博安生物(06955.HK)：度拉糖肽注射液博優平®在中國獲批上市 用於成人2型糖尿病患者的血糖控制
格隆匯8月8日丨博安生物(06955.HK)宣佈，公司自主開發的博優平®(度拉糖肽注射液)已獲得國家藥品監督管理局的上市批準，用於成人2型糖尿病患者的血糖控制。該產品是全球首個且當前唯一獲批上市的度易達®(英文商品名：Trulicity®)的生物類似藥，國內尚無其他國產度拉糖肽注射液進入上市許可申請(BLA)階段。博優平®在中國大陸的商業化由本公司與上藥控股有限公司("上藥控股")合作開展。
度拉糖肽是一種長效胰高血糖素樣肽-1(GLP-1)受體激動劑，每週給藥一次。度拉糖肽可改善胰島β細胞的功能，穩定、有效地降低血糖及糖化血紅蛋白(HbA1c)水平。除了實現良好的血糖控制，度拉糖肽亦具備多重臨牀獲益，包括可減少主要心血管不良事件，減輕體重，對腎臟具有保護作用，且低血糖發生率低，胃腸道不良反應低。此外，其每週一次的給藥頻率可減少患者用藥不便，有助於提升治療依從性。
作爲一種多肽-Fc融合蛋白，度拉糖肽的工藝複雜程度高，其生物類似藥的藥學(「CMC」)開發難度大。公司在CMC領域具有豐富的技術專長和經驗積累，其先進的工藝開發平臺在控制融合蛋白分子GLP-1端的截短、羥基化與氧化、甲醯化、丙酮酸醯化等方面發揮了很強的技術優勢；同時，其高效的分析平臺獨創開發了上述關鍵質量屬性的控制方法，通過全面的質控策略賦能工藝開發及可比性分析，成功攻克了CMC技術難題，推動博優平®率先獲批上市。在中國市場之外，博優平®也已在美國獲準開展臨牀試驗。
博優平®的研發過程嚴格遵循中國、美國、歐盟的生物類似藥相關指導原則，通過藥學、非臨牀、人體藥代動力學、臨牀有效性、安全性和免疫原性一系列逐步遞進的研究，科學、完整的確證了其與度易達®的整體相似性。二者在質量、有效性、安全性和免疫原性上高度相似，無臨牀意義上的差異。博優平®與度易達®在中國的兩項關鍵臨牀研究中進行了頭對頭比對，其中Ⅰ期臨牀研究結果已發表於國際學術期刊《Expert Opinionon Biological Therapy》，Ⅲ期臨牀研究結果已發表於國際學術期刊《Journalof Diabetes》。Ⅲ期臨牀研究結果證實博優平®能夠快速、穩定且持久降低血糖，並降低體重；其與度易達®在治療中國成人2型糖尿病患者的療效一致，並在安全性、免疫原性和藥代動力特徵等方面高度相似。
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