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Sino Medical Secures Approval for Innovative Drug-Coated Stent System Targeting Intracranial Stenosis
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Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced that it has received marketing approval from the Center for Medical Device Evaluation for its innovative self-expanding intracranial drug-coated stent system. This approval was granted through the special review channel, recognizing the device’s potential to treat intracranial atherosclerotic…
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Junshi Biosciences Files for Approval of Ongericimab, Targeting Key Cholesterol Disorders
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China’s Junshi Biosciences (HKG: 1877; SHA: 688180) has announced the submission of two market approval filings for its PCSK9 monoclonal antibody, ongericimab (JS002). The filings target heterozygous familial hypercholesterolemia and primary hypercholesterolemia, as well as mixed dyslipidemia in patients who are intolerant to or contraindicated for statins. The National Medical…
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Takeda’s Strategic Shift: China Becomes Integral to Global R&D Pipeline
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Japan’s Takeda Pharmaceuticals (NYSE: TAK) has underscored its commitment to the Chinese market at this week’s Takeda R&D China Innovation Forum 2024 in Shanghai. The forum highlighted the integration of China into the company’s global research pipeline, with President Andy Plump announcing that Chinese sites are now participating in 100%…
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Zai Lab Announces Positive Phase III Data for Krazati in KRASG12C-mutated NSCLC, Plans NDA Filing in China
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Zai Lab (NASDAQ: ZLAB; HKG: 9688), a China-based biotech company, has announced positive Phase III results for Krazati (adagrasib) in the treatment of KRASG12C-mutated non-small cell lung cancer (NSCLC) as a second-line therapy. The company is now preparing to submit a New Drug Application (NDA) to China’s National Medical Products…
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Alexion’s Voydeya Earns FDA Nod as Add-on Therapy for PNH-Associated Extravascular Hemolysis
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Alexion, the rare disease unit of AstraZeneca (AZ; NASDAQ: AZN) based in the UK, has secured regulatory approval from the US Food and Drug Administration (FDA) for its Factor D inhibitor Voydeya (danicopan). The drug is approved as an add-on therapy to ravulizumab or eculizumab, which are marketed as Ultomiris…
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Viatris Launches Ryzumvi in the US for Rapid Reversal of Pharmacologically-Induced Pupil Dilation
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Viatris Inc. (NASDAQ: VTRS) has launched its alpha-adrenergic blocker Ryzumvi (phentolamine) in the US market, targeting the reversal of pharmacologically-induced pupil dilation caused by adrenergic agonists or parasympatholytic agents. The ophthalmic solution, which received regulatory approval last year, demonstrated in clinical trials that it could reverse eye dilation within 90…
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Huihe Healthcare’s Vispearl Microsphere Earns Marketing Approval in China for Innovative Cancer Treatment
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Shanghai-based Huihe Healthcare, a developer of interventional medical devices for structural heart diseases, has secured marketing approval in China for its innovative Vispearl drug-loaded microsphere product. This product is designed for use in the embolization treatment of malignant tumors within vascular-rich parenchymal organs and is recognized as the first of…
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J&J’s Nipocalimab Fast-Tracked by FDA for Reducing FNAIT Risk in Pregnant Adults
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The US Food and Drug Administration (FDA) has accepted Johnson & Johnson’s (J&J; NYSE: JNJ) FcRn blocker nipocalimab into its fast-track program for development as a therapy to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults. This move comes after the drug was classified as…
