SAN FRANCISCO and SUZHOU, China, Jan. 15, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major…

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Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 (Anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

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SAN FRANCISCO, USA, and SUZHOU, China, Jan. 16, 2025 /PRNewswire/ — Innovent Biopharmaceutical Group (HKEx: 01801), a company dedicated to the research, development, production and sales of oncology, autoimmunity, metabolism, ophthalmology, etc. A biopharmaceutical company with innovative drugs in the field of major diseases, announced that its anti-tight junction protein 18.2 (CLDN18.2) antibody-ixotecan conjugate (ADC) IBI343 has been approved…

美國舊金山和中國蘇州2025年1月16日 /美通社/ — 信達生物制藥集團（香港聯交所股票代碼：01801），一家致力於研發、生產和銷售腫瘤、自身免疫、代謝、眼科等重大疾病領域創新藥物的生物制藥公司，宣布其抗緊密連接蛋白18.2（CLDN18.2）抗體-依喜替康偶聯物（ADC）IBI343已被中國國家藥品監督管理局（NMPA）藥品評審中心（CDE）納入突破性治療藥物（BTD）品種名單，擬定適應症為至少接受過一種系統性治療的CLDN18.2表達陽性的晚期胰腺導管腺癌。 本次突破性治療藥物認定是基於一項正在中國、澳洲和美國進行的I期臨床研究結果（NCT05458219），IBI343單藥在晚期胰腺導管腺癌患者中顯示了令人鼓舞的療效和良好的耐受性。該I期擴展隊列的數據在2024年歐洲腫瘤內科學會亞洲年會（ESMO Asia）大會上口頭形式報道： 
共43例CLDN18.2陽性（定義為≥60%腫瘤細胞中CLDN18.2染色強度≥1+）晚期胰腺癌受試者接受IBI343 6 mg/kg Q3W治療…

信達生物IBI343 (CLDN 18.2 ADC) 獲國家藥品監督管理局納入突破性治療藥物品種，治療晚期胰腺導管腺癌患者

Macau Business

Innovent's IBI343 (CLDN 18.2 ADC) has been designated as a breakthrough therapy drug by the National Medical Products Administration for the treatment of patients with advanced pancreatic ductal adenocarcinoma.

Innovent's IBI343 receives NMPA Breakthrough Therapy Designation for advanced pancreatic cancer, showing 23.3% response rate in Phase 1 trials. Drug advances in US and China.

stocktitan.net

Innovent's IBI343 Cancer Drug Secures Second Breakthrough Status for Pancreatic Cancer Treatment

SAN FRANCISCO and SUZHOU, China, Jan. 16, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA)…

vir.com.vn

Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 as Monotherapy for Advanced Pancreatic Cancer

SAN FRANCISCO and SUZHOU, China, Jan. 16, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) …

Laotian Times

The CDE of China's NMPA has granted BTD to Innovent Biologics' IBI343 as a monotherapy treatment for CLDN18.2-positive PDAC patients.

Innovent Receives NMPA Breakthrough Therapy Designation for IBI343 (Anti-CLDN18.2 ADC) as Monotherapy for Advanced Pancreatic Cancer

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