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Hainan Introduces Management Regulations for Urgently Needed Import Drugs and Devices in Boao Lecheng
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The Hainan provincial government has issued a Notice on the Management Regulations for Clinically Urgently Needed Import Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone. These regulations, set to take effect from May 1, 2023, outline key procedures and responsibilities for the procurement and use…
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Minghui Pharmaceutical’s MH004 Cream Shows Positive Results in Atopic Dermatitis Phase II Trial
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China-based Minghui Pharmaceutical has unveiled positive top-line data from a Phase II trial of its MH004 cream, which is being evaluated as a treatment for adolescents and adults with mild-to-moderate atopic dermatitis (AD). The cream, a pan-JAK inhibitor, successfully met its primary endpoint and all key secondary endpoints, demonstrating its…
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AffaMed Therapeutics Gets NMPA Approval for Phase III Dextenza Study in Post-Ophthalmic Surgery
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China-based AffaMed Therapeutics has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase III regulatory study. The study will assess the efficacy and safety of Dextenza in subjects following ophthalmic surgery, marking a significant step forward for the company. Dextenza’s Development and…
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NHC Proposes Updates to Access Standards for Class A and B Medical Equipment
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The National Healthcare Commission (NHC) has released two proposed updates to the Access Standards for Large Medical Equipment, which will impact Class A and Class B devices. These updates are currently open for public comments, allowing stakeholders to provide feedback on the proposed changes. Details of the Proposed UpdatesAs per…
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Harbour Biomed to Present Early Clinical Data for CTLA-4 Antibody Combo at AACR 2023
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China-based Harbour Biomed (HKG: 2142) is set to release early clinical data for its CTLA-4 antibody in combination with Junshi Biosciences’ (HKG: 1877, SHA: 688180) programmed death-1 (PD-1) inhibitor toripalimab as a treatment for neuroendocrine neoplasms (NENs). The findings will be presented via a poster at the upcoming American Association…
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RemeGen’s Disitamab Vedotin (RC48) Clears for Phase I Study in HER2-Positive Tumors
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its antibody-drug conjugate (ADC) candidate, disitamab vedotin (RC48). This single-arm, open, single-center study aims to evaluate the safety and maximum tolerable…
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Junshi Biosciences’ JS401 Receives NMPA Approval for Hyperlipidemia Clinical Trial
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Junshi Biosciences (HKG: 1877, SHA: 688180), a leading China-based biopharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for JS401, an injectable co-developed with Risen Pharma, for the treatment of hyperlipidemia. JS401’s Mechanism of ActionJS401 is an innovative angiopoietin-like 3 (ANGPTL3)…
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Jiangxi Jemincare Group Secures Exclusive Rights to Promote MabPharm’s Biosimilar CMAB007
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Jiangxi Jemincare Group, a China-based healthcare company, has entered into a licensing agreement with fellow Chinese firm MabPharm Ltd (HKG: 2181) to obtain exclusive promotion rights to CMAB007, a prospective biosimilar of Roche/Genentech’s anti-IgE drug omalizumab, known under the trade name Xolair. The agreement encompasses rights across Greater China, including…
