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]

度拉糖肽是一种长效胰高血糖素样肽-1(GLP-1)受体激动剂，每周给药一次。度拉糖肽可改善胰岛β细胞 的功能，稳定、有效地降低血糖及糖化血红蛋白(HbA1c)水平。除了实现良好的血糖控制，度拉糖肽亦 具备多重临床获益，包括可减少主要心血管不良事件，减轻体重，对肾脏具有保护作用，且低血糖发生 率低，胃肠道不良反应低。此外，其每周一次的给药频率可减少患者用药不便，有助于提升治疗依从 性。 作为一种多肽-Fc融合蛋白，度拉糖肽的工艺复杂程度高，其生物类似药的药学(CMC)开发难度大。公 司在CMC领域具有丰富的技术专长和经验积累，其先进的工艺开发平台在控制融合蛋白分子GLP-1端的 截短、羟基化与氧化、甲醯化、丙酮酸醯化等方面发挥了很强的技术优势;同时，其高效的分析平台独 创开发了上述关键质量属性的控制方法，通过全面的质控策略赋能工艺开发及可比性分析，成功攻克了 CMC技术难题，推动博优平率先获批上市。在中国市场之外，博优平也已在美国获准开展临床试验。 博优平的研发过程严格遵循中国、美国、欧盟的生物类似药相关指导原则，通过药学、非临床、人体药 代动力学、临床有效性、安全性和免疫原性一系列逐步递进的研究，科学、完整的 ...