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GLP - 1R/GIPR双靶点激动剂
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时迈药业拟赴香港上市;映恩生物治疗恶性实体瘤创新药获批临床
Mei Ri Jing Ji Xin Wen· 2025-11-13 23:13
Group 1 - Shimai Pharmaceutical plans to list on the Hong Kong Stock Exchange, having submitted its application with Huatai International as the sole sponsor [1] - Established in 2017, Shimai is a pioneer in next-generation T-cell engagers (TCE) aimed at utilizing the human immune system to combat cancer, with four self-developed clinical-stage candidates [1] - The company's core technology, the masking TCE, is designed for selective activation in tumors, focusing on solid tumors, which aligns with the growth trend in the TCE sector [1] Group 2 - Gilead Sciences announced the entry of its new generation of drugs ASC36 and ASC35 into clinical development, targeting obesity with a planned FDA submission in Q2 2026 [2] - ASC36 and ASC35 are proprietary long-acting combination formulations with superior physicochemical stability, designed to avoid aggregation and precipitation [2] - ASC36 is positioned as a cornerstone therapy for treating metabolic diseases, potentially offering better efficacy and tolerability compared to GLP-1 therapies [2] Group 3 - InnoCare Pharma's new drug DB-1418 has been approved for clinical trials in China, targeting advanced/metastatic solid tumors as an EGFR/HER3 bispecific antibody-drug conjugate (ADC) [3] - The approval of DB-1418 aims to address treatment bottlenecks in resistant solid tumors, enhancing the company's pipeline competitiveness [3] Group 4 - InnoCare Pharma reported a nearly 60% increase in total revenue for the first three quarters of 2025, reaching 1.12 billion yuan, driven by the sales growth of its core product, BTK inhibitor Orelabrutinib [4] - Orelabrutinib's revenue increased by 45.8% year-on-year, surpassing last year's total revenue, while the company's losses narrowed by 74.8% to 70 million yuan [4] - The revenue growth and reduced losses indicate a potential profitability turning point, which may accelerate the advancement of the innovation pipeline and strengthen the company's position in the BTK field [4]
歌礼制药-B(01672.HK):选定同类最佳每月一次皮下注射GLP-1R/GIPR双靶点激动剂多肽ASC35进入临床开发阶段
Ge Long Hui· 2025-10-13 00:14
Core Viewpoint - The company has selected ASC35, a potential best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist peptide, as a clinical development candidate for obesity treatment, with plans to submit an IND application to the FDA in Q2 2026 [1] Group 1: Product Development - ASC35 is expected to demonstrate best-in-class efficacy and a monthly dosing frequency, which may lead to superior weight loss results and a more patient-friendly titration scheme [1] - The initiation of clinical development for ASC35 highlights the company's commitment to innovation and complements its small molecule drug pipeline targeting obesity and other metabolic diseases [1] Group 2: Strategic Vision - The founder and CEO of the company emphasized the strategic importance of ASC35 in enhancing the company's portfolio and addressing unmet needs in obesity treatment [1]
歌礼制药:选定激动剂多肽ASC35进入临床开发阶段
Core Viewpoint - The company, Gilead Sciences, has selected ASC35 as a clinical development candidate, which is expected to be a best-in-class monthly subcutaneous injection GLP-1R/GIPR dual agonist for treating obesity and related metabolic diseases [1] Group 1 - Gilead plans to submit an Investigational New Drug (IND) application to the FDA in the second quarter of 2026 for ASC35 [1] - ASC35 is being developed as both a monotherapy and in combination therapy for treating cardiovascular metabolic diseases, including obesity, diabetes, and metabolic dysfunction-associated steatotic liver disease (MASH) [1]