Financial Performance - Revenue increased by 36.7% from RMB 673.05 million in 2023 to RMB 919.50 million in 2024, driven by a 27.4% growth in mainland China[6] - Other income and gains decreased from RMB 1,157.86 million in 2023 to RMB 488.70 million in 2024, primarily due to a reduction in foreign exchange gains[6] - Net loss decreased by 45.1% from RMB 5,811.83 million in 2023 to RMB 3,192.50 million in 2024[7] - Adjusted net loss decreased by 42.9% from RMB 5,339.04 million in 2023 to RMB 3,045.72 million in 2024, reflecting effective cost reduction strategies[8] - The company achieved a net loss of RMB 319,250,000 in 2024, which is a 45.0% improvement compared to a net loss of RMB 581,183,000 in 2023[46] - The pre-tax loss for 2024 was RMB 144,408,000, significantly reduced from RMB 282,437,000 in 2023[63] - The adjusted loss for the year improved from RMB 533.9 million in 2023 to RMB 304.6 million in 2024, reflecting a reduction of about 43.1%[99] Research and Development - R&D costs reduced by 36.2% from RMB 4,056.69 million in 2023 to RMB 2,589.12 million in 2024, attributed to improved R&D efficiency[6] - The company has made steady progress with its preclinical candidates, including ATG-042, ATG-201, ATG-102, ATG-106, ATG-107, and ATG-110[14] - The new "2+1" T cell engager platform, AnTenGagerTM, has shown steady progress, enhancing efficacy and reducing the risk of cytokine release syndrome (CRS)[15] - The Phase I trials for ATG-101 in treating advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL) are ongoing in mainland China, Australia, and the United States[17] - The company is conducting key clinical trials in the US for its bispecific antibody products[22] - The company has initiated multiple Phase II and III clinical trials for its drug candidates[22] - The company reported an overall response rate (ORR) of 42.9% in a trial for ATN-022 in advanced or metastatic gastric cancer patients[41] Product Development and Approvals - Selinexor received approval for reimbursement in South Korea for treating relapsed or refractory multiple myeloma starting July 1, 2024[9] - New indications for Selinexor were approved in China for treating relapsed/refractory diffuse large B-cell lymphoma in July 2024[9] - The company has received NDA approvals for its product, Cevinostat, in multiple regions including mainland China, Australia, and several Southeast Asian countries[20] - The first commercial product, XPOVIO® (Selinexor), is a selective nuclear export inhibitor approved for multiple myeloma and solid tumors, with exclusive rights in Greater China and several other regions[24] - XPOVIO® received accelerated approval from the FDA for treating adult patients with relapsed/refractory multiple myeloma after at least four lines of therapy[25] - The company has received conditional approval from NMPA for XPOVIO® to treat adult patients with relapsed/refractory DLBCL after at least two lines of therapy[29] - The company has received multiple NDA approvals for its product, Xivio® (Selinexor), in various regions, including approvals in 2021, 2022, and upcoming approvals in 2024 and 2025[44] Cost Management - Sales and distribution expenses decreased by 61.5% from RMB 1,927.39 million in 2023 to RMB 737.30 million in 2024, with no milestone payments related to the commercialization of Selinexor in the Asia-Pacific region[7] - Administrative expenses fell by 28.2% from RMB 1,480.56 million in 2023 to RMB 1,062.63 million in 2024, mainly due to reduced employee costs[7] - Research and development costs decreased to RMB 258,912,000 in 2024 from RMB 405,669,000 in 2023, reflecting a 36.3% reduction[45] - Selling and distribution expenses dropped from RMB 192.7 million in 2023 to RMB 73.7 million in 2024, mainly due to the absence of milestone payments and reduced employee costs[94] - Employee costs decreased from RMB 77.5 million in 2023 to RMB 20.5 million in 2024, representing a decline of about 73.5%[96] Market Expansion and Strategy - The company is focusing on expanding its market presence in Greater China, South Korea, Singapore, Malaysia, Indonesia, Vietnam, Laos, Cambodia, the Philippines, Thailand, and Mongolia[22] - The company is exploring new strategies for commercialization and market expansion[22] - The company plans to establish a dedicated AI department to accelerate the development of a next-generation proprietary T cell engager platform[15] - The company is preparing its commercial team for the launch of Xivio® in the Asia-Pacific region to address unmet medical needs[44] Financial Position - The total assets less current liabilities amounted to RMB 1,198,407,000 in 2024, down from RMB 1,427,699,000 in 2023[48] - Cash and bank balances decreased to RMB 900,138,000 in 2024 from RMB 1,187,703,000 in 2023, indicating a liquidity reduction[48] - The company’s total equity decreased to RMB 850,801,000 in 2024 from RMB 1,147,384,000 in 2023, reflecting a decline in shareholder value[48] - The debt-to-asset ratio increased to 36.7% in 2024 from 29.1% in 2023, indicating a rise in leverage[105] Corporate Governance - The audit committee, consisting of three independent non-executive directors, has reviewed the financial performance and confirmed compliance with relevant accounting standards and regulations[120] - The company has maintained a public float of at least 25% of its total issued share capital in accordance with listing rules[124] - The company has adopted the "Standard Code" for securities trading by directors and confirmed compliance throughout the reporting period[114] - The company will continue to review and monitor its corporate governance practices to ensure compliance with the Corporate Governance Code[113]

德琪醫藥有限公司 （於開曼群島註冊成立之有限公司） （股份代號：6996） 香港交易及結算所有限公司及香港聯合交易所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依 賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 董事會會議日期通告 德琪醫藥有限公司（「本公司」）董事會（「董事會」）謹此宣佈，本公司將於2025年 3月21日（星期五）舉行董事會會議，藉以（其中包括）考慮並批准本公司及其附屬 公司截至2024年12月31日止年度業績及其發佈。 承董事會命 德琪醫藥有限公司 董事長 梅建明博士 香港，2025年3月11日 於本公告日期，董事會包括執行董事梅建明博士及龍振國先生；及獨立非執行董 事錢晶女士、唐晟先生及Rafael Fonseca博士。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司（「香港聯交所」）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，概不對因本公告全部或任何部份內 容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 德琪醫藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：6996） 自願公告 希維奧®的新藥上市申請獲印度尼西亞食品藥品監督管理局批准 本公告由德琪醫藥有限公司（「本公司」，連同其附屬公司統稱為「本集團」）自願作 出，以向本公司股東及有意投資者提供有關本集團的最新業務發展資料。本公司 董事會（「董事會」）欣然宣佈，印度尼西亞食品藥品監督管理局(BPOM)已批准希 維奧® （塞利尼索片）用於三項適應症的新藥上市申請(NDA)：(1)與硼替佐米和地 塞米松聯用，用於治療既往接受過至少一種先前治療的多發性骨髓瘤(MM)的成年 患者；(2)聯合地塞米松用於治療既往接受過至少四次既往治療且對至少兩種蛋白 酶體抑制劑(PI)、至少兩種免疫調節劑(IMiD)、一種抗CD38單克隆抗體難治的復 發或難治性多發性骨髓瘤(rrMM)的成年 ...

（股份代號：6996） 香港交易及結算所有限公司及香港聯合交易所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，概不對因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 德琪醫藥有限公司 （於開曼群島註冊成立的有限公司） 香港，2025年2月19日 於本公告日期，董事會包括執行董事梅建明博士及龍振國先生；及獨立非執行董 事錢晶女士、唐晟先生及Rafael Fonseca博士。 自願公告 業務進展及更新 本公告乃由德琪醫藥有限公司（「本公司」，連同其附屬公司統稱為「本集團」）自願 作出，以向本公司股東及有意投資者提供有關本集團的最新業務發展資料。本公 司董事會（「董事會」）欣然宣佈，本公司計劃加大投入，整合資源成立專門的AI部 門。這一舉措包括本地部署DeepSeek以加速具有空間位元阻遮蔽效應的T細胞銜 接器(TCE)平台後續管線研發。 本公司早在2021年便以天使投資人身份投資杭州德睿智藥AI藥物發現平台，並借 此戰略性的切入了AI藥物發現賽道。這一戰略舉措使本公司能夠在內部利用AI能 ...

（於開曼群島註冊成立的有限公司） （股份代號：6996） 自願公告 希維奧®獲批納入台灣全民健康保險 本公告乃由德琪醫藥有限公司（「本公司」，連同其附屬公司統稱為「本集團」）自 願作出，以向本公司股東及有意投資者提供有關本集團的最新業務發展資料。 本公司董事會（「董事會」）欣然宣佈，希維奧® （塞利尼索）（與硼替佐米和地塞米 松(XVd)聯用，用於治療既往接受過至少兩種治療的復發╱難治性多發性骨髓瘤 (rrMM)成年患者）已在台灣獲批納入全民健康保險。自2025年3月1日起，希維 奧®將獲正式納入台灣《全民健康保險用藥品項表》。 香港交易及結算所有限公司及香港聯合交易所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，概不對因本公告全部或任何部份內容而產生或因依 賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 德琪醫藥有限公司 1 關於希維奧® （塞利尼索） 希維奧®是世界首款獲批准的核輸出蛋白口服選擇性XPO1抑制劑。其具有新穎的 作用機制，在聯合治療中具有協同作用，快速起效，且反應持久。 此為本公司刊發的自願公告。本公司 ...

香港交易及結算所有限公司及香港聯合交易所有限公司「香港聯交所」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，概不對因本公告全部或任何部份內 容而產生或因依賴該等內容而引致的任何損失承擔任何責任。 Antengene Corporation Limited 德琪醫藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：6996） 自願公告 希維奧®用於治療瀰漫大B細胞淋巴瘤的適應症 成功納入2024年版國家醫保藥品目錄 本公告乃由德琪醫藥有限公司（「本公司」，連同其附屬公司統稱為「本集團」）自願 作出，以向本公司股東及有意投資者提供有關本集團的最新業務發展資料。本公 司董事會（「董事會」）欣然宣佈，希維奧® （塞利尼索片）的新適應症，用於治療接 受過至少兩線系統性治療的複發或難治性瀰漫大B細胞淋巴瘤(rrDLBCL)成年患 者，已被納入於2025年1月1日起正式生效的2024年版國家醫保藥品目錄(NRDL)。 此為本公司刊發的自願公告。本公司股東及有意投資者於買賣本公司股份時務請 審慎行事。 承董事會命 德琪醫藥有限公司 董事長 梅建明博士 香港，2024年11月28日 於本公告日 ...

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 60.8 million, a decrease of 15.6% from RMB 72.0 million for the same period in 2023[3]. - Other income and gains fell to RMB 27.3 million, down RMB 93.8 million from RMB 121.1 million in the prior year, primarily due to a decrease in foreign exchange gains[4]. - Loss for the period narrowed to RMB 167.0 million, a decrease of RMB 51.7 million from RMB 218.7 million in the prior year[5]. - Adjusted loss for the period, excluding the impact of equity-settled share-based payments, was RMB 152.6 million, down RMB 36.8 million from RMB 189.4 million[6]. - Adjusted loss excluding foreign exchange gains was RMB 158.7 million, a significant decrease of 43.7% from RMB 281.7 million in the previous year, driven by effective cost reduction strategies[6]. - The gross profit for the six months ended June 30, 2024, was RMB 51.9 million, compared to RMB 59.4 million for the same period in 2023[33]. - The pre-tax loss for the six months ended June 30, 2024, was RMB 167.0 million, compared to RMB 218.7 million for the same period in 2023[33]. - Total comprehensive loss for the period was RMB 168,242,000, compared to RMB 276,243,000 in the same period last year, showing a 39.2% decrease[86]. - The company reported a net loss of RMB 167,033,000 for the six months ended June 30, 2024, compared to a net loss of RMB 218,694,000 for the same period in 2023, representing a 23.5% improvement[88]. Research and Development - R&D expenses decreased to RMB 130.8 million, down RMB 95.3 million from RMB 226.1 million in the previous year, attributed to improved R&D efficiency[5]. - The company maintains a strategic focus on advancing core R&D programs without engaging in new business development activities during the reporting period[16]. - The company has a pipeline that includes one commercialized product, eight clinical assets, and several preclinical projects, emphasizing a "combination and complementary" R&D strategy[18]. - The product pipeline includes 10 candidates focused on oncology, with various stages from preclinical to late-stage clinical trials[19]. - The company is conducting several late-stage clinical studies for Xivio® (Selinexor), including a Phase III trial in combination with bortezomib and low-dose dexamethasone for relapsed/refractory multiple myeloma[26]. - The latest results from the I/II phase TORCH-2 study of Onatasertib (ATG-008) showed an overall response rate (ORR) of 53.3% and a disease control rate (DCR) of 86.7% in cervical cancer patients who had not previously received checkpoint inhibitors[8]. - The I phase trials of ATG-101 for advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL) are ongoing in mainland China, Australia, and the United States[9]. - The I phase trial of ATG-022 (Claudin 18.2 antibody-drug conjugate) has shown preliminary efficacy data with one complete response (CR) and one partial response (PR) among gastric cancer patients[12]. Cost Management - Selling and distribution expenses were RMB 56.0 million, a reduction of RMB 32.2 million from RMB 88.2 million, mainly due to the absence of milestone payments related to commercialization in the Asia-Pacific region[5]. - Administrative expenses decreased to RMB 58.5 million, down RMB 25.3 million from RMB 83.8 million, primarily due to reduced employee costs[5]. - Employee costs dropped from RMB 86.9 million to RMB 51.3 million, reflecting a decrease of RMB 35.6 million[36]. - The company reported no milestone payments related to commercialization in the Asia-Pacific region for the six months ended June 30, 2024, compared to RMB 21.3 million for the same period in 2023[38]. - The adjusted R&D costs for the six months ended June 30, 2024, were approximately RMB 130.8 million, down from RMB 226.1 million for the same period in 2023[33]. Corporate Governance - The company is committed to maintaining high standards of corporate governance to protect shareholder interests and enhance corporate value[57]. - The board consists of three executive directors, one non-executive director, and three independent non-executive directors, ensuring sufficient checks and balances[57]. - The company plans to continue reviewing its corporate governance practices to ensure compliance with the Corporate Governance Code[57]. - The company appointed Dr. Mei Jianming as the Chairman and CEO, who has extensive experience in identifying strategic opportunities[55]. - Dr. Zhang Xiaojing, with over 20 years of experience in oncology and pharmaceuticals, was appointed as Chief Medical Officer in December 2022[55]. Market and Product Development - The company successfully integrated its product into the National Medical Insurance Directory in December 2023, leading to necessary price adjustments[4]. - The Korean National Health Insurance Service approved reimbursement for XPOVIO® (Selinexor) for adult patients with relapsed or refractory multiple myeloma (rrMM) effective July 1, 2024[7]. - The China National Medical Products Administration approved a new indication for XPOVIO® (Selinexor) as a monotherapy for adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two lines of systemic therapy[7]. - The company has submitted New Drug Applications (NDAs) for XPOVIO® (Selinexor) in multiple regions including Macau, Malaysia, Thailand, and Indonesia for the treatment of rrMM and rrDLBCL[18]. - The company is advancing its clinical trials globally with partners in various regions[19]. Shareholder Information - As of June 30, 2024, the board of directors and senior executives hold a total of 183,597,994 shares, representing approximately 27.20% of the company[63]. - The company has not purchased, sold, or redeemed any of its listed securities during the reporting period[59]. - The company has confirmed compliance with the standards set forth in the "Standard Code" for securities trading by directors throughout the reporting period[58]. - The company has not noted any incidents of employees failing to comply with the "Standard Code" during the reporting period[58]. - The company’s management has seen a significant number of options granted, with 1,020,000 options exercised by a senior executive[73]. Financial Position - Cash and bank balances as of June 30, 2024, were RMB 1,023.7 million, down from RMB 1,187.7 million as of December 31, 2023[43]. - Current assets totaled RMB 1,112.6 million, including cash and bank balances of RMB 1,023.7 million[43]. - The current ratio as of June 30, 2024, was 572.4%, down from 650.6% as of December 31, 2023[44]. - The company’s total liabilities for other payables and accrued items are unsecured and interest-free, with their book value approximating fair value due to their short-term nature[126]. - The company’s total reserves as of June 30, 2024, were RMB 993,608,000, down from RMB 1,713,322,000 as of June 30, 2023[88].

[Financial and Business Summary](index=1&type=section&id=Financial%20and%20Business%20Summary) [Financial Summary](index=1&type=section&id=Financial%20Summary) In H1 2024, revenue decreased by 15.6% to RMB 60.78 million, yet net loss significantly narrowed from RMB 219 million to RMB 167 million due to substantial expense reductions Key Financial Indicators H1 2024 (RMB thousand) | Indicator | H1 2024 (Unaudited) | H1 2023 (Unaudited) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | Revenue | 60,779 | 72,016 | -15.6% | | R&D Costs | (130,841) | (226,093) | -42.1% | | Sales & Distribution Expenses | (56,028) | (88,246) | -36.5% | | Administrative Expenses | (58,478) | (83,756) | -30.2% | | Loss for the Period | (167,033) | (218,694) | +23.6% (Loss narrowed) | | Adjusted Loss for the Period* | (152,567) | (189,437) | +19.5% (Loss narrowed) | - Revenue decline was primarily due to price reductions for core product XPOVIO® (Selinexor) after its inclusion in the National Reimbursement Drug List in December 2023, and transitional impacts from the initial commercialization partnership with Hansoh Pharmaceutical; however, significant sales volume increases largely offset the price decrease[3](index=3&type=chunk) - R&D costs decreased by **RMB 95.3 million** year-on-year, mainly due to reduced employee costs and drug development expenses from improved R&D efficiency, along with lower licensing fees[3](index=3&type=chunk) - Sales and distribution expenses decreased by **RMB 32.2 million** year-on-year, primarily due to no new APAC commercialization milestone payments in 2024 and reduced Greater China-related expenses following the partnership with Hansoh Pharmaceutical[3](index=3&type=chunk) [Business Summary](index=3&type=section&id=Business%20Summary) During the reporting period, the company achieved significant pipeline and operational advancements, including Selinexor's (XPOVIO®) expanded market access in Korea and China, positive data for Onatasertib in cervical cancer, and steady progress across multiple clinical-stage assets - **Commercialization Asset Progress**: * **Selinexor (ATG-010, XPOVIO®)**: * Approved for reimbursement in Korea for rrMM in June 2024, effective July 1 * Received NMPA approval in China for a new indication in rrDLBCL in July 2024[4](index=4&type=chunk) - **Late-Stage Asset Progress**: * **Onatasertib (ATG-008)**: I/II TORCH-2 study results showed an ORR of **53.3%** and DCR of **86.7%** when combined with toripalimab in cervical cancer patients, with good tolerability[4](index=4&type=chunk) - **Other Clinical-Stage Asset Progress**: * **ATG-101 (PD-L1/4-1BB)**: Phase I trials are ongoing in China, Australia, and the US * **ATG-037 (CD73 Inhibitor)**: Phase I trials are ongoing in China and the US * **ATG-022 (Claudin 18.2 ADC)**: Phase II CLINCH trial initiated in China and Australia, with Phase I data showing preliminary efficacy * **ATG-031 (Anti-CD24 mAb)**: Phase I PERFORM trial is ongoing in the US[4](index=4&type=chunk)[5](index=5&type=chunk) - During the reporting period, the company did not engage in any new business development activities, strategically focusing on advancing core R&D projects[5](index=5&type=chunk) [Management Discussion and Analysis](index=5&type=section&id=Management%20Discussion%20and%20Analysis) [Company Overview](index=5&type=section&id=Overview) Antengene is a commercial-stage biopharmaceutical company focused on innovative oncology drugs in APAC, with a 'combination and complementary' R&D strategy encompassing one commercial product and eight clinical-stage programs - The company is positioned as a commercial-stage biopharmaceutical company in the Asia-Pacific region, focusing on innovative oncology drugs[7](index=7&type=chunk) - The company employs a 'combination and complementary' R&D strategy, with a pipeline comprising **one commercial product**, **eight clinical-stage projects**, and multiple preclinical projects[7](index=7&type=chunk) [Product Pipeline](index=6&type=section&id=Product%20Pipeline) The company's oncology-focused pipeline includes 10 drug candidates from preclinical to commercial stages, featuring core product Selinexor (ATG-010) and late-stage asset Onatasertib (ATG-008) in Phase II clinical trials Key Product Pipeline and Status | Investigational Product | Target (Drug Type) | Key Indication | Development Stage | | :--- | :--- | :--- | :--- | | **ATG-010 (Selinexor)** | XPO1 (Small Molecule) | rrMM, rrDLBCL | Commercialized/Phase III | | **ATG-008 (Onatasertib)** | mTORC1/2 (Small Molecule) | Cervical Cancer & Advanced Solid Tumors | Phase II Clinical | | **ATG-022** | Claudin 18.2 (ADC) | Solid Tumors | Phase II Clinical | | **ATG-037** | CD73 (Small Molecule) | Hematologic Malignancies/Solid Tumors | Phase I Clinical | | **ATG-101** | PD-L1/4-1BB (Bispecific Antibody) | Hematologic Malignancies/Solid Tumors | Phase I Clinical | | **ATG-031** | CD24 (Monoclonal Antibody) | Hematologic Malignancies/Solid Tumors | Phase I Clinical | [Business Review](index=7&type=section&id=Business%20Review) H1 2024 saw steady business progress, with core product Selinexor (XPOVIO®) gaining expanded market access in Korea and China, advancing commercial partnerships, and positive clinical data reported for multiple pipeline assets [Commercialization Stage Product: Selinexor (ATG-010)](index=7&type=section&id=Commercialization%20Stage%20Product) Selinexor (XPOVIO®), the company's first commercial product, achieved key advancements during and after the reporting period, including expanded approvals and reimbursement in APAC, and a commercialization partnership with Hansoh Pharmaceutical in mainland China - A collaboration agreement with Hansoh Pharmaceutical for XPOVIO®'s commercialization in mainland China entitles Antengene to an upfront payment of up to **RMB 200 million** and milestone payments of up to **RMB 535 million**[11](index=11&type=chunk) - In December 2023, XPOVIO® was included in China's National Reimbursement Drug List for relapsed/refractory multiple myeloma, effective January 1, 2024[11](index=11&type=chunk) - In June 2024, it received reimbursement approval for rrMM in Korea; in the same month, it was approved for a new indication in rrDLBCL in China[9](index=9&type=chunk) [Late-Stage Candidate Product: ATG-008 (Onatasertib)](index=9&type=section&id=Late-Stage%20Candidate%20Product) ATG-008 (Onatasertib), an mTORC1/2 inhibitor, is undergoing a Phase I/II TORCH-2 study in combination with toripalimab for cervical cancer, with recent positive results presented at ASCO 2024 demonstrating good anti-tumor activity and tolerability - The Phase I/II TORCH-2 study showed that ATG-008 combined with toripalimab achieved an ORR of **53.3%** and a DCR of **86.7%** in CPI-naïve cervical cancer patients[13](index=13&type=chunk) [Other Clinical Candidate Drugs](index=9&type=section&id=Other%20Clinical%20Candidate%20Drugs) Several other clinical candidates are progressing positively, including ATG-101 (PD-L1/4-1BB bispecific) in multi-country Phase I studies, ATG-037 (CD73 inhibitor) completing Phase I, ATG-022 (Claudin 18.2 ADC) initiating Phase II with two FDA Orphan Drug Designations, and ATG-031 (CD24 antibody) completing its first dosing level in Phase I - ATG-101 (PD-L1/4-1BB bispecific antibody) received Orphan Drug Designation from the US FDA for the treatment of pancreatic cancer[13](index=13&type=chunk) - ATG-022 (Claudin 18.2 ADC) has initiated Phase II trials and received two Orphan Drug Designations from the FDA for gastric and pancreatic cancer[14](index=14&type=chunk) - ATG-031 (CD24 antibody) Phase I trial completed first patient dosing in December 2023 and has passed the initial dosing level[15](index=15&type=chunk) [Research and Development](index=10&type=section&id=Research%20and%20Development) The company focuses on differentiated 'combination and complementary' R&D strategies for cancer treatment, with nine clinical studies ongoing and adjusted R&D costs significantly reduced to **RMB 122 million** in H1 2024, while strengthening its intellectual property portfolio - As of June 30, 2024, the company has **nine clinical studies** ongoing in mainland China, the US, and Australia[16](index=16&type=chunk) R&D Cost Comparison (Non-IFRS) | Period | Adjusted R&D Costs (RMB million) | | :--- | :--- | | H1 2024 | Approx. 121.7 | | H1 2023 | Approx. 207.7 | - As of June 30, 2024, the company has filed **nine patent applications** in mainland China and **eleven international applications** under PCT[16](index=16&type=chunk) [Future and Outlook](index=11&type=section&id=Future%20and%20Outlook) The company plans to advance its 'combination and complementary' R&D strategy, developing nine clinical-stage products through a dual-engine approach of external partnerships and internal discovery, while preparing for XPOVIO®'s APAC launch with its experienced commercial team - Continue advancing the development of **nine clinical-stage products** across multiple therapeutic areas[19](index=19&type=chunk) - Continue implementing a dual-engine approach of external collaborations and internal discovery to build a global and APAC pipeline[19](index=19&type=chunk) - Leverage the experience of the core commercial team to prepare for XPOVIO®'s first-in-class launch in the APAC region[19](index=19&type=chunk) [Financial Review](index=24&type=section&id=Financial%20Review) H1 2024 revenue was **RMB 60.8 million**, a 15.6% decrease due to XPOVIO® price adjustments and commercial transition, partially offset by sales volume growth, while significant cost controls led to a narrowed loss from **RMB 219 million** to **RMB 167 million** - Revenue decreased by **15.6%** from **RMB 72 million** to **RMB 60.8 million**, primarily due to price reductions for XPOVIO® after its inclusion in the National Reimbursement Drug List and transitional impacts from the partnership with Hansoh Pharmaceutical[53](index=53&type=chunk) - Other income and gains significantly decreased from **RMB 121 million** to **RMB 27.3 million**, mainly due to net foreign exchange gains falling from **RMB 92.3 million** in the prior period to **RMB 6.2 million** this period[54](index=54&type=chunk) R&D Cost Components (RMB thousand) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Employee Costs | 51,327 | 86,920 | | Licensing Fees | – | 40,464 | | Drug Development Expenses | 62,479 | 76,812 | | **Total** | **130,841** | **226,093** | Sales & Distribution Expense Components (RMB thousand) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Milestone Payments | – | 21,286 | | Employee Costs | 12,603 | 42,571 | | Market Development Expenses | 42,729 | 22,754 | | **Total** | **56,028** | **88,246** | - Administrative expenses decreased by **30.2%** from **RMB 83.8 million** to **RMB 58.5 million**, primarily due to reduced employee costs[58](index=58&type=chunk) [Liquidity and Financial Resources](index=29&type=section&id=Liquidity%20and%20Financial%20Resources) As of June 30, 2024, the company held **RMB 1.024 billion** in cash and bank balances, a decrease from **RMB 1.188 billion** at year-end 2023, primarily used for operating expenses, maintaining sufficient liquidity with a current ratio of **572.4%** and a healthy gearing ratio of **32.0%** Financial Position Overview (June 30, 2024) | Indicator | Amount/Ratio (RMB) | | :--- | :--- | | Cash and Bank Balances | 1.024 billion | | Current Assets | 1.113 billion | | Current Liabilities | 194.4 million | | Current Ratio | 572.4% | | Gearing Ratio | 32.0% | - Cash and bank balances are primarily held in US dollars and Renminbi[62](index=62&type=chunk) - As of June 30, 2024, the Group had pledged leased land totaling **RMB 43 million** for bank financing[64](index=64&type=chunk) [Financial Statements](index=12&type=section&id=Financial%20Statements) [Interim Condensed Consolidated Statement of Profit or Loss](index=12&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss) For the six months ended June 30, 2024, the company reported **RMB 60.78 million** in revenue and **RMB 51.92 million** in gross profit, with net loss significantly narrowing from **RMB 219 million** to **RMB 167 million** due to effective cost control, resulting in a basic and diluted loss per share of **RMB 0.27** Profit or Loss Statement Summary (RMB thousand) | Item | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Revenue | 60,779 | 72,016 | | Gross Profit | 51,923 | 59,367 | | Loss Before Tax | (167,033) | (218,694) | | Loss for the Period | (167,033) | (218,694) | | Basic and Diluted Loss Per Share | (0.27) RMB | (0.36) RMB | [Interim Condensed Consolidated Statement of Financial Position](index=14&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, the company's total assets were **RMB 1.461 billion**, total liabilities **RMB 468 million**, and net assets **RMB 994 million**, with **RMB 1.113 billion** in current assets, including **RMB 1.024 billion** in cash and bank balances, indicating a robust financial position and ample liquidity Statement of Financial Position Summary (RMB thousand) | Item | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total Non-Current Assets | 348,737 | 376,763 | | Total Current Assets | 1,112,624 | 1,241,824 | | **Total Assets** | **1,461,361** | **1,618,587** | | Total Current Liabilities | 194,384 | 190,888 | | Total Non-Current Liabilities | 273,369 | 280,315 | | **Total Liabilities** | **467,753** | **471,203** | | **Net Assets** | **993,608** | **1,147,384** | [Notes to Interim Condensed Consolidated Financial Information (Excerpts)](index=16&type=section&id=Notes%20to%20Interim%20Condensed%20Consolidated%20Financial%20Information) Financial notes indicate the company operates in a single segment: R&D and commercialization of pharmaceutical products, with Greater China as the primary revenue source, accounting for **89%** of total revenue, and high customer concentration, as revenue from the largest customer A comprised **88%** of total revenue, while trade receivables increased from **RMB 9.68 million** to **RMB 30.12 million** Revenue from External Customers by Geographical Area (RMB thousand) | Region | H1 2024 | H1 2023 | | :--- | :--- | :--- | | Greater China | 54,044 | 67,255 | | Other Countries/Regions | 6,735 | 4,761 | | **Total** | **60,779** | **72,016** | - During the reporting period, revenue from a single major customer (Customer A) was **RMB 53.57 million**, accounting for **88.1%** of total revenue[31](index=31&type=chunk) - Net foreign exchange gains within other income and gains significantly decreased from **RMB 92.25 million** in the prior period to **RMB 6.18 million**[33](index=33&type=chunk) [Corporate Governance and Other Information](index=31&type=section&id=Corporate%20Governance%20and%20Other%20Information) [Compliance with Corporate Governance Code](index=31&type=section&id=Compliance%20with%20Corporate%20Governance%20Code) During the reporting period, the company largely complied with the Corporate Governance Code, with the only deviation being the Chairman and CEO roles held by Dr. Jianming Mei, an arrangement the Board believes enhances strategic execution and communication, balanced by the board's composition including three independent non-executive directors - The company deviated from Code Provision C.2.1 of the Corporate Governance Code, where the roles of Chairman and Chief Executive Officer are held by the same individual (Dr. Jianming Mei)[65](index=65&type=chunk) - The Board believes this arrangement facilitates effective execution of strategic initiatives and communication, with the Board's structure providing sufficient checks and balances[65](index=65&type=chunk) [Use of Net Proceeds](index=32&type=section&id=Use%20of%20Net%20Proceeds) As of June 30, 2024, approximately **RMB 508 million** of IPO net proceeds remained unutilized, with a reallocation in March 2024 to prioritize preclinical and clinical trial funding, and full utilization expected by December 31, 2025 Use of Net Proceeds (RMB million) | Item | Revised Allocation | Unutilized Amount as of June 30, 2024 | | :--- | :--- | :--- | | Clinical Development & Commercialization of Core Products | 932.63 | – | | Four Other Clinical-Stage Drugs | 117.29 | 3.60 | | Preclinical Research & Clinical Trials | 758.65 | 479.28 | | Pipeline Expansion (BD Activities) | 215.91 | 25.47 | | **Total** | **2,274.70** | **508.35** | - On March 22, 2024, the company reallocated approximately **RMB 554 million** of unutilized net proceeds to 'fund ongoing preclinical research and planned clinical trials for other preclinical candidates in our pipeline'[70](index=70&type=chunk)

Clinical Development - The company received IND approval from the National Medical Products Administration in March 2023 for the ATG-022 treatment for advanced or metastatic solid tumors [26]. - The first patient in Australia was dosed in the CLINCH trial in March 2023, followed by the first patient in mainland China in May 2023 [27][28]. - ATG-022 received orphan drug designation from the FDA for the treatment of gastric cancer and pancreatic cancer in May 2023 [27]. - Preliminary clinical data from the CLINCH trial showed complete response (CR) and partial response (PR) in 2 out of 7 gastric cancer patients [30]. - The clinical pipeline demonstrated promising early results, with four global assets showing positive outcomes in Phase I dose escalation studies [45]. - ATG-008, an mTORC1/2 inhibitor, achieved an objective response rate (ORR) of 53.3% in cervical cancer patients who had not previously used immune checkpoint inhibitors (ICIs) [51]. - ATG-101, a bispecific antibody, showed promising results with partial responses in metastatic colorectal cancer patients, indicating potential for further development [51]. - The first patient in the PERFORM trial for ATG-031 was dosed in December 2023 [119]. - The company received FDA IND approval for ATG-031 to initiate Phase I trials for advanced solid tumors or B-NHL patients in May 2023 [119]. - The first patient was dosed in the I phase study of ATG-017 (ERK1/2 inhibitor) for advanced solid tumors and hematologic malignancies in July 2023 [146]. - Early data from the I phase trial of ATG-101 (a novel PD-L1/4-1BB bispecific antibody) showed partial response in a patient with metastatic colon adenocarcinoma, with ongoing trials in mainland China, Australia, and the US [147]. - The first patient was dosed in July 2023 in mainland China for the I phase trial of ATG-037 (CD73 inhibitor) as monotherapy and in combination with a PD-1 antibody for locally advanced or metastatic solid tumors [148]. - In May 2023, the company announced the latest results of the I/II phase TORCH-2 study for Onatasertib (ATG-008), which were subsequently presented at the ASCO 2023 conference [144]. - The open-label Phase II study of Eltanexor (ATG-016) for high-risk myelodysplastic syndromes was completed in mainland China [145]. Financial Performance - The company reported a cash balance of RMB 1.188 billion, ensuring funding for future drug development pipelines without the need for additional financing [54]. - The company has a 10-year validity period for its 2022 Restricted Share Unit Plan, with approximately 7.5 years remaining [16]. - The company has adopted a dividend policy without a preset payout ratio, considering financial performance, cash flow, and future operations when deciding on dividends [157]. - The company anticipates achieving significant clinical data for each project in its product portfolio and advancing at least one new project into the clinical stage in 2024 [169]. Corporate Governance - The company has adopted the principles and code provisions of the Corporate Governance Code as the basis for its corporate governance practices [33]. - The board consists of seven members, including three executive directors, one non-executive director, and three independent non-executive directors [36]. - The board held six meetings during the fiscal year ending December 31, 2023, exceeding the minimum requirement of four regular meetings per year [86]. - The company aims to maintain at least 10% female representation on the board, currently achieved with one female director among seven members [99]. - The board has delegated the responsibility of selecting and appointing directors to the nomination and corporate governance committee [103]. - The company has established procedures for identifying, handling, and disclosing inside information, including annual reviews of the insider information disclosure policy [93]. - The board is responsible for ensuring effective internal controls to safeguard shareholder investments, with policies in place for ongoing risk identification and assessment [90]. - The board consists of at least one-third independent non-executive directors, aligning with the company's diversity policy [102]. - The nomination and corporate governance committee evaluates the independence of non-executive directors based on criteria outlined in the listing rules [105]. - The company has implemented measures to ensure compliance with corporate governance codes and regularly reviews its governance policies [97]. - The board has reviewed the effectiveness of the risk management and internal control systems and deemed them effective and adequate [117]. Strategic Partnerships and Market Expansion - The commercial business achieved three key milestones, including the commercial partnership for the drug Xivio® in China and its inclusion in the national medical insurance catalog [53]. - The company is focused on expanding the regulatory and reimbursement approval scope for Xivio® in the Asia-Pacific region, aiming for increased market potential [53]. - In August 2023, the company entered a commercialization agreement with Hansoh Pharmaceutical for the drug Xivivo® (Selinexor) in mainland China, with a maximum upfront payment of RMB 200 million, including RMB 100 million upon signing [56]. - Xivivo® (Selinexor) was included in the National Medical Insurance Catalog (2023 version) effective January 1, 2024, for treating adult patients with relapsed/refractory multiple myeloma (rrMM) who have received at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 monoclonal antibody [56]. - In May 2023, the company submitted a New Drug Application (NDA) for Xivivo® (Selinexor) to the Indonesian Food and Drug Authority for treating rrMM and relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) [57]. - In June 2023, Xivivo® (Selinexor) was included in the Pharmaceutical Benefits Scheme (PBS) in Australia for treating adult patients with rrMM who have received at least one prior treatment [57]. - In July 2023, the Hong Kong Department of Health approved the NDA for Xivivo® (Selinexor) for treating adult patients with rrMM who have undergone at least four prior treatments and experienced disease progression [57]. - The company will continue to record revenue from Selinexor sales in mainland China while Hansoh Pharmaceutical will charge service fees [125]. Risk Management and Compliance - The company has established a comprehensive risk management policy to identify, assess, and monitor key risks related to its strategic objectives [112]. - The company has established a strict anti-corruption policy for personnel with external communication functions to ensure compliance with promotional and advertising regulations [140]. - The company has set up an internal audit function, risk management, and internal control systems deemed appropriate for its business operations [140]. - The company has not identified any significant uncertainties that may affect its ability to continue as a going concern [118]. Environmental, Social, and Governance (ESG) - The company emphasizes a corporate culture focused on employee development, workplace safety, and sustainability [32]. - The company has established a management framework for environmental, social, and governance (ESG) strategies, with the board fully responsible for the sustainability strategy and reporting [191]. - A total of HKD 5 million has been deposited as green deposits to support eligible green projects, including green buildings and renewable energy initiatives [200]. - The company plans to establish several ESG-related goals and conduct progress reviews to enhance its sustainability efforts based on actual business conditions [191]. - The company encourages shareholders to provide email addresses for timely and effective communication [170]. - The company received recognition as one of the "Top 10 Most Growth-Oriented Antibody Drug Enterprises" at the 2023 China Biopharmaceutical Innovation Cooperation Conference [190]. - The company aims to maintain strategic thinking with a strong emphasis on quality, integrity, and financial standards in its operations [169].

Financial Performance - Other income and revenue decreased from RMB 293.9 million for the year ended December 31, 2022, to RMB 115.8 million for the year ended December 31, 2023, a decline of 60.6% primarily due to a decrease in net foreign exchange gains[2]. - Loss for the year decreased from RMB 601.5 million for the year ended December 31, 2022, to RMB 581.2 million for the year ended December 31, 2023, a reduction of 3.9%[3]. - Adjusted loss for the year decreased from RMB 550.2 million for the year ended December 31, 2022, to RMB 533.9 million for the year ended December 31, 2023, a decrease of 3.0% attributed to reduced sales and distribution expenses, R&D costs, and administrative expenses[17]. - Total revenue for 2023 was RMB 67,305 thousand, down from RMB 160,135 thousand in 2022, indicating a decline of about 58.1%[66]. - The company reported a pre-tax loss of RMB (581,183) thousand for 2023, an improvement from a loss of RMB (601,488) thousand in 2022[77]. - The company’s gross profit for the year was RMB 55,012 thousand, compared to RMB 132,004 thousand in the previous year[116]. - The adjusted loss for the year was RMB (533,904) thousand, an improvement from RMB (550,184) thousand in the previous year[117]. - The company’s basic loss per share for 2023 was calculated based on a weighted average of 615,438,058 shares, compared to 617,822,464 shares in 2022[79]. - Revenue decreased from RMB 1,601 million in 2022 to RMB 673 million in 2023, a decline of approximately 57.9%[91]. Expenses and Costs - Sales and distribution expenses decreased from RMB 355.4 million for the year ended December 31, 2022, to RMB 192.7 million for the year ended December 31, 2023, a reduction of 45.9% due to commercialization cooperation with Hansoh Pharmaceutical[16]. - Research and development expenses decreased significantly from RMB 307,132,000 in 2022 to RMB 183,269,000 in 2023, a reduction of approximately 40.5%[92]. - Administrative expenses decreased from RMB 167.1 million for the year ended December 31, 2022, to RMB 148.1 million for the year ended December 31, 2023, a reduction of RMB 19.0 million[145]. - Employee costs increased to RMB 151,674,000 in 2023 from RMB 142,137,000 in 2022, representing a rise of about 6.8%[92]. - The company’s share-based payment expenses amounted to RMB 47,279 thousand, down from RMB 51,304 thousand in the previous year[122]. Revenue Growth and Agreements - The company recorded revenue of RMB 359,949 thousand in the Greater China region for 2023, a significant increase from RMB 228,715 thousand in 2022, representing a growth of approximately 57.3%[53]. - The company entered into a commercialization agreement with Hansoh Pharmaceutical for Selinexor in mainland China, with a potential upfront payment of up to RMB 200 million[33]. - In August 2023, the company entered into a commercialization agreement with Hansoh Pharmaceutical for XPOVIO® (Selinexor) in mainland China, with a maximum upfront payment of RMB 200 million, including RMB 100 million upon signing the agreement[41]. - The company expects future revenue growth due to the inclusion of its product in the national medical insurance catalog effective January 1, 2024[91]. Assets and Liabilities - The company’s non-current assets totaled RMB 365,817 thousand in 2023, compared to RMB 237,162 thousand in 2022, representing a growth of approximately 54.2%[53]. - The total liabilities decreased from RMB 363,061,000 in 2022 to RMB 179,766,000 in 2023, a decline of about 50.5%[86]. - Trade receivables as of December 31, 2023, were RMB 9,684,000, significantly lower than RMB 29,767,000 in 2022, indicating a decrease of approximately 67.5%[83]. - The company’s debt-to-asset ratio increased to 29.1% as of December 31, 2023, up from 20.0% in the previous year[125]. - The company has no significant contingent liabilities as of December 31, 2023[150]. Research and Development - The company received IND approval from the FDA in March 2023 to initiate a Phase I trial for ATG-031 in patients with advanced solid tumors or B-NHL[39]. - The new "2+1" T cell engager platform AnTenGagerTM is making steady progress, designed to conditionally activate T cells and reduce the risk of cytokine release syndrome (CRS)[40]. - The company reported a total of 103 employees in R&D, accounting for 51.2% of total employees[123]. - The company plans to allocate approximately 25% of the net proceeds from fundraising to ongoing and planned clinical trials for four other clinical-stage drug candidates, amounting to RMB 568.67 million[182]. Government Grants and Other Income - The company received government grants totaling RMB 29,881 thousand in 2023, compared to RMB 10,426 thousand in 2022, reflecting an increase of approximately 187.5%[59]. - The company’s other income totaled RMB 68,709 thousand in 2023, up from RMB 38,649 thousand in 2022, marking an increase of about 77.9%[59]. - The total other income and gains for the year were RMB 115,786 million, compared to RMB 293,904 million in the previous year[187]. Future Plans and Investments - The company plans to continue recording revenue from the sales of XPOVIO® (Selinexor) in mainland China, while Hansoh Pharmaceutical will charge service fees[41]. - The company has no significant investment or capital asset plans as of December 31, 2023[100]. - The company has pledged a total of RMB 43.4 million of leased land to secure bank financing[127]. - Approximately 14% of the net proceeds from fundraising is planned to be used to expand the pipeline, including the discovery of new drug candidates[136]. - The company plans to invest in expanding its pipeline, including discovering new drug candidates and business development activities, with a budget allocation of 14% of net proceeds, amounting to RMB 318.46 million[191]. Compliance and Governance - The company’s financial performance for the year ended December 31, 2023, has been reviewed and deemed compliant with relevant accounting standards and regulations[192]. - The board of directors includes executive director Dr. Jianming Mei, who also serves as the chairman and CEO, promoting effective execution of strategic initiatives[152]. - The company does not recommend the distribution of dividends for the year ended December 31, 2023[164].