公告称，亏损减少主要是由于期内的研发开支减少、行政开支减少、外汇收益净额上升及毛利上升。 智通财经APP讯，科济药业-B(02171)公布2025年中期业绩，收益为5096.1万元，同比增长703.8%;毛利 2936.9万元，同比增长约17.16倍;净亏损7548.3万元，同比收窄78.53%;每股亏损0.14元。 ...

Performance Highlights [Financial Highlights](index=1&type=section&id=Financial%20Highlights) For the six months ended June 30, 2025, the company significantly improved its financial position, with revenue of RMB 51 million, gross profit of RMB 29 million, and a narrowed net loss of RMB 75 million, supported by strong cash reserves Key Financial Indicators for the Six Months Ended June 30, 2025 | Metric | H1 2025 (Million RMB) | H1 2024 (Million RMB) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | Approx. 51 | Approx. 6.3 | +704% | | Gross Profit | Approx. 29 | Approx. 1.6 | +1712% | | Net Loss | Approx. 75 | Approx. 352 | Loss narrowed by 78.7% | | Adjusted Net Loss | Approx. 72 | Approx. 342 | Loss narrowed by 79.0% | | Cash and Bank Balances at Period-End | Approx. 1,261 | - | - | - The significant reduction in net loss was primarily due to: (i) increased net other income; (ii) a **RMB 116 million** decrease in R&D expenses; (iii) a **RMB 47 million** decrease in administrative expenses; and (iv) increased gross profit[5](index=5&type=chunk) - As of June 30, 2025, cash and bank balances were approximately **RMB 1.261 billion**, with existing funds projected to support operations until 2028[7](index=7&type=chunk) [Business Highlights](index=3&type=section&id=Business%20Highlights) The company achieved significant business progress, with successful commercialization of core product CT053, NDA acceptance for CT041, and active advancement of differentiated allogeneic CAR-T pipelines using proprietary platforms - Commercialization of **CT053 (Zevor-cel)** in mainland China, in collaboration with Huadong Medicine, progressed smoothly, securing **111 valid orders** in H1 2025[9](index=9&type=chunk) - The New Drug Application (NDA) for **CT041 (Sure-cel)** for advanced gastric cancer was accepted by China's NMPA, granted priority review, and designated as a breakthrough therapy[10](index=10&type=chunk) - The company is advancing multiple allogeneic CAR-T cell products, including CT0596, using its proprietary THANK-uCAR® and upgraded THANK-u Plus™ platforms to overcome limitations of existing therapies[11](index=11&type=chunk) Business Review and Outlook [Company Overview and Strategy](index=4&type=section&id=Company%20Overview%20and%20Strategy) Coherent Biopharma is a biopharmaceutical company focused on innovative CAR-T cell therapies with end-to-end capabilities, strategically optimizing its pipeline for differentiated clinical and commercial value while expanding into the US market - The company is positioned as a biopharmaceutical firm dedicated to developing innovative CAR-T cell therapies addressing unmet clinical needs in hematological malignancies, solid tumors, and autoimmune diseases[12](index=12&type=chunk) - The company's strategy focuses on developing breakthrough CAR-T products, regularly evaluating its pipeline for differentiated projects, and actively integrating resources to advance its US market strategy[13](index=13&type=chunk) [Product Pipeline Review](index=4&type=section&id=Product%20Pipeline%20Review) The company boasts a rich product pipeline, including commercialized CT053, NDA-accepted CT041, and multiple clinical and preclinical candidates targeting novel antigens and allogeneic CAR-T, demonstrating robust R&D innovation Key Product Pipeline Progress | Candidate Product | Target | Primary Indication | Latest Progress | | :--- | :--- | :--- | :--- | | **Zevor-cel (CT053)** | BCMA | Relapsed/Refractory Multiple Myeloma | Commercialized in China | | **Sure-cel (CT041)** | Claudin18.2 | Gastric Cancer/GEJ Adenocarcinoma | NDA accepted in China | | **CT071** | GPRC5D | Relapsed/Refractory Multiple Myeloma | Phase I clinical, ORR data 100% | | **CT011** | GPC3 | Hepatocellular Carcinoma | NMPA IND approved | | **Allogeneic CAR-T** | BCMA, CD19/20, etc. | Multiple Myeloma, B-cell Lymphoma, etc. | Multiple products in IIT stage, CT0596 showing positive preliminary efficacy | [Zevor-cel (CT053) - BCMA CAR-T](index=5&type=section&id=Zevor-cel%20(CT053)%20-%20BCMA%20CAR-T) Zevor-cel (CT053), an NMPA-approved all-human BCMA CAR-T product, is commercializing well in China with 111 orders in H1 2025 and showed a 92.2% ORR in LUMMICAR-1, though its US/Canada LUMMICAR-2 study priority has been strategically reduced - In collaboration with Huadong Medicine for commercialization in mainland China, Coherent Biopharma is eligible for up to **RMB 1.025 billion** in regulatory and sales milestone payments, having secured **111 valid orders** in H1 2025[17](index=17&type=chunk) - LUMMICAR-1 study data showed an **Overall Response Rate (ORR) of 92.2%** and a **stringent Complete Response (sCR)/Complete Response (CR) rate of 71.6%** in 102 patients[20](index=20&type=chunk) - As part of a strategic adjustment, the company decided to de-prioritize the LUMMICAR-2 study for Zevor-cel in the US and Canada[21](index=21&type=chunk) [Sure-cel (CT041) - Claudin18.2 CAR-T](index=6&type=section&id=Sure-cel%20(CT041)%20-%20Claudin18.2%20CAR-T) Sure-cel (CT041), a potential global first-in-class Claudin18.2 CAR-T, received NMPA NDA acceptance, priority review, and breakthrough therapy designation in June 2025 for advanced gastric/GEJ adenocarcinoma, demonstrating significant PFS/OS improvement and manageable safety in a confirmatory Phase II trial - In June 2025, the NDA for Sure-cel was accepted by China's NMPA for Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma patients who failed at least two prior lines of therapy[23](index=23&type=chunk) - Confirmatory Phase II clinical trial (CT041-ST-01) data showed a **median Overall Survival (mOS) of 9.17 months** for Sure-cel-treated patients, compared to only **3.98 months** for the control group[24](index=24&type=chunk) - The company is actively exploring the product's application in earlier cancer treatment and perioperative settings, including adjuvant therapy for pancreatic cancer and post-gastrectomy consolidation therapy for gastric cancer[25](index=25&type=chunk) [CT011 - GPC3 CAR-T](index=8&type=section&id=CT011%20-%20GPC3%20CAR-T) CT011, an autologous GPC3-targeted CAR-T product for hepatocellular carcinoma (HCC), received NMPA IND approval in January 2024 for adjuvant therapy in GPC3-positive Stage IIIa HCC patients at risk of recurrence post-surgery, building on the founder's pioneering work - CT011 is an autologous GPC3-targeted CAR-T product for the treatment of hepatocellular carcinoma (HCC)[30](index=30&type=chunk) - In January 2024, CT011 received NMPA IND approval for adjuvant therapy in GPC3-positive Stage IIIa HCC patients at risk of recurrence after surgical resection[30](index=30&type=chunk) [CT071 - GPRC5D CAR-T](index=9&type=section&id=CT071%20-%20GPRC5D%20CAR-T) CT071, an autologous GPRC5D-targeted CAR-T developed with the CARcelerate® platform to reduce manufacturing time to 30 hours, demonstrated a **100% ORR** and **70% sCR** in a Phase I investigator-initiated trial for newly diagnosed multiple myeloma, highlighting its significant therapeutic potential - CT071, developed using the proprietary CARcelerate® platform, reduces manufacturing time to approximately **30 hours**, yielding younger and more potent CAR-T cells[32](index=32&type=chunk) - In a Phase I study for high-risk newly diagnosed multiple myeloma, CT071 achieved a **100% Overall Response Rate (ORR)**, with **70% of patients achieving stringent Complete Response (sCR)**[32](index=32&type=chunk) [Allogeneic CAR-T Cell Products](index=9&type=section&id=Allogeneic%20CAR-T%20Cell%20Products) Leveraging its proprietary THANK-uCAR® and upgraded THANK-u Plus™ platforms, the company is aggressively advancing its allogeneic CAR-T pipeline, with BCMA-targeted CT0596 showing encouraging efficacy and safety in R/R MM, and a dedicated subsidiary, Youkai-cel, established for R&D and commercialization of multiple allogeneic products - The company developed the THANK-u Plus™ platform as an upgrade to THANK-uCAR® technology, aiming to overcome the potential impact of NKG2A expression levels on allogeneic CAR-T efficacy[34](index=34&type=chunk) - In a preliminary clinical study of allogeneic product CT0596 for R/R MM, **3 out of 5 (60%)** patients who completed initial efficacy assessment achieved sCR/CR, **4 (80%)** achieved MRD negativity, with good safety[36](index=36&type=chunk) - The company established Youkai-cel, a subsidiary, and secured **RMB 80 million** in external investment, focusing on the R&D, manufacturing, and commercialization of allogeneic CAR-T cell therapies in China[38](index=38&type=chunk) [Technology Platforms and Innovation](index=11&type=section&id=Technology%20Platforms%20and%20Innovation) The company addresses CAR-T challenges through innovative platforms: THANK-uCAR®/THANK-u Plus™ for effective allogeneic CAR-T, CARcelerate® for 30-hour manufacturing, and CycloCAR®/LADAR™ for enhanced solid tumor efficacy and improved target availability/safety, holding over 300 patents Core Technology Platforms | Technology Platform | Goals and Advantages | | :--- | :--- | | **THANK-uCAR® / THANK-u Plus™** | Develop allogeneic CAR-T, improve patient accessibility, enhance cell expansion and persistence | | **CARcelerate®** | Reduce CAR-T cell manufacturing time to approximately 30 hours, improving production efficiency and cell potency | | **CycloCAR®** | Co-express IL-7 and CCL21, enhance efficacy against solid tumors, reduce lymphodepletion requirements | | **LADAR™** | Precisely control CAR-T cell activation through dual-antigen recognition, enhance safety, and address target availability challenges | - As of June 30, 2025, the company holds over **300 patents**, including **140 globally authorized patents**, demonstrating a robust intellectual property portfolio[44](index=44&type=chunk) [Manufacturing Capabilities](index=14&type=section&id=Manufacturing%20Capabilities) The company has established vertically integrated GMP manufacturing capabilities for plasmids, lentiviral vectors, and CAR-T cell products, supporting clinical trials and commercialization, with its Shanghai Jinshan plant serving China and the US RTP facility cleared by FDA for overseas clinical trials - The company has established vertically integrated CAR-T manufacturing capabilities, encompassing plasmids, lentiviral vectors, and CAR-T cell products, enhancing efficiency, control, and cost reduction[46](index=46&type=chunk) - The Shanghai Jinshan facility supports the commercial production of Zevor-cel and prepares for the commercialization of Sure-cel[46](index=46&type=chunk) - The RTP manufacturing facility in North Carolina, USA, passed an FDA re-inspection with zero deficiencies in September 2024, leading to the lifting of clinical hold on three trials by the FDA in October of the same year[47](index=47&type=chunk) [Market Outlook and Future Prospects](index=15&type=section&id=Market%20Outlook%20and%20Future%20Prospects) The global CAR-T market shows strong growth, with significant unmet needs in solid tumors; the company aims to advance core products into earlier treatment, develop innovative technologies, expand manufacturing, and seek collaborations to maximize value - The global CAR-T market is experiencing strong growth, yet significant unmet needs persist in solid tumor treatment, presenting development opportunities for the company[48](index=48&type=chunk) - The company's future focus includes: 1) advancing core products into earlier treatment; 2) developing other clinical and preclinical products; 3) continuously innovating CAR-T technologies; 4) expanding US and China manufacturing capabilities; and 5) establishing more external collaborations[49](index=49&type=chunk) Financial Review [Operating Performance Analysis](index=16&type=section&id=Operating%20Performance%20Analysis) During the reporting period, the company's operating loss significantly narrowed from RMB 362 million to RMB 77 million, with net loss decreasing by RMB 277 million to RMB 75 million, primarily due to controlled expenses, increased foreign exchange gains, and higher gross profit Operating Loss and Net Loss | Metric | H1 2025 (Million RMB) | H1 2024 (Million RMB) | | :--- | :--- | :--- | | Operating Loss | 77 | 362 | | Net Loss | 75 | 352 | - The reduction in loss was primarily attributed to decreased R&D expenses, reduced administrative expenses, increased net foreign exchange gains, and higher gross profit[51](index=51&type=chunk) [Non-IFRS Measures](index=16&type=section&id=Non-IFRS%20Measures) To better assess core business performance, the company reported Non-IFRS measures, with adjusted net loss for the six months ended June 30, 2025, significantly narrowing to RMB 71.8 million from RMB 342 million after excluding non-cash items like share-based compensation Reconciliation of Net Loss to Adjusted Net Loss (RMB Thousand) | Item | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--- | :--- | :--- | | Loss for the period | (75,483) | (351,558) | | Add: Share-based payment expenses | 3,684 | 9,190 | | **Adjusted Net Loss** | **(71,799)** | **(342,368)** | [Analysis of Key Financial Items](index=17&type=section&id=Analysis%20of%20Key%20Financial%20Items) During the period, the company effectively controlled expenses, with revenue growing over 7-fold to RMB 50.96 million, R&D expenses decreasing by **47%** to RMB 130 million, and administrative expenses by **54%** to RMB 39 million, primarily due to lower staff costs, professional fees, and depreciation - R&D expenses decreased by **47%** from **RMB 246 million** to **RMB 130 million**, primarily due to reduced employee benefit expenses, testing and clinical expenses, and depreciation of property, plant, and equipment[58](index=58&type=chunk) - Administrative expenses decreased by **54%** from **RMB 86 million** to **RMB 39 million**, mainly due to reduced employee benefit expenses, professional service fees, and depreciation of property, plant, and equipment[59](index=59&type=chunk)[60](index=60&type=chunk) - Total employee benefit expenses decreased from **RMB 154 million** to **RMB 89.79 million**, primarily due to a reduction in headcount and lower remuneration[60](index=60&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held RMB 1.261 billion in cash and bank balances, with improved net cash outflow from operating activities of RMB 196 million and a net outflow of RMB 30 million from financing activities, resulting in zero total borrowings and a reduced liability ratio of **7.2%**, indicating a more robust financial structure Condensed Cash Flow Statement (RMB Thousand) | Item | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--- | :--- | :--- | | Net cash used in operating activities | (196,308) | (255,947) | | Net cash generated from investing activities | 1,715 | 6,584 | | Net cash (used in)/generated from financing activities | (29,635) | 24,688 | | **Cash and cash equivalents at period-end** | **1,260,793** | **1,652,569** | - As of June 30, 2025, the Group's total borrowings decreased to **zero**, and the liability ratio (sum of borrowings and lease liabilities/total equity) decreased from **15.75%** at the end of 2024 to **7.2%**[69](index=69&type=chunk) - As of June 30, 2025, the company's total headcount was **371**, a reduction from **468** at the end of 2024[78](index=78&type=chunk) Supplemental Announcement Regarding 2024 Annual Report [Impairment Background and Reasons](index=24&type=section&id=Impairment%20Background%20and%20Reasons) This supplemental announcement clarifies asset impairments in the 2024 annual report, stemming from a strategic shift to allogeneic CAR-T pipelines due to strong data and competitive changes, reallocating resources from certain autologous pipelines lacking clear commercialization plans - For the year ended December 31, 2024, the company recorded an impairment of **RMB 162.3 million** for property, plant, and equipment, **RMB 26.5 million** for right-of-use assets, and **RMB 0.3 million** for intangible assets[81](index=81&type=chunk) - The primary reason for impairment was a strategic shift: due to excellent allogeneic CAR-T data, the company decided to reallocate resources from certain autologous CAR-T pipelines to allogeneic pipelines[82](index=82&type=chunk)[83](index=83&type=chunk) [Key Assumptions and Impairment Testing](index=24&type=section&id=Key%20Assumptions%20and%20Impairment%20Testing) The company conducted impairment tests on long-term assets based on strategic adjustments, using the Value in Use (VIU) method for autologous pipeline assets without clear commercialization plans, and fully impairing assets solely dedicated to these pipelines due to zero expected future cash inflows - Key impairment testing assumptions included reduced resource allocation to autologous pipelines without clear commercialization plans, and no definite commercialization plans for other autologous pipelines beyond those already marketed or in NDA stage[83](index=83&type=chunk) - The company used the Value in Use (VIU) method for impairment testing, with assets solely dedicated to de-prioritized autologous pipelines assigned a **zero VIU**, leading to a full impairment provision[84](index=84&type=chunk)[85](index=85&type=chunk) Condensed Consolidated Financial Statements [Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=26&type=section&id=Consolidated%20Statement%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income) For the six months ended June 30, 2025, the company reported a gross profit of RMB 29.37 million, a significantly narrowed operating loss of RMB 76.70 million from RMB 362 million, and a net loss of RMB 75.48 million, representing a **78.5%** year-over-year reduction, with basic loss per share at **RMB 0.14** Condensed Interim Consolidated Statement of Profit or Loss Summary (RMB Thousand) | Item | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--- | :--- | :--- | | Revenue | 50,961 | 6,340 | | Gross Profit | 29,369 | 1,617 | | Operating Loss | (76,704) | (361,540) | | Loss before income tax | (75,483) | (351,558) | | **Loss for the period attributable to owners of the parent** | **(75,483)** | **(351,558)** | | Basic and diluted loss per share (RMB) | (0.14) | (0.63) | [Consolidated Statement of Financial Position](index=27&type=section&id=Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2025, the company reported total assets of RMB 1.513 billion, total liabilities of RMB 551 million, and net assets of RMB 962 million, with strong liquidity from RMB 1.380 billion in current assets, including RMB 1.261 billion in cash and bank balances, and an optimized balance sheet with zero interest-bearing bank borrowings Condensed Interim Consolidated Statement of Financial Position Summary (RMB Thousand) | Item | As of June 30, 2025 (Unaudited) | As of December 31, 2024 (Audited) | | :--- | :--- | :--- | | Total non-current assets | 133,498 | 142,759 | | Total current assets | 1,379,893 | 1,530,275 | | **Total Assets** | **1,513,391** | **1,673,034** | | Total current liabilities | 213,799 | 254,007 | | Total non-current liabilities | 337,459 | 362,320 | | **Total Liabilities** | **551,258** | **616,327** | | **Net Assets** | **962,133** | **1,056,707** | | Total Equity | 962,133 | 1,056,707 | Corporate Governance and Other Information [Dividends and Securities Transactions](index=36&type=section&id=Dividends%20and%20Securities%20Transactions) The Board recommends no interim dividend for the six months ended June 30, 2025, with no purchases, sales, or redemptions of listed securities by the company or its subsidiaries during the period, and all directors confirmed compliance with the adopted standard code - The Board recommends no interim dividend for the reporting period[116](index=116&type=chunk) - During the reporting period, neither the company nor its subsidiaries acquired, disposed of, or redeemed any of the company's listed securities[117](index=117&type=chunk) [Use of Proceeds from Global Offering](index=37&type=section&id=Use%20of%20Proceeds%20from%20Global%20Offering) The company, listed in June 2021, utilized approximately RMB 2.497 billion of its HKD 3.008 billion net global offering proceeds by June 30, 2025, primarily for CT053 development, pipeline R&D, and manufacturing, with the remaining balance expected to be fully used by 2026 Use of Proceeds from Global Offering (As of June 30, 2025) | Use of Proceeds | Planned Allocation (Million RMB) | Amount Utilized (Million RMB) | Balance (Million RMB) | | :--- | :--- | :--- | :--- | | Development of core product BCMA CAR-T (CT053) | 851.7 | 851.7 | 0 | | R&D for other pipelines | 849.9 | 759.6 | 90.3 | | Manufacturing and commercialization capabilities | 548.3 | 415.2 | 133.1 | | Technology upgrades and early-stage R&D | 274.1 | 214.7 | 59.4 | | Working capital and others | 255.5 | 255.5 | 0 | | **Total** | **2,779.5** | **2,496.7** | **282.8** | - The unutilized portion of the net proceeds is expected to be fully used for its intended purposes by 2026[124](index=124&type=chunk)

Core Viewpoint - The investment bank maintains a cautiously optimistic outlook on the Chinese pharmaceutical industry, noting a significant average increase of 137% in Hong Kong biotech stocks since early 2025, driven by cash returns from innovative drug licensing deals and unaffected by upcoming U.S. tariffs [1] Group 1: Market Performance - The biotech sector has recently experienced some pullback due to disappointing sales figures from major companies in the first half of 2025, including Hutchison China MediTech [1] - Concerns have arisen regarding Trump's phased implementation of drug tariffs, which could escalate to 150% within a year and ultimately reach 250% [1] Group 2: Company Recommendations - The bank's top pick is BeiGene (06160), with a target price set at HKD 230 and a rating of "Outperform," citing strong performance in the first half of 2025 and an improved gross margin guidance despite U.S. tariff impacts [1] - CanSino Biologics (09926) is expected to report adjusted earnings of RMB 23 million for the first half of 2025, benefiting from revenue growth from its drugs AK104 and AK112, also rated "Outperform" [1] - The target price for Innovent Biologics (01801) has been raised by 10% from HKD 100 to HKD 110, with a rating of "Outperform," reflecting confidence in the company's projected 37% year-on-year revenue growth [1] Group 3: Focus on Innovative Drugs - The bank continues to pay attention to licensing deals for Chinese innovative drugs, with expectations of increased subsidies for high-priced innovative drugs, which may drive sales growth for companies such as Kintor Pharmaceutical (02171), Fosun Pharma (02196), WuXi AppTec (02126), and Kelun-Biotech (06990) [2]

Summary of Key Points Core Viewpoint - The report highlights the top short-selling stocks in Hong Kong, indicating significant short-selling activity in companies like New World Development, Hong Kong Exchanges, and BYD, with notable short-selling ratios and amounts [1][2]. Short-Selling Ratios - New World Development (80016) has the highest short-selling ratio at 100.00% - Hong Kong Exchanges (80388) follows with a short-selling ratio of 94.27% - BYD (81211) has a short-selling ratio of 94.13% [1][2]. Short-Selling Amounts - Alibaba (09988) leads in short-selling amount with HKD 1.546 billion - Tencent (00700) has a short-selling amount of HKD 1.265 billion - Xiaomi (01810) follows with HKD 1.188 billion [1][2]. Deviation Values - Hong Kong Exchanges (80388) has the highest deviation value at 54.37% - New World Development (80016) has a deviation value of 41.90% - Alibaba (89988) shows a deviation value of 39.84% [1][2].

Core Insights - The recent government policies aim to support innovative drugs, including "first launch price protection" for CAR-T therapies, which will not be included in centralized procurement for the first five years post-launch [1] - Despite these policies, the payment challenges for CAR-T therapies remain significant, with prices ranging from 999,000 to 1,290,000 RMB, far exceeding the implicit thresholds of 300,000 RMB for basic medical insurance [1][2] - The focus for the 2025 negotiations will be on the long-term competitiveness of companies, assessing their ability to manage price pressures, cost control, and commercialization efficiency [2] Group 1: CAR-T Products and Pricing - Six CAR-T products will participate in commercial health insurance negotiations in September 2025, but basic medical insurance access is unlikely [3] - The current pricing for the listed CAR-T products is as follows: - Axicabtagene ciloleucel (Fosun Kite): 1,200,000 RMB - Relmacabtagene autoleucel (WuXi AppTec): 1,290,000 RMB - Nanjing Biomedicine's product: 999,000 RMB - Others range from 1,280,000 to 1,290,000 RMB [4] Group 2: Economic Evaluation and Price Pressure - Only three of the six CAR-T products have published cost-effectiveness analysis reports for the Chinese market, which will influence their negotiation positions [5] - The incremental cost-effectiveness ratios (ICER) for these products are as follows: - Axicabtagene ciloleucel: 463,000 RMB/QALY - Relmacabtagene autoleucel: 203,000 RMB/QALY - Other products show varying ICERs, indicating different levels of price pressure [6] Group 3: Competitive Strategies and Market Dynamics - The negotiation dynamics will depend on the companies' ability to demonstrate cost control and effective commercialization strategies [2][14] - Companies like WuXi AppTec and Legend Biotech have competitive advantages due to their existing ICERs being closer to the expected thresholds, while others may need to prove the reliability of unpublished data or offer price concessions [14] Group 4: Future Market Potential and Insurance Access - The potential for CAR-T therapies to enter the insurance market hinges on their ability to lower costs and expand patient access, particularly in the context of solid tumors [16][22] - The expected patient population for blood cancers is approximately 26,000 to 48,000 annually, while solid tumors could see a much larger patient base, enhancing the long-term viability of CAR-T therapies [20][22] Group 5: Key Observations for Investors - The completeness of health economic data will determine the negotiation eligibility for insurance access, while the feasibility of price reductions and commercialization efficiency will influence the speed of market entry [14][15] - The ability to expand hospital coverage and partnerships with health insurance will be critical for companies to achieve rapid market penetration and revenue growth [15]

Group 1 - The pharmaceutical sector is experiencing a general decline, with CRO and innovative drug concepts leading the losses. Notable declines include: Innovent Biologics (09969) down 7.68% to HKD 17.54, WuXi AppTec (06127) down 5.88% to HKD 23.06, Tigermed (03347) down 5.6% to HKD 53.1, and Kintor Pharmaceutical (02171) down 5.4% to HKD 19.96 [1] - U.S. President Trump announced plans to introduce new tariffs on pharmaceuticals, with initial "small tariffs" on imported drugs expected to be revealed next week. The tariffs are projected to increase to 150% within a year and potentially reach 250% thereafter, aimed at boosting domestic drug production [1] - Tianfeng Securities expressed confidence in the long-term competitive advantages of the pharmaceutical industry, noting that the innovative drugs and related supply chains are still viewed positively despite potential challenges. The relative certainty of domestic consumption is also seen as improving [1]

Group 1 - Pharmaceutical stocks generally declined, with CRO and innovative drug concepts experiencing the largest drops [1] - Notable declines included: Innovent Biologics (09969) down 7.68% to HKD 17.54, Zai Lab (603127) down 5.88% to HKD 23.06, Tigermed (300347) down 5.6% to HKD 53.1, and Kintor Pharmaceutical (02171) down 5.4% to HKD 19.96 [1] - The market is reacting to President Trump's announcement of new tariffs on pharmaceuticals, which will start with a "small tariff" and potentially increase to 150% within a year, and up to 250% thereafter [1] Group 2 - Tianfeng Securities noted that the market remains confident in the long-term competitive advantages of the pharmaceutical industry, despite potential challenges [1] - The innovative drugs and related industry chain are still viewed as promising directions, with increasing certainty in domestic consumption [1]

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7月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 科濟藥業控股有限公司 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02171 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 200,000,000,000 | USD | 0.00000025 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | USD | | | | 本月底結存 | | | 200,000,000,000 | USD | 0.00000025 | USD | | 50,000 | 本月底法定/註冊股本總額： USD 50 ...

Core Insights - The article emphasizes the need to resolve the contradiction between the high costs of CAR-T therapy and the payment system, which relies on both technological cost reduction and the expansion of research pipelines to access a broader patient market [1] - The focus is on the potential market growth in the solid tumor sector, which could significantly alter the CAR-T market landscape [1] Industry Trends - The global CAR-T research initially focused on hematological tumors, with existing products targeting CD19 and BCMA, covering conditions like non-Hodgkin lymphoma (NHL) and multiple myeloma (MM). The research is now expanding towards solid tumors, with the proportion of clinical trials for solid tumors expected to rise from 15% in 2020 to 30% by 2025 [2][3] - The incidence of solid tumors is significantly higher than that of hematological cancers, indicating a potential exponential growth in the patient population. This growth can help distribute costs through economies of scale and enhance market competitiveness [2] Patient Population Insights - In China, the annual incidence rates for NHL and MM are 6.97 and 1-2 per 100,000 respectively, with approximately 40,000 new cases of DLBCL and 14,000-28,000 new cases of MM each year [2] - For solid tumors, the annual incidence of gastric cancer is between 10-20 per 100,000, with 140,000-280,000 new cases annually, and liver cancer has a similar incidence rate with a potential treatable population of 98,000-196,000 patients per year [3] Technical Challenges - Solid tumors present unique challenges for CAR-T therapies, including tumor microenvironment suppression, antigen heterogeneity, infiltration barriers, and T cell exhaustion [4] Domestic Trends - In China, all six approved CAR-T therapies target hematological tumors, but the proportion of clinical trials for solid tumors is expected to reach 42% by 2024. Key drivers for this shift include technological advancements, policy support, and a large patient base for solid tumors [5] Company Pipeline Analysis - Companies are focusing on expanding their CAR-T pipelines to include solid tumors, with several firms reporting promising clinical trial results and plans for future submissions [6][10][15][20][23][35] - For instance, Kexing Biopharm's Claudin18.2 CAR-T for gastric cancer has shown a 22% objective response rate in Phase II trials, while another company, Yuanqi Bio, reported a 56.5% response rate for GPC3 CAR-T in liver cancer [5][10] Market Potential - The potential market for CAR-T therapies in solid tumors is vast, with estimates suggesting that the annual patient population for gastric and liver cancers alone could reach between 126,000 and 280,000, far exceeding the total for hematological cancers [3][5]

（於開曼群島註冊成立的有限公司） （股份代號：2171） 董事會會議召開日期 科濟藥業控股有限公司（「本公司」，連同其附屬公司及併表聯屬實體統稱「本集 團」）董事會（「董事會」）茲通告謹定於2025年8月14日（星期四）舉行董事會會議， 以考慮及通過本集團截至2025年6月30日止六個月的中期業績，以及處理其他事 項。 香港交易及結算所有限公司、香港聯合交易所有限公司及香港中央結算有限公司對本公告的內 容概不負責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任 何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 CARsgen Therapeutics Holdings Limited 科濟藥業控股有限公司 於本公告日期，本公司董事會包括執行董事李宗海博士、王華茂博士及蔣華博 士；非執行董事郭炳森先生、郭華清先生及謝榕剛先生；獨立非執行董事顏光美 博士、趙向可女士及周文博士。 承董事會命 科濟藥業控股有限公司 董事長 李宗海博士 香港，2025年8月1日 ...