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Chengdu Kanghua Receives FDA Approval for Clinical Trial of Norovirus Vaccine
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China-based Chengdu Kanghua Biological Products Co., Ltd (SHE: 300841) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its recombinant hexavalent norovirus vaccine. This development marks a significant step forward in addressing the global health challenge posed by norovirus, which is…
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Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
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US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have…
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Biocytogen Pharmaceuticals Enters Agreement with Myricx Bio for ADC Development
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced an antibody evaluation, option, and license agreement with Myricx Bio, a UK biotech company specializing in the discovery and development of a novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs). These payloads are based on inhibitors of…
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Danaher Partners with Beijing’s Changping District to Accelerate Science and Technology Innovation Center
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US-headquartered Danaher (NYSE: DHR), a Fortune 500 science and technology innovator, has entered into a partnership with the Changping District People’s Government of Beijing Municipality. The collaboration aims to jointly accelerate the construction of Danaher’s science and technology innovation center in the North and a leading synthetic biology innovation service…
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Chongqing Unveils Three-Year Public Health Action Plan Draft for Public Feedback
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The health commission of Chongqing province has released the “Chongqing Public Health Capacity Improvement Three-year Action Plan (2023-2025)(draft proposal)” and is soliciting public feedback until September 22, 2023. The plan outlines a strategic approach to enhance the comprehensive public health service capacity and elevate the health standards of residents to…
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Immunofoco’s IMC008 Earns Orphan Drug Designation for Pancreatic Cancer from FDA
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Suzhou-based cell therapy developer Immunofoco has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration for its next-generation autologous CAR-T therapy, IMC008, for the treatment of pancreatic cancer. This follows the company’s first ODD status granted for gastric cancer in the country less…
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Shanghai Haihe Pharmaceutical’s Glumetinib Filed for Marketing in Japan for NSCLC Treatment
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Shanghai Haihe Pharmaceutical Co., Ltd has announced the filing for marketing approval in Japan for its Category 1 product, glumetinib, indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET 14 exon mutation. Glumetinib’s Development and EfficacyCo-developed by Haihe Pharma and the Chinese Academy…
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Eminence Biotechnology Launches Fully Operational Cell Culture Media Facility in Suzhou
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China-based Eminence Biotechnology (Suzhou) Co., Ltd. has announced the full operation of its state-of-the-art cell culture media facility, which will cater to the production of vaccines, gene therapies, cell therapies, antibodies, and recombinant proteins. The new facility, located at the BIOBAY Phase II in Suzhou Industrial Park, spans approximately 7,000…