君實生物(01877.HK):UBP1213sc注射液獲得藥物臨牀試驗批准通知書
格隆匯11月4日丨 君實生物(01877.HK)公吿,公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,UBP1213sc注射液(項目代號"UBP1213sc")的臨牀試驗申請獲得批准,現將相關情況公吿如下:
UBP1213sc注射液的活性成份是重組人源化抗B淋巴細胞刺激因子單克隆抗體,用於治療系統性紅斑狼瘡。SLE是一種高度異質性的系統性自身免疫病,且目前缺乏根治的治療方法。根據Rheumatology期刊及Arthritis Research & Therapy期刊中的數據,目前全球SLE患病率為0~241/10萬,中國大陸地區SLE患病率約為30~70/10萬。B細胞過度活化和產生大量自身抗體是SLE的突出特徵,抗BLyS單克隆抗體通過與可溶性BLyS結合,抑制B細胞的增殖和存活,達到長期緩解SLE、減少病情復發的效果。
2016年11月,UBP1213的靜脈注射劑型(IV)獲得國家藥監局的藥物臨牀試驗批件,公司成為國內首家申報抗BLyS靶點單克隆抗體藥物的中國企業。本次臨牀試驗申請將給藥途徑改變為皮下注射(SC),患者通過培訓後可自行給藥,提高了患者的順應性。
全球首個靶向BLyS靶點治療SLE的新藥為葛蘭素史克公司("GSK")的Benlysta (Belimumab,貝利木單抗),其靜脈注射劑型於2011年獲美國食品藥品監督管理局("FDA")批准上市。2017年Benlysta的皮下注射劑型獲FDA批准上市,根據GSK年報,該劑型上市後Benlysta的全球銷售額以每年超過25%的增速提升,2019年達6.13億英鎊,其中皮下注射劑型銷售額為2.68億英鎊。
2020年,Benlysta全球銷售額為7.19億英鎊,增速放緩至17%,但皮下注射劑型銷售額同比增長32%至3.54億英鎊,增速遠超靜脈注射劑型,充分體現新增的皮下注射劑型對藥品銷售的積極影響。
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