Core Viewpoint - Maiwei Biotech has received FDA approval for the clinical trial application of its innovative antibody-drug conjugate (ADC) 7MW4911, which targets cadherin 17 (CDH17) using its proprietary IDDC technology platform [1] Company Summary - The company announced the receipt of a Clinical Research Continuation Notification from the FDA on August 18, indicating that the clinical trial for 7MW4911 can proceed [1] - 7MW4911 is developed based on the company's own intellectual property rights and represents a significant advancement in targeted cancer therapy [1]

Group 1 - The core point of the announcement is that Shanghai Fosun Pharmaceutical (Group) Co., Ltd.'s subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the U.S. FDA to conduct Phase I clinical trials for the new drug HLX43, which is a targeted PD-L1 antibody-drug conjugate for the treatment of thymic carcinoma [2][3] - The new drug HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor with a self-developed PD-L1 targeting antibody, aimed at treating advanced/metastatic solid tumors [3] - As of June 2025, the cumulative R&D investment for this new drug by the group is approximately RMB 182 million (unaudited) [3] Group 2 - There are currently no approved PD-L1 targeted antibody-drug conjugates available in the global market [4]

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., has received FDA approval to initiate Phase I clinical trials for HLX43, a targeted PD-L1 antibody-drug conjugate for thymic carcinoma treatment [1] Group 1: Company Developments - The new drug HLX43 is a conjugate of a novel DNA topoisomerase I inhibitor small molecule toxin-peptide linker and a self-developed PD-L1 targeting antibody [1] - The clinical trials will be conducted globally in locations including Australia, Japan, and the United States once conditions are met [1] Group 2: Industry Context - The targeted PD-L1 antibody-drug conjugate (ADC) is aimed at treating advanced/metastatic solid tumors [1]

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, for the treatment of thymic carcinoma [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 and Investment - HLX43 is a conjugate developed by linking a novel DNA topoisomerase I inhibitor small molecule toxin-peptide chain with a self-developed targeted PD-L1 antibody, aimed at treating advanced/metastatic solid tumors [1] - As of June 2025, the cumulative R&D investment for this drug is approximately RMB 182 million (unaudited, single drug) [1] - Currently, there are no approved PD-L1 targeted antibody-drug conjugates available globally [1]

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。 ...