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Sciwind’s XW003 Shows Positive Weight Loss Results in Phase Ic/IIa Study
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Hangzhou-based Sciwind announced positive interim topline results from a 26-week Phase Ic/IIa clinical study of its drug candidate XW003 (ecnoglutide) in overweight or obese Chinese adult patients. Study DetailsThe ongoing multicenter Phase 1c/2a study in China involved 60 non-diabetic overweight or obese adult subjects. Participants were randomized into three cohorts…
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Hansoh Pharma Licenses TiumBio’s TU2670 for Endometriosis Treatment in Greater China
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced a licensing agreement with South Korea’s TiumBio Co., Ltd (KOSDAQ: 321550), securing exclusive development, regulatory filing, and commercialization rights to TiumBio’s drug candidate TU2670 in Greater China, including Hong Kong, Macau, and Taiwan. Agreement DetailsUnder the agreement, Hansoh has the rights…
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Gan & Lee Pharmaceuticals’ GZR4 Wins FDA Approval for Diabetes Treatment
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China-based Gan & Lee Pharmaceuticals (SHA: 603087) announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 therapeutic biologic product GZR4 for the treatment of diabetes. Product DetailsThe half-life of long-acting basal insulin analogs currently on the market ranges from…
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GeneoDx Biotech’s Cervical Cancer Screening Kit Wins NMPA Approval
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Shanghai GeneoDx Biotech Co., Ltd, a medical diagnosis unit of Sinopharm, has announced that it has received medical device approval from the National Medical Products Administration (NMPA) for its “human ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 gene methylation detection kit (fluorescent PCR method).” This marks the first approval in China…
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MicroPort CardioFlow Medtech’s VitaFlow Liberty and Angelguide Approved in Colombia
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China-based MicroPort Scientific Corp’s (HKG: 0853) spin-off MicroPort CardioFlow Medtech Co., Ltd (HKG: 2160) announced that it has received marketing approval in Colombia for its second-generation transcatheter aortic valve implantation (TAVI) products, the VitaFlow Liberty transcatheter aortic valve implantation system and the first-generation tip pre-shaped super-stiff guide wire Angelguide. Product…
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HeNan Genuine Biotech Sets Azvudine Price at RMB300 per Bottle for COVID-19 Therapy
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China-based HeNan Genuine Biotech Co., Ltd has set the price of its COVID-19 therapy azvudine at no more than RMB300 (USD44.41) per bottle, according to Henan Daily, a local media outlet. Each bottle contains 35 pieces, with each tablet weighing 1mg. Drug BackgroundAzvudine is a Category 1 anti-HIV/AIDS drug targeting…
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Sinotherapeutics Inc. to Raise RMB600m via STAR Board IPO for Generic Drug Expansion
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Sinotherapeutics Inc., a Shanghai-based generic drug developer, is set to make an initial public offering (IPO) of 45.34 million shares on Shanghai’s Sci-Tech Innovation Board (STAR). The proceeds, amounting to RMB600 million (USD88.8 million), will be used for the construction of a preparation production complex and related supporting facilities, high-end…
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CDE Issues Q&As on COVID-19 Antiviral Drug Evaluation Criteria
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The Center for Drug Evaluation (CDE) has published a list of Q&As regarding the non-clinical and clinical evaluation criteria for new antiviral drugs against emerging COVID-19 variants. The aim is to guide the scientific research, development, and evaluation of new COVID-19 drugs. Clinical Study EndpointFor the primary efficacy endpoint of…
