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Easton Pharmaceutical Co., Ltd (SHA: 688513), based in Chengdu, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s oxcarbazepine. This neurogenic drug is now approved for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or…
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Daiichi Sanky (TYO: 4568), a pharmaceutical company based in Japan, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Tarlige (mirogabalin) for the treatment of diabetes peripheral neuropathic pain (DPNP). Mirogabalin is a gabapentinoid drug, which belongs to the same class…
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received new indication approval from the National Medical Products Administration (NMPA) for its drug Xpovio (selinexor). The drug is now approved for the treatment of adult patients with recurrent or refractory (R/R) diffuse large…
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Luye Pharma Group (HKG: 2186), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its oxycodone, naloxone product, LY 021702. The drug is indicated for use in adults requiring opioid analgesics to manage severe pain, including both…
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Johnson & Johnson (J&J; NYSE: JNJ) has announced that Rybrevant (amivantamab) has received its first market approval in Canada. The drug is approved as a first-line treatment in combination with chemotherapy for advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating epidermal growth factor receptor (EGFR) Exon…
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Blue Sail Medical Co., Ltd (SHE: 002382), a medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category III medical device, Fastroad. Fastroad is a distal pathway catheter designed for radial artery neurovascular access and was…
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Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pacira’s Exparel (bupivacaine liposome). This approval positions Hengrui as the first…
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MabPharm Ltd (HKG: 2181), a biosimilar specialist in monoclonal antibody (mAb) based in Taizhou, has announced that it has received market approval for CMAB807, a biosimilar version of Johnson & Johnson (J&J)’s Remicade (infliximab), in Peru. The approval encompasses all six indications, which include adult ulcerative colitis, ankylosing spondylitis, rheumatoid…
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Eisai Co., Ltd (TYO: 4523), a Japanese pharmaceutical company, in partnership with Biogen Inc. (NASDAQ: BIIB), has announced the official market launch of Leqembi (lecanemab), a therapy for Alzheimer’s disease (AD), in China. This follows the drug’s official market approval in China in January this year. Leqembi is a humanized…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its proline, henagliflozin. The Category 1 drug is now approved for use in combination with retagliptin and metformin to…
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic…
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug BAT2094 (Betagrin). The drug is indicated for use in patients with acute coronary syndrome who are undergoing percutaneous…
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Bio-Thera Solutions Ltd (SHA: 688177), a biopharmaceutical company based in China, has announced that it has received market approval from the European Commission (EC) for BAT1806, a biosimilar version of Roche Holding AG’s (OTCM: RHHBY) Actemra/RoActemra (tocilizumab). BAT1806 is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,…
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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 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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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…