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中國生物製藥：自願公告 - 抗PD-L1「貝莫蘇拜單抗(TQB2450注射液）」納入優先審評審批程序

SINO BIOPHARM: VOLUNTARY ANNOUNCEMENT - ANTI PD-L1 "BENMELSTOBART (TQB2450 INJECTION)" INCLUDED IN PRIORITY REVIEW AND APPROVAL PROCEDURES

香港交易所 · Feb 7 05:14

SINO BIOPHARM +0.00%

Summary by Moomoo AI

中國生物製藥有限公司（「中國生物製藥」）於2024年2月7日宣佈，其附屬公司正大天晴藥業集團股份有限公司開發的抗PD-L1藥物「貝莫蘇拜單抗（TQB2450注射液）」已被中國國家藥品監督管理局藥品審評中心（CDE）納入優先審評審批程序。該藥物用於聯合鹽酸安羅替尼膠囊治療復發性或轉移性子宮內膜癌。貝莫蘇拜單抗是一款全新序列的創新全人源化抗PD-L1單克隆抗體，於2022年4月被CDE納入突破性治療品種，並於2023年1月的新藥上市申請獲CDE正式受理，用於一線治療小細胞肺癌。中國生物製藥表示，此次優先審評有望加速藥物上市審評，滿足臨床需求，造福國內患者。該公司亦正在進行多項貝莫蘇拜單抗聯合安羅替尼的臨床III期試驗，以推進藥物開發，為更多患者提供新的治療選擇。

China Biopharmaceuticals Co., Ltd. (“China Biopharmaceuticals”) announced on 7 February 2024 that the anti-PD-L1 drug “Bemosubainide (TQB2450 Injection)” developed by its subsidiary Cheng Tai Tin Ching Pharmaceutical Group Co., Ltd., has been subject to drug review by the China National Drug Administration Heart (CDE) is included in the Priority Review Approval Process. THE DRUG IS USED IN COMBINATION WITH ALOTINIC HYDROCHLORIDE CAPSULES FOR THE TREATMENT OF RECURRENT OR TRANSIENT ENDOMETRIAL CANCER. Bemosubainide is a novel series of innovative fully humanized anti-PD-L1 monoclonal antibody that was included in a breakthrough therapeutic strain by CDE in April 2022 and a new drug application was formally accepted by CDE in January 2023 for the first-line treatment of small cell lung cancer. China Biopharmaceuticals said that this priority review is expected to accelerate drug market reviews to meet clinical needs and benefit domestic patients. The company is also conducting a series of Phase III clinical trials of bemosubayone anti-conjugated alotine to advance drug development to offer new treatment options to more patients.

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