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Triastek’s 3D-Printed T20G Receives US Clinical Approval for NOAC Treatment
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China-based Triastek Inc., a pharmaceutical-focused 3D printing company, has announced receiving clinical approval in the US for its T20G. This 3D-printed non-vitamin K antagonist oral anticoagulant (NOAC) was previously cleared for trials in China in January of last year. T20G’s Technological AdvantagesT20G leverages Triastek’s patented 3D Microstructure for Gastric Retention…
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Changchun High & New Technology Industries Receives US Trial Approval for GenSci120 in Rheumatoid Arthritis
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China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced its subsidiary GenScipt Biotech Corp. receiving approval to initiate a clinical study for its GenSci120 in rheumatoid arthritis (RA) in the United States. This marks a significant step forward in the development of this innovative biologic product for…
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Junshi Biosciences Receives NMPA Approval for JS212 in Advanced Solid Tumors
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its JS212, a bispecific antibody drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3). This marks a…
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Joyo Pharma’s JYP0035 Receives Clinical Trial Approval for Breast Cancer Treatment
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On March 14, 2025, Joyo Pharma announced that its independently developed next-generation, highly selective Class 1 new drug, the PI3Kα inhibitor JYP0035 capsule, received clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of targeted therapies for breast cancer patients…
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Tonghua Dongbao Initiates Phase III Trial for Insulin Degludec, Liraglutide Combo in Type 2 Diabetes
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has initiated a Phase III clinical study for its insulin degludec and liraglutide combination drug, administering the first dose to a patient in China. This marks a significant step forward in the development of this biosimilar version of Novo Nordisk’s Xultophy. Drug Profile and…
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Livzon Pharmaceutical Receives Approval for Clinical Trials of Adjuvanted Influenza Vaccine LZSN2401
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China-based Livzon Pharmaceutical Group Inc. (HKG: 1513) announced receiving clinical trial approval for its investigational adjuvanted quadrivalent influenza vaccine LZSN2401 in China. This marks a significant step forward in the development of more effective influenza prevention solutions. Vaccine InnovationLZSN2401 is positioned as the world’s first adjuvanted quadrivalent influenza vaccine to…
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Rona Therapeutics Initiates Phase II Study for RN0361 in Severe Hypertriglyceridemia
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Shanghai-based Rona Therapeutics Inc. announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase II clinical study for its RN0361, an APOC3-targeted siRNA therapeutic. The study will assess the drug’s efficacy and safety in patients with severe hypertriglyceridemia (SHTG), mixed dyslipidemia, and familial chylomicronemia syndrome…
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Frontera Therapeutics Receives NMPA Approval for FT-003 in Diabetic Retinopathy Study
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Sino-US firm Frontera Therapeutics, Inc. announced receiving approval from China’s National Medical Products Administration (NMPA) to initiate a clinical study for its FT-003, a recombinant adeno-associated virus (rAAV) gene therapy for diabetic retinopathy (DR). This follows previous approvals for studies in neovascular age-related macular degeneration (nAMD) and diabetic macular edema…
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Doma Biopharmaceutical’s HER3-MUC1 Targeted ADC DM002 Receives NMPA Clinical Approval
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China-based Doma Biopharmaceutical (Suzhou) Co., Ltd announced receiving clinical approval from the National Medical Products Administration (NMPA) for its Category 1 drug DM002. This marks a significant milestone in the development of the company’s innovative bispecific antibody drug conjugate (ADC) targeting human epidermal growth factor receptor 3 (HER3) and mucin…
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CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
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Shanghai Fosun Pharmaceutical Gains NMPA Approval for XH-S003 in PNH Treatment
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for XH-S003. The company will initiate Phase II clinical studies for this Category 1 chemical drug candidate as a treatment for paroxysmal nocturnal hemoglobinuria (PNH). Mechanism and…
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Tasly Pharma’s NR-20201 Receives NMPA Approval for Acute Ischemic Stroke Trial
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China-based Tasly Pharma Co., Ltd (SHA: 600535) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its NR-20201, an in-house developed allogeneic adipose-derived mesenchymal stromal cell-based therapy. This marks a significant step forward in the development of innovative treatments for acute ischemic stroke…
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Jiangsu Aidea’s AD108 Receives NMPA Approval for Acute Ischemic Stroke
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China’s Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced receiving clinical approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug AD108. This modified version of Japan-based Nichi-Iko Pharmaceutical Co., Ltd’s kallidinogenase is designed to improve neurological deficits caused by acute ischemic stroke (AIS). Drug Mechanism and…
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China Medical System’s CMS-D003 Receives NMPA Approval for Clinical Study in oHCM
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China Medical System Holdings (CMS; HKG: 0867) announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacological characteristics of its investigational drug CMS-D003. The study will focus on healthy adults and those with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…
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Haisco Pharmaceutical’s HSK44459 Receives NMPA Approval for Psoriasis and Atopic Dermatitis Trials
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its Category 1 chemical drug HSK44459. The drug will be assessed for use in treating psoriasis and atopic dermatitis (AD), chronic, recurrent, and immune-inflammatory skin diseases with…
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Jiuzhitang’s Stem Cell Therapy for Autism Receives NMPA Clinical Trial Approval
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China-based Jiuzhitang Co. Ltd (SHE: 000989) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic product, human bone marrow mesenchymal stem cells (hBMSCs), to treat autism spectrum disorder (ASD). This marks a significant step forward in exploring novel therapeutic options for ASD.…
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Biogen Initiates TRANSCEND Study for Felzartamab in Late AMR Kidney Transplant Patients
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US-based Biogen Inc. (NASDAQ: BIIB) announced the initiation of the TRANSCEND study, a global Phase III trial evaluating the efficacy and safety of its investigational drug felzartamab compared to placebo in adult kidney transplant recipients with late antibody-mediated rejection (AMR). This marks a significant step forward in addressing a critical…
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MindRank Ltd Receives FDA Clearance for MRANK-106 Clinical Study in Solid Tumors
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China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced receiving clearance from the US Food and Drug Administration (FDA) to initiate a clinical study for its MRANK-106, a dual inhibitor of WEE1 and YES1 kinases. This marks a significant milestone for the company as it expands its innovative oncology pipeline…
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Ascletis Pharma’s ASC47 Shows Positive Results in Phase Ib Study for Weight Loss
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China-based Ascletis Pharma Inc. (HKG: 1672) announced positive topline results from a Phase Ib clinical study of its ASC47 in Australia. This adipose-targeted drug candidate, developed in-house, is designed to achieve weight loss without losing muscle mass. Clinical Study ResultsIn the study, ASC47 demonstrated a half-life of up to 26…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for HRS-4029 in Acute Ischemic Stroke
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for HRS-4029. The novel neuroprotective agent will now be assessed in a clinical study as a treatment for acute ischemic stroke (AIS). Preclinical FindingsPreclinical studies have demonstrated that HRS-4029 can…
