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Zhaoke Ophthalmology Completes Enrollment for Intrarosa Phase III Trial
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has completed patient enrollment in a Phase III clinical study for Intrarosa (prasterone). The drug is a vaginal non-estrogen treatment for moderate to severe painful sex due to menopause. Phase III Trial DesignThe multi-center, randomized Phase III…
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JW Therapeutics Partners with 2seventy bio to Develop Cell Therapy Platform
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China-based JW Therapeutics (HKG: 2126) has entered into a partnership with US firm 2seventy bio Inc. (NASDAQ: TSVT) to establish a cell therapy translational and clinical development platform. The collaboration aims to enhance the development of T-cell therapies in mainland China, Hong Kong, and Macau. Initial Focus on MAGE-A4 T-Cell…
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Ascletis Pharma Files IND for Monkeypox Antiviral ASC10 with FDA
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the submission of an Investigational New Drug (IND) filing with the US FDA for its ASC10, an oral antiviral drug candidate targeting the viral polymerase of the monkeypox virus. This marks a significant step in the development of new treatments for monkeypox, a…
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Simcere Receives FDA Clearance for Clinical Study of SIM0237
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China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US FDA to conduct a clinical study for its SIM0237, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and interleukin-15 (IL-15). The molecule is intended for the treatment of locally advanced, unresectable metastatic…
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Ping An Life Insurance Reports Q3 Results, Advances Healthcare Strategy
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Ping An Life Insurance Company of China Ltd released its 2022 Q3 financial report, showing a 6.3% year-on-year (YOY) decrease in net profits to RMB 76.46 billion (USD 10.59 billion). The decline was attributed to the short-term impact of pandemic disruptions and a volatile capital market. However, the company’s operational…
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United Labs Gains NMPA Approval for Ozempic Biosimilar IND
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide). Ozempic is a novel long-acting glucagon-like peptide-1 (GLP-1) analog with a seven-day half-life, used to treat…
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China’s NMPA Issues New Drug Recall Management Measures
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The National Medical Products Administration (NMPA) has released the “Drug Recall Management Measures,” which took effect on November 1, 2022. These measures outline the procedures for drug recalls, which refer to the withdrawal of marketed drugs by Marketing Authorization Holders (MAHs) due to quality issues or other potential safety hazards.…
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AccuMedical’s Blood Flow-Guided Stent Wins NMPA Approval for Brain Aneurysms
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AccuMedical Beijing Ltd has secured approval from China’s National Medical Products Administration (NMPA) for its blood flow-guided dense mesh stent, marking it as the 181st novel medical device approved in the country. The stent is indicated for the treatment of unruptured saccular or spindle wide-necked aneurysms in the internal carotid…
