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Chipscreen Biosciences Licenses First-in-Class BsAb YH008 from Eucure
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China-based biopharma Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has announced a licensing agreement with Eucure Biopharma, a wholly-owned subsidiary of Sino-US contract research organization (CRO) Biocytogen. The deal grants Chipscreen exclusive development, manufacturing, and commercialization rights to Eucure’s bispecific antibody (BsAb) YH008 in Greater China, including Hong Kong, Macau,…
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Novartis’ LNP023 and Janssen’s Tremfya on Track for Breakthrough Designations
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The Center for Drug Evaluation (CDE) website indicates that Swiss major Novartis’ (NYSE: NVS) LNP023 and US giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Tremfya (guselkumab) are on course to obtain breakthrough therapy designations (BTDs). LNP023 is to be awarded BTD status for its use in paroxysmal nocturnal hemoglobinuria…
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Suzhou Porton Biologics Partners with CorrGene for Cell and Gene Therapy
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China-based contract development and manufacturing organization (CDMO) Suzhou Porton Biologics Ltd has announced a strategic partnership with compatriot firm CorrGene, a rare disease and cancer gene and cell therapy developer headquartered in Wuxi. The collaboration aims to deepen the companies’ involvement in the cell and gene therapy (CGT) field. No…
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Sanofi’s Sarclisa Approved for Import in Shenzhen via Greater Bay Area Scheme
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced import approval in Shenzhen via the Greater Bay Area special drug entry scheme for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab). The approval covers Sarclisa in combination with pomalidomide plus dexamethasone for the treatment of multiple myeloma (MM) in patients who have…
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Innovent Biologics Begins Phase I Trial for IBI333 in Neovascular AMD
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first subject dosing in a Phase I clinical study assessing the safety and tolerability of intravitreal injection of IBI333. This recombinant anti-VEGF-A and anti-VEGF-C bispecific antibody (BsAb) was independently developed by Innovent and is being evaluated for the treatment of neovascular…
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Hybio’s COVID-19 Nasal Spray HY3000 Gets FDA Clinical Trial Approval
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving tacit clinical trial approval from the US FDA for its Category 1.1 chemical drug HY3000 nasal spray targeting COVID-19. This approval marks a significant step forward in the development of novel treatments for the virus, offering a new approach to…
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Junshi Biosciences’ PCSK9 Inhibitor Ongericimab Meets Phase III Endpoints
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China’s Junshi Biosciences (HKG: 1877, SHA: 688180) has announced that two randomized, double-blind, placebo-controlled, multi-center Phase III clinical studies for its PCSK9 monoclonal antibody (mAb) ongericimab (JS002) have reached their primary endpoints. The studies focused on primary hypercholesterolemia and mixed hyperlipidemia, demonstrating significant lipid-lowering effects and good safety profiles. Clinical…
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Oricell Therapeutics Closes $45M Series B1 Round for Cellular Immunotherapy
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China-based tumor cellular immunotherapeutics developer Oricell Therapeutics Co., Ltd has announced the closing of a USD 45 million Series B1 investment round. The round was led by premier global industry investors RTW Investments, LP and Qatar Investment Authority, with participation from existing investors, including Qiming Venture Partners and C&D Emerging…