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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…
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ImmuneOnco Biopharmaceuticals Receives NMPA Approval for CD47 and CD20 Dual-Targeted BsAb in SLE
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for IMC-002, a bispecific antibody (BsAb) targeting CD47 and CD20 for the treatment of systemic lupus erythematosus (SLE). IMC-002 is designed to enhance antibody dependent cell phagocytosis…
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Sichuan Biokin Pharmaceutical Gets NMPA Go-Ahead for BL-M17D1 Solid Tumor Clinical Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bispecific antibody drug conjugate (ADC), BL-M17D1, which is designed for the treatment of advanced solid tumors.…
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StarryGene Initiates Phase I Clinical Trial for XMVA09 Gene Therapy in wAMD
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StarryGene, a biotech company specializing in gene therapy and based in Hefei, China, has announced that the first patient has been dosed in a Phase I clinical study for its gene therapy XMVA09 injection, which is designed to treat wet age-related macular degeneration (wAMD). XMVA09 is positioned as the world’s…
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Gilead’s Lenacapavir Shows 100% Efficacy in Phase III HIV PrEP Study
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Gilead Sciences Inc. (NASDAQ: GILD), a U.S. biopharmaceutical company, has announced topline results from the Phase III PURPOSE 1 study. The study indicates that lenacapvir has successfully demonstrated its potential as a twice-yearly pre-exposure prophylaxis (PrEP) drug to prevent HIV infection. The trial involved 5,300 cisgender women and adolescent girls…
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Zai Lab’s Partner Argenx Receives FDA Approval for CIDP Treatment Vygart Hytrulo
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Argenx SE (NASDAQ: ARGX), the U.S. partner of China-based biopharmaceutical company Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688), has announced that the U.S. Food and Drug Administration (FDA) has granted approval for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).…
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Qilu Pharmaceutical’s Generic Version of Vyndaqel Receives NMPA Marketing Approval
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The National Medical Products Administration (NMPA) has granted marketing approval to Qilu Pharmaceutical’s generic version of Pfizer’s Vyndaqel (tafamidis meglumine), marking it as the first generic to pass the generic quality consistency evaluation (GQCE) in China. This development is highlighted on the NMPA’s official website. Tafamidis meglumine is indicated for…
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Zhangzhou Pien Tze Huang’s PZH2113 Receives NMPA Clinical Trial Approval for Lymphoma Treatment
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Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436), a renowned traditional Chinese medicine (TCM) company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its PZH2113. This is an in-house developed Category 1 chemical drug intended for the treatment…
