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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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Moderna’s RSV Vaccine Efficacy Wanes to 50% After 18 Months, Shares Slide
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Moderna Inc. (NASDAQ: MRNA), a U.S.-based biopharmaceutical company, has announced long-term efficacy data for its recently approved respiratory syncytial virus (RSV) vaccine, mResvia, showing a decline in effectiveness to approximately 50% after 18 months. This is notably lower than the efficacy rates of RSV vaccines from competitors GSK and Pfizer,…
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J&J Halts Mid-Stage Trial for Tremfya in Giant Cell Arteritis Due to Efficacy Concerns
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S.-based healthcare company, has reportedly discontinued a mid-stage trial for its autoimmune drug Tremfya (guselkumab) in the treatment of giant cell arteritis, according to a report from BioSpace. An emailed statement from J&J cited “insufficient efficacy findings” as the reason for this…
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AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
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Sino Biopharmaceutical Gains NMPA Approval for Liraglutide Biosimilar for Type 2 Diabetes
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Sino Biopharmaceutical Ltd (HKG: 1177), a major player in China’s pharmaceutical industry, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s Victoza (liraglutide), a treatment designed to control blood sugar levels in patients with type 2 diabetes…
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CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
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Novo Nordisk’s Semaglutide for Long-Term Weight Management Receives NMPA Approval
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Novo Nordisk (NYSE: NVO, CPH: NOVO-B), a leading healthcare company from Denmark, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for semaglutide, indicated for long-term weight management. Globally, Novo Nordisk markets semaglutide under the trade name Wegovy for weight loss. The STEP series…
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Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
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Merck KGaA’s Xevinapant Misses Primary Endpoint in Phase III Head and Neck Cancer Trial
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Merck KGaA (NYSE: MRK), a leading German pharmaceutical company, has encountered a setback in the Phase III clinical trial for xevinapant, a drug licensed from Debiopharm in a deal valued at over USD 1 billion in 2021. The drug, which combines with chemoradiotherapy (CRT), was being investigated in the TrilynX…
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J&J’s Tecvayli Earns NMPA Approval for Relapsed or Refractory Multiple Myeloma
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Johnson & Johnson (J&J; NYSE: JNJ), a leading U.S. healthcare company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Tecvayli (teclistamab) for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have received three or…
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Alebund Pharmaceuticals’ AP306 Earns Breakthrough Designation for Chronic Kidney Disease
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Alebund Pharmaceuticals, based in Shanghai, has announced that its drug candidate AP306 (EOS789), a pan-inhibitor of phosphate transporter proteins NaPi-IIb, PiT-1, and PiT-2, has been granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation. The drug is intended for the treatment of chronic kidney disease hyperphosphatemia. As the…
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Staidson Pharmaceutical Gets FDA Clearance for TNFR2-Targeted mAb SBT-1901
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its TNFR2-targeted monoclonal antibody (mAb), SBT-1901, for the treatment of locally advanced or metastatic solid tumors. Preclinical studies have demonstrated…
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Hybio Pharmaceutical’s Biosimilar Liraglutide Gets Temporary FDA Nod Pending Patent Expiry
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Hybio Pharmaceutical Co., Ltd (SHE: 300199), a Chinese pharmaceutical company, has announced that it has received temporary approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) filing for a biosimilar version of Novo Nordisk’s Victoza (liraglutide). This indicates that the drug has met…
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Asieris Pharmaceuticals Gets NMPA Green Light for APL-1202 Clinical Trial in FLA Infections
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Asieris Pharmaceuticals (SHA: 688176), a Chinese specialist in urogenital cancer, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate APL-1202 for the treatment of free-living amoebae (FLA) infections. APL-1202, an oral MetAP2 inhibitor, is currently in a Phase III…
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Shanghai Haihe Pharmaceutical’s Glumetinib Earns Marketing Approval in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd, a Chinese pharmaceutical company, has announced that it has received marketing approval in Japan for its MET targeted tyrosine kinase inhibitor (TKI), glumetinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with a MET 14 exon mutation. The approval is…
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Haisco Pharmaceutical Gets NMPA Green Light for Cofrogliptin to Treat Type 2 Diabetes
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug cofrogliptin (HSK7653), a long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor. The drug is now approved for use in improving blood sugar control in patients with…
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Gan & Lee Pharmaceuticals’ GZR18 Outperforms Market Similars in Weight Reduction Study
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the presentation of results from a Phase Ib/IIa study for GZR18, a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist, at the American Diabetes Association’s (ADA’s) 84th Scientific Sessions. The study evaluated GZR18’s efficacy in weight reduction for obese/overweight Chinese…
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Novo Nordisk’s Once-Weekly Insulin Awiqli Approved by China’s NMPA for Type 2 Diabetes
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The National Medical Products Administration (NMPA) has granted market approval for Awiqli (insulin icodec), a type 2 diabetes treatment developed by Denmark-based Novo Nordisk (NYSE: NVO). Awiqli, the first and only weekly insulin preparation globally, marks a significant milestone as it was developed concurrently in China, the European Union, and…
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Innovent Biologics’ Mazdutide Shows Promise in Phase III Obesity Trial
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Innovent Biologics Inc. (HKG: 1801), a biopharmaceutical company based in China, has announced the presentation of key results from the first Phase III clinical trial of mazdutide in Chinese adults with overweight or obesity at the ADA Scientific Sessions 2024. The trial, known as GLORY-1 (NCT05607680), is a multi-center, randomized,…
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Takeda’s Fruquintinib for Metastatic Colorectal Cancer Receives European Commission Marketing Approval
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its partner Takeda (TYO: 4502, NYSE: TAK) has received marketing approval from the European Commission for fruquintinib, a treatment for adult patients with metastatic colorectal cancer (CRC) who have previously been treated with chemotherapy regimens based on fluorouracil, oxaliplatin, and…
