Group 1 - The Hang Seng Index Company announced the quarterly review results for the Hang Seng Index series as of June 30, 2025, with InnoCare Pharma-B (09606) being included in the Hang Seng Composite Index, effective after market close on September 5, 2023, and effective from September 8, 2023 [1] - According to Huatai Securities research, InnoCare Pharma-B is likely to be included in the Hong Kong Stock Connect due to meeting various criteria including market capitalization, liquidity, and listing time [1] - InnoCare Pharma announced that its key product DB-1310, a targeted antibody-drug conjugate (ADC) for human epidermal growth factor receptor 3 (HER3), has received Fast Track designation from the U.S. FDA for treating adult patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have disease progression after treatment with EGFR tyrosine kinase inhibitors (TKIs) and platinum-based chemotherapy [1] Group 2 - DB-1310 is a next-generation ADC product targeting HER3 developed using the company's proprietary DITAC technology platform [2] - In June 2025, InnoCare Pharma presented the initial results of the Phase I/IIa clinical study (NCT05785741) of DB-1310 at the American Society of Clinical Oncology (ASCO) annual meeting, showing encouraging efficacy and manageable safety in patients with advanced solid tumors who had failed standard treatments [2]

Core Viewpoint - The company, Fuhong Hanlin (02696), has announced the completion of the first patient dosing in the United States for an international multicenter phase II clinical trial of HLX43, a PD-L1 targeted antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Trial Details - The phase II clinical trial is designed to evaluate the efficacy and safety of HLX43 in patients with advanced NSCLC [1] - The study consists of two phases: the first phase focuses on dose exploration to select an appropriate dose for the second phase, which is a single-arm, multicenter phase II clinical study [1] - The primary objective of the study is to assess the clinical efficacy of HLX43 in advanced NSCLC, with the main endpoint being the objective response rate evaluated by a blinded independent review committee according to RECIST v1.1 criteria [1] Group 2: Market Context - As of the date of the announcement, there are no approved PD-L1 targeted antibody-drug conjugates available in the global market [1]

Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced the completion of the first patient dosing in the United States for an international multicenter phase 2 clinical trial of HLX43, a PD-L1 targeted antibody-drug conjugate, in patients with advanced non-small cell lung cancer (NSCLC) [1] Group 1: Clinical Trial Details - The phase 2 clinical trial is designed to evaluate the efficacy and safety of HLX43 in patients with advanced NSCLC [1] - The study consists of two phases: the first phase focuses on dose exploration to select an appropriate dose for the second phase, while the second phase is a single-arm, multicenter phase 2 clinical study [1] - The primary objective of the study is to assess the clinical efficacy of HLX43 in advanced NSCLC, with the main endpoint being the objective response rate evaluated by a blinded independent review committee according to RECIST v1.1 criteria [1] Group 2: Market Context - As of the date of the announcement, there are no approved PD-L1 targeted antibody-drug conjugates available in the global market [1] - The company plans to conduct clinical trials in Australia and Japan once conditions are suitable, in addition to the ongoing trials in China (excluding Hong Kong, Macau, and Taiwan) [1]

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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，一項注射用HLX43（靶向PD-L1 抗體偶聯藥物）（「HLX43」）在晚期非小細胞肺癌(NSCLC)患者中開展的國際 多中心2期臨床研究已完成美國首例患者給藥。該2期臨床研究亦正同步於中 國境內（不包括港澳台地區，下同）開展，本公司擬於條件具備後於澳大利亞 及日本等國家開展臨床試驗。 B. 臨床試驗設計及目的 本研究為一項評估HLX43在晚期非小細胞肺癌(NSCLC)患者的開放、國際 多中心2期臨床試驗，旨在評估HLX43在晚期非小細胞肺癌(NSCLC)患者中 的有效性和安全性 ...

Core Viewpoint - 康宁杰瑞制药-B's stock price increased by 14.03% to HKD 10.81, with a trading volume of HKD 73.86 million, following the announcement of a board meeting to approve mid-term results [1] Financial Performance - The company expects to report a profit of no less than RMB 20 million for the first half of the year, compared to a loss of approximately RMB 44.90 million in the same period last year [1] - The turnaround from loss to profit is attributed to milestone revenues from three licensing agreements and sales revenue from commercialized products [1] Product Development - The clinical trial application for JSKN022, a dual-specific antibody-drug conjugate targeting PD-L1 and integrin αvβ6, has been officially accepted by the National Medical Products Administration of China [1] - The company plans to initiate the first human clinical study for JSKN022 aimed at treating advanced malignant solid tumors [1] - Currently, there are no marketed antibody-drug conjugates targeting integrin αvβ6 or PD-L1 globally, with related investigational drugs still in clinical research stages [1]

Core Insights - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has developed an innovative drug LM-302, which has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) in China for the treatment of CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in combination with PD-1 monoclonal antibody [1][2] - LM-302 is a first-in-class antibody-drug conjugate (ADC) targeting CLDN18.2, showing clinical efficacy in patients with gastric cancer, pancreatic cancer, and biliary tract cancer, including those with low expression of Claudin 18.2 and PD-L1 [1] - Recent data presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicated an overall response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients, with ORR of 71.9% and DCR of 96.9% in 32 patients with CLDN18.2 expression ≥25% [1] Clinical Development - LM-302 is currently undergoing Phase III clinical trials in China for the treatment of CLDN18.2 positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma after progression on two or more lines of systemic therapy [2] - The inclusion in the Breakthrough Therapy Designation program is expected to accelerate the approval process for LM-302, providing innovative treatment options for more CLDN18.2 positive gastric cancer patients [2]

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]