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AIM Vaccine’s mRNA-based Shingles Vaccine Receives FDA Approval for Clinical Study
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its mRNA-based shingles vaccine. This marks a significant milestone in the company’s efforts to develop innovative vaccine solutions for global markets. Pre-Clinical Study ResultsIn pre-clinical…
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FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
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The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL) to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) regarding its application for the combination of programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab with small-molecule targeted cancer therapy apatinib as a first-line treatment for irresectable…
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Shanghai Junshi Biosciences’ Loqtorzi Approved for Hepatocellular Carcinoma Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced receiving approval from the National Medical Products Administration (NMPA) for an additional indication for its PD-1 inhibitor Loqtorzi (toripalimab). The drug is now approved for use in combination with bevacizumab to treat first-line unresectable or metastatic hepatocellular carcinoma (HCC),…
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HutchMed’s Tazverik Receives Conditional Approval from China’s NMPA for Lymphoma Treatment
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) has announced receiving conditional marketing approval from the National Medical Products Administration (NMPA) for its drug Tazverik (tazemetostat), an EZH2 methyltransferase inhibitor. The approval allows Tazverik to treat relapsed or refractory (R/R) follicular lymphoma (FL) with EZH2 mutations in patients who have previously received…
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Innovent Biologics Doses First Patient with IBI354 in HeriCare-Ovarian01 Study
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China-based Innovent Biologics, Inc. (HKG: 1801) has administered the first dose of its antibody-drug conjugate (ADC) IBI354 to a subject in the HeriCare-Ovarian01 study. This Phase III trial is a randomized, controlled, multicenter study designed to evaluate the safety and efficacy of IBI354 compared to chemotherapy in patients with HER2-expressing…
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Everest Medicines’ EVM14 mRNA Cancer Vaccine Clears US FDA IND Application
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China-based Everest Medicines (HKG: 1952) has announced that its Investigational New Drug (IND) application for EVM14, a tumor-associated antigen (TAA) vaccine, has been cleared by the US Food and Drug Administration (FDA). This milestone marks a significant advancement for the company’s innovative oncology pipeline. EVM14’s Mechanism and Pre-Clinical SuccessEVM14 is…
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CSPC Pharmaceutical Group Gains NMPA Approval for SYS6040 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational antibody-drug conjugate (ADC) SYS6040. The trial will focus on evaluating the safety and efficacy of SYS6040 in patients with advanced solid tumors. Promising Pre-Clinical…
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Daiichi Sankyo Launches Datroway in Japan for HR Positive, HER2 Negative Breast Cancer
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Japan-based Daiichi Sankyo (TYO: 4568) has announced the launch of Datroway (datopotamab deruxtecan) in Japan. The drug is approved for treating adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer who have undergone prior chemotherapy. First TROP2-Directed Therapy…
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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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Johnson & Johnson’s Tremfya Gains FDA Approval for Crohn’s Disease Treatment
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US pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) has announced receiving clearance from the US Food and Drug Administration (FDA) to market its Tremfya (guselkumab) as a treatment for moderately to severely active Crohn’s disease (CD). This IL-23 inhibitor now offers both subcutaneous (SC) and intravenous (IV) induction options…
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Elevation Oncology Halts EO-3021 Development After Poor Phase 1 Data
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US-based Elevation Oncology, Inc. (NASDAQ: ELEV) has announced the decision to terminate development of EO-3021 following disappointing Phase 1 data, which caused its stock price to plummet 41% before trading. EO-3021’s Background and Licensing DealEO-3021, a Claudin 18.2-targeted antibody drug conjugate (ADC) originated by China’s CSPC Pharmaceutical Group Ltd (HKG:…
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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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Novartis’ Fabhalta Approved by FDA for C3 Glomerulopathy Treatment
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Swiss pharmaceutical giant Novartis’ (NYSE: NVS) iptacopan, marketed as Fabhalta, has received approval from the US Food and Drug Administration (FDA) for the treatment of adults with C3 glomerulopathy (C3G). This marks the first and only approved therapy specifically targeting this rare kidney disease, which is characterized by a poor…
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Arcutis Biotherapeutics’ Zoryve Cream Nears FDA Approval for Pediatric Atopic Dermatitis
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its US partner Arcutis Biotherapeutics, Inc. (NASDAQ: ARQT) has filed a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast) 0.05% with the US Food and Drug Administration (FDA). The application seeks approval for the topical use of Zoryve in children…
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Kintor Pharmaceutical’s KX-826 Shows Promising Results in Alopecia Phase III Trial
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced positive topline results from the long-term safety Phase III study for its KX-826 (pyrilutamide) in alopecia. The trial met the primary endpoint with statistical significance and demonstrated the drug’s outstanding safety and efficacy. Clinical Trial ResultsAt week 52, patients showed significant improvements in…
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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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Hengrui’s Trastuzumab Rezetecan Nears 8th Breakthrough Therapy Designation
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its trastuzumab rezetecan (SHR-A1811), an HER2-targeted antibody-drug conjugate (ADC), is on course to receive its 8th Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA). The targeted indication is recurrent or metastatic…
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Fosun’s Henlius Receives FDA Orphan Drug Designation for HER2-Targeting HLX22
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On March 19, 2025, Fosun Pharmaceutical (SHA: 600196) announced that its subsidiary, Henlius, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for HLX22, a monoclonal antibody targeting HER2, for the treatment of gastric cancer (GC). This designation marks a significant milestone in the development of…
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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…
