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GSK’s Nucala Gains NMPA Approval for Severe Eosinophilic Asthma in China
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UK-based GSK plc (NYSE: GSK) has announced that a market approval filing for Nucala (mepolizumab) has been accepted by the National Medical Products Administration (NMPA) in China. The anti-interleukin-5 (IL-5) monoclonal antibody is seeking a second indication approval for use as an add-on maintenance treatment for severe eosinophilic asthma (SEA)…
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Juventas Cell Therapy’s CNCT19 Receives FDA IND Approval for r/r B-ALL Treatment
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China-based Juventas Cell Therapy Ltd’s chimeric antigen receptor (CAR) T-cell therapy, CNCT19 (Inaticabtagene Autoleucel), has obtained Investigational New Drug (IND) approval from the US FDA for the treatment of recurrent or refractory B-cell acute lymphocytic leukemia (r/r B-ALL). Previous Approvals and StatusCNCT19, a CD19-targeted CAR-T therapy, has previously earned IND…
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Bio-Thera Solutions Initiates First Patient Dosing in Phase I Study of BAT8007
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China-based Bio-Thera Solutions, Ltd. (SHA: 688177) has announced the first patient dosing in a multi-center, open, Phase I clinical study to assess the safety, tolerability, and preliminary efficacy of BAT8007, an antibody-drug conjugate (ADC) targeting Nectin-4. The study’s primary indication is general advanced solid tumors, with the goal of determining…
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Antengene to Begin Phase I Clinical Study of ATG-022 for Advanced Solid Tumors
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China-based Antengene Corporation Ltd (HKG: 6996) is poised to commence a Phase I clinical study to assess the safety and tolerability of ATG-022 in patients with advanced and metastatic solid tumors. The study will also determine the bioactive dose, maximum tolerable dose (MTD), and recommended Phase II dose (RP2D). ATG-022…
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Guangdong Zhongsheng’s RAY1225 Receives NMPA Approval for Clinical Study
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative polypeptide drug, RAY1225. This long-acting glucagon-like peptide-1 (GLP-1) drug features dual activation of the GLP-1 receptor and glucose-dependent…
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AnnJi Pharma Signs USD 250 Million Licensing Deal with Avenue Therapeutics for Kennedy’s Disease Drug
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Taiwan-based AnnJi Pharmaceutical Co., Ltd has announced the signing of a licensing agreement with US firm Avenue Therapeutics Inc. (NASDAQ: ATXI) for its innovative small-molecule drug candidate AJ201, targeting the rare Kennedy’s disease. Under the agreement, AnnJi Pharma will receive up to USD 250 million in licensing fees, including an…
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Vcanbio’s VUM02 Gains CDE Review for Liver Failure and ARDS Clinical Trials
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Vcanbio Cell & Gene Engineering Corp., Ltd (SHA: 600645) has announced that two additional clinical trial filings for its VUM02 (human umbilical cord-derived mesenchymal stem cells) have been accepted for review by the Center for Drug Evaluation (CDE). The Chinese firm is seeking clinical approval for this Category 1 therapeutic…
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Luye Pharma’s Biosimilar BA9101 Completes Phase III Study Enrollment with Ocumension
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China-based Luye Pharma Group’s (HKG: 2186) controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has completed the enrollment of all subjects in a Phase III safety and efficacy comparison study for its in-house developed ophthalmology product BA9101, a biosimilar version of Bayer’s Eylea (aflibercept). The study is being jointly conducted by…
