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綠葉製藥(02186.HK):度拉糖肽注射液(BA5101)在中國獲批進行臨牀試驗
格隆匯 09-27 20:19

格隆匯9月27日丨綠葉製藥(02186.HK)公吿,公司附屬公司山東博安生物技術股份有限公司開發的度拉糖肽注射液(BA5101)已獲中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)批准進行臨牀試驗。BA5101注射液是Trulicity(度易達)生物類似藥,適用於成人2型糖尿病患者的血糖控制。

Trulicity是美國禮來公司研發的新型長效胰高血糖素樣肽-1(GLP-1)受體激動劑,可激活GLP-1受體,增加β細胞內環磷酸腺苷(cAMP)含量,導致葡萄糖依賴性胰島素釋放,同時抑制胰高血糖素分泌並延緩胃排空。與其他原有降糖藥相比,其優勢是能夠改善胰島β細胞功能、有效降低血糖及HbA1c水準,且極少引起低血糖,同時能減輕體重,減少主要心血管事件。多項相關臨牀研究表明其是一種安全有效的長效治療2型糖尿病藥物,每週1次的給藥方式可以降低患者用藥時產生的抵抗心理及不便,提高依從性,改善2型糖尿病患者生活品質。

2014年,Trulicity首先在美國上市,隨後已在多個其他國家或地區上市,如歐盟、日本、中國等。Trulicity在全球範圍內獲批准的適應症有:(1)適用於成人2型糖尿病的血糖控制;及(2)用於降低伴有心血管疾病或具有多重心血管風險因數的成人2型糖尿病患者的主要心血管事件風險。2019年2月,Trulicity經NMPA批准在中國上市。根據公開的財務報吿,Trulicity於2020年的全球銷售額為50.7億美元,同比年增長率為23%。臨牀前研究顯示,BA5101注射液在藥學、藥代動力學及毒理學方面與Trulicity具有高度相似性。除中國市場外,博安生物同時擬在全球其他國家和地區開展BA5101的註冊工作。

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