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Shyndec’s Generic Cytosar-U Gains Marketing Approval in China
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China-based Shanghai Shyndec Pharmaceutical Co., Ltd (SHA: 600420) has announced that its generic version of Pfizer’s (NYSE: PFE) Cytosar-U (cytarabine) has obtained marketing approval in China. This marks the first generic to pass the generic quality consistency evaluation among similar products in the country. Product Profile and Market ContextCytarabine for…
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Sino Medical Sciences’ NC Rockstar Catheter Approved by US FDA
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving market approval from the US FDA for its NC Rockstar noncompliant balloon catheter. This marks the first device approval for Sino in the US market, highlighting the company’s expanding global presence. Product Profile and FeaturesThe NC Rockstar is applicable…
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Antengene Files for Xpovio Approval in Macau, Malaysia, and Thailand
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Antengene Corp., Ltd (HKG: 6996) has announced market filings for its Xpovio (selinexor) in Macau, Malaysia, and Thailand, with indications for relapsed or refractory multiple myeloma (R/R MM) and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The China-based biopharma also plans to make another market filing in Indonesia…
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Eisai and Biogen Initiate BLA in China for Alzheimer’s Therapy Lecanemab
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Japan-based Eisai Co., Ltd (TYO: 4523) and its US co-development partner Biogen Inc. (NASDAQ: BIIB) have revealed that Eisai has initiated a Biologics License Application (BLA) in China for lecanemab, their innovative Alzheimer’s disease therapy. The filing is supported by data from the Phase II Study 201 trial in mild…
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Qitan Tech Raises RMB 700 Million in Series C Financing Led by Meituan
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Qitan Tech, a nanopore gene sequencer maker based in Chengdu, has reportedly raised RMB 700 million (USD 100 million) in a Series C financing round led by Meituan. Other investors included Huagai Capital and BioTrack Capital. The proceeds will be used to ramp up the product matrix, the launch of…
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Kanghong’s Escitalopram Oral Solution Receives NMPA Marketing Approval
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Category 3 chemical product escitalopram oral solution. The product is approved to treat depression and panic disorder with or without agoraphobia, marking a significant milestone in the…
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Tonghua Dongbao Receives NMPA Approval for THDBH151 Clinical Study in Gout and Hyperuricemia
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China-based Tonghua Dongbao Pharmaceuticals (SHA: 600867) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its dual-targeted drug candidate THDBH151 in gout and hyperuricemia. This marks a significant step forward in the development of innovative treatments for these conditions. Existing Therapies and…
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Innovent Biologics Announces Strategic Partnerships to Form Tumor Diagnosis and Treatment Alliance
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China-based Innovent Biologics (HKG: 1801) has announced a series of strategic partnerships with compatriot firms Xinyi Biology, LBP Medicine, Xiangxin Biotechnology, Wuhan HealthCare Biotechnology Co., Ltd, Amoy Diagnostics Co., Ltd, and Shanghai OrigiMed Co., Ltd. The aim is to jointly establish a tumor diagnosis and treatment biosphere alliance. Financial details…
