甘李药业公告称，其全资子公司甘李药业山东有限公司收到国家药监局下发的关于在研药品GLR1044注 射液的《药物临床试验批准通知书》，同意开展用于治疗成人中重度特应性皮炎的临床试验。该产品是 度普利尤单抗的生物类似药，截至2025年9月30日，公司在该项目累计投入研发费用6572.45万元。目前 国内仅有原研厂家赛诺菲的度普利尤单抗注射液获批上市，2024年度其全球销售额为130.72亿欧元。 ...

Market Overview - The biopharmaceutical sector experienced a decline of 1.72% on December 2, with Aopumai leading the drop [1] - The Shanghai Composite Index closed at 3897.71, down 0.42%, while the Shenzhen Component Index closed at 13056.7, down 0.68% [1] Individual Stock Performance - Dongbao Bio (300239) closed at 5.80, up 1.05% with a trading volume of 93,700 shares and a transaction value of 53.99 million yuan [1] - Aopumai (688293) saw a significant drop of 8.01%, closing at 50.32 with a trading volume of 33,400 shares and a transaction value of 171 million yuan [2] - Other notable declines included Kanghong Pharmaceutical (002773) down 3.78% and Watson Bio (300142) down 3.17% [2] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 456 million yuan from institutional investors, while retail investors saw a net inflow of 270 million yuan [2] - Notable stocks with significant capital inflows included He Yuan Bio (688765) with a net inflow of 17.69 million yuan from institutional investors [3] - Conversely, stocks like Rongchang Bio (688331) and Shenzhou Cell (688520) also saw mixed capital flows, indicating varied investor sentiment [3]

Core Insights - Indian pharmaceutical companies have made significant inroads into the Chinese market, winning multiple bids in the latest national drug procurement round, with prices drastically lower than original branded drugs, indicating a new competitive phase in the market [1][2] - The entry of Indian generics is seen as a major challenge for domestic Chinese generic drug manufacturers, who face both internal and external pressures [1][2] Group 1: Indian Pharmaceutical Companies' Market Entry - Indian companies like Hetero Labs, Cipla, Annora Pharma, and Natco Pharma have collectively won bids for seven drug varieties, marking a record for Indian firms in China's national procurement [1] - Hetero Labs' bid price of 0.215 yuan per tablet is significantly lower than AstraZeneca's original drug price of 4.36 yuan, showcasing the competitive pricing strategy of Indian generics [1] - Indian pharmaceutical firms have prepared extensively for the Chinese market, with many holding multiple registration certificates and having passed consistency evaluations for generics [2] Group 2: Competitive Advantages of Indian Generics - Indian companies benefit from lower production costs, with labor costs being 1/2 to 1/3 of those in China, and significantly lower costs for bioequivalence testing [2] - The production capacity utilization of Indian firms is around 50%, allowing them to offer competitive pricing due to excess capacity [2] - India has become the largest exporter of generics globally, supplying 20% of the world's generics and meeting 40% of the U.S. demand for generics [3] Group 3: Challenges for Chinese Generic Drug Companies - Despite having a large number of pharmaceutical companies, China struggles with quality issues, with many generics failing to meet the efficacy of original drugs [5] - Chinese generic drug companies face significant challenges from price pressures due to national procurement policies and the potential market entry of Indian generics [6] - Companies like Huahai Pharmaceutical and Kelun Pharmaceutical are already experiencing revenue declines and margin pressures due to these competitive dynamics [6] Group 4: Strategies for Chinese Pharmaceutical Companies - Chinese firms are encouraged to enhance R&D investments, focusing on complex formulations and first-generic drugs to differentiate themselves [7] - Expanding into international markets is another strategy, with companies like Ganli Pharmaceutical successfully securing large contracts in Brazil [7] - Smaller companies are advised to specialize in niche areas such as rare diseases and high-tech generics to avoid direct competition with Indian firms [7] Conclusion - The competition in the pharmaceutical market is shifting from national origin to quality, with Indian generics leveraging their scale and cost advantages [8] - The ongoing competition may lead to significant transformations within the industry, with some companies thriving while others may exit the market [8]

中证报中证网讯(王珞)11月27日，甘李药业（603087）宣布，其自主研发的胰高血糖素样肽-1受体激动 剂(GLP-1RA)博凡格鲁肽注射液正式启动中国首个"每月一次"给药的减重III期临床研究(GRADUAL- 3)。 该研究标志着中国首个启动III期的GLP-1RA月制剂进入关键阶段，有望显著提升患者用药依从性，为 长期体重管理提供更优解决方案。 据了解，甘李药业此次启动的GRADUAL-3研究是一项旨在评估每月一次皮下注射博凡格鲁肽的减重疗 效和安全性的随机对照试验。该研究已在药物临床试验登记与信息公示平台登记(登记号： CTR20254659)，由北京大学人民医院纪立农教授牵头，主要终点为治疗24周后体重较基线的变化值和 变化百分比。 与当前市场上周制剂GLP-1药物相比，博凡格鲁肽月制剂方案有望将每年注射次数从52次大幅减少至12 次，注射频次降低近80%，并显著改善患者治疗体验和长期用药依从性。在需要长期维持的体重管理领 域，用药依从性已成为影响临床结果的关键因素。月制剂GLP-1方案直击这一临床痛点，通过减少注射 频率，可降低治疗负担，提高患者生活质量。 GRADUAL系列研究是博凡格鲁肽注射 ...

Core Insights - Gan & Lee Pharmaceuticals has initiated the GRADUAL-3 phase 3 clinical study for its GLP-1 receptor agonist, bofanglutide, targeting adults with obesity or overweight [1][3] - The study aims to evaluate the efficacy and safety of once-monthly bofanglutide injection over a 24-week period [2][7] - Previous studies, GRADUAL-1 and GRADUAL-2, have established the groundwork for assessing bofanglutide's effectiveness in weight management [3][7] Study Design and Objectives - GRADUAL-3 is designed to explore the potential of bofanglutide to maintain weight loss and improve long-term adherence by administering the injection subcutaneously once every four weeks [1][4] - The primary endpoints of the study include changes in body weight and percentage change from baseline at Week 24 [2][7] - The study is part of a broader GRADUAL clinical development program, which includes three large-scale phase 3 studies with over 1,000 participants planned for enrollment [4] Previous Clinical Studies - GRADUAL-1 involved approximately 630 Chinese adults and assessed the weight-loss efficacy and safety of bofanglutide over 52 weeks [7] - GRADUAL-2 included around 471 participants and compared bofanglutide with semaglutide (Wegovy) in a head-to-head study [3][7] - Both previous studies aimed to confirm the efficacy and safety of bofanglutide in managing obesity and its impact on metabolic parameters [3][5] Product Overview - Bofanglutide (research code: GZR18) is a novel GLP-1 RA developed by Gan & Lee, focusing on obesity/overweight and type 2 diabetes indications [5] - Clinical studies have shown that bofanglutide provides significant weight-loss and glucose-lowering effects, with a safety profile consistent with existing GLP-1 RAs [5]

Core Points - As of September 30, 2025, the number of shareholders for Ganli Pharmaceutical (603087) is reported to be 94,714 [1]

Core Viewpoint - The company acknowledges the feedback from the capital market and understands investors' concerns regarding its long-term value, emphasizing that short-term stock price fluctuations do not fully reflect its operational quality and growth potential [1] Group 1: Company Strategy - The company plans to enhance its independent research and development capabilities and international expansion efforts [1] - It aims to strengthen its research and development across the entire field of diabetes diagnosis and treatment while also exploring other research pipelines [1] - The company is focused on continuously increasing its intrinsic value [1]

Core Viewpoint - The company, Ganli Pharmaceutical, reported a significant increase in revenue for the first three quarters of 2025, indicating strong business performance and growth potential [1] Financial Performance - For the first three quarters of 2025, the company's revenue reached 3.047 billion yuan, an increase of 802 million yuan compared to the same period last year, representing a year-on-year growth of 35.73% [1]

Core Viewpoint - The company emphasizes the importance of market value management and acknowledges that stock price fluctuations are influenced by various factors such as industry cycles, macroeconomic conditions, and stock market volatility [1] Group 1 - The company's board and management are highly focused on market value management [1] - The company plans to enhance capital returns and improve investor communication as part of its market value management strategy [1] - The goal is to promote the long-term sustainable growth of the company's value [1]

Core Viewpoint - Ganli Pharmaceutical (603087) has officially launched a Phase III clinical trial (GRADUAL-3) for its self-developed glucagon-like peptide-1 receptor agonist (GLP-1RA) Bofanglutide (development code: GZR18) targeting obesity or overweight indications [1] Group 1 - The Phase III clinical trial is the third large-scale study for Bofanglutide in the obesity/overweight field [1] - The study will utilize a monthly injection regimen, administering the drug subcutaneously once every four weeks [1] - The aim of the trial is to explore the clinical potential of Bofanglutide injection in controlling and maintaining weight [1]