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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its ⁹⁹ᵐTc tetrofosmin, a SPECT myocardial perfusion imaging agent. This radiopharmaceutical drug, which is utilized for myocardial perfusion imaging in…
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Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294), a pharmaceutical company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug, fotagliptin. This drug is intended to improve blood sugar control in adult patients with type 2 diabetes,…
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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced that it has received an additional indication approval from the National Medical Products Administration (NMPA) for its drug Alecensa (alectinib). This new indication is for use as a post-surgery adjuvant therapy in patients with stage 1B to stage IIIA non-small cell…
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Immorna (Hangzhou) Biotechnology, a biotech company specializing in mRNA-based vaccines and located in Hangzhou, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its self-replicating RNA cancer therapy, JCXH-211-IV (intravenous injection). JCXH-211-IV is a potential first-in-class…
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The National Medical Products Administration (NMPA) has granted approval to Novo Nordisk (NYSE: NVO), a Denmark-based pharmaceutical giant, for its drug Esperoct (turoctocog alfa pegol). This marks Esperoct as the first and only long-acting recombinant coagulation factor VIII approved in China for on-demand treatment and control of bleeding events, as…
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Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced a new set of agreements with IASO Biotechnology, a domestic firm, to adjust the terms of their earlier partnership. According to the new deals, IASO will acquire from Innovent its rights to the BCMA-targeted chimeric antigen…
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PharmaEssentia Corporation (TPE: 6446, FRA: 8Z1), a biopharmaceutical company based in Taiwan, has announced that its drug Besremi (ropeginterferon alfa-2b) has been approved by the National Medical Products Administration (NMPA) to treat adult polycythemia vera (PV) in China. This ultra-long-acting interferon, developed in-house, is already registered in the European Union,…
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has approved an additional market approval filing for its drug candidate crisugabalin (HSK16149). This latest approval expands the drug’s indication to include the treatment of post-herpetic neuralgia…
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its drug candidate HP537 in the treatment of hematologic malignancies. The Category 1 chemical had previously…
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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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Amoytop Biotech Co. Ltd (SHA: 688278), based in Xiamen, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, peginterferon α-2b, which is indicated for the treatment of primary thrombocytosis. As the first domestically developed long-acting peginterferon α-2b for…
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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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Sirnaomics Ltd (HKG: 2257) has announced the completion of the Phase I second sequence for its drug candidate STP122G, which is being developed as an anticoagulation treatment, along with the release of interim data. The Factor XI program, to which STP122G belongs, has broad therapeutic potential as an anticoagulant across…
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Roche (SWX: ROG; SWX: RO; OTCMKTS: RHHBY), the Swiss pharmaceutical giant, has announced that a Phase II/III clinical trial for its TIGIT-targeted antibody tiragolumab, designed for non-small cell lung cancer (NSCLC), did not outperform Keytruda (pembrolizumab), a PD-1 inhibitor. The trial, known as SKYSCRAPER-06, was evaluating the efficacy of tiragolumab…
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Medigene AG (ETR: MDG1), a biopharmaceutical company based in Germany, has announced that it has been granted patent protection in China for its T cell receptor (TCR) technology targeting NY-ESO-1 and LAGE 1a. This development pertains to the company’s lead pipeline candidate, MDG1015, which is a first-in-class, third-generation TCR-T therapy.…
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug HRS-9813, which is intended for the treatment of idiopathic pulmonary fibrosis (IPF). Preclinical efficacy data from…
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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…