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Roche (SWX: RO), the Swiss pharmaceutical giant, has announced the conclusion of the voluntary recall of its Susvimo (ranibizumab) 100mg/mL intravitreal ocular implant in the U.S. market. The implant, indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), has received approval from the U.S. Food and Drug Administration…
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Ascentage Pharma (HKG: 6855), a biopharmaceutical company based in China, has announced that it has received marketing approval from the Macau Special Administrative Region (SAR) of China for its drug olverembatinib. This novel BCR-ABL1 tyrosine kinase inhibitor (TKI) is indicated for the treatment of adult patients with chronic-phase chronic myeloid…
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its co-developed FH-2001 in combination with HanSiZhuang (serplulimab, HLX10) for the treatment of advanced…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate SYS6023. The study will initially focus on patients with general advanced solid tumors.…
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Allist Pharmaceuticals Co., Ltd, a Shanghai-based biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study. The study will assess the efficacy and safety of Allist’s furmonertinib in combination with chemotherapy compared to osimertinib (Tagrisso) in…
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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…