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Wantai Biological Forecasts Sharp Drop in 2023 Net Profits Amid HPV Vaccine Sales Slump
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a Chinese pharmaceutical company, has issued a forecast for its 2023 performance, warning that net profits are expected to be within the range of RMB 1.2-1.35 billion (USD 169-190 million), marking a significant year-on-year (YOY) decrease of 74.66%-71.49%. The company’s sales…
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Eli Lilly’s Subsidiary Akouos Reports Positive Preliminary Results for Gene Therapy in Hearing Loss
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Eli Lilly (NYSE: LLY) has announced preliminary results from a Phase I/II study conducted by its subsidiary Akouos for gene therapy AK-OTOF, which is being investigated for the treatment of sensorineural hearing loss due to mutations in the otoferlin gene (OTOF). The press release reported that the first participant in…
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Shanghai Pharmaceuticals and HKSTPC Launch 01LABS@Hong Kong Incubator
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01LABS@Hong Kong, a Shanghai-Hong Kong innovation incubator, has officially commenced operations. The incubator was jointly established by China-based Shanghai Pharmaceuticals Holding Co., Ltd (SHA: 601607; HKG: 2607; SPH), Shanghai Biopharmaceutical Frontier Industry Innovation Center Co., Ltd, a subsidiary of SPH, and the Hong Kong Science & Technology Parks Corporation (HKSTPC).…
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Biosion’s SIRPα-Targeting Monoclonal Antibody BSI-082 Clears US FDA Clinical Trial Hurdle
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Biosion, a global clinical-stage biotechnology company dedicated to developing antibody-based therapies for immune and oncologic diseases, has announced that it has received clinical trial clearance from the US Food and Drug Administration (FDA) for its pipeline candidate BSI-082. This monoclonal antibody (mAb) targets SIRPα and is under development for the…
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IASO Biotechnology Secures NMPA Approval for Fucaso in Refractory Myasthenia Gravis
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China-based IASO Biotechnology has received clinical trial approval from the National Medical Products Administration (NMPA) for its BCMA-directed CAR T cell therapy, Fucaso (equecabtagene autoleucel), now indicated for the treatment of refractory systemic myasthenia gravis (MG). Originally approved for marketing in China in June 2022 for recurrent and refractory multiple…
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MSD’s Keytruda Combines with PharmAbcine’s PMC-309 in Phase Ia/b Solid Tumor Trial
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its blockbuster anti-PD-1 drug Keytruda (pembrolizumab) has entered a Phase Ia/b trial in combination with South Korea-based PharmAbcine’s (KOSDAQ: 208340) VISTA-inhibiting biologic PMC-309 for the treatment of advanced or metastatic solid tumors. The study aims to determine the recommended dose,…
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NMPA Proposes Streamlined Market Approval Process for Domestically Produced Overseas Drugs
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The National Medical Products Administration (NMPA) has released a draft proposal titled “Optimizing the Market Approval Filing Matters for Overseas Drugs Already Marketed in China to Be Manufactured in China.” The document is open for public feedback from January 25 to February 23, 2024. The draft proposal outlines several key…
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GSK In-Licenses Elegen’s Cell-Free DNA Tech to Advance Next-Gen Gene Therapies and Vaccines
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GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical giant, has this week in-licensed US partner Elegen’s cell-free DNA manufacturing technology to bolster the potential development of next-generation mRNA, cell, and viral gene therapies, as well as RNA-based vaccines. Elegen will receive upfront fees, purchase commitments, potential equity investment, and milestone payments…