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MindRank AI Receives FDA Approval for MDR-001 Clinical Study in Obesity
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Hangzhou-based artificial intelligence (AI)-driven biotech MindRank AI has announced obtaining approval from the US FDA to conduct a clinical study for its oral, small molecule GLP-1 receptor agonist (RA) drug MDR-001 in obesity. This marks a significant milestone in the development of MDR-001, positioning MindRank AI to advance its innovative…
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Tonghua Dongbao Receives NMPA Approval for THDBH151 Clinical Study in Gout and Hyperuricemia
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its dual-targeted drug candidate THDBH151 in gout and hyperuricemia. This marks a significant step forward in the development of innovative treatments for these conditions. Existing Therapies and…
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Fosun Kite’s CAR-T Therapy FKC889 Approved for Clinical Trials in China
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that its subsidiary Fosun Kite Biotechnology Co., Ltd’s chimeric antigen receptor (CAR)-T cell therapy FKC889 has obtained clinical trial approval in mainland China to treat adult patients with relapsed or refractory precursor B-cell acute lymphoblastic leukemia (ALL).…
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Yantai Dongcheng Receives NMPA Approval for F18 PET Imaging Study
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for an F18 product for use in positron emission tomography (PET) imaging of fibroblast activating protein (FAP)-positive lesions. This marks a significant step forward in…
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Yipinhong’s AR882 Receives NMPA Approval for Gout Clinical Trial
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China-based Yipinhong Pharmacy Co., Ltd (SHA: 300723) has announced that its pipeline candidate AR882, under co-development with Arthrosi Therapeutics Inc., has obtained clinical trial approval from the National Medical Products Administration (NMPA). The targeted indication is gout, a condition characterized by high levels of uric acid in the blood. Drug…
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Kira Pharmaceuticals Gains NMPA and TGA Approvals for KP104 Phase II Study
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Sino-US biotech Kira Pharmaceuticals has announced receiving approvals from China’s National Medical Products Administration (NMPA) and the Australian Therapeutic Goods Administration (TGA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of its KP104 pipeline candidate. This marks a significant milestone in…
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Aosaikang Receives FDA Approval for ASKG915 Clinical Trial
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the US FDA. The intended indication is advanced solid tumors, marking a significant step forward in the development of innovative therapies for this condition. Drug Profile and DevelopmentASKG915 is…
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Neurophth’s NFS-02 Gene Therapy Gets FDA IND Approval for LHON Treatment
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China-based gene therapy specialist Neurophth Biotechnology Ltd has announced obtaining Investigational New Drug (IND) approval from the US FDA for its second ophthalmology gene therapy, NFS-02 (rAAV2-ND1). The intended indication is Leber’s hereditary optic neuropathy (LHON) caused by the ND1 mutation. NFS-02: A Promising Gene Therapy for LHONNFS-02, a recombinant…
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Jiangsu Recbio’s Herpes Zoster Vaccine REC610 Gets Clinical Trial Approval in Philippines
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced receiving clinical trial approval for its new adjuvant recombinant herpes zoster vaccine, REC610, in the Philippines. The randomized, observer-blinded, Shingrix-positive controlled Phase I study is designed to assess the safety and immunogenicity of REC610 in healthy subjects aged…
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GenFleet and Merck KGaA Partner on European Clinical Study for KRAS G12C Inhibitor
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China-based GenFleet Therapeutics Inc. has announced a European multi-center clinical study and drug supply agreement with Germany’s Merck KGaA. The collaboration will conduct an open, multi-center, Phase Ib/II clinical study to assess the efficacy of combining GenFleet’s KRAS G12C inhibitor, GFH925, with Merck’s Erbitux (cetuximab) in treatment-naïve advanced non-small cell…
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Henlius Biotech Initiates Phase I Trial for HLX60 in Australia
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Shanghai Henlius Biotech, Inc. (HKG: 2696) has announced the first subject dosed in a Phase I clinical trial in Australia for its independently developed HLX60 (recombinant anti-GARP humanized monoclonal antibody injection) in combination with Henlius’s innovative in-house anti-PD-1 mAb serplulimab. The trial is assessing the combination in treating general advanced…
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ImmuneOnco’s IMM2520 Receives FDA Clinical Trial Approval
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced receiving clinical trial approval from the US FDA for its IMM2520, a bispecific antibody (BsAb) targeting CD47 and PD-L1 in solid tumors. Mechanism of Action and Preclinical ResultsIMM2520, featuring functional IgG1 Fc, can activate macrophages and T cells simultaneously by targeting CD47 and PD-L1…
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Asieris Pharmaceuticals Enrolls First Patient in Phase II Study for APL-1202
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China-based Asieris Pharmaceuticals (SHA: 688176) announced the first patient enrollment in a Phase II clinical study for its oral drug candidate APL-1202 in combination with the PD-1 inhibitor tislelizumab as a neoadjuvant therapy for muscular invasive bladder cancer (MIBC). The open-label, multi-center Phase I/II clinical study is designed to evaluate…
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Jiangsu Yahong Administers First Dose of Hexvix in Hainan Pilot Zone
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) announced the first patient administration of Hexvix (hexyl aminolevulinate hydrochloride) in the Lecheng medical pilot zone in Hainan province. Hexvix is an optical imaging agent used to perform Blue Light Cystoscopy to detect carcinoma of the bladder for…
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Yantai Dongcheng Pharma Acquires Rights to 18F-APN-1607 from Aprinoia Therapeutics
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) announced the plan to acquire the clinical trial approval and research and development (R&D) materials of 18F-APN-1607, a Tau protein positron photography tracer used for PET imaging diagnosis, from Japan’s Aprinoia Therapeutics Inc. and Aprinoia Therapeutics Suzhou, along with exclusive clinical…
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MicuRx Pharmaceuticals Gains Clinical Trial Approvals for MRX-4 in Europe
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Sino-US firm MicuRx Pharmaceuticals Inc. announced receiving clinical trial approvals in France, Greece, Hungary, Italy, Latvia, Lithuania, Portugal, Spain, and Estonia for its novel anti-microbial agent MRX-4 combined with contezolid (MRX-I) as a sequential treatment for diabetic foot infection. Drug Overview and DevelopmentBoth drugs are in-house developed new-generation oxazolidinone antibiotics.…
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Hybio Receives Ethical Approval for HY3000 COVID-19 Nasal Spray Phase II Study
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) announced receiving ethical approval for a Phase II clinical study protocol for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. The clinical filing for the product was accepted for review by the National Medical Products Administration (NMPA) in August 2022. Study…
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Henlius Biotech Doses First Patient in Phase I Study for HLX60 in China
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Shanghai Henlius Biotech Inc. (HKG: 2696) announced the first patient dosing of a Phase I clinical study for its HLX60 in solid tumors and lymphomas in mainland China. Study Design and ObjectivesThe open, dose escalation, first-in-human Phase I study is designed to assess the safety and tolerability of the drug…
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Lynk Pharmaceuticals Doses First Patient in Phase II Study for LNK01003
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China-based Lynk Pharmaceuticals (Hangzhou) Co., Ltd announced first patient dosing in a Phase II clinical study assessing the efficacy and safety of its Category 1 innovative drug candidate LNK01003 in active ulcerative colitis (UC). Ulcerative Colitis and LNK01003Ulcerative colitis is one of the two main forms of inflammatory bowel disease…
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Innovent Biologics Doses First Volunteer in Orismilast Phase I Study
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China-based Innovent Biologics Inc., (HKG: 1801) and Denmark-based partner Union Therapeutics A/S revealed that a first healthy volunteer has been dosed in a Phase I study in China for orismilast (IBI353), a potential best-in-class PDE4 inhibitor. The study (CTR 20222393) is a dose-escalation Phase I designed to assess the pharmacokinetic…
