復宏漢霖-Ｂ(02696.HK)：重組抗CTLA-4全人單克隆抗體注射液臨牀申請獲藥監局受理
格隆匯1月10日丨復宏漢霖-Ｂ(02696.HK)公告，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、微衞星高度不穩定性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)的臨牀試驗申請已於近日獲國家藥品監督管理局受理。
Ipilimumab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。本公司自主研發的HLX13為Ipilimumab的生物類似藥，主要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數(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。
截至本公告日，於全球上市的CTLA-4靶點的單克隆抗體藥品有BristolMyersSquibb的Yervoy®(Ipilimumab)，於中國境內(不包括港澳台地區)尚無同靶點的同類藥物上市。根據IQVIACHPA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)，2018年度，Yervoy®(Ipilimumab)於全球銷售額約為13.28億美元。
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