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CSRC Aims to Rebalance Primary and Secondary Markets with New Regulatory Measures
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The China Securities Regulatory Commission (CSRC) has released a document with the aim of “rebalancing” coordinated primary and secondary markets, optimizing initial public offering (IPO) conditions, refining refinancing regulatory arrangements, and further standardizing stock reduction rules. Tightening IPO Conditions and Refinancing RestrictionsThe CSRC will periodically adjust IPO conditions in line…
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Neurodawn Pharmaceutical and China Medical System Holdings Ink Licensing Deal for Y-3
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Nanjing-based Neurodawn Pharmaceutical Co., Ltd has entered into a significant licensing deal with China Medical System Holdings (CMS; HKG: 0867), a fellow Chinese firm. The agreement grants CMS exclusive promotion rights for Neurodawn’s anti-ischemic stroke brain cell protective agent, Y-3, across mainland China, Hong Kong, and Macau. Y-3: A Promising…
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Jiangsu Kanion Pharmaceutical Gets NMPA Approval for SLE Clinical Trial with KYS202002A
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557), a prominent China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study of its pipeline candidate, KYS202002A, for the treatment of systemic lupus erythematosus (SLE). KYS202002A: A Monoclonal Antibody with Broad…
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Everest Medicines’ Nefecon NDA for IgAN Accepted for Review in Macao
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China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, intended for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been accepted for review by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. The…
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China Releases Third List of Pediatric Drugs to Guide Development and Filings
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The National Health Commission (NHC), National Healthcare Security Administration, National Medical Products Administration (NMPA), and two additional ministries have released a third list of pediatric drugs aimed at encouraging and guiding drug developers in product development and filings. The list includes a total of 24 varieties, involving 30 specifications and…
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NMPA Releases 72nd Batch of Reference Drugs for GQCE
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The National Medical Products Administration (NMPA) has released the 72nd batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 22 new specifications, of which three are injectables, and 27 specifications with modifications, including one injectable. These reference drugs are crucial for ensuring the quality and…
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Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
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Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory syncytial virus (RSV) vaccine, Abrysvo. The vaccine is approved for the prevention of lower respiratory tract disease (LRTD) caused by RSV in infants from birth through 6 months of age following maternal immunization during pregnancy,…
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FDA Approves Gilead’s Veklury for COVID-19 Treatment in Patients with Hepatic Impairment
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The US Food and Drug Administration (FDA) has approved a new indication for Gilead’s (NASDAQ: GILD) antiviral Veklury (remdesivir), allowing for the treatment of COVID-19 in individuals with mild, moderate, and severe hepatic impairment without the need for dose adjustments. This makes Veklury the only COVID-19 therapy cleared across all…
