康方生物(09926.HK)：開坦尼®(卡度尼利)和依達方®(依沃西)被納入國家醫保藥品目錄
格隆匯11月28日丨康方生物(09926.HK)宣佈，開坦尼®(卡度尼利，PD-1/CTLA-4)和依達方®(依沃西，PD-1/VEGF)均首次被納入中國國家醫療保障局公佈的最新版《國家基本醫療保險、工傷保險和生育保險藥品目錄》("國家醫保藥品目錄")。最新版國家醫保藥品目錄將於2025年1月1日起正式實施。
卡度尼利是公司自主研發的、全球首創PD-1/CTLA-4雙特異性腫瘤免疫治療藥物。卡度尼利本次被納入國家醫保藥品目錄的適應症為：既往接受含鉑化療失敗的復發或轉移性宮頸癌，此項適應症填補了中國晚期宮頸癌免疫藥物治療空白。除復發或轉移性宮頸癌外，卡度尼利一線治療晚期胃癌已於2024年9月獲批，卡度尼利一線治療晚期宮頸癌的新適應症上市申請("sNDA")正在審評中。目前，公司正在通過卡度尼利聯合療法開展覆蓋16項適應症的超過23個臨牀試驗，包括胃癌、肝癌、肺癌等。
依沃西是本公司自主研發的、全球首創PD-1/VEGF雙特異性腫瘤免疫治療藥物。依沃西本次被納入國家醫保藥品目錄的適應症為：聯合培美曲塞和卡鉑，用於經表皮生長因子受體(EGFR)酪氨酸激酶抑制劑(TKI)治療後進展的EGFR基因突變的局部晚期或轉移性非鱗狀非小細胞肺癌("NSCLC")。此外，依沃西單藥對照帕博利珠一線治療PD-L1陽性NSCLC的III期臨牀達到強陽性結果，該適應症的sNDA正在優先審評中。同時，依沃西在全球和中國近10個III期臨牀試驗正在高效推進中。依沃西已開展超過25項臨牀試驗，涵蓋治療肺癌、胰腺癌、乳腺癌、肝細胞癌、頭頸癌和結直腸癌等17種瘤種。
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