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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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Tianjin Municipality Boosts Biopharmaceutical Industry with New Measures
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An In – Depth Look at Tianjin’s Efforts to Accelerate Medical Innovation and Gather Resources:The People’s Government of Tianjin Municipality has released a set of measures aimed at bolstering the biopharmaceutical industry in the region. These measures seek to accelerate the construction of China’s medical science and technology innovation system…
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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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NMPA Seeks Public Feedback on Export Drug Manufacturing Rules
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An In – Depth Look at the New Draft Proposal for the Administration and Management of Export Drug Production in ChinaThe National Medical Products Administration (NMPA) has released a new notification soliciting public feedback on a set of rules related to the administration and management of export drug manufacturing. This…
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VectorBuilder and Eureka Bio Form Alliance to Advance CGT Solutions Globally
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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’s Drug Procurement Under Scrutiny: Addressing Quality Concerns and Policy Reforms
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An In – Depth Exploration of the Recent Survey on Bulk Drug Procurement in China and the Responses to Public ConcernsIn January of this year, concerns were raised by some experts about the potential quality risks of certain drugs under the centralized bulk procurement system in China, such as “ineffective…
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In-Depth Analysis of NHSA’s DRG/DIP Payment Reforms: A Path to Streamlined Healthcare Management
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Comprehensive Overhaul of Payment SystemsThe National Healthcare Security Administration (NHSA) has unveiled a series of measures aimed at enhancing the management of Diagnosis Related Groups (DRG) and Diagnosis-Intervention Packet (DIP) payment methods within China’s multi-tiered healthcare security framework, known as the “1+3+N” system. These reforms emphasize seamless integration with other…
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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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Regend Therapeutics’ Pulmovinci Receives FDA Orphan Drug Designation for IPF
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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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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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RemeGen’s Executive Director He Ruyi Resigns for Career Development
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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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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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Siemens Healthineers Posts Strong Q1 Results with 5.7% Revenue Growth
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Germany-based Siemens Healthineers AG (ETR: SHL) released its results for the first quarter of fiscal year 2025, ended December 31, 2024. The company showcased an excellent equipment book-to-bill ratio of 1.21 and comparable revenue growth of 5.7%. This marks a strong start to the fiscal year, driven by growth across…
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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…
