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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…
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Immunophage Biotech Raises RMB 200 Million in Series B1 Financing for Clinical Trials
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Nanjing-based Immunophage Biotech Co., Ltd reportedly raised close to RMB 200 million (USD 29.1 million) in the first phase of a Series B1 financing round, led by ZBJL Capital and supported by debt financing. The funds will be used to advance Phase II clinical studies for first-tier products and Phase…
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Akeso Biopharma Enrolls First Subject in Phase III Study of Cadonilimab for Gastric Cancer
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first subject in a pivotal Phase III study for its innovative bispecific antibody (BsAb), cadonilimab (AK104). The study will assess cadonilimab in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJC).…
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CSPC Pharmaceutical’s PD-1 Monoclonal Antibody Enlangsubai Completes NMPA Market Approval Filing
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced the completion of a market approval filing with the National Medical Products Administration (NMPA) in China for its programmed-death 1 (PD-1) monoclonal antibody (mAb), Enlangsubai. The targeted indication is recurrent or metastatic cervical cancer with positive PD-L1 expression that has failed…
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Boston Scientific Launches REPLACE Study for FARAPULSE PFA System in China
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US-based medical technology major Boston Scientific Corporation (NYSE: BSX) has announced the initiation of the real-world REPLACE study for its pulsed field ablation (PFA) system, FARAPULSE, in Chinese patients with paroxysmal atrial fibrillation (PAF). The study is being conducted at the Boao Lecheng Medical Tourism Pilot Zone of Hainan Province,…
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Chipscreen’s Epidaza Receives TFDA Approval for Breast Cancer Treatment in Taiwan
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Shenzhen Chipscreen Pharmaceutical Co., Ltd’s partner, GNT Biotech & Medicals Corporation, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for Epidaza (chidamide, Kepida in TW). This innovative class 1-selective oral histone deacetylase inhibitor was originally discovered by Chipscreen. Indication and Target Patient…
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Silicon Valley Bank Collapse Impacts Tech and Biotech Sectors Globally
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The tech and biotech sectors are grappling with the implications of the collapse of US-based Silicon Valley Bank (SVB; Nasdaq: SIVB), which specialized in working with the tech and biopharma venture capital sectors. The bank was seized by the US government’s Federal Deposit Insurance Corporation (FDIC) on Friday, March 10,…
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Allorion Therapeutics Raises USD 50 Million in Series B Financing to Advance Drug Development
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Allorion Therapeutics, a next-generation precision medicine small molecule drug developer based in Guangzhou, reportedly raised USD 50 million in a Series B financing round. The round was led by INCE Capital and Qiming Venture Partners, with contributions from TF Capital, LongRiver Investments, 3SBio, Octagon Capital, and Lichen Private Equity Fund.…
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XtalPi and Chia Tai Tianqing Achieve Phase II Milestone in Cancer Drug Development
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Sino-US artificial intelligence (AI) firm XtalPi Inc. has partnered with China’s Chia Tai Tianqing to reach the Phase II milestone in their small molecule cancer drug research and development (R&D) program. The collaboration leveraged Chia Tai Tianqing’s in-house innovative drug innovation platform and XtalPi’s AI drug discovery platform to achieve…
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Overland Pharmaceuticals Partners with GoBroad Healthcare to Strengthen Cell Therapy Research
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China-based firm Overland Pharmaceuticals has entered into a strategic partnership with GoBroad Healthcare Group to enhance Overland’s translational and clinical study capabilities in the cell therapy field. The collaboration aims to strengthen Overland’s development efforts in universal chimeric antigen receptor (CAR)-T cell therapy. No financial details were disclosed. Scope of…
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Haihe Pharmaceutical Initiates Global Phase I Clinical Study for BET-BD2 Inhibitor HH3806
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the first patient dosing of a global multi-center Phase I clinical study for its in-house developed BET-BD2 inhibitor, HH3806, in Australia. This marks a significant milestone in the development of the drug, which targets the bromo and extra terminal (BET) binding domain 2…
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CanSino Biologics Initiates Phase Ib Study for Innovative Protein-Based Pneumococcal Vaccine
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China-based vaccines specialist CanSino Biologics Inc. has announced the initiation and first subject enrollment of a Phase Ib clinical study for its in-house developed protein-based pneumococcal vaccine (PBPV). This marks a significant step forward in the development of a globally innovative vaccine. Innovation and AdvantagesCanSino’s PBPV represents the third generation…
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Zenshine Pharmaceuticals Raises RMB 100 Million in Series B Financing for Drug Development
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China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd reportedly raised over RMB 100 million in a Series B financing round. The round was led by Hankang Capital and included participation from Cybernaut, Yangzijiang Funds, Ennovation Ventures, and Matrix Partners China. The proceeds will be used to enhance the…
