格隆汇10月20日丨基石药业-B(02616.HK)宣布公司在2025年欧洲肿瘤内科学会(ESMO)年会上首次发表 CS2009(PD1/VEGF/CTLA-4三特异性抗体)的I期临床研究初步数据和CS5001(ROR1抗体偶联药物[ADC]) 的Ib期临床研究设计。 ...

Core Insights - 康方生物's HARMONi-6/AK112–306 study results were prominently presented at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivoris combined with chemotherapy compared to Tarelizumab combined with chemotherapy for advanced sq-NSCLC [1][2] Study Overview - HARMONi-6/AK112–306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivoris combined with chemotherapy versus Tarelizumab combined with chemotherapy as first-line treatment for advanced sq-NSCLC, with the primary endpoint being progression-free survival (PFS) evaluated by IRRC based on RECIST v1.1 [1][3] - The study enrolled 532 participants, with a balanced baseline, and 92.3% of subjects being in stage IV; the characteristics of squamous cell carcinoma were consistent with real-world patient distribution, with approximately 63% being central squamous cell carcinoma [1][3] Efficacy Results - The study achieved a significant positive result for the primary endpoint of PFS, with Ivoris showing a marked improvement over the control group, resulting in a PFS hazard ratio (HR) of 0.60 (p<0.0001) [1][2] - The median PFS for the Ivoris group was 11.14 months compared to 6.9 months for the control group, indicating an absolute improvement of 4.24 months in PFS [1][2] Subgroup Analysis - In the PD-L1 negative population (TPS ≤ 1%), the median PFS was 9.9 months versus 5.7 months, with a PFS HR of 0.55 [2] - In the PD-L1 positive population (TPS ≥ 1%), the median PFS was 12.6 months versus 8.6 months, with a PFS HR of 0.66 [2] - The PFS HR for patients with liver metastases was 0.53, while for those without liver metastases, it was 0.64; for patients with three or more baseline metastatic sites, the PFS HR was 0.46 [2] Safety Profile - The overall safety profile of the Ivoris group was favorable, with no new safety signals identified; the incidence of treatment-related serious adverse events and grade 3 or higher bleeding events was similar to the control group [2] Regulatory Status - The new indication application for Ivoris combined with chemotherapy for first-line treatment of sq-NSCLC has been accepted by the CDE and is currently under review, potentially offering hope to more patients [2]

Core Viewpoint - The company announced the presentation of multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1: Clinical Research Results - The company presented data on the targeted antibody-drug conjugate (ADC) sac-TMT (佳泰莱®), which targets trophoblast cell surface antigen 2 (TROP2) [1] - The company also showcased results for the HER2-targeted ADC A166 (舒泰莱®) [1] - Additionally, data related to the Claudin18.2 (CLDN18.2) ADC SKB315 was presented [1]

Core Insights - The clinical trial results of HARMONi-6 / AK112-306 were prominently presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivosidenib combined with chemotherapy for advanced sq-NSCLC [1][2] Group 1: Clinical Trial Overview - HARMONi-6 / AK112-306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivosidenib combined with chemotherapy versus Toripalimab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1][2] - The study enrolled 532 participants, with 92.3% of subjects in clinical stage IV, and the characteristics of squamous cell carcinoma were consistent with real-world patient distribution [1][2] Group 2: Key Findings - Ivosidenib combined with chemotherapy achieved a significant improvement in progression-free survival (PFS) compared to Toripalimab, with a hazard ratio (HR) of 0.60 and a p-value of <0.0001 [1] - The median PFS for the Ivosidenib group was 11.14 months, while the control group had a median PFS of 6.9 months, resulting in an absolute improvement of 4.24 months [1] Group 3: Subgroup Analysis - Significant benefits of Ivosidenib were observed across various subgroups, including those with different PD-L1 expression levels and liver metastasis status [1] - In the PD-L1 negative population, the median PFS was 9.9 months versus 5.7 months (HR = 0.55) [1] - In the PD-L1 positive population, the median PFS was 12.6 months versus 8.6 months (HR = 0.66) [1] Group 4: Safety Profile - The overall safety profile of the Ivosidenib group was favorable, with no new safety signals identified, and the incidence of treatment-related serious adverse events was similar to the control group [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966.HK) announced the research progress of JSKN003, a targeted HER2 bispecific ADC, which was presented at the 2025 ESMO conference from October 17 to October 21, 2025 [1] Group 1: Product Development - JSKN003 is a targeted HER2 bispecific ADC that connects a topoisomerase I inhibitor to the N-glycosylation site of the KN026 antibody using glycosylation point coupling technology [1] - The coupling reaction of the click reaction conjugate shows better serum stability compared to the maleimide-Michael reaction conjugate [1] - JSKN003 exhibits stronger endocytosis activity and bystander killing effect due to its dual targeting of HER2, demonstrating significant antitumor activity in HER2-expressing tumors [1] Group 2: Licensing and Clinical Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop, sell, and commercialize JSKN003 in mainland China for tumor-related indications [1] - Currently, three Phase III clinical trials for JSKN003 are ongoing, targeting HER2+ breast cancer, HER2-low expressing breast cancer, and PROC [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。 ……………………………………………… ...

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之內容概不負責，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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003於2025年ESMO大會上展示的研究進展 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，JSKN003的研究進展已於2025年 10月17日至10月21日舉行的2025年ESMO大會壁報展示期間公佈。此研究進展概 述如下。 JSKN003治療原發性鉑難治OC患者的療效及安全性 JSKN003-102為一項在中國晚期實體瘤患者中開展的I期（劑量遞增及劑量擴展） 及II期（隊列擴展）臨床研究。截至2025年6月13日，共有26名原發性鉑難治OC患 者接受JSKN003治療(6.3mg/kg，Q3W)。患者中位年齡為54歲，其 ...

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之內容概不負責，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。 ALPHAMAB ONCOLOGY 康寧傑瑞生物製藥 （於開曼群島註冊成立的有限公司） （股份代號：9966） 自願公告 JSKN003再次獲得CDE突破性療法認定 本公告乃由康寧傑瑞生物製藥（「本公司」，連同其附屬公司統稱「本集團」）自願作 出，以知會本集團股東（「股東」）及潛在投資者有關本集團之最新業務進展。 本公司董事（「董事」）會（「董事會」）欣然宣佈，與石藥集團有限公司（股份代號： 1093）附屬公司上海津曼特生物科技有限公司合作開發的JSKN003獲得CDE突破 性療法認定，用於治療既往經奧沙利鉑、氟尿嘧啶和伊立替康治療失敗的HER2+ 晚期CRC患者。此前，JSKN003已於2025年3月獲得CDE突破性療法認定，用於 治療PROC，且不限HER2表達水平。有關詳情請參閱本公司日期為2025年3月18 日的公告。 本公司曾在2025年美國臨床腫瘤學會(ASCO)年會上發表過一項JSKN00 ...

自願公告 JSKN 003於中國再次獲授予突破性治療認定 用於治療HER2陽性晚期結直腸癌患者 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之內容概不負責，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 生或因倚賴該等內容而引致之任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED 石 藥 集 團 有 限 公 司 （股份代號：1093） （於香港註冊成立之有限公司） 在 2025 年 美 國 臨 床 腫 瘤 學 會 (ASCO ) 年 會 上 ， 一 項「 JSKN 003 單 藥 治 療 晚 期 HER2 高 表 達 （ IHC3 + ）胃腸道腫瘤患者的兩項臨床研究匯總分析」被發表。該項匯總分析包括在澳大利亞 進行的I期臨床研究(JSKN 003 -101)和在中國進行的I / II期臨床研究(JSKN 003 -102)。截至2025 年2 月 28 日 ，兩項 研究 共入組 50 例 HER2高 表達 的晚期 胃腸道 腫瘤 患者（ 其 中23 例為結 直腸 癌 ），其中38 %的患者既往接受過≥ 3線抗腫瘤治療。初 ...

Core Viewpoint - The company announced the presentation of multiple clinical research results at the 2025 European Society for Medical Oncology (ESMO) conference held in Berlin from October 17 to 21 [1] Group 1: Clinical Research Results - The clinical studies include data on the antibody-drug conjugate (ADC) targeting Trophoblast Cell Surface Antigen 2 (TROP2), sac-TMT (佳泰莱®) [1] - The research also covers the ADC targeting Human Epidermal Growth Factor Receptor 2 (HER2), known as A166 (舒泰莱®) [1] - Additionally, data on Claudin18.2 (CLDN18.2) ADC SKB315 is presented [1]