Gan & Lee(603087)
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印度仿制药杀到家门口,国产仿制药如何打破增长天花板
3 6 Ke· 2025-11-28 06:19
曾第十一批国家药品集采中,印度药企以每片0.215元的"地板价"中标,将原研药20倍高价 碾压的同时,也让国内仿制药企业感受到前所未有的压力。 "狼真的来了!"在最近一轮国家药品集采中,5家印度知名制药企业首次集体突围,拿下7个品种,创下 历届国采印度药企中标数之最。 印度熙德隆(Hetero Labs)的中标价格仅为每片0.215元,作为对比,阿斯利康原研药的价格为每片4.36 元,仿制药的价格不到原研药的二十分之一。 在第十一批国家集采中,不止熙德隆,西普拉(Cipla)、安诺拉(Annora Pharma)、纳科(Natco Pharma)等印度药企也成功中标。 此次集采也被视为印度仿制药正式叩开中国主流医药市场大门的"信号弹",市场将进入到新的竞争阶 段。而这次,不仅有"内忧",还有"外患"。 印度仿制药大举进入中国市场 在全球仿制药版图上,印度始终是个绕不开的"狠角色"。 印度药企之所以能给出如此低的价格,一方面是产能优势,以熙德隆为例,其产线利用率仅约50%,全 球布局的多个生产基地存在大量富余产能;另一方面则是人工成本,在印度,人工成本只有中国的1/2 到1/3,生物等效性试验费用仅为15万美元 ...
甘李药业启动中国首个每月一次GLP-1RA减重III期临床研究
Zhong Zheng Wang· 2025-11-27 12:56
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 ...
Once-Monthly GLP-1 RA | Gan & Lee Pharmaceuticals Initiates Phase 3 Clinical Study (GRADUAL-3) of the First Chinese Once-Monthly GLP-1 RA for Weight Management
Prnewswire· 2025-11-27 08:49
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]
甘李药业:截至2025年9月30日,公司股东人数为94714户
Zheng Quan Ri Bao Wang· 2025-11-26 13:45
证券日报网讯甘李药业(603087)11月26日在互动平台回答投资者提问时表示,截至2025年9月30日, 公司股东人数为94,714户。 ...
甘李药业:公司高度关注资本市场的反馈
Zheng Quan Ri Bao Wang· 2025-11-26 13:41
证券日报网讯甘李药业(603087)11月26日在互动平台回答投资者提问时表示,公司高度关注资本市场 的反馈,也充分理解投资者对公司长期价值的关切。二级市场股价受宏观环境、行业周期、市场情绪等 多重因素影响,短期波动并不能完全反映公司的实际经营质量和发展潜力。未来,公司将持续提升自主 研发能力和国际化布局水平,在强化糖尿病诊断、治疗全领域研发的同时,不断开拓其他领域的研发管 线,持续增强公司内在价值。 ...
甘李药业:公司业务处于正常经营状态
Zheng Quan Ri Bao Wang· 2025-11-26 13:41
证券日报网讯甘李药业(603087)11月26日在互动平台回答投资者提问时表示,公司业务处于正常经营 状态,2025年前三季度,营业收入为30.47亿元,比上年同期增加8.02亿元,同比增长35.73%。 ...
甘李药业:公司董事会及管理层高度重视公司市值管理工作
Zheng Quan Ri Bao Wang· 2025-11-26 13:41
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]
甘李药业:博凡格鲁肽注射液正式启动一项针对肥胖或超重适应症的III期临床试验
Zheng Quan Shi Bao Wang· 2025-11-26 07:17
人民财讯11月26日电,11月26日,甘李药业(603087)宣布公司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(研发代号:GZR18)注射液正式启动一项针对肥胖或超重适应症的III期临床试 验(GRADUAL-3),这是博凡格鲁肽在肥胖/超重领域开展的第三项大规模III期临床研究。该研究将采取 每四周一次皮下注射给药的月制剂方案,旨在探索博凡格鲁肽注射液在控制和维持体重方面的临床潜 力。 ...
甘李药业创新药授权落地拉美市场 开启拉美市场商业化布局
Zhong Guo Zheng Quan Bao· 2025-11-26 05:05
Core Insights - 甘李药业 has entered into an exclusive licensing and commercialization agreement with Productos Científicos S.A. de C.V. to develop and commercialize its GLP-1RA drug, GZR18, in Latin America, marking its first international output of self-developed innovative drugs [1] - The collaboration combines 甘李药业's innovative research capabilities with the local advantages of PC to tap into the rapidly growing market for diabetes and obesity treatments in Latin America [2] Market Potential - The GLP-1 receptor agonist market in Latin America is projected to reach USD 1.323 billion in 2024, with expectations to exceed USD 3.5 billion by 2030, reflecting a compound annual growth rate (CAGR) of 16.8% from 2025 to 2030 [2] - The demand for convenient medication and treatment adherence in the region is increasing, making the bi-weekly administration of GLP-1RA formulations advantageous due to lower dosing frequency and improved treatment experience [2] Product Development - GZR18 is an innovative bi-weekly GLP-1RA formulation developed by 甘李药业, focusing on the treatment of type 2 diabetes and weight management for overweight individuals, showing promising results in both glycemic control and weight loss [3] - The company is accelerating the global clinical development of GZR18, with plans for Phase III clinical trials for weight loss and head-to-head trials against competitors scheduled for 2024 and 2025 [3] International Strategy - This licensing agreement represents a significant breakthrough for 甘李药业 in the Latin American market, following a previous long-term supply agreement worth no less than RMB 3 billion with a Brazilian pharmaceutical company [4] - The dual strategy of targeting both "mature products" and "innovative pipelines" illustrates the company's approach to solidifying its revenue base while unlocking long-term valuation through innovative drug licensing [4] - Analysts note that 甘李药业 is experiencing dual momentum from domestic recovery and international acceleration, with projected sales growth of 55.28% domestically and 74.68% internationally in the first half of 2025 [4]
甘李药业出海模式价值跃升 创新药授权落地拉美市场
Quan Jing Wang· 2025-11-26 04:22
Core Viewpoint - Gannee Pharmaceutical has entered into an exclusive licensing and commercialization agreement with Productos Científicos S.A. de C.V. to develop and commercialize its GLP-1 receptor agonist GZR18 in Latin America, marking the company's first international output of self-developed innovative drugs [1] Group 1: Market Potential and Product Advantages - The Latin American GLP-1 receptor agonist market is projected to reach $1.3232 billion in 2024, with expectations to exceed $3.5 billion by 2030, reflecting a compound annual growth rate (CAGR) of 16.8% from 2025 to 2030 [2] - The bi-weekly administration of GZR18 offers significant advantages in terms of convenience and treatment adherence, making it a favorable option in a region with high diabetes and obesity rates [2] Group 2: Clinical Development and Efficacy - GZR18 has shown promising results in clinical trials for both glycemic control and weight loss, potentially becoming the first bi-weekly GLP-1RA to market globally [3] - The company is accelerating the global clinical development of GZR18, with plans for head-to-head trials against Novo Nordisk products starting in 2025 [3] Group 3: International Strategy and Market Growth - The agreement with PC represents Gannee Pharmaceutical's second major breakthrough in the Latin American market, following a long-term supply agreement worth no less than 3 billion RMB with a Brazilian company [4] - The dual strategy of leveraging both mature products and innovative pipelines positions the company for sustained revenue growth and long-term valuation enhancement [4] Group 4: Financial Performance and R&D Investment - Gannee Pharmaceutical is experiencing a dual boost from domestic recovery and international acceleration, with projected sales growth of 55.28% domestically and 74.68% internationally in the first half of 2025 [5] - The company has invested 883 million RMB in R&D in the first three quarters of 2025, supporting the global clinical development of core products like GZR18 [5]