share_log

藥明巨諾-B：自願公告 - 業務更新 - 國家藥品監督管理局接受倍諾達治療復發或難治性細胞淋巴瘤患者的補充生物製品許可申請

JW THERAP-B: VOLUNTARY ANNOUNCEMENT - RESEARCH AND DEVELOPMENT UPDATE - NMPA ACCEPTANCE OF THE SUPPLEMENTAL BIOLOGICAL LICENSE APPLICATION FOR CARTEYVA IN PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA

香港交易所 ·  Jan 4 21:29
Summary by Futu AI
藥明巨諾-B（港交所代碼：2126）宣布，其自體CAR-T細胞免疫治療產品倍諾達®（瑞基奧侖賽注射液）用於治療復發或難治性套細胞淋巴瘤（r/r MCL）的新適應症上市許可申請已被中國國家藥品監督管理局受理。該產品於2022年3月獲得突破性治療藥物認定，並於2023年12月獲得優先審評資格。此次申請基於一項關鍵性臨床研究的結果，該研究顯示倍諾達®對r/r MCL患者展現了良好的臨床反應。藥明巨諾首席醫學官Mark J. Gilbert博士表示，倍諾達®有望成為中國首款用於治療r/r MCL的商業化CAR-T細胞產品。藥明巨諾是一家專注於細胞免疫治療產品的生物科技公司，旨在成為該領域的引領者。
藥明巨諾-B（港交所代碼：2126）宣布，其自體CAR-T細胞免疫治療產品倍諾達®（瑞基奧侖賽注射液）用於治療復發或難治性套細胞淋巴瘤（r/r MCL）的新適應症上市許可申請已被中國國家藥品監督管理局受理。該產品於2022年3月獲得突破性治療藥物認定，並於2023年12月獲得優先審評資格。此次申請基於一項關鍵性臨床研究的結果，該研究顯示倍諾達®對r/r MCL患者展現了良好的臨床反應。藥明巨諾首席醫學官Mark J. Gilbert博士表示，倍諾達®有望成為中國首款用於治療r/r MCL的商業化CAR-T細胞產品。藥明巨諾是一家專注於細胞免疫治療產品的生物科技公司，旨在成為該領域的引領者。
The pharmaceutical company Jeleno-B (HKEX code: 2126) announced that its application for a marketing authorisation for its autologous CAR-T cell immunotherapy product Benoda® (Ricciolense Injection) for the treatment of relapsed or incurable multiple cell lymphoma (r/r MCL) has been accepted by the National Drug Administration of China. The product was approved as a breakthrough therapeutic drug in March 2022 and qualified for priority review in December 2023. This application is based on the results of a critical clinical study showing that Benoda® demonstrated a good clinical response to r/r MCL patients. Dr. Mark J. Gilbert, Chief Medical Officer of Pharmacology, said that Benoda® is expected to be China's first commercialized CAR-T cell product for the treatment of r/r MCL. Pharmacyclo is a biotech company focused on cellular immunotherapy products and aims to be a leader in the field.
The pharmaceutical company Jeleno-B (HKEX code: 2126) announced that its application for a marketing authorisation for its autologous CAR-T cell immunotherapy product Benoda® (Ricciolense Injection) for the treatment of relapsed or incurable multiple cell lymphoma (r/r MCL) has been accepted by the National Drug Administration of China. The product was approved as a breakthrough therapeutic drug in March 2022 and qualified for priority review in December 2023. This application is based on the results of a critical clinical study showing that Benoda® demonstrated a good clinical response to r/r MCL patients. Dr. Mark J. Gilbert, Chief Medical Officer of Pharmacology, said that Benoda® is expected to be China's first commercialized CAR-T cell product for the treatment of r/r MCL. Pharmacyclo is a biotech company focused on cellular immunotherapy products and aims to be a leader in the field.
Helpful
Not Helpful

This announcement is a separate document:

Doc 1     View Translation

The translation is provided by third-party software.


The information provided by Futu AI is automatically generated by third-party artificial intelligence (AI) software based on news content. It is only available to users located outside of China mainland.


The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.