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Wuhan Institute’s Hexavalent Rotavirus Vaccine on Track for Priority Review by CDE
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The Center for Drug Evaluation (CDE) website has indicated that Wuhan Institute of Biological Products Co., Ltd’s oral hexavalent reconstituted rotavirus live vaccine (Vero cells) is on course for priority review. This priority status is granted for the vaccine’s use in preventing acute gastroenteritis caused by rotavirus in infants and…
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Kintor Pharmaceutical’s KX-826 Shows Promise in Phase II Study for Male Androgenetic Alopecia
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the conclusion of a randomized, double-blind, placebo-controlled Phase II clinical study for its drug candidate KX-826 (pyrilutamide) in the US for the treatment of male patients with androgenetic alopecia (AGA). The study demonstrated that KX-826 can promote hair growth, with statistically and…
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ZhenGe Biotech Partners with NNIT for Advanced Digitalization in Drug Development
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ZhenGe Biotech, a China-based Contract Development and Manufacturing Organization (CDMO), has entered into a strategic partnership with NNIT, a Denmark-headquartered provider of digital life sciences solutions. Under the terms of the agreement, NNIT will support ZhenGe in developing a more reliable digitalization platform that offers full lifecycle digital solutions, from…
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CNIPA Releases Patent Linkage Decisions, Paving Way for Generic Drugs in China
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The China National Intellectual Property Administration (CNIPA) has released the latest batch of completed patent linkage cases, following the new legal framework introduced with China’s amended Patent Law, which came into effect from July 2021. Decisions on Generic and Originator PatentsThe decisions covered 9 molecules and 19 patent challenge verdicts,…
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Guangdong Taienkang’s CKBA Ointment for Vitiligo Accepted for Review by China’s NMPA
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Guangdong Taienkang Pharmaceutical Co., Ltd, (SHE: 301263), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a Phase II clinical trial filing for its CKBA ointment in the treatment of vitiligo. The Category 1 chemical drug is also currently undergoing a Phase IIa clinical…
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Mabwell’s B7-H3 Targeting ADC 7MW3711 Accepted for Review by China’s NMPA
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that its clinical trial application for 7MW3711, an antibody drug conjugate (ADC) targeting B7-H3, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of advanced solid tumors.…
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CStone Pharmaceuticals’ Partner Servier Secures EU Approvals for IDH1 Inhibitor Tibsovo
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CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has announced receiving two new indication approvals for Tibsovo (ivosidenib), a first-in-class IDH1 inhibitor, from the European Committee. This marks a significant expansion in the drug’s approved uses for treating specific types of leukemia and cholangiocarcinoma. New Indications for Tibsovo in EuropeTibsovo is…
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Innovent Biologics’ Mazdutide Showcases Weight Loss Efficacy in Phase II Study for Chinese Adults
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China-based Innovent Biologics Inc., (HKG: 1801), has announced that a Phase II clinical study assessing the higher dose (9mg) of mazdutide (IBI362) in Chinese adults with obesity has achieved its 24-week primary endpoint. This milestone marks a significant step forward in the development of this potential treatment for obesity. Study…
