中國藥企首次參加ODAC會議文件掛網，分析人士：未見產品有效性和安全性挑戰，信達生物(1801.HK)股價或現黃金坑
2022年2月10日美東時間上午10:00，FDA即將就信達生物(1801.HK)和禮來製藥合作的PD-1單抗治療一線非鱗非小細胞肺癌的上市申請召開腫瘤藥物諮詢委員會(ODAC會議)，近日FDA官網已將首批會議材料掛網，包括FDA和信達的ODAC Briefing Document，預計後續更多雙方具體答辯材料將在會議前掛網。分析人士表示，市場應客觀冷靜分析官方材料，其中未見產品有效性和安全性挑戰。如早前報道所説，FDA將依此為中國藥企以單一或中國臨牀研究數據為主申請美國新藥上市的嘗試來“立規矩”。多家大行曾表示，信達當前價格已被低估，可以適時入手。
自2021年底開始，FDA腫瘤卓越中心主任Richard Pazdur博士的多篇論文和採訪中，對單一國家數據的產品在美國申報上市提出了若干挑戰和質疑，也反覆強調國際多中心臨牀研究(“MRCT”)是其更青睞的開發路徑。行業人士稱，FDA在ODAC會議之前做出如此之多的輿論引導實屬罕見，目的在於爭取ODAC會議委員的支持。其實就本次的議題“是否需要額外的臨牀研究證明美國患者和美國醫療實踐的適用性”而言，不同於以往ODAC會議討論單一產品的風險獲益比，FDA反覆提及已收到超過25個完全或主要基於中國數據的新藥申報，可見FDA是希望在公眾視野下對監管尺度變化進行充分説明，而非對於產品本身有任何安全性和有效性的問題進行質疑。
掛網資料説明態度的同時，文件中對於中國臨牀醫生經驗的質疑、對於中美兩國同類產品相同適應症相同臨牀試驗終點的兩級評判，引發行業熱議。在FDA官員承認目前態度與2019年截然不同的前提之下，行業人士呼籲理性看待掛網材料。
但是多家投資機構和行業人員認為，FDA早前輿論態度已讓市場對於信達和禮來此次能夠成功推動信迪利單抗在美上市的期待值降低，目前信達股票已經大大低於2021年信達與禮來合作推動產品出海之時的價格。而信達作為港股中平台化能力已驗證、全球化道路可期的生物醫藥稀缺標的，2021年是其上市以來取得業績最好的一年。與此同時，公司在2022-2023年將擁有近10款商業化產品，幾十個擁有全球權益的創新管線，目前價格顯然是個黃金坑。
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