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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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A Look at the New Rules for Chemical and Biological Drug Filings in China:The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has released the “Guidelines for Acceptance and Review of Chemical Drug Registration (Trial)” and “Guidelines for Acceptance and Review of Biological Product…
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A Comprehensive Look at Shanghai’s Efforts to Integrate Medical Care and Elderly Care:The Shanghai Civil Affairs Bureau has released the “Three – Year Action Plan for Improving the Quality of Elderly Care Institutions in Shanghai (2025 – 2027)”. The plan aims to promote the integration of medical care and elderly…
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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 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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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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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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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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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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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…