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三生國健(688336.SH):重組抗PD-1人源化單克隆抗體注射液獲得藥物臨牀試驗批准通知書
格隆匯 11-02 17:28

格隆匯11月2日丨三生國健(688336.SH)公佈,近日,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》,公司將在近期開展相關臨牀試驗。藥品名稱為重組抗PD-1人源化單克隆抗體注射液。

重組抗PD-1人源化單克隆抗體注射液(609A)為中美雙報抗PD-1人源化單抗產品,已在美國與中國同期開展多項臨牀試驗。目前609A已在國內開展的臨牀實驗,包括:

(1)評價與曲妥珠單抗聯合帕妥珠單抗、化療相比,PD-1單抗聯合伊尼妥單抗、帕妥珠單抗、化療和伊尼妥單抗聯合帕妥珠單抗、化療在新輔助治療早期HER2陽性乳腺癌患者中有效性和安全性II期臨牀研究;

(2)評價重組抗PD-1人源化單克隆抗體注射液(609A)聯合鹽酸多柔比星治療轉移性/不可切除的非特指型軟組織肉瘤的有效性和安全性的Ⅱ期臨牀研究;

(3)609A聯合貝伐珠單抗輔助經動脈化療栓塞術(TACE)對比TACE一線治療不適合根治性治療的肝細胞癌(HCC)的安全性和有效性的Ⅱ/Ⅲ期臨牀研究。

609A與已上市的兩種國內進口藥物(即百時美施貴寶的歐狄沃®與默沙東的可瑞達®)針對相同的靶點,但具有不同的氨基酸序列,在人源化PD-1小鼠模型顯示出比同靶點抗體Keytruda和Opdivo更強的腫瘤活性。

體內外比對研究結果顯示,609A項目在包括生物活性、藥效、藥代等各方面也與兩種進口藥物均具有相似性;臨牀前研究結果顯示,609A項目的分子結構明確,產品穩定性良好,藥物活性、動物藥物代謝動力學(PK)/藥物效應動力學(PD)均達到或超過了國外同類藥物;609A項目工藝簡單易行,批次間參數高度一致,細胞生長快速、後期活率高,抗體表達水平高,能低成本地實現藥物的產業化;609A項目將設計出不同的聯合用藥方案,與自身其它抗腫瘤藥物聯合使用、共同開展臨牀試驗,進一步增加公司抗腫瘤產品系列的綜合競爭力。

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