消息面上，科伦博泰生物-B发布公告，本公司已在于10月17日至21日在德国柏林举行的2025年欧洲肿瘤 内科学会(ESMO)大会上公布多项临床研究成果，涵盖靶向人滋养细胞表面抗塬2(TROP2)抗体偶联药物 (ADC)芦康沙妥珠单抗(sac-TMT)(佳泰莱)、靶向人类表皮生长因子受体2(HER2)ADC博度曲妥珠单抗(亦 称A166)(舒泰莱)以及Claudin18.2 (CLDN18.2) ADC SKB315的相关数据。 智通财经APP获悉，科伦博泰生物-B(06990)高开逾5%，截至发稿，涨5.37%，报483港元，成交额 159.39万港元。 ...

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 announcement highlights the collaboration between Shanghai Jinmant Biotech Co., Ltd. and Jiangsu Kanion Pharmaceutical Co., Ltd. for the development of JSKN003, a targeted HER2 bispecific antibody-drug conjugate, which has received breakthrough therapy designation from the National Medical Products Administration for treating HER2-positive advanced colorectal cancer patients who have failed previous treatments [1] Group 1 - The drug JSKN003 is specifically indicated for use as a monotherapy in patients with HER2-positive advanced colorectal cancer who have previously failed treatments with oxaliplatin, fluorouracil, and irinotecan [1] - The breakthrough therapy designation signifies the potential of JSKN003 to offer significant benefits over existing therapies for the targeted patient population [1]

Core Insights - The company Kogei Pharmaceutical-B (02171) announced the results of its clinical trial for the CAR-T cell therapy candidate, Shurui Jiao Lun Sai Injection (CT041), targeting Claudin18.2 for pancreatic cancer, which will be presented at the 2025 ESMO annual meeting [1][2] Group 1: Product Overview - Shurui Jiao Lun Sai Injection is a potential first-in-class autologous CAR-T cell therapy targeting Claudin18.2 protein, primarily for treating Claudin18.2 positive solid tumors, including gastric and pancreatic cancers [2] - Ongoing trials include various phases for different indications, such as advanced gastric/esophageal junction adenocarcinoma and adjuvant therapy for pancreatic cancer [2] Group 2: Regulatory Milestones - On June 25, 2025, the National Medical Products Administration (NMPA) of China accepted the New Drug Application (NDA) for Shurui Jiao Lun Sai Injection for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma patients who have failed at least second-line treatment [3] - The product received priority review status from the NMPA in May 2025 and was designated as a breakthrough therapy by the NMPA in March 2025 [3] - In January 2022, the product was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA in the United States for treating Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma [3]

Core Viewpoint - The announcement by Kintor Pharmaceutical regarding the clinical trial results of its CAR-T cell therapy candidate targeting Claudin18.2 for pancreatic cancer has significant implications for the company's future in oncology treatments [1][2]. Group 1: Clinical Trials and Research - The clinical trial CT041-ST-05, focusing on the use of Claudin18.2-targeted CAR-T cells for adjuvant therapy in high-risk pancreatic cancer, was presented at the 2025 ESMO annual meeting [1]. - Multiple clinical trials are underway for the candidate, including studies for advanced gastric/esophageal junction adenocarcinoma and pancreatic cancer, indicating a broad application of the therapy [2]. Group 2: Regulatory Approvals and Designations - The National Medical Products Administration (NMPA) in China accepted the New Drug Application (NDA) for the therapy on June 25, 2025, for treating advanced gastric/esophageal junction adenocarcinoma [3]. - The therapy has received priority review status and breakthrough therapy designation from the NMPA, highlighting its potential significance in treating patients who have failed at least second-line therapy [3]. - In the United States, the therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation and orphan drug status by the FDA, further emphasizing its innovative nature and potential market impact [3].

Core Insights - The company, Shiyao Group, announced that its subsidiary, Shanghai Jinmant Biotech Co., Ltd., has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for the treatment of HER2-positive advanced colorectal cancer patients who have failed previous treatments with oxaliplatin, fluorouracil, and irinotecan [1][4] Industry Context - Colorectal cancer is one of the most common malignancies globally, with 1.9262 million new cases and 903,900 deaths reported in 2022, ranking third in incidence and second in mortality among all cancers [2] - In China, colorectal cancer has a high incidence rate, second only to lung cancer, with over 500,000 new cases annually, and the number is rising [2] - Current approved treatments for HER2-positive advanced colorectal cancer patients who have failed previous therapies include regorafenib, fruquintinib, and trifluridine/tipiracil, but these have limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2] Clinical Research Findings - Preliminary clinical research results for JSKN003 show significant efficacy and good safety in the target patient population, with an objective response rate (ORR) of 61.9% and a disease control rate (DCR) of 95.2% among patients who had at least one tumor efficacy assessment [3] - The median progression-free survival (mPFS) for colorectal cancer patients treated with JSKN003 was reported at 13.77 months, with a median duration of response (mDoR) of 12.06 months [3] - Safety data indicated that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), and no TRAEs led to treatment discontinuation or death [3] Regulatory Developments - JSKN003 has received its second breakthrough therapy designation, previously granted for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4] - The ongoing clinical studies for JSKN003 in China include multiple Phase II and III trials for various solid tumors, including breast cancer, ovarian cancer, and gastric cancer, which will expedite the product's development and review process [4]

Core Viewpoint - The announcement highlights the breakthrough therapy designation granted to JSKN003, a targeted HER2 bispecific antibody-drug conjugate, for treating HER2-positive metastatic colorectal cancer patients who have failed previous treatments [1][4]. Group 1: Company Developments - Shanghai Jinmant Biotech, a subsidiary of the company, collaborates with Jiangsu Hengrui Medicine Co., Ltd. to develop JSKN003 [1]. - JSKN003 has received its second breakthrough therapy designation, previously granted for treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [4]. - The ongoing clinical studies for JSKN003 include multiple Phase II and III trials for treating breast cancer, ovarian cancer, and gastric cancer in China [4]. Group 2: Industry Context - Colorectal cancer is one of the most common malignancies globally, with 1.9262 million new cases and 903,900 deaths reported in 2022, ranking third in incidence and second in mortality among all cancers [2]. - In China, colorectal cancer has a high incidence rate, with over 500,000 new cases annually, making it the second most common cancer after lung cancer [2]. - Current approved treatments for HER2-positive metastatic colorectal cancer in China show limited efficacy, with median progression-free survival (mPFS) of only 2-3.7 months and median overall survival (mOS) of 7-10 months [2]. Group 3: Clinical Research Findings - Preliminary clinical research results for JSKN003 indicate significant efficacy and safety in treating HER2-positive metastatic colorectal cancer, with an objective response rate (ORR) of 61.9% and disease control rate (DCR) of 95.2% among patients who had at least one tumor efficacy assessment [3]. - The median progression-free survival (mPFS) for colorectal cancer patients treated with JSKN003 was reported at 13.77 months, with a median duration of response (mDoR) of 12.06 months [3]. - Safety data from the Phase II recommended dose cohort showed that only 14.0% of patients experienced grade 3 or higher treatment-related adverse events (TRAEs), with no treatment-related deaths reported [3].

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, focusing on various antibody-drug conjugates (ADCs) targeting specific cancer markers [1] Group 1: Clinical Research Results - The company presented data on the TROP2-targeted ADC sac-TMT (佳泰莱) [1] - The company showcased results for the HER2-targeted ADC A166 (舒泰莱) [1] - The company also reported findings related to the Claudin18.2-targeted ADC SKB315 [1]

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]