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复星医药(02196.HK):布瑞基奥仑赛注射液药品注册申请获国家药监局受理
Ge Long Hui· 2025-09-24 10:21
Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has received acceptance for the drug registration application of FKC889, a CAR-T cell therapy for adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL) [1] Company Summary - Fosun Kairui is developing FKC889, a targeted CD19 CAR-T cell therapy, based on technology transferred from Kite Pharma, a subsidiary of Gilead Sciences [1] - The product has been authorized for development and local production in China, including Hong Kong and Macau [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020, respectively [1] Industry Summary - The application for FKC889 is classified as a therapeutic biological product (Category 3.2) [1] - Before commercial production, the product must pass GMP compliance checks and obtain drug registration approval [1] - The acceptance of the drug registration application is not expected to have a significant impact on the group's current performance [1]
TScan Therapeutics Appoints Commercial Leader Stephen Camiolo as Senior Vice President, Market Access
Newsfilter· 2025-03-27 11:00
Core Insights - TScan Therapeutics, Inc. has appointed Stephen Camiolo as Senior Vice President, Market Access, bringing over 25 years of experience in market access and commercialization within the pharmaceutical and biotechnology sectors [1][2] - Camiolo's experience includes leading 16 successful product launches, including three cell therapies, which will be crucial as TScan prepares for a pivotal trial of TSC-101 targeting residual disease in patients with AML, ALL, and MDS [2] - TScan is advancing its clinical-stage pipeline, with ongoing enrollment in its ALLOHA™ Phase 1 trial for hematologic malignancies and the PLEXI-T™ Phase 1 trial for solid tumors [3] Company Overview - TScan Therapeutics focuses on developing T cell receptor (TCR)-engineered T cell (TCR-T) therapies for cancer treatment, specifically targeting hematologic malignancies and solid tumors [3] - The company is expanding its ImmunoBank, a repository of therapeutic TCRs, to provide customized multiplex TCR-T therapies for various cancers [3]