百奧泰(688177.SH)：擬調整BAT3306(帕博利珠單抗)開發策略
格隆匯5月22日丨百奧泰(688177.SH)公佈，公司對藥品監督管理政策動態等因素的審慎評估，計劃調整BAT3306（帕博利珠單抗）的開發策略，終止BAT3306正在開展的BAT3306-002研究（一項評價BAT3306聯合化療與可瑞達聯合化療在IV期非小細胞肺癌受試者中的藥代動力學、有效性和安全性的多中心、隨機、雙盲I/III期研究）。
BAT3306是公司開發的帕博利珠單抗（Keytruda）生物類似藥，目前正在開展的BAT3306-002研究是一項評價BAT3306聯合化療與Keytruda聯合化療在IV期非小細胞肺癌受試者中的藥代動力學、有效性和安全性的多中心、隨機、雙盲I/III期研究。根據美國食品藥品監督管理局（FDA）近期對生物類似物產品的技術溝通內容，以及歐盟藥品管理局（EMA）於2025年4月發佈的關於生物類似物審評的思考性文件，均體現出歐美藥監官方在審批生物類似物產品的上市申請時，療效比對研究的必要性已經大大下降，對於大多數生物類似物產品，療效比對研究已經不是上市審批時需要提交的必要數據。目前，全球已有兩家開發帕博利珠單抗生物類似藥的公司宣佈停止其產品的III期療效比對臨牀研究：德國藥企FormyconAG的帕博利珠單抗生物類似藥申請取消了III期臨牀研究，改爲僅基於I期和分析數據進行申報；瑞士藥企SandozAG宣佈將精簡對帕博利珠單抗生物類似藥在未經治療的轉移性非鱗狀非小細胞肺癌（NSCLC）患者中的III期臨牀試驗。
經審慎考慮，公司認爲目前正在開展的BAT3306-002研究對於BAT3306在歐美藥監官方的上市審評已無必要，公司決定終止該研究。公司將持續與藥品監督管理部門保持密切溝通，針對生物類似物審評的最新政策動態，公司將審慎評估並作出決策後決定未來是否繼續推進BAT3306項目。
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