Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1: FDA Approval and Clinical Trials - The FDA has approved the initiation of Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate [1] - Fuhong Hanlin plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] Group 2: Drug Development - HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor small molecule toxin-peptide chain with a self-developed PD-L1 targeting antibody [1] - The drug is intended for the treatment of advanced/metastatic solid tumors [1]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech Co., Ltd., has received FDA approval to conduct Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1 - The new drug HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody [1] - The company plans to conduct global multi-center clinical research in Australia, Japan, and the United States once conditions are met [1] - HLX43 is intended for the treatment of advanced/metastatic solid tumors [1]

Core Viewpoint - The company, Fuhong Hanlin (02696.HK), has received FDA approval to initiate a Phase 1 clinical trial for HLX43, a targeted PD-L1 antibody-drug conjugate, for the treatment of thymic carcinoma (TC) [1] Group 1 - HLX43 is a novel targeted PD-L1 antibody-drug conjugate developed by the company, combining a licensed DNA topoisomerase I inhibitor small molecule toxin with a self-developed PD-L1 targeting antibody [1] - The company plans to conduct clinical trials for the TC indication in countries such as Australia, Japan, and the United States once conditions are met [1] - As of the announcement date, there are no approved PD-L1 targeted antibody-drug conjugates available globally [1]

Core Viewpoint - The company, Fuhong Hanlin (02696), has received FDA approval to initiate a Phase 1 clinical trial for HLX43, a PD-L1 targeted antibody-drug conjugate, for the treatment of thymic carcinoma (TC) [1] Group 1 - The FDA approval allows the company to proceed with further clinical-related work for HLX43 [1] - The company plans to conduct clinical trials for thymic carcinoma in countries such as Australia, Japan, and the United States once conditions are met [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has received FDA approval to initiate a Phase 1 clinical trial for HLX43, a PD-L1 targeted antibody-drug conjugate, for the treatment of thymic carcinoma (TC) [1] Group 1 - The FDA has approved the clinical trial for HLX43, allowing the company to proceed with further clinical-related work [1] - The company plans to conduct clinical trials for thymic carcinoma in countries such as Australia, Japan, and the United States once conditions are met [1]

格隆汇8月7日丨复星医药(600196.SH)公布，控股子公司上海复宏汉霖生物技术股份有限公司及其控股 子公司获美国FDA（即美国食品药品监督管理局）批准开展注射用HLX43（即靶向PD-L1抗体偶联药 物，简称"该新药"）用于治疗胸腺癌（TC）的I期临床试验。复宏汉霖拟于条件具备后于澳大利亚、日 本、美国等地开展该适应症的全球多中心临床研究。该新药为复宏汉霖将许可引进的新型DNA拓扑异 构酶I抑制剂小分子毒素-肽链连接子与复宏汉霖自主研发的靶向PD-L1的抗体进行偶联开发的靶向PD- L1的抗体偶联药物（ADC），拟用于晚期/转移性实体瘤的治疗。 ...

Core Viewpoint - The initiation of Phase III clinical trials for MRG004A, a targeted antibody-drug conjugate developed by Lepu Biopharma, represents a significant advancement in the treatment of pancreatic cancer, offering new hope for patients suffering from this highly lethal disease [1][4]. Group 1: Drug Development and Mechanism - MRG004A is an innovative antibody-drug conjugate (ADC) targeting tissue factor (TF), utilizing advanced coupling and spacing technologies to link a TF-targeting monoclonal antibody with a potent microtubule inhibitor, MMAE [2][3]. - The mechanism of MRG004A involves the antibody recognizing and binding to TF antigens overexpressed on cancer cells, leading to internalization and release of the cytotoxic agent MMAE, which induces cancer cell death [3]. Group 2: Clinical Trial Data - In the Phase I/II clinical studies presented at the 2024 ASCO annual meeting, MRG004A demonstrated significant anti-tumor activity in pancreatic cancer patients, with an objective response rate (ORR) of 33.3% and a disease control rate (DCR) of 83.3% in a cohort of 12 evaluable patients [3]. - Among patients with a TF expression rate of ≥50% and intensity of 3+, 80% achieved partial response (PR) or stable disease (SD) after treatment with MRG004A [3]. Group 3: Regulatory Approvals and Market Potential - MRG004A has received several regulatory designations, including orphan drug status from the FDA in December 2023 and fast track designation in March 2024 for the treatment of pancreatic cancer [4]. - Given the high mortality rate associated with pancreatic cancer, with a 5-year overall survival (OS) rate of approximately 10% for advanced cases, the successful completion of the Phase III trial could significantly alter the treatment landscape for this challenging disease [4].

Core Viewpoint - The company has received formal acceptance of its clinical trial application for the injectable 7MW4911 from the National Medical Products Administration (NMPA) and an IND Acknowledgement Letter from the FDA, indicating progress in its drug development pipeline [1] Group 1 - The injectable 7MW4911 is an innovative antibody-drug conjugate (ADC) targeting cadherin 17 (CDH17) developed based on the company's proprietary IDDC antibody conjugation technology platform [1] - The acceptance of the clinical trial application by NMPA marks a significant milestone for the company in advancing its drug candidate [1] - The receipt of the IND Acknowledgement Letter from the FDA confirms that the company has submitted its IND application for 7MW4911, facilitating its entry into the U.S. market [1]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received FDA approval for JSKN003 to conduct a Phase II clinical study in the U.S., marking a significant milestone in the company's global development of its innovative pipeline [1] Group 1: Clinical Study Details - JSKN003-202 is a randomized, open-label, multicenter Phase II clinical study aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, collectively referred to as platinum-resistant ovarian cancer (PROC) [1] - The study will evaluate the efficacy and safety of JSKN003 in the specified patient population and determine the recommended dose for Phase III trials [1] Group 2: Product Characteristics - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the antibody KN026 using glycoengineering technology, offering better serum stability compared to traditional coupling methods [2] - The bispecific HER2 targeting allows JSKN003 to induce stronger internalization and bystander killing effects, providing significant anti-tumor activity in HER2-expressing tumors [2] Group 3: Licensing and Ongoing Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. to develop and commercialize JSKN003 in mainland China for tumor-related indications [2] - Currently, JSKN003 is undergoing three Phase III clinical trials in China for treating HER2-positive breast cancer, HER2-low expressing breast cancer, and platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [2]

Core Viewpoint - Corning Jereh Pharmaceutical-B (09966) has received FDA approval for JSKN003 to conduct a Phase II clinical study in the U.S., marking a significant milestone in the company's global development of its innovative pipeline [1][2]. Group 1: Clinical Trial Details - JSKN003-202 is a randomized, open-label, multi-center Phase II clinical study aimed at treating platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, collectively referred to as platinum-resistant ovarian cancer (PROC) [1]. - The trial will evaluate the efficacy and safety of JSKN003 in the specified patient population and determine the recommended dose for Phase III trials [1]. Group 2: Product Information - JSKN003 is a targeted HER2 bispecific antibody-drug conjugate (ADC) that connects a topoisomerase I inhibitor to the antibody KN026 using glycosylation site-specific conjugation technology, offering better serum stability compared to traditional conjugation methods [2]. - The bispecific HER2 targeting of JSKN003 enhances its internalization and bystander killing effect, providing strong anti-tumor activity in HER2-expressing tumors [2]. Group 3: Licensing and Ongoing Trials - In September 2024, the company entered into a licensing agreement with Shanghai Jinmant Biotechnology Co., Ltd. for the development and commercialization of JSKN003 in mainland China for tumor-related indications [2]. - Currently, JSKN003 is undergoing three Phase III clinical trials in China for treating HER2-positive breast cancer, HER2-low expressing breast cancer, and platinum-resistant recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer [2].