloads for the treatment of non-oncology diseases, such as **autoimmune diseases**[169](index=169&type=chunk) [Enhance End-to-End Drug R&D and Commercialization Capabilities](index=42&type=section&id=Enhance%20End-to-End%20Drug%20R%26D%20and%20Commercialization%20Capabilities) The company will strengthen R&D capabilities by recruiting experienced professionals and integrating AI into R&D processes, while continuously expanding cGMP manufacturing facilities through internal capacity expansion or collaboration with reputable contract manufacturers, and upgrading its quality management system, and in commercialization, will refine commercialization strategies for late-stage drug candidates, prioritize medical needs in the Chinese market, and create synergistic licensing and collaboration opportunities globally - Continue to enhance R&D capabilities by recruiting experienced professionals from around the world and plan to continue introducing AI into multiple R&D processes[171](index=171&type=chunk) - Continuously expand cGMP manufacturing facilities and continuously enhance manufacturing capabilities through expanding internal capacity or collaborating with reputable contract manufacturers in the industry[171](index=171&type=chunk) - Marketing approvals for sac-TMT (Aitaiwei®), tagolimab (Ketaiwei®), and cetuximab N01 (Daitaiwei®) have been obtained, and commercialization has commenced[172](index=172&type=chunk) - Expected to launch core product bodotuximab (Shutaiwei®) in the Chinese market and submit an NDA for A400 in the **second half of 2025**[172](index=172&type=chunk) [Expand Global Footprint and Deepen Strategic Partnerships to Fully Unlock the Value of Our Product Pipeline](index=42&type=section&id=Expand%20Global%20Footprint%20and%20Deepen%20Strategic%20Partnerships%20to%20Fully%20Unlock%20the%20Value%20of%20Our%20Product%20Pipeline) The company will continue to adopt an out-licensing collaboration model, leveraging partners' global clinical development and commercialization capabilities to bring products to global markets, and in the long term, will learn from global experience, explore diversified "going global" pathways, gradually initiate international multi-center registration clinical studies and establish commercialization systems, while actively seeking opportunities to introduce new drug candidates and innovative technologies, and strengthening collaborations with domestic and international key opinion leaders, top hospitals, and academic institutions - Plans to continue adopting an out-licensing collaboration model, fully leveraging partners' global clinical development and commercialization capabilities to bring products to global markets[173](index=173&type=chunk) - In the long term, will explore diversified "going global" pathways, gradually initiate and promote international multi-center registration clinical studies, and establish commercialization systems[173](index=173&type=chunk) - Closely monitor global opportunities to license in new drug candidates and innovative technologies that can form strategic synergies with the pipeline and technology platforms[175](index=175&type=chunk) [Optimize Operating System to Become a Globally Leading Biopharmaceutical Company](index=43&type=section&id=Optimize%20Operating%20System%20to%20Become%20a%20Globally%20Leading%20Biopharmaceutical%20Company) The company will continuously review and optimize internal procedures, especially R&D management processes, to improve operational efficiency, while planning to attract and recruit outstanding scientific, marketing, and management personnel, and actively seeking opportunities to expand its global presence and enhance international brand awareness, committed to addressing significant unmet medical needs domestically and internationally - Continuously review and optimize internal procedures, especially R&D management processes, to improve operational efficiency[176](index=176&type=chunk) - Plans to attract and recruit outstanding scientific, marketing, and management personnel to its talent pool[176](index=176&type=chunk) - Actively seek opportunities to expand its global presence and enhance international brand awareness[176](index=176&type=chunk) Corporate Governance and Other Information This section details the company's corporate governance practices, securities transactions, post-reporting period events, interim results review, dividend policy, changes in key personnel, and interests of directors, chief executives, and major shareholders [Purchase, Sale or Redemption of the Company's Listed Securities](index=44&type=section&id=Purchase%2C%20Sale%20or%20Redemption%20of%20the%20Company%27s%20Listed%20Securities) For the six months ended June 30, 2025, neither the company nor its subsidiaries purchased, sold, or redeemed any of the company's listed securities, and the company held no treasury shares - For the six months ended June 30, 2025, neither the company nor any of its subsidiaries purchased, sold, or redeemed any of the company's listed securities[177](index=177&type=chunk) - As of **June 30, 2025**, the company held no treasury shares[178](index=178&type=chunk) [Corporate Governance](index=44&type=section&id=Corporate%20Governance) The company has adopted the Corporate Governance Code set out in Appendix C1 of the Listing Rules as its corporate governance practice code and strictly complied with it during the reporting period - The company has adopted corporate governance practices in accordance with the principles and code provisions set out in the **Corporate Governance Code** contained in Appendix C1 of the Listing Rules[179](index=179&type=chunk) - For the six months ended June 30, 2025, the company has strictly complied with the Corporate Governance Code[180](index=180&type=chunk) [Standard Code for Securities Transactions](index=44&type=section&id=Standard%20Code%20for%20Securities%20Transactions) The company has adopted the Model Code set out in Appendix C3 of the Listing Rules as the code of conduct for directors, supervisors, and employees dealing in the company's securities, and all directors and supervisors confirmed compliance with the code during the reporting period - The company has adopted the **Model Code** set out in Appendix C3 of the Listing Rules as the code of conduct for directors, supervisors, and employees of the Group dealing in the company's securities[182](index=182&type=chunk) - All directors and supervisors confirmed that they have complied with the Model Code during the six months ended June 30, 2025[182](index=182&type=chunk) [Post-Reporting Period Events](index=44&type=section&id=Post-Reporting%20Period%20Events) After the reporting period, Phase 2 clinical data for sac-TMT combined with PD-L1 mAb tagolimab for first-line treatment of advanced or metastatic NSCLC was published in Nature Medicine, and the company was selected for Fortune magazine's "2025 Fortune China Tech 50" in August 2025 - On **August 19, 2025**, Phase 2 clinical data for sac-TMT combined with PD-L1 mAb tagolimab for first-line treatment of advanced or metastatic NSCLC was published in **Nature Medicine**[184](index=184&type=chunk) - The company was selected for **Fortune magazine's "2025 Fortune China Tech 50"** on **August 21, 2025**[184](index=184&type=chunk) [Review of Interim Results](index=45&type=section&id=Review%20of%20Interim%20Results) The Audit Committee has reviewed the unaudited interim condensed consolidated financial information for the six months ended June 30, 2025, with management and the auditor, deeming it compliant with applicable accounting standards and legal regulations, and KPMG, the independent auditor, has reviewed the interim financial information in accordance with Hong Kong Standard on Review Engagements 2410 - The Audit Committee has reviewed the Group's unaudited interim condensed consolidated financial information for the six months ended June 30, 2025, with the company's management and auditor[185](index=185&type=chunk) - The Audit Committee believes that the interim results comply with applicable accounting standards and legal regulations, and appropriate disclosures have been made by the company[185](index=185&type=chunk) - KPMG, the independent auditor, has reviewed the interim financial information in accordance with **Hong Kong Standard on Review Engagements 2410**[185](index=185&type=chunk) [Interim Dividend](index=45&type=section&id=Interim%20Dividend) The Board of Directors does not recommend the payment of any interim dividend for the six months ended June 30, 2025 - The Board of Directors does not recommend the payment of any interim dividend for the six months ended June 30, 2025[186](index=186&type=chunk) [Changes in Information of Directors, Supervisors and Chief Executive](index=45&type=section&id=Changes%20in%20Information%20of%20Directors%2C%20Supervisors%20and%20Chief%20Executive) Since the publication of the 2024 Annual Report, the company's Supervisory Committee was abolished on June 20, 2025, with former supervisors ceasing their roles, Dr. Ge Junyou was elected as an employee representative director, Ms. Liao Yihong was appointed as a non-executive director, and some directors' committee roles also changed - The company has abolished the Supervisory Committee as of **June 20, 2025**, and former supervisors Ms. Liao Yihong, Dr. Song Hongmei, Ms. Yang Qiuyan, and Dr. Qing Yan no longer serve as supervisors[187](index=187&type=chunk) - Dr. Ge Junyou was elected as an employee representative director of the Fourth Board of Directors on **June 20, 2025**[187](index=187&type=chunk) - Ms. Liao Yihong was appointed as a non-executive director effective **June 20, 2025**[187](index=187&type=chunk) - Dr. Zheng Qiang was appointed as a member of the Audit Committee and ceased to be a member of the Nomination Committee effective **June 20, 2025**[191](index=191&type=chunk) [Interests and Short Positions of Directors and Chief Executive in the Shares, Underlying Shares and Debentures of the Company and its Associated Corporations](index=46&type=section&id=Interests%20and%20Short%20Positions%20of%20Directors%20and%20Chief%20Executive%20in%20the%20Shares%2C%20Underlying%20Shares%20and%20Debentures%20of%20the%20Company%20and%20its%20Associated%20Corporations) As of June 30, 2025, several directors and the chief executive held interests in the company's shares or its associated corporations, with Mr. Liu Gexin, as the ultimate controlling shareholder of Kelun Pharmaceutical, holding significant interests in the company's H shares and unlisted shares, and Dr. Ge Junyou, Mr. Lai Degui, Mr. Feng Hao, and Ms. Liao Yihong holding interests in the company's H shares through employee incentive platforms Interests of Directors or Chief Executive in the Company's Shares (As of June 30, 2025) | Name of Director or Chief Executive | Position | Nature of Interest | Number and Class of Shares Held | Approximate Percentage of Shareholding in Relevant Class (%) | Approximate Percentage of Total Issued Shares (%) | | :--- | :--- | :--- | :--- | :--- | :--- | | Liu Gexin | Chairman and Non-executive Director | Interest in controlled corporation | 92,345,543 H shares (L) | 56.73 | 39.60 | | | | Interest in controlled corporation | 62,201,712 unlisted shares (L) | 88.33 | 26.67 | | Ge Junyou | Executive Director, General Manager and CEO | Other | 2,250,000 H shares (L) | 1.38 | 0.96 | | Lai Degui | Non-executive Director | Other | 465,000 H shares (L) | 0.29 | 0.20 | | Feng Hao | Non-executive Director | Other | 465,000 H shares (L) | 0.29 | 0.20 | | Liao Yihong | Non-executive Director | Other | 170,000 H shares (L) | 0.10 | 0.07 | Interests of Directors or Chief Executive in Shares of Associated Corporations (As of June 30, 2025) | Name of Associated Corporation | Name of Director or Chief Executive | Position | Nature of Interest | Number of Shares in Associated Corporation Held | Approximate Percentage of Total Issued Shares of Associated Corporation (%) | | :--- | :--- | :--- | :--- | :--- | :--- | | Kelun Pharmaceutical | Liu Gexin | Chairman and Non-executive Director | Beneficial owner | 379,128,280 (L) | 23.72 | | | Ge Junyou | Executive Director and General Manager | Beneficial owner | 295,000 (L) | 0.02 | | Zhejiang Keyun | Lai Degui | Non-executive Director | Beneficial owner | 2,000,000 (L) | 10.00 | | | | Interest in controlled corporation | 3,200,000 (L) | 16.00 | | | Feng Hao | Non-executive Director | Beneficial owner | 2,000,000 (L) | 10.00 | | | | Interest in controlled corporation | 3,200,000 (L) | 16.00 | [Interests and Short Positions of Substantial Shareholders in the Shares and Underlying Shares of the Company](index=49&type=section&id=Interests%20and%20Short%20Positions%20of%20Substantial%20Shareholders%20in%20the%20Shares%20and%20Underlying%20Shares%20of%20the%20Company) As of June 30, 2025, Kelun Pharmaceutical was a substantial shareholder of the company, holding significant interests in the company's H shares and unlisted shares directly and through controlled corporations, Kelun Jingchuan, as the general partner of an employee incentive platform, held a portion of H shares, and Merck & Co., Inc. and its subsidiary Merck Sharp & Dohme LLC also held interests in the company's H shares Interests of Substantial Shareholders in the Company's Shares and Underlying Shares (As of June 30, 2025) | Name of Shareholder | Nature of Interest | Number and Class of Shares Held | Approximate Percentage of Shareholding in Relevant Class (%) | Approximate Percentage of Total Issued Shares (%) | | :--- | :--- | :--- | :--- | :--- | | Kelun Pharmaceutical | Beneficial owner | 57,777,843 H shares (L) | 35.50 | 24.78 | | | Interest in controlled corporation | 34,567,700 H shares (L) | 21.24 | 14.82 | | | Beneficial owner | 62,201,712 unlisted shares (L) | 88.33 | 26.67 | | Kelun Jingchuan | Interest in controlled corporation | 30,000,000 H shares (L) | 18.43 | 12.87 | | Merck & Co., Inc. | Interest in controlled corporation | 13,443,693 H shares (L) | 8.26 | 5.77 | | Merck Sharp & Dohme LLC | Beneficial owner | 13,443,693 H shares (L) | 8.26 | 5.77 | [Pre-IPO Employee Incentive Scheme](index=50&type=section&id=Pre-IPO%20Employee%20Incentive%20Scheme) The company's Pre-IPO Employee Incentive Scheme, adopted in 2016 and subsequently amended, aims to attract and retain core talent through equity incentives, implemented via four limited partnership employee incentive platforms holding a total of 30,000,000 company shares, with 22,976,250 share awards granted to participants as of June 30, 2025 - The Pre-IPO Employee Incentive Scheme was adopted and approved by written resolution of the Board in **2016**, and further amended in **May 2020 and January 2023**[205](index=205&type=chunk) - The scheme aims to provide equity incentives to core employees to attract and retain skilled talent and fully motivate them[207](index=207&type=chunk) - Four employee incentive platforms (in the form of limited partnerships) have been established, holding a total of **30,000,000 shares**[205](index=205&type=chunk) - As of **June 30, 2025**, a total of **22,976,250 share awards** (approximately **76.59%** of the total shares under the Pre-IPO Employee Incentive Scheme) have been granted to participants[219](index=219&type=chunk) [Use of Net Proceeds from Global Offering and Over-allotment Option](index=55&type=section&id=Use%20of%20Net%20Proceeds%20from%20Global%20Offering%20and%20Over-allotment%20Option) The total net proceeds from the company's global offering and full exercise of the over-allotment option amounted to approximately HKD 1,454.9 million, with most funds utilized as disclosed in the prospectus by the end of the reporting period, primarily for R&D and commercialization of core and other key products, technology platform development, capacity expansion, and working capital - The total net proceeds from the global offering and full exercise of the over-allotment option amounted to approximately **HKD 1,454.9 million**[221](index=221&type=chunk) Use of Net Proceeds from Global Offering and Over-allotment Option (As of the end of the reporting period) | Intended Use | Allocation of Net Proceeds (RMB million) | Percentage of Net Proceeds | Net Proceeds Utilized (RMB million) | Net Proceeds Unutilized (RMB million) | | :--- | :--- | :--- | :--- | :--- | | Research, R&D and commercialization of core products SKB264 and A166 | 600.9 | 45% | 600.9 | 0 | | R&D and commercialization of other key products (A140, A167, A400 and A223) | 400.6 | 30% | 400.6 | 0 | | Continuous development of technology platforms, advancement of other existing pipeline assets, and exploration and development of new drug candidates | 160.2 | 12% | 139.5 | 20.7 | | Expansion of production capacity and quality control systems to support the expected commercialization of late-stage assets | 106.8 | 8% | 100.9 | 5.9 | | Working capital and general corporate purposes | 66.9 | 5% | 66.9 | 0 | | **Total** | **1,335.4** | **100%** | **1,308.8** | **26.6** | [Use of Net Proceeds from May 2024 Placement](index=57&type=section&id=Use%20of%20Net%20Proceeds%20from%20May%202024%20Placement) The company completed the placement of 3,648,600 H shares in May 2024, raising net proceeds of approximately HKD 541.4 million, with most funds utilized by the end of the reporting period for R&D, clinical trials, registration filings, manufacturing, and commercialization of core and other products, as well as enhancing internal R&D technical capabilities - Net proceeds from the May 2024 placement amounted to approximately **HKD 541.4 million**[224](index=224&type=chunk) Use of Net Proceeds from May 2024 Placement (As of the end of the reporting period) | Intended Use | Allocation of Net Proceeds (RMB million) | Percentage of Total Net Proceeds | Net Proceeds Utilized (RMB million) | Net Proceeds Unutilized (RMB million) | | :--- | :--- | :--- | :--- | :--- | | R&D, clinical trials, registration filings, manufacturing and commercialization: core products | 172.1 | 35% | 172.1 | 0 | | R&D, clinical trials, registration filings, manufacturing and commercialization: other products | 172.1 | 35% | 171.4 | 0.7 | | Enhancement of internal R&D technical capabilities, strengthening external collaborations, and expanding product pipeline portfolio | 122.9 | 25% | 61.3 | 61.6 | | Working capital and general corporate purposes | 24.5 | 5% | 23.9 | 0.6 | | **Total** | **491.6** | **100%** | **428.7** | **62.9** | [Use of Net Proceeds from Subscription](index=58&type=section&id=Use%20of%20Net%20Proceeds%20from%20Subscription) The company completed the subscription of 4,423,870 domestic shares by Kelun Pharmaceutical in December 2024, raising net proceeds of approximately RMB 601.4 million, with most funds utilized by the end of the reporting period for R&D, clinical trials, registration filings, manufacturing, and commercialization of core and other products, as well as enhancing internal R&D technical capabilities - Net proceeds from the subscription amounted to approximately **RMB 601.4 million**[227](index=227&type=chunk) Use of Net Proceeds from Subscription (As of the end of the reporting period) | Intended Use | Allocation of Net Proceeds (RMB million) | Percentage of Total Net Proceeds | Net Proceeds Utilized (RMB million) | Net Proceeds Unutilized (RMB million) | | :--- | :--- | :--- | :--- | :--- | | R&D, clinical trials, registration filings, manufacturing and commercialization: core products | 210.5 | 35% | 209.2 | 1.3 | | R&D, clinical trials, registration filings, manufacturing and commercialization: other products | 210.5 | 35% | 118.7 | 91.8 | | Enhancement of internal R&D technical capabilities, strengthening external collaborations, and expanding product pipeline portfolio | 150.3 | 25% | 66.6 | 83.7 | | Working capital and general corporate purposes | 30.1 | 5% | 30.1 | 0 | | **Total** | **601.4** | **100%** | **424.6** | **176.8** | [Use of Net Proceeds from June 2025 Placement](index=59&type=section&id=Use%20of%20Net%20Proceeds%20from%20June%202025%20Placement) The company completed the placement of 5,918,000 H shares in June 2025, raising net proceeds of approximately HKD 1,943.0 million, which remained unutilized by the end of the reporting period, primarily planned for product R&D, clinical trials, registration filings, manufacturing, and commercialization, enhancing internal R&D technical capabilities, and working capital - Net proceeds from the June 2025 placement amounted to approximately **HKD 1,943.0 million** (equivalent to RMB 1,777.4 million)[229](index=229&type=chunk) Use of Net Proceeds from June 2025 Placement (As of the end of the reporting period) | Intended Use | Allocation of Net Proceeds (RMB million) | Percentage of Total Net Proceeds | Net Proceeds Utilized (RMB million) | Net Proceeds Unutilized (RMB million) | | :--- | :--- | :--- | :--- | :--- | | R&D, clinical trials, registration filings, manufacturing and commercialization products | 1,421.9 | 80% | 0 | 1,421.9 | | Enhancement of internal R&D technical capabilities, strengthening external collaborations, and expanding product pipeline portfolio | 266.6 | 15% | 0 | 266.6 | | Working capital and general corporate purposes | 88.9 | 5% | 0 | 88.9 | | **Total** | **1,777.4** | **100%** | **0** | **1,777.4** | Interim Financial Information Review Report This section presents the independent auditor's review report on the company's interim financial information, including the basis of preparation, scope of review, and conclusion [Introduction](index=59&type=section&id=Introduction) KPMG has reviewed the company's interim financial report for the six months ended June 30, 2025, prepared in accordance with the Listing Rules and International Accounting Standard 34, with the Board of Directors responsible for its preparation and presentation - KPMG has reviewed the company's interim financial report for the six months ended June 30, 2025[232](index=232&type=chunk) - The interim financial report was prepared in accordance with the **Listing Rules** and **International Accounting Standard 34 "Interim Financial Reporting"**[232](index=232&type=chunk) [Scope of Review](index=60&type=section&id=Scope%20of%20Review) The review was conducted in accordance with Hong Kong Standard on Review Engagements 2410 issued by the Hong Kong Institute of Certified Public Accountants, with a scope smaller than an audit, thus no audit opinion is expressed - The review was conducted in accordance with **Hong Kong Standard on Review Engagements 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity"** issued by the Hong Kong Institute of Certified Public Accountants[233](index=233&type=chunk) - The scope of review is substantially less than an audit, and therefore no audit opinion is expressed[233](index=233&type=chunk) [Conclusion](index=60&type=section&id=Conclusion) Based on the review, no matters were identified that indicate the interim financial report as of June 30, 2025, was not prepared in all material respects in accordance with International Accounting Standard 34 - No matters were identified that lead us to believe that the interim financial report as of **June 30, 2025**, was not prepared in all material respects in accordance with **International Accounting Standard 34 "Interim Financial Reporting"**[234](index=234&type=chunk) Consolidated Statement of Profit or Loss This section presents the company's consolidated statement of profit or loss, detailing revenue, cost of sales, gross profit, expenses, and net profit or loss for the reporting period [Summary of Consolidated Statement of Profit or Loss](index=61&type=section&id=Summary%20of%20Consolidated%20Statement%20of%20Profit%20or%20Loss) For the six months ended June 30, 2025, the company's revenue was RMB 950.4 million, with a gross profit of RMB 660.0 million, and due to higher R&D, selling, and distribution expenses, as well as changes in other net income and income tax, the company recorded a loss of RMB 145.2 million for the period, with basic and diluted loss per share of RMB 0.64 Summary of Consolidated Statement of Profit or Loss (For the six months ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Revenue | 950,445 | 1,382,791 | | Cost of sales | (290,457) | (306,101) | | Gross profit | 659,988 | 1,076,690 | | Other net income | 31,787 | 94,395 | | Administrative expenses | (73,844) | (65,839) | | Selling and distribution expenses | (178,925) | (41,151) | | R&D expenses | (611,539) | (652,337) | | Operating (loss)/profit | (172,533) | 411,758 | | Finance costs | (3,022) | (2,507) | | (Loss)/Profit before tax | (175,555) | 409,251 | | Income tax | 30,380 | (99,025) | | (Loss)/Profit for the period attributable to equity holders of the company | (145,175) | 310,226 | | Basic and diluted (loss)/earnings per share (RMB) | (0.64) | 1.41 | Consolidated Statement of Profit or Loss and Other Comprehensive Income This section presents the company's consolidated statement of profit or loss and other comprehensive income, showing the total comprehensive income or loss for the reporting period [Summary of Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=62&type=section&id=Summary%20of%20Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2025, the company recorded a loss of RMB 145.2 million for the period, with other comprehensive income (after tax) showing a loss of RMB 2.4 million due to exchange differences, resulting in a total comprehensive loss of RMB 147.6 million for the period Summary of Consolidated Statement of Profit or Loss and Other Comprehensive Income (For the six months ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | (Loss)/Profit for the period | (145,175) | 310,226 | | Other comprehensive income for the period (after tax): | | | | Exchange differences on translation of financial statements of foreign operations | (2,407) | 1,337 | | Other comprehensive income for the period | (2,407) | 1,337 | | Total comprehensive income for the period attributable to equity holders of the company | (147,582) | 311,563 | Consolidated Statement of Financial Position This section presents the company's consolidated statement of financial position, outlining its assets, liabilities, and equity as of the reporting date [Summary of Consolidated Statement of Financial Position](index=63&type=section&id=Summary%20of%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, the company's total assets less current liabilities were RMB 5,162.5 million, and total equity was RMB 5,014.3 million, representing significant growth from December 31, 2024, with net current assets increasing substantially by 64.1% to RMB 4,402.3 million, primarily driven by growth in cash and financial assets Summary of Consolidated Statement of Financial Position (As of June 30, 2025) | Indicator | As of June 30, 2025 (RMB thousand) | As of December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Non-current assets | 760,226 | 775,196 | | Current assets | 5,192,660 | 3,492,806 | | Current liabilities | 790,352 | 809,841 | | Net current assets | 4,402,308 | 2,682,965

Core Viewpoint - The Trump administration is drafting an executive order that will impose three major restrictions on commercial transactions involving Chinese innovative drug patents or rights, focusing on national security reviews by the Committee on Foreign Investment in the United States (CFIUS) [1][2]. Summary by Sections Executive Order Details - The draft includes three main provisions: 1. Inclusion of Chinese innovative drug BD transactions in the CFIUS mandatory review list, ending the previous "low-risk automatic exemption" practice [2]. 2. FDA will implement "racial sensitivity supplementary reviews" for drugs relying on Chinese clinical data, requiring at least 20% comparative data from non-Asian populations [2]. 3. Establishment of a "key drug domestic production fund" to provide production subsidies for 15 categories of drugs, including antibiotics and acetaminophen, while implementing a "domestic priority" principle in federal procurement [2]. Market Reaction - The market reacted swiftly to the policy risks, with the Hong Kong innovative drug index (HK1105) dropping 3.82% on September 11, 2025, and the A-share innovative drug sector (BK1106) declining 2.17%, with over 80% of stocks in the sector experiencing pullbacks [3]. - The following day, the indices showed signs of recovery, indicating investors' responses to policy uncertainties and rational corrections [3]. Globalization Trends - Despite the geopolitical risks, the trend of Chinese innovative drugs going global remains intact, with total license-out transactions to Europe and the U.S. reaching $9.43 billion as of September 2025 [3]. - Major transactions include a $950 million licensing deal between BeiGene and Royalty Pharma, and a $6 billion global licensing agreement between 3SBio and Pfizer, highlighting a shift towards milestone payments and regional licensing [3]. Industry Challenges - The domestic market faces challenges, with annual growth in medical insurance fund spending (approximately 12%) lagging behind the growth in innovative drug R&D investment (approximately 25%) [4]. - The average reduction in medical negotiations remains high at 54%, and commercial health insurance coverage for innovative drugs is below 15%, creating a supply-demand imbalance that necessitates going global [4]. Risk Resilience Assessment - Goldman Sachs has categorized Chinese innovative drug companies into three risk resilience tiers based on their sensitivity to policy changes and operational capabilities [4][5]. - Companies with mature global layouts exhibit the strongest resilience, while those heavily reliant on domestic markets show the weakest resilience [5][10]. Strategic Defense Framework - A three-dimensional defense system is proposed to address risks associated with the executive order, focusing on transaction review, data compliance, and supply chain security [13]. - Strategies include conducting national security risk pre-assessments for transactions over $50 million and establishing partnerships with U.S. law firms to navigate regulatory challenges [14][15]. Conclusion - The construction of a quantifiable "risk resilience index" is essential for Chinese innovative drugs in the global 2.0 era, emphasizing the need for companies to embed policy hedging clauses in transaction structures and consider racial diversity data in clinical stages [23].

Core Viewpoint - The article discusses the significant fluctuations in stock prices of innovative pharmaceutical companies, highlighting both the successes and failures in the market, particularly focusing on the performance of companies that reached historical highs in 2025 and those that have experienced substantial declines. Group 1: Performance of Innovative Pharmaceutical Companies - As of September 11, 2025, 90% of Hong Kong and STAR Market innovative pharmaceutical companies have seen significant stock price increases since the beginning of the year [6] - A total of 17 companies reached historical highs in stock price and market capitalization in 2025, with notable companies including BeiGene (688235.SH) and Innovent Biologics (01801.HK) [7][10] - Among these 17 companies, 12 have entered or are about to enter the commercialization phase, establishing stable revenue sources [7] Group 2: Key Events and Financial Performance - BeiGene and Innovent Biologics achieved their first profits in the first half of 2025, with BeiGene reporting a net profit of approximately 450 million yuan, a significant turnaround from a loss of 2.877 billion yuan in the same period last year [10] - Innovent Biologics reported a net profit of 834 million yuan, benefiting from the growth of PD-1 and other oncology drugs in the domestic market [10] - Other companies like Kintor Pharmaceutical (06990.HK) and Rongchang Biologics (688331.SH) have also made significant progress through BD transactions and drug approvals [11] Group 3: Declining Companies and Market Challenges - Despite the successes, 50% of innovative pharmaceutical companies still have stock prices below their initial offering prices, with 31 out of 55 Hong Kong 18A innovative pharmaceutical stocks experiencing declines [14][15] - Companies like Tengsheng Bo Pharmaceutical (02137.HK) and Akeso (09939.HK) have seen significant drops in stock prices, with some losing over 90% of their value since their IPOs [20][21] - The article notes that many of these declining companies faced challenges such as failed drug trials or adverse market conditions, leading to substantial losses [20][21] Group 4: Recent Trends and Future Outlook - Three companies, including Tongyuan Kang Pharmaceutical (02410.HK), have seen stock price declines of 70% or more since the beginning of the year, indicating ongoing volatility in the sector [25] - The article emphasizes the importance of BD transactions and successful drug approvals as key factors for recovery and growth in the innovative pharmaceutical market [12][22]

Core Viewpoint - The stock prices of several innovative pharmaceutical companies in A-shares and Hong Kong stocks have significantly declined following reports of a potential U.S. government order to restrict American companies from purchasing Chinese drugs under development, although the White House later stated that the government was not actively considering such a draft [2][3]. Group 1: Stock Performance and Market Trends - As of September 11, 2025, 90% of Hong Kong and STAR Market innovative pharmaceutical companies have seen substantial stock price increases since the beginning of 2025, with 17 companies reaching historical highs in stock price and market capitalization [3][6]. - The stock price surge has been driven by the commercialization of innovative drugs, with 12 out of the 17 companies having entered or about to enter the commercialization phase, generating stable revenue [3][6]. - Notably, companies like BeiGene (688235.SH) and Innovent Biologics (01801.HK) achieved their first profits in the first half of 2025, with BeiGene reporting a net profit of approximately 450 million yuan, a turnaround from a loss of 2.877 billion yuan in the same period last year [6][7]. Group 2: Company Highlights - Companies such as Kintor Pharmaceutical (688506.SH) and Hengrui Medicine (09926.HK) have also made significant strides, with Kintor achieving a market capitalization of 139.5 billion yuan [5]. - The stock price of Kintor has risen significantly since its listing, with its stock reaching a peak of 541.5 HKD on September 9, 2025, and a total market capitalization exceeding 110 billion HKD [7]. - Rongchang Biotechnology (688331.SH) has seen its stock price increase by 246% in A-shares and 625% in Hong Kong stocks since the beginning of the year, driven by significant BD transactions [7][8]. Group 3: Market Challenges - Despite the successes of some companies, 50% of innovative pharmaceutical companies still have stock prices below their initial public offering (IPO) prices, with 31 out of 55 Hong Kong innovative pharmaceutical stocks experiencing a decline [8][9]. - The highest rate of stock price decline is observed among companies listed between 2021 and 2023, with over 70% of these companies currently trading below their IPO prices [8][9]. - Companies like Tengsheng Bo Pharmaceutical (02137.HK) and Akeso (09939.HK) have seen their stock prices drop significantly, with declines of 90% or more from their peak prices shortly after listing [12][13].

Group 1 - The overall performance of the pharmaceutical industry is weak, with an average revenue growth of 1.6% and a decline in average net profit by 3.2% for the first half of 2025 compared to the full year of 2024 [2] - The industry is expected to take time for performance improvement, with ongoing support policies for innovative drugs and devices, as well as improvements in global biopharmaceutical financing driving recovery [2] - A significant drop in stock prices was observed among innovative drug concept stocks in the Hong Kong market, with Huaneng Pharmaceutical down nearly 15% and Kelun-Bio down over 12% [4] Group 2 - The report by CMB International analyzed the performance of 393 pharmaceutical companies listed in A-shares and Hong Kong stocks, indicating a deterioration in both revenue and profit compared to the previous year [2] - The domestic centralized procurement policy optimization and continuous support for innovative drugs and devices are seen as crucial for the industry's recovery [2] - The stock performance of various pharmaceutical companies reflects the overall market sentiment, with multiple companies experiencing declines exceeding 9% [4]

Core Viewpoint - The report emphasizes the sustained high growth in the innovative pharmaceutical and medical device sectors, recommending continued investment in these areas [1]. Investment Highlights - The report maintains a recommendation for innovative pharmaceuticals and medical devices, highlighting the potential for value re-evaluation in the Pharma sector, with specific buy ratings for companies such as 恒瑞医药, 翰森制药, 三生制药, and 华东医药 [2]. - It continues to recommend Biopharma/Biotech companies that are gradually realizing their innovative pipelines and entering a performance growth phase, with buy ratings for 科伦博泰生物, 信达生物, 康方生物, 新诺威, 映恩生物, 京新药业, 微芯生物, 特宝生物, 我武生物, and 来凯医药 [2]. - The report also suggests investment in CXO and upstream pharmaceutical companies benefiting from innovation and recovery, maintaining buy ratings for 百普赛斯, 药明康德, 药明合联, 泰格医药, and 美诺华 [2]. - It recommends leading medical device companies expected to recover, with buy ratings for 微创医疗, 联影医疗, and 惠泰医疗 [2]. Market Performance - In the first week of September 2025, the A-share pharmaceutical sector outperformed the broader market, with the SW pharmaceutical and biotech index rising by 1.4% while the Shanghai Composite Index fell by 1.2% [3]. - Within the biopharmaceutical sector, the chemical preparations segment saw a notable increase of 4.5%, while biological products and medical services rose by 1.9% and 1.7%, respectively [3]. - The top-performing stocks included 海辰药业 (+28.7%), 长春高新 (+24.2%), and 百花医药 (+21.3%), while the worst performers were 舒泰神 (-24.0%), 广生堂 (-15.8%), and 塞力医疗 (-15.6%) [3]. - In the Hong Kong market, the healthcare sector also outperformed, with the Hang Seng Healthcare index rising by 7.0% and the biotech index by 7.3%, compared to a 1.4% increase in the Hang Seng Index [3]. - The top gainers in the Hong Kong market were 三叶草生物-B (+99%), 圣诺医药-B (+62%), and 加科思-B (+41%), while the biggest losers included 美中嘉和 (-11%), 科笛-B (-9%), and 思路迪医药股份 (-6%) [3]. - In the US market, the healthcare sector performed in line with the broader market, with the S&P Healthcare Select Sector Index increasing by 0.3%, matching the S&P 500's performance [4]. - The top gainers in the US healthcare sector included 德康医疗 (+7%), 生物基因 (+6%), and 环球健康服务 (+5%), while the largest declines were seen in KENVUE (-10%), REVVITY (-4%), and MOLINA HEALTHCARE (-3%) [4].

Group 1 - The top three companies with the highest short positions as of August 29 are ZTE Corporation (00763) at 16.47%, COSCO Shipping Holdings (01919) at 13.94%, and CATL (03750) at 13.88% [1][2] - The company with the largest increase in short positions is Ganfeng Lithium (01772), which rose by 2.85% to 12.46% [2][3] - The companies with the largest decrease in short positions include Hisense Home Appliances (00921), which decreased by 3.57% to 4.72%, and WuXi AppTec (02359), which decreased by 2.44% to 11.64% [3][4] Group 2 - The latest short position data shows that the top ten companies with the highest short ratios include China Ping An (02318) at 12.58% and Zijin Mining (02899) at 11.91% [2] - The companies with the most significant increases in short positions also include Huahong Semiconductor (01347) with an increase of 2.56% to 9.73% and Meitu (01357) with an increase of 1.80% to 4.85% [2] - The companies with the most significant decreases in short positions also include Weimob (02013) with a decrease of 1.66% to 9.40% and Linklogis Technology (09959) with a decrease of 1.43% to 2.76% [3][4]

致：香港交易及結算所有限公司 公司名稱: 四川科倫博泰生物醫藥股份有限公司 (於中華人民共和國註冊成立的股份有限公司) 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年8月31日 狀態: 新提交 | 3. 股份分類 | 普通股 | 股份類別 | 其他類別 (請註明) | 於香港聯交所上市 (註1) | 否 | | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | N/A | 說明 | 非上市外資股 | | | FF301 第 1 頁 共 11 頁 v 1.1.1 FF301 | | 法定/註冊股份數目 | | 面值 | | 法定/註冊股本 | | --- | --- | --- | --- | --- | --- | | 上月底結存 | | 4,642,190 RMB | | 1 RMB | 4,642,190 | | 增加 / 減少 (-) | | | | RMB | | | 本月底結存 | | 4,642,190 RMB | | 1 RMB | ...

Investment Rating - The investment rating for the company is "Buy" (maintained) due to its considerable commercialization momentum and steady progress in its pipeline [5]. Core Views - The company reported a revenue of RMB 950 million for the first half of 2025, a year-on-year decrease of 31.3%, with a net loss attributable to shareholders of RMB 145 million [7]. - The company has made significant strides in commercialization, having obtained marketing approvals for several products and initiated their commercialization processes [7]. - The existing product indications are being expanded, and the potential pipeline is actively advancing, providing ample space for future growth [7]. - The company is expected to achieve total revenues of RMB 20.30 billion, RMB 32.77 billion, and RMB 53.63 billion for the years 2025 to 2027, respectively [7]. Financial Performance Summary - Revenue for 2023 is projected at RMB 1,540.49 million, with a year-on-year growth rate of 91.6%. For 2024, revenue is expected to be RMB 1,933.05 million, reflecting a growth rate of 25.5% [6]. - The net profit attributable to shareholders is forecasted to be a loss of RMB 560.39 million in 2025, with a significant recovery expected in 2027, reaching a profit of RMB 876.84 million [6]. - The company's cash and financial assets totaled RMB 4.528 billion as of June 30, 2025, an increase of 47.2% compared to the end of 2024 [7].

Group 1 - The biotechnology sector in the Hong Kong stock market experienced a significant decline, with several companies reporting substantial drops in their stock prices [1] - Notable declines include Clover Biopharmaceuticals, which fell by 14.13%, and Beigene, which dropped by 8.33% [2] - Other companies such as Innovent Biologics and WuXi Biologics also saw declines exceeding 5%, indicating a broader trend of negative performance in the sector [1][2] Group 2 - The following companies reported specific percentage declines: Clover Biopharmaceuticals (-14.13%), Beigene (-8.33%), and Innovent Biologics (-6.50%) [2] - Additional companies with notable declines include Kintor Pharmaceutical (-6.38%), CanSino Biologics (-5.98%), and Zai Lab (-5.50%) [2] - The overall trend suggests a challenging environment for biotechnology stocks in the Hong Kong market [1]