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Burning Rock’s CanCatch MRD Product Shows Superiority in Postoperative NSCLC Monitoring
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China-based medtech firm Burning Rock Ltd (NASDAQ: BNR) has revealed positive findings from a five-year clinical trial of its liquid assay-based personalized minimal residual disease (MRD) product, CanCatch (PROPHET panel; Patient-specific pROgnostic and Potential tHErapeutic marker Tracking). The results, published in Cancer Cell under the title “Individualized tumor-informed circulating tumor…
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Clover Biopharmaceuticals Launches AdimFlu-S, the Only Imported Quadrivalent Influenza Vaccine in China
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the launch of AdimFlu-S (QIS) in mainland China, marking it as the only imported quadrivalent seasonal influenza vaccine approved for use in individuals aged three years and older. The vaccine has been listed in 26 provinces and municipalities across the country, gearing…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
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Hybio Pharmaceutical’s Semaglutide Clinical Trial Filing Accepted by China’s NMPA
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for semaglutide, a Category 2.2 product. Category 2.2 products in China are new formulations of known drugs that aim to offer a demonstrable clinical benefit over the originator…
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Hasten Biopharmaceutical Secures Licensing Deal for LIB’s Lerodalcibep in Greater China
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China-based Hasten Biopharmaceutical Co., Ltd has entered into a licensing agreement with US firm LIB Therapeutics Inc., securing the development and commercial rights to LIB’s lerodalcibep for the Greater China territory, which includes mainland China, Hong Kong, Macau, and Taiwan. The agreement involves an upfront payment of USD 20 million…
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FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension for its SARS-CoV-2 Omicron XBB.1.5 single-dose monovalent vaccine, Comirnaty. The vaccine is now approved for individuals aged 12 years and older, in addition to receiving an emergency use authorization (EUA) for children between 6 months…
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Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
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Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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