三生國健(688336.SH)：10天獲得5張臨牀試驗通知書
三生國健(688336.SH)公佈，近日，公司收到4項國家藥監局核准簽發的《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。加上國慶節前公司公吿，其雙特異性抗體SSGJ-705在中國獲批臨牀，短短10天，三生國健已獲批5項臨牀試驗，涉及3款創新藥，公司研發進展進入快車道。
其中，重組抗PD-1人源化單克隆抗體SSGJ-609A和抗HER2單抗伊尼妥單抗分別收到批件，同意開展用於HER2陽性乳腺癌治療的臨牀試驗，具體為：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的隨機、開放、平行對照的II期臨牀研究。
除此之外，SSGJ-609A還收到兩個臨牀批件，其一是同意開展一項II期臨牀研究，具體為：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單臂、開放、多中心的Ⅱ期臨牀研究。
其二是同意開展一項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。
公吿顯示，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臨牀I期試驗。伊尼妥單抗(賽普汀®)於2020年6月正式獲得國家藥監局批准。2020年12月底，伊尼妥單抗通過醫保談判，首次被納入《國家醫保目錄》。今年4月，伊尼妥單抗被納入CSCO乳腺癌診療指南，成為全程抗HER2治療的基礎藥物。
值得一提的是，根據9月29日公吿披露，公司雙特異抗體注射用SSGJ-705收到國家藥監局核准簽發的《藥物臨牀試驗批准通知書》，並將於近期開展I期臨牀試驗。此前，該藥已於6月獲得美國食品藥品管理局的IND。
公司研發的抗HER2x抗PD1雙特異抗體(SSGJ-705)是一種同時針對HER2和PD1的雙特異性抗體(簡稱"BsAb")，將HER2靶向治療與免疫檢查點PD1阻斷相結合，從而更有效地治療HER2陽性實體瘤。BsAb療法相比單抗而言，具備直接抗腫瘤和免疫激活雙重協同效應，是一種新穎的、具有潛力的治療晚期轉移性HER2陽性癌症的療法，有望為HER2陽性實體瘤提供更優的解決方案。
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