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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that it has entered into a licensing agreement with Intas Pharmaceuticals Ltd., granting the Indian firm exclusive commercialization rights to its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), in the United States. Details of the AgreementUnder the terms of the…
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China-based Changchun GeneScience Pharmaceutical Co., Ltd announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its GenSci120 in rheumatoid arthritis (RA). The monoclonal antibody (mAb) was previously approved for studies in adult systemic lupus erythematosus, adult primary Sjogren’s syndrome, and inflammatory bowel…
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the first patient treated with its allogeneic BCMA chimeric antigen receptor (CAR)-T therapy, developed on the THANK-u Plus platform, achieved a stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment. Patient Background and TreatmentThe patient, diagnosed…
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Shenzhen-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced the registration of a new business in Delaware, United States. The company has established a USD 50,000 subsidiary named Hexgen Pharmaceutical Holding Limited, marking its latest move to accelerate global expansion and enhance its core competitiveness on an international scale.…
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Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a human vaccine and therapeutic biologics manufacturer, announced that it has submitted a Biologic License Application (BLA) for its LZ901 to the National Medical Products Administration (NMPA), which has been accepted for review. Vaccine DetailsLZ901 is a recombinant herpes zoster vaccine developed based…
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The Hainan Boao Lecheng Pilot Zone Management Bureau announced the implementation of Baclofen Intrathecal Sintetica, a special treatment for severe spasms, at the Ruijin-Hainan Hospital Shanghai Jiao Tong University School of Medicine and Hainan Boao Research Hospital. This therapy is suitable for patients with severe spinal cord-derived chronic spasticity (related…
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Shenzhen-based QuantumPharm Inc. (HKG: 2228), also known as Xtalpi Inc., announced a strategic investment in Alternative Bio, alongside an in-depth research partnership with the Wuxi-based biotech firm. Alternative Bio’s Innovative Drug DevelopmentAlternative Bio, founded by three serial entrepreneur scientists, focuses on developing small molecule targeted innovative drugs for major diseases…
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that the National Medical Products Administration (NMPA) has granted priority review status to a new indication approval filing for its Uplizna (inebilizumab), a CD19 monoclonal antibody (mAb) co-developed with US-based Viela Bio Inc. The Chinese firm is seeking approval for the drug…
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China-based gene delivery technology developer VectorBuilder has formed a strategic alliance with compatriot firm Shenzhen Eureka Biotechnology Co., Ltd., a specialist in cell and gene therapy (CGT). The partnership, which leverages the companies’ respective expertise and successful track records in virus vector production, aims to deliver innovative solutions in the…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its mRNA vaccine SYS6017. The trial will focus on herpes zoster, a painful condition caused by the reactivation of the varicella zoster virus (VZV).…
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China-based Nuance Pharma announced that it has received regulatory approval in Macau for its Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD). This approval marks a significant milestone in the company’s efforts to expand the availability of Ohtuvayre in the Greater China region. Innovative Dual-Inhibitor TherapyEnsifentrine…
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Suzhou-based stem cell therapy specialist Regend Therapeutics announced that the US Food and Drug Administration (FDA) has granted its airway basal layer stem cell product, Pulmovinci, Orphan Drug Designation (ODD) for the treatment of idiopathic pulmonary fibrosis (IPF). This designation is a significant milestone in the development of Pulmovinci, highlighting…
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab (trade name: Erbitux). The drug, to be traded under the name Datailai, is approved…
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China-based vaccines specialist CanSino Biologics Inc. (HKG: 6185) announced that the New Drug Application (NDA) for its DTcP vaccine for infants and young children (under 2 years old), which was accepted for review by the National Medical Products Administration (NMPA) in December of last year, is now under priority review.…
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China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its Kangyueda (stapokibart), an anti-IL-4Rα monoclonal antibody (mAb), this time for its use in seasonal allergic rhinitis. Stapokibart previously gained NMPA approval for the treatment of severe atopic…
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Denmark-based Novo Nordisk A/S (NYSE: NVO) released interim results from the Phase III FRONTIER3 study, demonstrating the benefit of Mim8 in 70 children (aged 1-11 years old) with hemophilia A, both with and without inhibitors. The trial initially assessed once-weekly prophylaxis treatment with the investigational drug, offering participants the option…
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China-based pharmaceutical firm RemeGen (HKG: 9995) announced the resignation of Mr. He Ruyi, Executive Director and core technical personnel of the company, from his posts as executive Director of the second session of the Board, member of the strategic committee of the Board, and Chief Strategy Officer of the company,…
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its BL-M07D1. The randomized, controlled trial will assess BL-M07D1 versus trastuzumab emtansine as a postoperative adjuvant treatment for HER2-positive breast cancer…
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US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Emblaveo (aztreonam and avibactam). The drug is the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic approved for use in combination with metronidazole for patients 18…