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信達生物(01801.HK):信必樂®(託萊西單抗注射液)新藥、耐立克®(奧雷巴替尼)新增適應症納入2024年版國家醫保藥品目錄

格隆匯11月28日丨信達生物(01801.HK)宣佈,信必樂®(託萊西單抗注射液,抗PCSK9單克隆抗體)新藥和耐立克®(奧雷巴替尼,BCR-ABL抑制劑)新增適應症成功納入新版《國家基本醫療保險、工傷保險和生育保險藥品目錄(2024年)》("國家醫保目錄")。新版國家醫保目錄將於2025年1月1日起正式實施。

此次,信必樂®(託萊西單抗注射液)新藥納入國家醫保目錄,用於治療原發性高膽固醇血癥(包括雜合子型家族性和非家族性高膽固醇血癥)和混合型血脂異常的成人患者。作為信達生物佈局心血管及代謝("CVM")疾病領域的首款產品,信必樂®(託萊西單抗注射液)提供2/4/6週三種治療間隔的靈活用藥方案,在顯著降低低密度膽固醇("LDL-C")水平同時兼顧脂蛋白a("Lp(a)")的明顯下降,LDL-C降幅近70%,Lp(a)降幅近50%。信必樂®(託萊西單抗注射液)成功成為中國首個納入國家醫保的本土原研PCSK9抑制劑,為中國血脂臨牀管理帶來了優質治療選擇,也將提升廣大高膽固醇血癥患者的整體生活質量。

同時,耐立克®(奧雷巴替尼)原目錄內適應症成功續約,新增適應症通過簡易續約程序成功納入國家醫保目錄,目前醫保支付範圍為:T315I突變的慢性髓細胞白血病("CML")慢性期("-CP")或加速期("-AP")的成年患者;對一代和二代酪氨酸激酶抑制劑("TKI")耐藥及╱或不耐受的CML-CP成年患者。耐立克®(奧雷巴替尼)是中國國家藥品監督管理局("NMPA")批准上市的首個第三代BCRABL抑制劑。耐立克®(奧雷巴替尼)在中國的商業化推廣由信達生物和亞盛醫藥(6855.HK)共同負責。

公司很高興高品質、高臨牀需求的創新產品納入國家醫保藥品目錄,大大提高了患者的可及性和可負擔性。公司戰略佈局並堅定投入在腫瘤、CVM、自免及眼科等社會負擔較重的疾病領域,將堅持以患者為中心,積極配合醫保政策在各統籌地區落地,讓高質量藥物儘快惠及更多患者及其家庭。

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