Core Viewpoint - The company Boan Biotech (06955.HK) 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. This product is the world's first and currently the only approved biosimilar to Trulicity® and is the only domestic dulaglutide injection that has not entered the Biologics License Application (BLA) stage in China [1]. Group 1 - Boan Biotech's Boyouping® is the first and only approved biosimilar to Trulicity® globally [1] - The product is specifically designed for blood sugar control in adult type 2 diabetes patients [1] - The commercialization of Boyouping® in mainland China will be conducted in collaboration with Shanghai Pharmaceuticals Holding Co., Ltd [1]

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]