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Innovent Biologics’ Tyvyt Secures NMPA Approval for EGFR-Mutated NSCLC Treatment
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China-based Innovent Biologics Inc., (HKG: 1801) has announced that the National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) for patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC)…
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China’s NHC Releases Draft Guidelines for Somatic Cell Clinical Research, Seeks Public Input
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The National Health Commission (NHC) has released the “Somatic Cell Clinical Research Guidelines (draft proposal)” and is soliciting public feedback until May 24, 2023. These guidelines are designed to provide direction for companies and institutions engaged in clinical trials that do not seek formal market approval, which would otherwise necessitate…
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Zion Pharma’s ZN-A-1041 Acquired by Roche for Global Development and Commercialization
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China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has announced that Roche (SWX: ROG) has acquired the global rights to Zion’s lead program, ZN-A-1041. This orally administered selective tyrosine kinase inhibitor (TKI) targets the human epidermal growth factor receptor 2 (HER2) and is designed…
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Grand Pharmaceutical Group Files NDA for Ophthalmic Analgesic APP13007 with US FDA
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the filing of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for APP13007 (GPN00833), a modified hormone nano suspension eye drop co-developed with Taiwan-based Formosa Pharmaceuticals Inc., (TPE: 6838). The drug is in development as an…
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Neuro3 Therapeutics Secures Exclusive License Deal with Lundbeck for KCNQ2 Activator Programs
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Neuro3 Therapeutics (Neuro3), a biotechnology company specializing in central nervous system (CNS) diseases with operations in Suzhou, China, and the US, has announced the signing of an exclusive license and option agreement with Denmark-based Lundbeck (OTCMKTS: HLUBF). This deal grants Neuro3 a global license to the intellectual property encompassing two…
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Organon Reports Q1 2023 Revenue Growth, Highlights Women’s Health and Biosimilars Progress
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Organon (NYSE: OGN) has released its financial report for the first quarter of 2023, announcing a 3% year-on-year (YOY) increase in revenues, excluding foreign exchange effects, amounting to USD 1.54 billion. This growth was driven by a 3% increase in Women’s Health revenues, a 20% increase in Biosimilars, and a…
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US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi
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China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company’s co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has…
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Acorda Therapeutics Strikes Deal with Hangzhou Chance for Inbrija Distribution in China
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US-based Acorda Therapeutics Inc., (Nasdaq: ACOR) has announced a distribution and supply agreement with Hangzhou Chance Pharmaceuticals Co., Ltd, a Chinese pharmaceutical company. This deal will facilitate the supply of Inbrija (levodopa inhalation powder) to the mainland China market, where it will be used as an intermittent treatment for episodic…
