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Sinopep-Allsino Wins NMPA Approval for Generic Liptruzet in China
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Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Organon’s (NYSE: OGN) Liptruzet (ezetimibe, atorvastatin), becoming the first such product approved in China. The drug, used to treat hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH), was…
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Changchun GeneScience’s GenSci120 Receives NMPA Approval for Rheumatoid Arthritis Trials
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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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CARsgen’s Allogeneic BCMA CAR-T Therapy Achieves sCR in First Patient
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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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Beijing Luzhu Submits BLA for LZ901 Herpes Zoster Vaccine to NMPA
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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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Hainan Boao Lecheng Pilot Zone Implements Baclofen Intrathecal Therapy
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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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NMPA Approves Sinocelltech’s Finotonlimab for Head and Neck Cancer
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The National Medical Products Administration (NMPA) of China has approved Sinocelltech Group Ltd’s (SHA: 688520) finotonlimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb), for use in combination with platinum-based chemotherapy as a first-line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Sunshine Lake Pharma’s Antaitasvir…
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Hansoh Pharma’s Uplizna Receives Priority Review for IgG4-RD Treatment
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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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CSPC Pharmaceutical’s mRNA Vaccine SYS6017 Gains NMPA Approval for Herpes Zoster Study
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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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Nuance Pharma’s Ohtuvayre Receives Regulatory Approval in Macau for COPD Treatment
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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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Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
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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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CanSino Biologics’ DTcP Vaccine for Infants Gains Priority Review in China
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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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Keymed Biosciences’ Kangyueda Gains NMPA Approval for Seasonal Allergic Rhinitis
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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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Novo Nordisk’s Mim8 Shows Promise in Hemophilia A Trial with 98% Caregiver Preference
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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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Biokin Pharmaceutical’s BL-M07D1 Gains NMPA Approval for Phase III Study
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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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AbbVie’s Emblaveo Wins FDA Approval for Complicated Intra-Abdominal Infections
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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…
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Zhongsheng Pharma Gains FDA Approval for Phase II Study of RAY1225
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its polypeptide drug candidate RAY1225 in obese and overweight patients. This marks a significant step forward in the global development of…
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Bio-Thera’s Biosimilars BAT2306 and BAT2506 Accepted for Review by NMPA and EMA
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China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that the market filings for its biosimilars BAT2306 and BAT2506 have been accepted for review by China’s National Medical Products Administration (NMPA) and the European Medicines Agency (EMA), respectively. BAT2306 is a biosimilar version of Novartis’ (NYSE: NVS) Cosentyx (secukinumab), while BAT2506 is…
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CanSino’s Tetanus Vaccine NDA Accepted for Review by NMPA
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China-based vaccines specialist CanSino Biotechnology Inc. (HKG: 6185) announced that the National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for its adsorbed tetanus vaccine for review. The vaccine is indicated for the prevention of non-neonatal tetanus. This acceptance marks a significant milestone in the development and…
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Huahai Pharma Set to Launch IL-17 Antibody HB0017 Clinical Study for HS
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) is poised to initiate a clinical study for its interleukin-17 (IL-17) monoclonal antibody (mAb) HB0017 in hidradenitis suppurativa (HS) after receiving approval from the National Medical Products Administration (NMPA). This marks a significant step forward in the development of novel treatments for…
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Hotgen Biotech Gains NMPA Approval for AA001 Clinical Trials in Alzheimer’s Disease
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China’s Hotgen Biotech Co., Ltd (SHA: 688068) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb) AA001. The drug is intended for the treatment of mild cognitive impairment caused by Alzheimer’s disease (AD) and mild to moderate AD. This…
