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EOC Pharma’s Entinostat Secures Chinese Approval for Breast Cancer Treatment
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US-China biotech firm EOC Pharma has received market approval from China’s National Medical Products Administration (NMPA) for its entinostat, an oral histone deacetylase (HDAC) inhibitor, for the treatment of locally advanced or metastatic breast cancer in patients with hormone receptor (HR) positive and human epidermal growth factor receptor-2 (HER2) negative…
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iRegene’s Pioneering Cell Therapy NouvNeu001 Administered in Wuhan for Parkinson’s Disease
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Wuhan-based cell therapy developer iRegene has reached a clinical milestone with the administration of its novel treatment, NouvNeu001, to a patient at Zhongnan Hospital of Wuhan University. The patient’s postoperative condition has been reported as good. In August 2023, NouvNeu001 received approval to be evaluated in a multi-center, open Phase…
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Chengdu Kanghong Pharmaceutical Gets US FDA Nod for Clinical Trial of KH658 for Wet AMD
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a leading pharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence clinical trials for its KH658 eye injection. The drug is designed for the treatment of neovascular (wet) age-related…
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CARsgen Therapeutics Submits CAPA Report to US FDA Following Clinical Hold
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced the filing of its Corrective And Preventive Actions (CAPAs) report with the US Food and Drug Administration (FDA). This follows a previous request by the FDA in December last year…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for Advanced Solid Tumor Therapy
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has been granted clinical trial approval by the National Medical Products Administration (NMPA) for its innovative drug, 177Lu-LNC1008. This targeted radioactive in vivo therapeutic drug is designed to treat general advanced…
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Keymed Biosciences’ Stapokibart Meets Primary Endpoint in Phase III Seasonal Allergic Rhinitis Study
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China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), has successfully achieved its primary endpoint in a Phase III clinical trial for seasonal allergic rhinitis (SAR). The Phase III study, which was multi-center, randomized, double-blinded, and placebo-parallel-controlled, aimed to…
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Pfizer’s Gene Therapy Beqvez Wins FDA Nod for Moderate-to-Severe Hemophilia B
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The US Food and Drug Administration (FDA) has granted marketing authorization to Pfizer (NYSE: PFE) for its gene therapy Beqvez (fidanacogene elaparvovec) for the treatment of adults with moderate-to-severe hemophilia B. The one-time treatment is indicated for patients using factor IX prophylaxis therapy, those experiencing life-threatening hemorrhages, or those with…
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Bio-Thera Solutions’ BAT1806 Receives Positive CHMP Recommendation for EU Approval
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China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the market approval filing of BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab). The CHMP’s recommendation…
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HutchMed’s Partner Takeda Gets CHMP Nod for Fruquintinib as CRC Treatment in Europe
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its collaborator Takeda (TYO: 4502, NYSE: TAK) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of fruquintinib for the treatment of adult patients with…
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Novartis’s Iptacopan (Fabhalta) Receives Marketing Approval in China for PNH Treatment
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received marketing approval from China for its iptacopan (trade name: Fabhalta) for the treatment of adult paroxysmal nocturnal hemoglobinuria (PNH) in patients previously untreated with complement inhibitor. PNH is a rare and life-threatening blood disorder characterized by anemia, hemoglobinuria, bone marrow failure, and…
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AbbVie’s Rinvoq Outperforms Sanofi’s Dupixent in Moderate-to-Severe Atopic Dermatitis Trial
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AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing its JAK inhibitor Rinvoq (upadacitinib) with Sanofi’s (NASDAQ: SNY) interleukin blocker Dupixent (dupilumab) in patients with moderate-to-severe atopic dermatitis. The trial demonstrated that Rinvoq was superior in improving eczema area and severity as well as…
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Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
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Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its proprietary BRD-03. This autologous CD99-targeted CAR-T therapy is classified as a Category 1 biologic therapeutic…
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US FDA Greenlights Henlius Biotech’s Hanquyou as Biosimilar to Roche’s Herceptin
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Shanghai Henlius Biotech Inc. (HKG: 2696) has achieved a significant milestone with the US Food and Drug Administration’s (FDA) approval for marketing Hanquyou (trastuzumab; HLX02), a biosimilar to Roche (SWX: ROG)’s cancer treatment Herceptin (trastuzumab). The biosimilar will be available in the US under the trade name Hercessi. Originally approved…
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Novartis Receives Positive Interim Results for Antimalarial Coartem in Infants
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced interim results from a Phase II/III clinical trial for its antimalarial drug Coartem (artemether + lumefantrine) in infants with uncomplicated Plasmodium falciparum malaria. The trial data indicates that the tablet formulation meets pharmacokinetic (PK), efficacy, and safety requirements, achieving the primary PK…
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Hebei Changshan Biochemical’s Albenatide File for Type 2 Diabetes Accepted by China’s NMPA
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Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced that the National Medical Products Administration (NMPA) has accepted its market approval filing for albenatide (CJC‑1134‑PC) for review. The company is seeking initial approval for the drug as an adjunct to diet and exercise to improve blood glucose control…
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Betta Pharmaceuticals’ BPI-16350 Combo Therapy Shows Improved PFS in Breast Cancer Trial
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an update on its Phase III clinical study for BPI-16350, a cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, used in combination with fulvestrant for the treatment of locally advanced or recurrent hormone receptor positive (HR+) HER2-negative metastatic breast cancer in patients…
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Novartis’s Lutathera Secures FDA Approval for Pediatric Gastroenteropancreatic NETs
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The US Food and Drug Administration (FDA) has granted regulatory approval to Novartis (NYSE: NVS) for its radioligand therapy (RLT) Lutathera (lutetium Lu 177 dotatate) for the treatment of SSTR+ gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in patients aged 12 and older. This expansion of the drug’s original indication for adult patients…
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Shanghai Junshi Biosciences’ PD-1 Inhibitor Toripalimab Files for Two Indications in Hong Kong
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the Hong Kong Drug Office (DO) has accepted two indication approval filings for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The filings seek approval for the drug in combination with chemotherapy as a first-line treatment for metastatic or…
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Abbisko Therapeutics’ Irpagratinib Earns Orphan Drug Designation from US FDA for Hepatocellular Carcinoma
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Shanghai-based biotechnology company Abbisko Therapeutics Co., Ltd (HKG: 2256) has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its novel small-molecule FGFR4 inhibitor, irpagratinib. The designation is in recognition of the drug’s potential in treating hepatocellular carcinoma (HCC). Irpagratinib, an FGFR4 inhibitor originally discovered…
