Core Viewpoint - The company announced that its self-developed product, BoYouPing® (Dulaglutide Injection), has received approval from the National Medical Products Administration for use in blood sugar control in adult patients with type 2 diabetes, marking it as the first and only approved biosimilar of Trulicity® globally [1][2]. Group 1: Product Approval and Market Position - BoYouPing® is the first and currently the only approved biosimilar of Trulicity® in the market, with no other domestic dulaglutide injections having entered the BLA stage in China [1]. - The commercialization of BoYouPing® in mainland China will be conducted in collaboration with Shanghai Pharmaceuticals Holding Co., Ltd [1]. Group 2: Product Characteristics and Benefits - Dulaglutide is a long-acting GLP-1 receptor agonist administered once a week, which improves pancreatic beta-cell function and effectively lowers blood sugar and HbA1c levels [1]. - In addition to good blood sugar control, dulaglutide offers multiple clinical benefits, including reducing major cardiovascular adverse events, weight loss, renal protection, and a low incidence of hypoglycemia and gastrointestinal adverse reactions [1]. - The weekly administration frequency enhances patient compliance by reducing medication inconvenience [1]. Group 3: Development and Clinical Research - The development of BoYouPing® adhered strictly to biosimilar guidelines from China, the US, and the EU, confirming its overall similarity to Trulicity® through a series of studies [3]. - Key clinical studies in China demonstrated that BoYouPing® can rapidly, stably, and persistently lower blood sugar while also reducing weight, showing consistent efficacy with Trulicity® in treating adult patients with type 2 diabetes [3]. - The results of the Phase I and Phase III clinical studies have been published in international academic journals, confirming the high similarity in quality, efficacy, safety, and immunogenicity between BoYouPing® and Trulicity® [3].
博安生物(06955.HK)：度拉糖肽注射液博优平®在中国获批上市 用于成人2型糖尿病患者的血糖控制