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Hengrui Pharmaceuticals Receives FDA ANDA Approval for Gadobutrol Generic
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving Abbreviated New Drug Application (ANDA) status from the US FDA for its generic version of Bayer’s Gadovist (gadobutrol injection), marking the first generic approval of this kind in the United States. This approval positions Hengrui to expand its presence in the…
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Fosun Pharma’s Bivalent COVID-19 Vaccine Comirnaty Authorized in Hong Kong
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Shanghai Fosun Pharmaceutical Group Co (SHA: 600196) has announced obtaining emergency use authorization (EUA) in Hong Kong for its bivalent COVID-19 original strain/Omicron variant BA.4-5 vaccine Comirnaty (BNT162b2) as a booster shot for populations aged 12 and above. This marks a significant step in the company’s efforts to provide enhanced…
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IASO Biotherapeutics Reports Positive Phase I Results for CAR-T Therapy in NMOSD
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China-based IASO Biotherapeutics has announced the interim results of a Phase I investigator-initiated-trial (ITT) for its BCMA chimeric antigen receptor autologous T (CAR-T) cell therapy equecabtagene autoleucel (CT103A) in neuromyelitis optica spectrum disorder (NMOSD). The study (NCT04561557) is the world’s first to assess a CAR-T therapy in aquaporin 4 (AQP4)-mediated…
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ViVest Medical Raises Funds for Wearable Cardioverter Defibrillator Development
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Suzhou-based device maker ViVest Medical Technology Co., Ltd has reportedly raised “hundreds of millions” of RMB in a Pre-Series B financing round led by SDIC Unity Capital. Other investors included Dingxin Capital and Anji Liangshan State-owned Holdings. The proceeds will be used to advance a clinical study for its fully…
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Mabwell Receives Approval for Clinical Study of 9MW3011 in Polycythemia Vera
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced receiving approval to conduct a clinical study assessing its Category 1 drug candidate 9MW3011 in polycythemia vera. The drug’s clinical trial filing was accepted for review in China last month, marking a significant step forward in its development. Drug Profile9MW3011…
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China’s CDE, HNMPA, and Bo’ao Lecheng Release Real-world Drug Research Measures
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The Center for Drug Evaluation (CDE), Hainan Medical Products Administration (HNMPA), and Bo’Ao Lecheng Medical Tourism Pilot Zone management bureau have jointly released a set of “Real-world Drug Research Implementation Measures.” The new rules take effect immediately, aiming to streamline the process for conducting real-world studies of clinically urgent imported…
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Hotgen Biotech Receives FDA EUA for COVID-19 Antigen Home Test
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving Emergency Use Authorization (EUA) from the US FDA for its Hotgen COVID-19 antigen home test. This approval marks a significant milestone in the company’s efforts to provide accessible and convenient testing solutions for the novel Coronavirus (2019-nCoV). Test ProfileThe Hotgen…
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Wolters Kluwer Partners with China’s NCID to Advance Infectious Disease Diagnosis
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Holland-based information and software solutions provider Wolters Kluwer has announced a partnership with China’s National Center for Infectious Disease (NCID). The collaboration aims to enhance evidence-based diagnosis and treatment in the infectious disease field through joint efforts in discipline development and talent cultivation. Financial details of the partnership were not…
