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QYuns Therapeutics’ QX002N Meets Primary Endpoint in AS Phase III Study
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China-based Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509) announced that its Phase III study of QX002N, an anti-IL-17A monoclonal antibody, in ankylosing spondylitis (AS) has met its primary endpoint. The multi-center, randomized, double-blinded, placebo-controlled trial enrolled 641 patients with moderate to severe AS. Study Results
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Takeda’s Takhzyro Receives EMA Approval for New Administration Form in HAE Patients
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Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved a label extension for Takhzyro (lanadelumab) for subcutaneous administration in adolescents aged 12 and above and adult patients with Hereditary Angioedema (HAE) using a 2 mL pre-filled pen. Drug ProfileTakhzyro is now approved in the…
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Meyer FSMP Hong Kong Secures NMPA Approval for First FSMP in Greater China
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Hong Kong-based Meyer FSMP Hong Kong Limited, an oncology-focused foods for special medical purpose (FSMP) company, announced it has received marketing approval from China’s National Medical Products Administration (NMPA) for its carbohydrate component formula. The product is the first FSMP approved in the Hong Kong, Macao, and Taiwan regions. Product…
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Pfizer Halts Global Development of Hemophilia B Gene Therapy Beqvez Amid Limited Demand
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Pfizer Inc. (NYSE: PFE) has terminated the development and commercialization of Beqvez (fidanacogene elaparvovec), its hemophilia B gene therapy, globally, citing “limited interest” from patients and physicians, according to reports in Nikkei Asia and Reuters. The move marks the U.S. pharma giant’s exit from virally delivered gene replacement treatments. Decision…
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CSPC Pharmaceutical Initiates Phase III Trial for Ammuxetine in Depression Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced the start of a Phase III clinical trial for its Category 1 chemical drug ammuxetine at the Shanghai Mental Health Center, a top-tier Class 3A mental hospital. Drug ProfileAmmuxetine, a small molecule SNR inhibitor discovered by the Chinese Academy of Military Medical…
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Innorna’s IN013 Receives FDA Rare Pediatric Designation for Wilson’s Disease Treatment
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Shenzhen-based Innorna Co., Ltd, a platform company leveraging mRNA and lipid nanoparticle (LNP) delivery technologies, announced that its IN013 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food and Drug Administration (FDA). The mRNA drug is designed to treat hepatolenticular degeneration (HLD), also known as Wilson’s disease, a…
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Joyo Pharma’s JYP0015 Receives CDE Approval for RAS Mutation Cancer Trials
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China’s Center for Drug Evaluation (CDE) has tacitly approved Joyo Pharma’s Category 1 drug JYP0015, a molecular glue product, for clinical studies in hematological and solid tumors with RAS mutations. The approval follows positive preclinical data and a strategic licensing deal with U.S.-based Erasca, Inc. Drug ProfileJYP0015, a novel pan-RAS…
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Zhejiang Huahai Pharma’s HB0056 Receives NMPA Approval for Asthma Trials
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that its bispecific antibody HB0056 has received clinical trial approval from China’s National Medical Products Administration (NMPA) for asthma. The approval follows similar clearances in New Zealand (October 2024) and the U.S. (January 2025), positioning the drug for global development. Clinical…
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Zhejiang Dian Diagnostics Partners with Best Covered to Tackle Alzheimer’s Disease
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Zhejiang Dian Diagnostics Co., Ltd (SHE: 300244), a China-based medical diagnostics firm, has formed a strategic partnership with Shanghai-based Best Covered, a technology company specializing in Alzheimer’s disease (AD). The collaboration aims to enhance early screening, precise testing, personalized intervention, and digital management of AD. Partnership GoalsThe two companies will…
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Coherent Biopharma’s CBP-1019 Granted FDA Fast Track Status for Endometrial Cancer
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Coherent Biopharma Ltd, a Suzhou-based specialist in bispecific-ligand drug conjugates (Bi-XDC), announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to its lead candidate, CBP-1019, for the treatment of recurrent endometrial cancer in patients who have received prior platinum-based chemotherapy. FDA Designation and Drug ProfileThe…
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Sanofi and Teva’s Duvakitug Hits Key Milestones in UC and CD Study at ECCO Congress
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Sanofi (EPA: SAN, NASDAQ: SNY) and Teva Pharmaceutical Industries Ltd (NYSE: TEVA) presented Phase IIb data for duvakitug, their experimental monoclonal antibody targeting TL1A, at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress. The RELIEVE UCCD study evaluated the drug in moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD),…
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Triastek’s 3D-Printed Drug D23 Shows Promise in Treating IgA Nephropathy
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China-based Triastek Inc., a pioneer in pharmaceutical 3D printing, announced positive outcomes from a clinical study of its 3D-printed drug product D23, a budesonide ileum-targeted tablet designed to treat IgA nephropathy (IgAN). The study highlights the drug’s precise intestinal targeting and efficacy in addressing the root cause of the disease.…
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J&J’s Tremfya Meets All Endpoints in Phase III UC Study, Eyes FDA Approval for SC Induction
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U.S. pharmaceutical giant Johnson & Johnson (J&J, NYSE: JNJ) presented positive results from the Phase III ASTRO study of its Tremfya (guselkumab) subcutaneous (SC) induction therapy for adults with moderately to severely active ulcerative colitis (UC) at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO). The data…
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AIM Vaccine Leverages DeepSeek AI to Optimize mRNA Shingles Vaccine Design
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has filed its mRNA-based shingles vaccine with the U.S. Food and Drug Administration (FDA), marking a milestone for the company’s entry into the global vaccine market. The submission follows promising preclinical data and positions AIM as a pioneer in mRNA shingles vaccine development,…
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Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA), has accepted the New Drug Application (NDA) for ipilimumab, an anti-CTLA-4 monoclonal antibody (mAb), and granted it Priority Review designation. The application covers the drug’s use in combination with sintilimab as…
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Roche’s Tecentriq Wins Japan Approval for Alveolar Soft Part Sarcoma
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) and its Japanese partner Chugai Pharmaceutical Co., Ltd. (TYO: 4519) announced that the Ministry of Health, Labour and Welfare of Japan has approved Tecentriq (atezolizumab) for the treatment of unresectable alveolar soft part sarcoma. This marks the first approval of an immune…
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GSK’s Nucala Receives NMPA Review for COPD Treatment
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GSK plc (LON: GSK, NYSE: GSK) announced that the National Medical Products Administration (NMPA) has accepted another indication approval filing for its anti-interleukin-15 (IL-15) biologic Nucala (mepolizumab) for review. The UK-based company is seeking approval for the drug’s use as an add-on maintenance treatment for patients with chronic obstructive pulmonary…
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Nuwacell Biotech’s NCR101 Approved for ILD Clinical Study by China’s CDE
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According to the Center for Drug Evaluation (CDE) website, China-based Nuwacell Biotechnology Co., Ltd. has obtained approval for its NCR101 to conduct clinical trials in interstitial lung disease (ILD). Drug ProfileNCR101 is an induced pluripotent stem cell (iPSC)-derived mesenchymal-like cells (MSCs) therapy. The product has achieved large-scale production and ensures…
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Bristol-Myers Squibb’s Opdivo Shows Survival Benefit in CheckMate-816 Study
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced the final analysis of overall survival (OS) data from the Phase III CheckMate-816 study for its Opdivo (nivolumab) in patients with resectable non-small cell lung cancer (NSCLC). Study HighlightsThe CheckMate-816 study evaluated Opdivo in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult…
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Corxel Pharmaceuticals to Test JX10 in Acute Ischemic Stroke Patients with NMPA Approval
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China-based Corxel Pharmaceuticals (CORXEL) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the functional recovery of acute ischemic stroke (AIS) patients treated with JX10 within a time window of 4.5 to 24 hours from the “last known well.” Drug ProfileJX10 is an…
