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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals Ltd, has achieved a significant milestone with the acceptance of their marketing approval filing for Quviviq (daridorexant) by China’s National Medical Products Administration (NMPA). Quviviq is an innovative anti-insomnia drug that has already gained commercial…
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Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced the submission of a market approval filing to the National Medical Products Administration (NMPA) for their co-developed biosimilar version of Bayer’s Eylea (aflibercept). This biosimilar has the potential to be the latest entry in the…
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading pharmaceutical company based in China, has announced positive interim data from a Phase III clinical study for its drug anlotinib. The study combines anlotinib with chemotherapy as a first-line treatment for advanced unresectable or metastatic soft-tissue sarcoma. The Independent Data Monitoring Committee (IDMC)…
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Eli Lilly & Co. (NYSE: LLY) has encountered a setback in its drug development pipeline with the failure of the Phase II trial for LY3361237, an antibody agonist targeting the BTLA immune checkpoint, in the treatment of systemic lupus erythematosus (SLE). The trial, registered on clinicaltrials.gov as NCT05123586, was terminated…
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…
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Celling Biotechnology Co., Ltd, a Guangzhou-based biopharmaceutical company, has announced that its pipeline candidate CEL001 has received tacit clinical trial approval in China. The drug candidate is an antibody fusion protein targeting PD-1, TIGIT, and IL-15, and is intended for the treatment of advanced solid tumors, with a particular focus…
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced that the Center for Drug Evaluation (CDE) in China has accepted for review its market approval filing for the investigational Category 1 drug rovadicitinib (TQ05105). The drug is being developed for the treatment of moderate- to high-risk myelofibrosis (MF), a serious bone marrow…
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Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a Chinese biopharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for HY07121, an innovative antibody fusion protein targeting PD-1, TIGIT, and IL-15 for the treatment of advanced solid tumors. The drug candidate, classified as…
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Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its EYP-1901 intravitreal implant, intended for the treatment of wet age-related macular degeneration (wAMD). The drug candidate is a combination of vorolanib, a multi-target tyrosine kinase VEGFR/PDGFR inhibitor, and…
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Shenzhen Tyercan Bio-pharm Co., Ltd, a biopharmaceutical company based in China, has announced that it has received tacit Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its anti-tumor drug TYE1001. The drug is intended for the treatment of advanced solid tumors and lymphomas. TYE1001…
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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…