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Solasia Pharma Reduces China Operations, Transfers Drug Rights to Lee’s
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Japan-based Solasia Pharma KK (TYO: 4597) announced that it will reduce its direct operations in China by transferring all promotion rights for two drugs to its existing partner, Lee’s Pharmaceutical Holdings Ltd (HKG: 0950). The move aims to enhance sales efficiency across the mainland China market. Drugs InvolvedThe two drugs…
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NMPA Releases Plans to Support HK and Macau Drug, Device Production in Mainland Cities
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The National Medical Products Administration (NMPA) has released two implementation plans aimed at supporting Hong Kong and Macau drug marketing authorization holders and medical device registrants to produce drugs and devices in nine mainland cities within the Greater Bay Area. These initiatives allow drug Marketing Authorization Holders (MAHs) and device…
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Bio-Thera Solutions’ BAT8010 Receives NMPA Approval for Solid Tumor Clinical Trials
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) announced that it has received approval from the National Medical Products Administration (NMPA) for its BAT8010 to enter clinical trials for the treatment of general solid tumors. The drug, independently developed by Bio-Thera, is an HER2-targeted antibody-drug conjugate (ADC) consisting of a recombinant humanized anti-HER2…
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Kelun Pharma’s SKB264 ADC Receives Breakthrough Therapy Designation for TNBC
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The Center for Drug Evaluation (CDE) website indicates that Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) SKB264, an antibody – drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), has been awarded a breakthrough therapy designation (BTD) for the treatment of locally advanced or metastatic triple – negative breast cancer…
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Burning Rock Biotech Launches PREVENT Study for Early Cancer Detection
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Chengdu-based medical device firm Burning Rock Biotech Ltd (NASDAQ: BNR) announced the launch of a ground-breaking interventional validation study focused on the application of its early cancer test, OverC, in detecting various cancer types in asymptomatic patients. The PREVENT (Prospective multi-canceR Early-detection and interVENTional) study will enroll 12,500 individuals to…
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Harbour BioMed’s Partner NK Celltech Raises RMB 100M in Series A Financing
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China-based Harbour BioMed (HKG: 2142) announced that its strategic partner NK Celltech, a company focusing on NK cell-based cell therapies, has successfully raised over RMB 100 million (USD 14.9 million) in a Series A financing round. The round was led by HUAGAI Capital, with participation from CAS Venture Capital, Qiandao…
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NMPA Releases 55th Batch of Reference Drugs for Generic Evaluation
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The National Medical Products Administration (NMPA) has released the 55th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 16 injectables among a total of 78 new specifications. Additionally, 21 specifications saw modifications, including four injectables. Batch DetailsThe latest batch aims to provide updated reference…
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BeiGene’s Tislelizumab Shows Survival Benefit in Esophageal Cancer Study
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BeiGene (NASDAQ: BGNE) has released the latest results of the global Phase III RATIONALE 306 study, which evaluated the efficacy of its programmed death – 1 (PD – 1) inhibitor tislelizumab in combination with chemotherapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have not previously…
