三生製藥(01530.HK)與輝瑞就PD-1/VEGF雙特異性抗體(SSGJ-707)訂立許可協議，首付款12.5億美元
格隆匯5月20日丨三生製藥(01530.HK)發佈公告，2025年5月19日，公司、瀋陽三生製藥有限責任公司(“瀋陽三生”，公司的全資附屬公司)及輝瑞公司(“輝瑞”)已訂立獨家許可協議。三生國健藥業(上海)股份有限公司(“三生國健”，公司附屬公司)亦將透過加入協議作爲簽署方加入。
根據許可協議，公司及瀋陽三生將向輝瑞授予獨家許可，以在全球(不包括中國內地)(“許可地區”)開發、生產、商業化及以其他方式開發其突破性PD-1/VEGF雙特異性抗體(“許可產品”或“SSGJ-707”)。公司及瀋陽三生將保留許可產品於中國內地的開發、製造、商業化及其他開發權。輝瑞將擁有在中國商業化許可產品的選擇權。輝瑞應負責承擔許可產品在許可地區內的所有未來試驗的開發及監管事務的所有費用。
根據許可協議，集團將收到12.50億美元的首付款，並可獲得總額最多爲48億美元的潛在付款，包括開發、監管批準及銷售里程碑付款。上述所有款項均不可退還且不可抵扣。集團亦將就許可地區的產品淨銷售額收取雙位數百分比的梯度特許權使用費。
該許可產品爲集團基於其專有CLF2平臺自主研發的靶向PD-1/VEGF的雙特異性抗體。其目前正在中國進行多項臨牀研究，包括計劃啓動獲國家藥品監督管理局(“國家藥監局”)藥品審評中心(“CDE”)批準的用於一線治療PD-L1陽性局部晚期或轉移性非小細胞肺癌(“NSCLC”)的III期臨牀研究，並已獲得中國突破性療法認定資格。此外，SSGJ-707注射液正在中國進行多項II期研究，包括聯合化療一線治療晚期NSCLC、轉移性結直腸癌及晚期婦科腫瘤。其亦獲得了美國食品藥品監督管理局關於其新藥臨牀試驗申請的批準。
此外，輝瑞將於生效日期根據股份認購協議(“正式協議”)所載條款，按30日成交量加權平均價認購公司價值1億美元的普通股(“可能認購事項”)，該協議將由訂約方於許可協議日期後另行磋商及協定。公司將向輝瑞(或其代名人)配發及發行新股份的確切條款及數目將於正式協議中釐定及最終確定。於訂立正式協議後，公司將於適當時候根據上市規則的適用規定作出進一步公告。
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