Core Viewpoint - Henlius USA Inc., a wholly-owned subsidiary of the company, has received Orphan-drug Designation from the FDA for HLX43, a targeted PD-L1 antibody-drug conjugate intended for the treatment of thymic epithelial tumors (TETs) [1][2] Group 1: Product Development - HLX43 is a novel antibody-drug conjugate developed by the company, combining a DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody, aimed at treating advanced/metastatic solid tumors [1][2] - The Phase 1 clinical trial data for HLX43, particularly in lung cancer populations, will be updated at the World Conference on Lung Cancer (WCLC) in September 2025, showing a 37.0% objective response rate (ORR) and an 87.0% disease control rate (DCR) in patients with advanced solid tumors [2] Group 2: Regulatory and Market Implications - The Orphan-drug Designation from the FDA will facilitate the subsequent research, registration, and commercialization of HLX43 for TETs in the U.S., providing benefits such as tax credits for clinical trial costs, waiver of new drug application fees, and seven years of market exclusivity post-approval [2] - If other similar drugs for the same indication are approved before HLX43, the company must demonstrate clinical superiority to maintain the market exclusivity benefits associated with the Orphan-drug status [3]

Core Insights - Hansoh Pharmaceutical has entered into a licensing agreement with a Roche subsidiary for its investigational drug HS-20110, allowing global development, production, and commercialization while retaining rights in Greater China [1] - The deal includes an upfront payment of $80 million and potential milestone payments totaling up to $1.45 billion, with a total potential deal value of $1.53 billion [1] - The drug is a targeted ADC (antibody-drug conjugate) aimed at CDH17, currently in global Phase I clinical trials for colorectal cancer and other solid tumors [1] Company Summary - Hansoh Pharmaceutical has previously engaged in two licensing deals in the ADC field with GlaxoSmithKline, with upfront payments of $85 million and $185 million, and potential milestone payments of $1.485 billion and $1.525 billion respectively [2] - The company reported a research and development expenditure of approximately RMB 1.441 billion in the first half of 2025 [1] - Following the announcement of the licensing deal, Hansoh Pharmaceutical's stock rose by 3.92%, reaching HKD 37.1 per share, with a total market capitalization of HKD 224.6 billion [2] Industry Summary - ADC drugs have become a highly competitive area in the innovative pharmaceutical sector, with major multinational companies actively acquiring ADC assets [2] - Roche has significantly increased its investment in ADC assets, completing three licensing deals in the ADC field within three months earlier this year, with a cumulative potential total amount exceeding $4 billion [2]

Core Viewpoint - The company, Maiwei (Shanghai) Biotechnology Co., Ltd., announced the presentation of clinical research data for its antibody-drug conjugate 7MW3711 at the 2025 European Society for Medical Oncology (ESMO) conference, highlighting its potential in treating advanced solid tumors with promising efficacy and safety profiles [1][2][3]. Group 1: Drug Overview - 7MW3711 is an antibody-drug conjugate targeting B7-H3, designed for advanced malignant solid tumors, with B7-H3 being overexpressed in many cancer types but low in normal tissues [2][3]. - The drug exhibits structural stability, high purity, and ease of industrial scaling, utilizing a novel camptothecin-based toxin that shows superior anti-tumor activity compared to similar drugs [3][4]. - The clinical trial data presented at ESMO indicates that among 54 evaluable patients receiving a dose of 4.0 mg/kg or higher, 19 patients achieved partial or complete responses [1][4]. Group 2: Clinical Trial Results - As of September 15, 2025, a total of 74 patients were enrolled in the I/II phase clinical study, with no dose-limiting toxicities observed and the maximum tolerated dose not yet reached [3][4]. - In the 4.0 mg/kg or higher dose group, the objective response rate (ORR) for esophageal cancer patients was 42.9%, with a disease control rate (DCR) of 100% [1][4]. - For lung cancer patients in the same dose group, the ORR for small cell lung cancer (SCLC) and squamous non-small cell lung cancer (Sq-NSCLC) was 50.0% and 38.5%, respectively, with DCRs of 90.0% and 92.3% [1][4].

Core Viewpoint - 基石药业-B (02616) is preparing to present clinical data for its drug candidates CS2009 and CS5001 at the upcoming ESMO annual meeting in October 2025, highlighting its advancements in cancer treatment [1] Group 1: Clinical Trials and Data - CS2009, a tri-specific antibody targeting PD-1/VEGF/CTLA-4, has preliminary data from a Phase I dose-escalation study involving 9 patients, which will be presented at the ESMO conference [1] - The company will showcase initial data from approximately 70 patients with advanced solid tumors for CS2009, marking the first known clinical data release globally for this tri-specific antibody [1] - CS5001, an antibody-drug conjugate targeting ROR1, has its Phase Ib clinical study design summary published on the ESMO website [1]

Core Viewpoint - The announcement highlights the upcoming presentation of clinical data for two key drug candidates, CS2009 and CS5001, at the 2025 ESMO annual meeting, marking significant milestones for the company in the oncology sector [1] Group 1: Clinical Trials and Data - The company will present preliminary data from the ongoing Phase I dose-escalation study of CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, involving approximately 70 patients with advanced solid tumors [1] - The abstract for CS2009 includes data from 9 patients as of the submission deadline on May 8, 2025, fulfilling ESMO's submission requirements [1] - The clinical data for CS5001, an antibody-drug conjugate targeting ROR1, will also be summarized in the ongoing Phase Ib study design [1]

Core Insights - The upcoming European Society for Medical Oncology (ESMO) annual meeting will take place from October 17 to 21, 2025, in Berlin, Germany [1] - The company has announced that preliminary data for its core clinical pipeline, CS2009 (a PD-1/VEGF/CTLA-4 tri-specific antibody), will be presented at the ESMO conference [1] - CS2009's abstract includes data from 9 patients as of the submission deadline on May 8, 2025, fulfilling ESMO's submission requirements [1] - The company will showcase initial data from a Phase I dose-escalation study of CS2009 involving approximately 70 patients with advanced solid tumors, marking the first known clinical data on a PD-1/VEGF/CTLA-4 tri-specific antibody globally [1]

科伦药业（002422）(002422.SZ)发布公告，公司近日获悉，公司控股子公司四川科伦博泰生物医药股 份有限公司(简称"科伦博泰")靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗 (sac-TMT，亦称SKB264/MK-2870)(佳泰莱)获国家药品监督管理局(NMPA)批准第三项适应症，用于治 疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR基因突变阳性的局部晚期或 转移性非鳞状非小细胞肺癌(NSCLC)成人患者。 芦康沙妥珠单抗(sac-TMT)是迄今为止全球首个且唯一对比含铂双药化疗显示出显著的总生存期(OS)获 益，并且已获批用于仅接受过TKI治疗后进展(2L)的晚期NSCLC的ADC。在预设的OS期中分析中，与 目前含铂双药化疗标准治疗相比，芦康沙妥珠单抗(sac-TMT)单一疗法在无进展生存期和总生存期均具 有显著统计学意义和临床意义的改善，显著延长此类患者的无进展生存期和总生存期。 ...

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct clinical trials for HLX43 and HLX07 in treating advanced/metastatic solid tumors [1] Group 1: Clinical Trial Approval - The company has been granted permission to initiate clinical trials for the combination treatment of HLX43 and HLX07 [1] - The clinical trials will be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] Group 2: Drug Details - HLX43 is a targeted PD-L1 antibody-drug conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors [1]

Core Viewpoint - The company announced the approval of a clinical trial application for HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - HLX43 is a targeted PD-L1 antibody-drug conjugate (ADC) developed by the company, utilizing a novel DNA topoisomerase I inhibitor small molecule toxin linked to a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors [1] Group 2: Clinical Trials - The 1b/2 phase clinical trial results for HLX07 in combination with chemotherapy for advanced solid tumors showed good safety and tolerability [1] - Multiple phase 2 clinical studies for HLX07 are currently underway in China, including studies for HLX07 as a monotherapy for advanced cutaneous squamous cell carcinoma (CSCC) and in combination with Hanshu® for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) [1]

Core Viewpoint - The announcement highlights the approval of a clinical trial application for HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - HLX43 is a novel antibody-drug conjugate (ADC) targeting PD-L1, developed by the company using a licensed small molecule toxin-peptide linker and its own PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting EGFR, intended for the treatment of advanced solid tumors [1] Group 2: Clinical Trials - The 1b/2 phase clinical study of HLX07 in combination with chemotherapy for advanced solid tumors showed good safety and tolerability as of February 2023 [1] - Multiple phase 2 clinical studies of HLX07 are currently underway in China, including trials for advanced cutaneous squamous cell carcinoma (CSCC) and advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) [1]