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歌礼制药-B(01672.HK):选定口服胰淀素受体激动剂多肽ASC36进行临床开发
Ge Long Hui· 2026-02-10 23:13
Core Viewpoint - The company, Gilead Sciences-B (01672.HK), has selected its first oral glucagon-like peptide-1 receptor agonist, ASC36 oral tablets, for clinical development, with plans to submit an Investigational New Drug (IND) application to the FDA in Q2 2026 for obesity treatment [1][2] Group 1 - ASC36 oral tablets have shown an absolute oral bioavailability of 6% to 8% in non-human primate studies, utilizing Gilead's proprietary oral peptide delivery enhancement technology (POTENT) [1] - In non-human primates, ASC36 oral tablets led to an average weight reduction of up to 13.2% relative to baseline after 7 days of once-daily dosing, significantly reducing food intake [1] - In a head-to-head study using a diet-induced obesity (DIO) rat model, ASC36 demonstrated weight loss effects that were approximately 32% and 91% greater compared to eloralintide and petrelintide, respectively [1] Group 2 - The company has three key glucagon-like peptide-1 candidates: oral small molecule GLP-1, oral GLP-1 peptide, and monthly subcutaneous GLP-1 peptide, with ASC36 oral tablets being a significant GLP-1 agonist [2] - Gilead's competitive and differentiated product pipeline is supported by three proprietary technology platforms: AISBDD, Ultra-Long-Acting Platform (ULAP), and POTENT, aimed at addressing diverse treatment needs for obesity and other metabolic diseases [2]
礼来(LLY.US)胰淀素受体激动剂启动III期临床
智通财经网· 2025-12-16 13:22
Group 1 - The core point of the article is that Eli Lilly (LLY.US) has initiated its first Phase III clinical trial (ENLIGHTEN-2) for Eloralintide (LY3841136) on December 15, focusing on its efficacy and safety in treating obese or overweight patients with type 2 diabetes [1] - The Phase III study aims to evaluate the effectiveness of Eloralintide, administered in four doses via subcutaneous injection, compared to a placebo [1] - The primary endpoint of the study is the percentage change in body weight from baseline at week 64 [1] Group 2 - Eloralintide is an AMYR receptor agonist developed by Eli Lilly, which may reduce caloric intake by influencing appetite or increasing satiety [1]
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]