三生製藥(01530.HK)：三生國健(688336.SH)將609A用於腫瘤免疫聯合療法syncrovax的全球權益授權給美國Syncromune公司
2022年1月4日，中國生物製藥領軍企業三生製藥(01530.HK)近日宣佈，旗下子公司三生國健藥業（上海）股份有限公司（證券代碼：688336）簽署授權協議，將其研發品種609A（抗PD-1人源化單克隆抗體注射液）用於腫瘤免疫聯合療法syncrovax的全球權益授權給美國Syncromune公司。根據協議，三生國健將有望基於609A的臨牀價值前景、重要監管及銷售里程碑，以及其他商業化價值，獲得數億美元的首付款、里程碑付款及其他的激勵。雅法資本擔任本次交易Syncromune的財務顧問。
根據協議條款，Syncromune公司獲得將609A用於其腫瘤免疫療法syncrovax?的全球開發及商業化權益。三生國健銷售分成及里程碑收入將源自syncrovax聯合療法的銷售總金額，同時三生國健將繼續保有609A全球任何syncrovax?療法以外的權益。
609A為三生國健研發的一款中美雙報的抗PD-1人源化單抗，美國已完成I期臨牀，國內已進入II期臨牀階段。根據公開資料，609A在早期動物模型的數據顯示出比Keytruda和Opdivo更強的抗腫瘤活性。
臨牀前研究結果顯示，609A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。
三生國健董事長婁競博士表示：“609A是三生國健首個出海的創新藥產品，公司很高興能與Syncromune公司合作。本次交易除為公司帶來現金流和收益外，也為609A未來的對外合作及國內的臨牀研究和註冊審批帶來了積極的影響，同時彰顯了三生國健的研發實力”。
據悉，609A是三生國健研發的一款中美雙報的抗PD-1人源化單抗，與已上市的兩種進口藥物（Keytruda和Opdivo）針對相同靶點，但具有不同的氨基酸序列，在人源化PD-1小鼠模型中顯示出較Keytruda和Opdivo更強的腫瘤活性。體內外比對研究結果表示，SSGJ-609A在包括生物活性、藥效、藥代等各方面與兩種進口藥物均具有相似性；臨牀前研究結果顯示，609A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。
Syncromune是總部在美國的創新生物製藥公司，專注於新一代瘤內給藥的腫瘤免疫療法的開發。核心技術syncrovax療法為個性化的自體疫苗平台，致力於通過克服轉移性癌症的免疫抑制特性，來解決當前系統免疫療法的侷限性，從而實現對多種實體瘤的治療目的。
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