恒瑞醫藥同日公告：一款1類新藥獲批上市，三款創新藥齊獲臨床批准

每日經濟新聞

08/20

8月20日盤後，恒瑞醫藥（SH600276，股價49.50元，市值3285億元）連發四份公告，宣佈其自主研發的1類新藥富馬酸立康可泮（HRS-5965）膠囊獲國家藥監局批准上市，同時旗下三款創新藥SHR-8203注射液、SHR-7012注射液、HRS-3095片分別獲得藥物臨床試驗批准通知書，研發管線再迎密集進展。　　兩款創新藥獲臨床試驗批准佈局紅斑狼瘡與晚期實體瘤　　根據公告，恒瑞醫藥子公司...

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　　根據公告，恒瑞醫藥子公司廣東恒瑞醫藥有限公司收到國家藥監局核准簽發的關於SHR-7012注射液的《藥物臨床試驗批准通知書》，該藥為公司自主研發的創新型藥物，擬用於治療皮膚型紅斑狼瘡（CLE），其臨床試驗申請於2026年5月21日獲受理。經查詢，國內外目前暫無同靶點藥物獲批上市。截至目前，SHR-7012注射液相關項目累計研發投入約2550萬元（未經審計）。　　另一款獲臨床試驗批准的SHR-8203注射液由子公司北京盛迪醫藥有限公司申報，為公司自主研發的創新型抗腫瘤藥物，擬用於治療晚期實體瘤。臨床試驗申請於2026年5月28日獲受理，國家藥監局同意本品單藥在晚期實體瘤中開展臨床試驗。經查詢，目前國內外尚無同類藥上市。截至目前，SHR-8203注射液累計研發投入約2040萬元（未經審計）。　　一款1類新藥獲批上市 　　在藥品註冊方面，恒瑞醫藥子公司成都盛迪醫藥有限公司收到國家藥監局通知，批准公司自主研發的1類新藥富馬酸立康可泮（HRS-5965）膠囊上市。該藥為化學藥品1類，規格25mg，適用於治療既往未接受過補體抑制劑治療的陣發性睡眠性血紅蛋白尿症（PNH）成人患者。PNH是一種後天獲得性溶血性疾病，已被納入國家《第一批罕見病目錄》。富馬酸立康可泮膠囊是一種補體因子B抑制劑，通過抑制旁路途徑的異常激活與補體擴增循環，從機制層面同時抑制血管內溶血和血管外溶血。　　針對本適應症，同靶點藥物國內已有諾華的鹽酸伊普可泮膠囊（Fabhalta）於2024年獲批上市，朗來科技的鹽酸蘭諾可泮片（依適寧）和海思科的琥珀酸思普可泮片（優可盼）於2026年獲批上市。　　據EvaluatePharma數據庫，2025年Fabhalta全球銷售額約為5.05億美元。　　同時，恒瑞醫藥的產品用於治療既往使用C5補體抑制劑治療後仍貧血的PNH患者的上市許可申請也在審評中。截至目前，富馬酸立康可泮膠囊相關項目累計研發投入約27750萬元（未經審計）。　　此外，恒瑞醫藥子公司成都盛迪醫藥有限公司還收到國家藥監局核准簽發的關於HRS-3095片的《藥物臨床試驗批准通知書》，同意該產品開展原發免疫性血小板減少症（ITP）和自身免疫性溶血性貧血（AIHA）的臨床試驗。HRS-3095片是公司自主研發的靶向免疫細胞的小分子化合物，對自身免疫性血液病具有良好的治療效果，其用於慢性自發性蕁麻疹的臨床研究正推進至Ⅱ期。經查詢，針對ITP和AIHA適應症，目前國內暫無同靶點藥物獲批上市。截至目前，HRS-3095片相關項目累計研發投入約3960萬元（未經審計）。（文章來源：每日經濟新聞）","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":false,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}