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Eyebright Medical Technology’s Intraocular Lenses Earn Fast-Track Status in China
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Beijing-based Eyebright Medical Technology Co., Ltd (SHE: 688050) has announced that its “intraocular lenses with crystalline eyes” have been granted fast-track status as an innovative medical device in China. This designation underscores the potential impact of the company’s technology on the field of ophthalmology. Refractive Intraocular Lenses for Myopia CorrectionThe…
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Beijing Balance Medical’s Transcatheter Valve System Enters China’s Innovative Device Review
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China’s Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that its transcatheter valve system has entered the innovative medical device special review process in China, marking a significant step forward in the advancement of valve replacement therapies. A New Approach to Postoperative Valve ReplacementThe interventional valve system is…
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Jiangsu Recbio’s ReCOV Vaccine Receives Emergency Use Authorization in Mongolia
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China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced that it has received Emergency Use Authorization (EUA) from Mongolia for its ReCOV, a recombinant COVID-19 vaccine co-developed by the Chinese Academy of Sciences. This authorization marks a significant milestone in the global distribution and accessibility of the…
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CDE Issues Guidelines on Single-Arm Clinical Trials for Antitumor Drugs
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for the Applicability of Single-arm Clinical Trials to Support the Market Filing for Antitumor Drugs.” The document provides clarity on the limitations of single-arm clinical trials, their applicability, and the requirements for confirmatory clinical trials in support of both…
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Pudong New Area Grants Duty-Free Import Qualifications to Seven Companies
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Seven companies have been awarded scientific and technological innovation duty-free import qualification designations by the foreign R&D center in Pudong New Area. Among the awardees are Fosun Kite Biotechnology Co., Ltd, a joint venture (JV) between Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) and Gilead subsidiary Kite Pharma, as…
