港股異動 | 復宏漢霖漲5% 治療晚期實體瘤注射液臨牀試驗獲批
格隆匯5月4日丨復宏漢霖(2696.HK)漲5.63%,報18.4港元,總市值100億港元。復宏漢霖4月28日公佈,公司自主研發的HLX26(重組抗LAG-3人源化單克隆抗體注射液)聯合漢斯狀(斯魯利單抗注射液)用於治療晚期/轉移性實體瘤或淋巴瘤的1期臨牀試驗申請獲國家藥品監督管理局批准。而公司自主開發的帕妥珠單抗生物類似藥HLX11用於HER2陽性且HR陰性的早期或局部晚期乳腺癌新輔助治療的III期臨牀研究於中國境內完成首例患者給藥。另外,復宏漢霖全資子公司上海復宏漢霖生物醫藥近日收到上海市藥品監督管理局簽發的《藥品生產現場檢查結果吿知書》,集團位於上海市松江區的生物藥生產基地中,用於生產產品「漢曲優®」的原液生產西線和東線、製劑(DP)生產線及包裝線,已通過上海市藥品監督管理局組織開展的藥品生產質量管理規範符合性檢查(藥品GMP符合性檢查)。公司表示,是次通過檢查,標誌著其已具備符合中國GMP法規要求的質量管理體系,待漢曲優生產工藝及生產場地變更等的補充申請(sNDA)獲NMPA批准後,松江基地方可開展漢曲優中國境內的商業化生產。

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