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]
博安生物(06955)：度拉糖肽注射液博优平®在中国获批上市