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宜明昂科-B涨超12% IMM2510两项III期注册临床试验已递交EOP2
Zhi Tong Cai Jing· 2025-09-29 02:42
Group 1 - The stock of Yiming Oncology-B (01541) increased by over 12%, reaching HKD 12.72 with a trading volume of HKD 23.9 million [1] - Yiming Oncology has submitted two EOP2 communication requests for its self-developed VEGF×PD-L1 bispecific antibody IMM2510 to the National Medical Products Administration for Phase III clinical trials targeting different types of lung cancer, marking a critical stage in its clinical development [1] - The IMM2510 is developed based on the "mAb-Trap" technology platform and demonstrates antitumor effects through multiple mechanisms [1] Group 2 - Phase I clinical trials showed that IMM2510 achieved an objective response rate (ORR) of 35.3% and a disease control rate of 76.5% in patients with advanced squamous non-small cell lung cancer (sq-NSCLC), with a median progression-free survival (PFS) of 9.4 months and manageable safety [1][2] - Preliminary data from the Phase I clinical study presented at the 2025 World Lung Cancer Conference indicated excellent clinical data and good safety for IMM2510 as a monotherapy in advanced sq-NSCLC patients [2] - Based on positive results, Yiming Oncology plans to further validate the efficacy and safety of IMM2510 in Phase III clinical trials [1]
华东医药:注射用 HDM2012 获得药物临床试验批准通知书
news flash· 2025-07-18 07:50
Core Viewpoint - Huadong Medicine (000963) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of HDM2012, a novel antibody-drug conjugate targeting Mucin17 (MUC-17) [1] Company Summary - HDM2012 is an innovative antibody-drug conjugate (ADC) developed independently by Huadong Medicine, consisting of an anti-MUC-17 monoclonal antibody linked to a topoisomerase I inhibitor via a cleavable linker, with a drug-antibody ratio (DAR) of 8 [1] - The product is a first-in-class biological product globally, with Huadong Medicine holding worldwide intellectual property rights [1] - HDM2012 specifically targets MUC-17 positive tumor surface antigens, facilitating internalization into tumor cells and releasing cytotoxic agents to exert anti-tumor effects [1] - Preclinical studies indicate that HDM2012 demonstrates good drug-like properties, safety, and efficacy [1]
白云山:分公司获得甲苯磺酸索拉非尼化学原料药上市申请批准
news flash· 2025-05-29 08:20
Core Viewpoint - Baiyunshan (600332) has received approval from the National Medical Products Administration for the marketing application of Tofacitinib Tosylate, which is primarily used for the first-line treatment of advanced liver cancer, advanced kidney cancer, and locally advanced or metastatic thyroid cancer resistant to radioactive iodine therapy [1] Group 1 - Baiyunshan Chemical Pharmaceutical Factory has invested approximately 3.3655 million yuan in the research and development of Tofacitinib Tosylate [1] - The approval will enhance the variety of anti-tumor products offered by Baiyunshan Chemical Pharmaceutical Factory, thereby improving the company's competitiveness in the anti-tumor market [1]