復宏漢霖(02696.HK)：重組抗CTLA-4全人單克隆抗體注射液(HLX13)臨牀試驗申請獲國家藥品監督管理局批准
格隆匯4月8日丨復宏漢霖－Ｂ(02696.HK)發佈公告，近日，公司研製的用於無法切除或轉移性黑色素瘤、晚期腎細胞癌、微衞星高度不穩定或錯配修復缺陷的轉移性結直腸癌治療以及黑色素瘤輔助治療的重組抗CTLA-4全人單克隆抗體注射液(“HLX13”)的臨牀試驗申請獲國家藥品監督管理局批准。
根據披露，Ipilimumab(伊匹木單抗，商品名：Yervoy )是全人、具有κ輕鏈的抗 CTLA-4(細胞毒T淋巴細胞相關抗原4，又稱CD152)的IgG1型單克隆抗體。公司自主研發的HLX13為Ipilimumab的生物類似藥，擬用於以下適應症的治療：1、無法切除或轉移性黑色素瘤；2、黑色素瘤的輔助治療；3、晚期腎細胞癌；4、微衞星高度不穩定或錯配修復缺陷的轉移性結直腸癌。 CTLA-4 主要表達在調節性T細胞(Treg)和活化的T細胞上，通過與CD28競爭抗原呈遞細胞上的B7配體(B7-1和B7-2)，從而抑制T細胞的增殖和細胞因子(IL-2 和IFN-γ)產生。 Ipilimumab通過阻斷CTLA-4與配體的結合，增強免疫反應進而達到殺傷腫瘤的目的。根據《生物類似藥研發與評價技術指導原則(試行)》，公司對HLX13與原研藥Ipilimumab從臨牀前藥理學、藥代動力學和毒理學三方面進行了頭對頭比較。比較結果顯示，HLX13和Ipilimumab的體外體內藥效、藥代動力學和毒代動力學特徵、免疫原性和毒性特徵均相似或未見明顯差異。
截至該公告日，於全球範圍內上市的靶向CTLA-4 的單克隆抗體藥品有 Bristol-Myers Squibb的Yervoy(Ipilimumab)，於中國大陸尚無同靶點的同類藥物上市。根據IQVIA MIDAS資料(由IQVIA提供， IQVIA是全球領先的醫藥健康產業專業資訊和戰略諮詢服務提供者)，2019年度，Yervoy(Ipilimumab)於全球範圍內的銷售額約為15.23億美元。
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