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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that China’s National Medical Products Administration (NMPA) has granted approval for a Phase II clinical study of its antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4, in patients with triple negative breast cancer (TNBC). The study will evaluate the efficacy and…
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Ipsen S.A. (EPA: IPN; OTCMKTS: IPSEY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its six-month dosage form of Diphereline (triptorelin), a treatment for central precocious puberty (CPP), a condition that leads to early sexual development in children. This makes Diphereline the…
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Shanghai HeartCare Medical Technology Co., Ltd (HKG: 6609), a leading player in the Chinese medical device industry, has announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its innovative vascular closure device, the first home-grown femoral artery occluder. The device, which was approved…
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In a significant move to curb drug prices, the U.S. Senate unanimously passed the Affordable Prescriptions for Patients Act of 2023 (S-150) last week. This legislation is designed to foster greater competition from generic and biosimilar drugs against their brand-name counterparts. The act’s primary objective is to impose a limit…
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Shanghai Ruijin Hospital’s Hainan subsidiary has initiated a real-world study for Orserdu (elacestrant), a next-generation selective estrogen receptor degrader (SERD) originally developed by Eisai (TYO: 4523). The drug was transferred to Radius Health for global development back in 2006. In a strategic move in July 2020, the Menarini Group, based…
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Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced positive top-line results from a multi-center Phase III clinical study for its Velsipity (etrasimod) in moderate-to-severe active ulcerative colitis (UC) during the maintenance period in Asia. This landmark trial is the largest Phase III study for moderately-to-severely…
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, announced that its co-development partner Arcutis Biotherapeutics Inc., (NASDAQ: ARQT), has received approval from the U.S. Food and Drug Administration (FDA) for a supplementary New Drug Application (sNDA) for Zoryve cream (roflumilast). This clearance is for treating mild to moderate…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that it has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its investigational antibody-drug conjugate (ADC), 9MW2821. This candidate is designed to target Nectin-4 and is currently in development…
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3SBio Inc. (HKG: 1530), a leading biopharmaceutical company based in China, has announced that the National Medical Products Administration has accepted its filing for market approval of SSS06, a recombinant erythropoiesis stimulating protein injection (rESP, CHO cells). This development marks a significant milestone for the company as it aims to…
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Huadong Medicine Co., Ltd (SHE: 000963), a prominent pharmaceutical company in China, has entered into an exclusive licensing agreement with Suzhou Auzone Biological Technology Co., Ltd, focusing on Auzone’s product candidate TTYP01, an oral formulation of edaravone. This strategic partnership positions Huadong to exclusively develop, regulate, manufacture, and commercialize the…
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Oricell Therapeutics Co., Ltd, a leading biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its innovative therapy, OriCAR-017. This chimeric antigen receptor (CAR)-T cell therapy is targeted at GPRC5D, aiming to treat recurrent refractory multiple myeloma…
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that its small-molecule COVID-19 therapy, Xiannuoxin (simnotrelvir, ritonavir), has received regular approval from the Chinese regulatory authorities, converting from its previous conditional approval status. This makes Xiannuoxin the first COVID-19 therapy of its kind to achieve full…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shanghai Regenelead Therapies Co., Ltd., has conducted the first surgical dosing in a clinical study for its dual adeno-associated virus (AAV) gene therapy, RGL-193, aimed at treating Parkinson’s disease (PD). The procedure…
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Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
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Eisai Co., Ltd, a Japanese pharmaceutical company, along with its co-development partner Biogen Inc. (NASDAQ: BIIB), has announced that they have received marketing approval in Hong Kong for their Alzheimer’s disease (AD) therapy Leqembi (lecanemab). Known as 乐意保 in Chinese, the drug is administered intravenously every two weeks and is…
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Pfizer Inc. (NSE: PFIZER), a leading pharmaceutical company in the U.S., has announced that a once-daily oral formulation of danuglipron, its investigational GLP-1 agonist for the treatment of type 2 diabetes and obesity, has been selected for full clinical development. This decision is based on positive findings from an ongoing…
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Novo Nordisk A/S (NYSE: NVO) announced that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) in response to the Biologics License Application (BLA) for Awiqli, the company’s once-weekly basal insulin icodec for diabetes treatment. The CRL from the FDA highlighted specific requests concerning the manufacturing process…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its candidate mRNA vaccine, SYS6016, targeting the respiratory syncytial virus (RSV). The vaccine, SYS6016, is designed using mRNA molecules that…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug candidate STC008. This study will focus on the treatment of tumor cachexia…