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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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Haisco Pharmaceutical Group Registers Delaware Subsidiary to Expand Global Operations
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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 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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Xtalpi Invests in Alternative Bio for Cancer and Inflammation Drugs
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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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NMPA’s New Guidelines for Drug Registration Review
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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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Shanghai’s Three-Year Plan to Boost Elderly Care Quality
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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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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.…
