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港股异动 博安生物(06955)涨超3% 度拉糖肽注射液博优平®在中国获批上市 商业化与上药控股合作开展
Jin Rong Jie· 2025-08-11 05:16
Core Insights - The stock of Boan Biotech (06955) has increased by over 3%, currently trading at 18.88 HKD with a transaction volume of 313 million HKD [1] Group 1: Product Approval - Boan Biotech announced that its self-developed product, Bo You Ping® (Dulaglutide injection), has received approval from the National Medical Products Administration for market launch, aimed at blood sugar control in adult patients with type 2 diabetes [1] - Bo You Ping® is the world's first and currently the only approved biosimilar to Trulicity® (the English brand name), with no other domestic dulaglutide injections having entered the Biologics License Application (BLA) stage in China [1] Group 2: Commercialization and Collaboration - The commercialization of Bo You Ping® in mainland China will be conducted in collaboration with Shanghai Pharmaceuticals Holding Co., Ltd [1] Group 3: Technical Expertise - The development of dulaglutide, as a peptide-Fc fusion protein, involves complex processes, and the biosimilar's pharmaceutical (CMC) development is challenging [1] - The company possesses extensive technical expertise and experience in the CMC field, with an advanced process development platform that effectively controls critical quality attributes [1] - The innovative analytical platform has successfully developed control methods for key quality attributes, overcoming CMC technical challenges and facilitating the early approval of Bo You Ping® [1] Group 4: Clinical Trials - Beyond the Chinese market, Bo You Ping® has also been approved to conduct clinical trials in the United States [1]
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
Ge Long Hui· 2025-08-08 09:11
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].