Summary of Key Points from the Conference Call Company and Industry Overview - The conference call focuses on the company 基石药业 (CS2009) and its innovative drug development in the oncology sector, particularly targeting non-small cell lung cancer (NSCLC) and other cancer types. Core Insights and Arguments - **CS2009 Drug Mechanism**: CS2009 is a tri-antibody structure designed to enhance T cell activation and tumor immune response while minimizing side effects on peripheral tissues. Its CTLA-4 affinity is approximately 20 nanomolar [2][4][6]. - **Clinical Trial Results**: Initial clinical trial data shows a disease control rate (DCR) of 71.4%, significantly higher than the typical 30% seen in phase I trials. The overall response rate (ORR) is reported at 14.3% [2][14][15]. - **Safety Profile**: The incidence of grade 3 or higher adverse events (T2A1) is 13.94%, with minimal VEGF-related toxicity. The drug demonstrates excellent tolerability with common adverse reactions at low levels and no significant accumulation effects, having a half-life of 6 to 8 days [2][11][13]. - **Phase II and Future Trials**: Phase II trials have commenced, focusing on NSCLC patients, with plans to communicate with the FDA in mid-2026 to advance to phase III trials. Future trials will include first-line NSCLC and other cancer types, potentially in combination with chemotherapy or ADC treatments [2][9][20]. Additional Important Insights - **Dosing Strategy**: The potential recommended phase II dose (RP2D) is being considered at 30 mg based on preliminary data showing good efficacy and low adverse event rates. Randomized controlled trials will compare 20 mg and 30 mg doses [5][22]. - **Patient Demographics**: The median age of patients in the trials is 60 years, with a maximum age of 80 years. Over half of the patients are from Australia, which is significant for safety validation [8]. - **Response in Various Cancer Types**: The treatment shows promise across various difficult-to-treat tumors, including small cell lung cancer, ovarian cancer, triple-negative breast cancer, and soft tissue sarcoma, with a notable 66.7% DCR in soft tissue sarcoma [16]. - **Comparative Analysis with Other Drugs**: CS2009's safety profile is favorable compared to other drugs like AK104 and AK112, which have higher rates of grade 3 or higher adverse events exceeding 20% [12]. - **Future Communication with FDA**: The company plans to provide phase I data during the IND stage and will decide on the RP4D after phase II completion, aiming to initiate phase III trials by mid-2026 [27]. Conclusion - The company is making significant strides in developing CS2009 as a promising treatment for various cancers, with a strong focus on safety and efficacy. The upcoming clinical trials and strategic partnerships are expected to enhance its market position and therapeutic potential.

每经AI快讯，10月20日，截至发稿，永泰生物-B(06978.HK)涨14.94%、和珀医药-B(02142.HK)涨 5.32%、荣昌生物(09995.HK)涨5.14%、药捷安康(02617.HK)涨5.02%、基石药业-B(02616.HK)涨3.92%。 ...

Core Insights - The company announced the presentation of preliminary data from its Phase I clinical study of CS2009 (a PD1/VEGF/CTLA-4 trispecific antibody) at the 2025 European Society for Medical Oncology (ESMO) annual meeting [1] - The company also revealed the design of its Phase Ib clinical study for CS5001 (a ROR1 antibody-drug conjugate) [1] Summary by Categories - **Clinical Research Updates** - Preliminary data for CS2009 was presented for the first time at a major oncology conference [1] - The design of the Phase Ib clinical study for CS5001 was disclosed [1]

Core Viewpoint - The company announced the presentation of preliminary data from its Phase I clinical study of CS2009 (a tri-specific antibody targeting PD1/VEGF/CTLA-4) and the design of the Phase Ib clinical study for CS5001 (a ROR1 antibody-drug conjugate) at the 2025 European Society for Medical Oncology (ESMO) annual meeting [1] Group 1 - The company is set to present its first clinical research data for CS2009 at a major oncology conference [1] - CS2009 is a tri-specific antibody that targets PD1, VEGF, and CTLA-4, indicating a novel approach in cancer treatment [1] - The design of the Phase Ib clinical study for CS5001 will also be unveiled, showcasing the company's ongoing research efforts in antibody-drug conjugates [1]

CStonePharmaceuticals 基石藥業 ( 於開曼群島註冊成立的有限公司 ) 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。 本公告所作出的前瞻性陳述僅與本文作出該陳述當日的事件或資料有關。除法律規定外，於作出前 瞻性陳述當日之後，無論是否出現新資料、未來事件或其他情況，我們並無責任更新或公開修改任 何前瞻性陳述及預料之外的事件。請細閱本公告，並理解我們的實際未來業績或表現可能與預期有 重大差異。本公告中有關我們或任何董事及╱或本公司的意向的陳述或提述乃於本公告刊發日期作 出。任何該等意向均可能因未來發展而出現變動。 (股份代號：2616) 自願 公告 ESMO 2025：基石藥業揭曉CS2009（PD-1/VEGF/CTLA-4三特異性抗體）Ⅰ期臨床試驗數據 本公告乃由基石藥業(「本公司」連同其附屬公司統稱(「本集團」或「基石藥業」)自願作出， 以使本公司股東及潛在投資者瞭解本集團的最新業務發展。 ……………………………………………… ...

Core Viewpoint - 基石药业's drug, Sugli monoclonal antibody, received a positive opinion from the European Medicines Agency (EMA) for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1% and have not progressed after platinum-based chemoradiotherapy [1] Group 1: Company Developments - The CEO of 基石药业, Dr. Yang Jianxin, expressed satisfaction with the rapid and positive progress of the EMA review for Sugli monoclonal antibody, marking the second positive recommendation from CHMP within a year [1] - If approved, Sugli monoclonal antibody will solidify its position as a core immunotherapy for lung cancer, significantly enhancing its market position and commercial potential [1] - The company aims to collaborate with partners to accelerate the comprehensive launch of Sugli monoclonal antibody in the European market, providing high-quality and affordable treatment options for more patients [1] Group 2: Clinical Research Insights - The positive opinion for the new indication of Sugli monoclonal antibody is based on the GEMSTONE-301 study, a multicenter, randomized, double-blind phase III clinical trial demonstrating dual benefits in progression-free survival and overall survival for stage III NSCLC patients [1] - If the new indication is approved, Sugli monoclonal antibody will become the second PD-(L)1 antibody approved for stage III NSCLC in Europe, addressing a critical need in this disease area and offering new hope for patients [1] - The efficient positive opinion from CHMP is seen as recognition of the clinical development and registration team's efforts at 基石药业, reinforcing the commitment to meet the urgent medical needs of patients in China and globally [1]

Core Insights - The biotechnology sector in the Hong Kong stock market has shown strong performance, with several stocks experiencing significant gains today, particularly药捷安康-B which surged over 30% [1] Stock Performance Summary - 药捷安康-B: Increased by 31.25%, latest price at 218.000, total market value of 86.524 billion, year-to-date increase of 1557.79% [2] - 康宁杰瑞制药-B: Increased by 7.15%, latest price at 14.680, total market value of 14.245 billion, year-to-date increase of 319.43% [2] - 帝王国际投资: Increased by 5.50%, latest price at 0.115, total market value of 0.0213 billion, year-to-date increase of 155.56% [2] - 映恩生物-B: Increased by 5.00%, latest price at 336.000, total market value of 29.58 billion, year-to-date increase of 255.18% [2] - 基石药业-B: Increased by 4.66%, latest price at 7.190, total market value of 10.612 billion, year-to-date increase of 212.61% [2] - 三叶草生物-B: Increased by 4.39%, latest price at 2.140, total market value of 2.776 billion, year-to-date increase of 787.97% [2] - 百奥塞图-B: Increased by 3.86%, latest price at 24.220, total market value of 9.673 billion, year-to-date increase of 184.94% [2] - 来凯医药-B: Increased by 3.71%, latest price at 14.540, total market value of 6.49217 billion, year-to-date increase of 55.18% [2] - 君实生物: Increased by 3.29%, latest price at 27.600, total market value of 28.337 billion, year-to-date increase of 138.34% [2] - MIRXES-B: Increased by 3.26%, latest price at 72.900, total market value of 20.145 billion, year-to-date increase of 212.88% [2]

每经AI快讯，基石药业-B(02616.HK)早盘涨超9%，截至发稿，涨6.11%，报7.29港元，成交额1204.8万 港元。 ...

Group 1 - The core point of the article highlights the significant stock price increase of Basestone Pharmaceuticals (02616), which rose over 9% in early trading and is currently at 7.29 HKD with a trading volume of 12.048 million HKD [1] - GIC has increased its stake in Basestone Pharmaceuticals to 6% as of October 13, marking its second substantial purchase in less than two months, having previously acquired 80.4 million shares for over 630 million HKD on August 18 [1] - The European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sugli monoclonal antibody for the treatment of adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed after platinum-based chemoradiotherapy [1]

Group 1 - The core viewpoint of the article highlights the significant stock price increase of Basilea Pharmaceutica (02616), which rose over 9% in early trading and is currently up 6.11% at HKD 7.29, with a trading volume of HKD 12.048 million [1] - GIC has increased its stake in Basilea Pharmaceutica to 6% as of October 13, marking its second substantial purchase in less than two months, having previously acquired 80.4 million shares for over HKD 630 million on August 18 [1] - The European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sugliatinib as a monotherapy for adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression ≥1% and have not progressed after platinum-based chemoradiotherapy [1]