整理 | GLP1减重宝典内容团队 美国加州生物技术公司ProLynx近日完成7000万美元A轮融资，目标直指一个核心痛点：让减重药物"打得更少、效果更久"。公司希望 通过独特的化学技术，将现有GLP-1类药物的给药周期，从每周一次，延长至每月甚至每季度一次，从而重塑减重治疗的依从性与商业 模式。 ProLynx成立于2010年，由两位化学家联合创立。一位是加州大学旧金山分校教授Daniel Santi，曾多次参与生物科技公司孵化；另一 位是拥有20多年产业经验的Gary Ashley。公司长期处于低调研发状态，直到本轮融资才首次系统性对外披露其技术路线与产品布局。 ProLynx的核心技术并不局限于减重领域，而是一种可广泛适用于小分子、肽类以及抗体药物的"半衰期延长平台"。其基本思路是构建 一种三段式分子结构：药物本体通过可调控释放的化学连接子，连接到微球状水凝胶载体上，从而在体内实现缓慢、可控释放。 Boulton指出，许多患者在注射后的前几天会出现明显不适，而到一周后期，食欲抑制效果又开始减弱。"如果能把这种波动拉平，让药 效更稳定、给药频率更低，将显著改善治疗体验，也能让更多患者长期坚持用药。" 正是 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for its self-developed product, Boyouping® (Dulaglutide Injection), which is the first and only biosimilar to Trulicity® approved for the treatment of type 2 diabetes in adults in China [1][3] Group 1: Product Development and Approval - Boyouping® is a long-acting GLP-1 receptor agonist that can improve pancreatic beta-cell function and effectively lower blood glucose and HbA1c levels [1] - The product's development process adhered to biosimilar guidelines from China, the US, and the EU, confirming its overall similarity to Trulicity® in quality, efficacy, safety, and immunogenicity [3] - The company has overcome complex CMC challenges in developing the biosimilar, leveraging its advanced technical expertise and analysis platforms [2] Group 2: Market Potential and Commercialization - China has the highest number of diabetes patients globally, with projections of approximately 148 million adults with diabetes in 2024, expected to rise to 168 million by 2050 [4] - The GLP-1 drug market in China is projected to reach approximately 6.376 billion RMB in 2024, driven by the increasing patient demand [4] - The company has granted exclusive commercialization rights of Boyouping® in mainland China to Shanghai Pharmaceuticals, which has a vast distribution network covering over 70,000 medical institutions [4]

Core Insights - The company has received approval from the National Medical Products Administration for its self-developed product, Boyouping (Dulaglutide Injection), aimed at blood sugar control in adult patients with type 2 diabetes, making it the first and only approved biosimilar of Trulicity globally [1][3] - Boyouping is developed in collaboration with Shanghai Pharmaceuticals Holding Co., Ltd., which will handle its commercialization in mainland China [1][4] Company Development - The complexity of the manufacturing process for Dulaglutide, a peptide-Fc fusion protein, presents significant challenges in developing its biosimilar, but the company has leveraged its expertise in Chemistry, Manufacturing, and Controls (CMC) to overcome these hurdles [2] - The company has established advanced platforms for process development and quality control, enabling it to successfully navigate CMC technical challenges and achieve market approval for Boyouping [2] Clinical Research - The development of Boyouping adhered to the biosimilar guidelines of China, the US, and the EU, confirming its overall similarity to Trulicity through a series of rigorous studies [3] - Key clinical studies comparing Boyouping and Trulicity in China demonstrated that Boyouping effectively lowers blood sugar and weight, with no clinically significant differences in safety and immunogenicity [3] Market Potential - China has the highest number of diabetes patients globally, accounting for over 25% of the total, with projections indicating approximately 148 million adult diabetes patients in China and 589 million worldwide by 2024 [4] - The GLP-1 drug market in China is expected to reach approximately 6.376 billion RMB in 2024, driven by the increasing patient demand [4] - The global sales of Trulicity are projected to be around 5.25 billion USD in 2024, highlighting the significant market opportunity for Boyouping [4]