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Shanghai Enhances Biomedicine IP Protection with New Procurement-Linked Measures
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The Shanghai Intellectual Property Administration (SIPA) has issued a notification highlighting the city’s intensified efforts to protect intellectual property (IP) rights within the biomedicine industry. This strategic move comes on the heels of several high-profile administrative rulings on biopharmaceutical patent infringement disputes in Shanghai, underscoring a commitment to a linkage…
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Hansoh Pharmaceutical Advances Schizophrenia Treatment with HS-10509 Clinical Trial Approval
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Hansoh Pharmaceutical (HKG: 3692) has announced that it has received approval to commence clinical trials for HS-10509, a Category 1 drug developed in-house for the treatment of schizophrenia. The specific indication for the drug will be determined through the clinical trial process.- Flcube.com
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Sino Biopharmaceutical Receives NMPA Approval for Generic Revolade Equivalent
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Sino Biopharmaceutical Ltd (HKG: 1177), a major player in the Chinese pharmaceutical industry, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s Revolade (eltrombopag olamine). The drug is indicated for the treatment of adults and children aged six and…
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Luye Pharma’s Biosimilar Bevacizumab Gets GMP Certification in Brazil
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Luye Pharma Group (HKG: 2186), a leading pharmaceutical company based in China, has announced that it has received Good Manufacturing Practice (GMP) certification from Brazil’s National Health Surveillance Agency (ANVISA) for its biosimilar version of Roche’s blockbuster drug Avastin (bevacizumab). This certification marks a significant step forward in Luye’s efforts…
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Regenxbio’s One-Time Gene Therapy for Wet AMD Shows Promise in Phase II Study
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Gene therapy specialist Regenxbio (NASDAQ: RGNX) has announced preliminary results from a Phase II study for ABBV-RGX-314, a VEGF pathway inhibitor developed in partnership with AbbVie (NYSE: ABBV) for the treatment of wet age-related macular degeneration (wet AMD). The therapy is designed to be administered as a one-time injection, aiming…
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Takeda’s Hyqvia Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
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Japanese pharmaceutical company Takeda (TYO: 4502) has received an indication extension approval from the US Food and Drug Administration (FDA) for its plasma-derived therapy Hyqvia (human immunoglobulin 10%). The therapy is now approved for use as a maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP). Initially approved in the US…
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China Regulators Chart Steady Path for ‘Huiminbao’ Medical Insurance Schemes
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The China Banking and Insurance Regulatory Commission (CBIRC) and National Healthcare Security Administration (NHSA) have issued a notification outlining measures to ensure a stable and orderly implementation of urban ‘Huiminbao’ commercial top-up medical insurance schemes. The notice is open for feedback from insurance companies and industry associations nationwide. The document…
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Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
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The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Previously approved in China…
