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China Tightens Medical Device Quality Oversight: 2025 Inspection Plan Unveiled
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China’s National Medical Products Administration (NMPA) has released its 2025 medical device inspection plan, outlining stricter quality oversight and compliance requirements. The new guidelines aim to enhance product safety, enforce regulatory standards, and streamline market access for domestic and international manufacturers. Key Policy Highlights Impact on Medical Device Manufacturers Reinspection…
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Policy Analysis: Shanghai’s 2025 Pharmaceutical Procurement Regulation and Market Implications
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Shanghai’s Medical Centralized Bidding and Procurement Affairs Management Office has released its January 2025 list of monitored pharmaceutical varieties under the public tendering and price negotiation framework. The policy, outlined in Document No. 104 of 2023, emphasizes transparency, fairness, and price rationality in inter-provincial drug procurement. This regulatory move underscores…
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Guangdong Accelerates Centralized Procurement for Apixaban and Key Therapeutics
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The Guangdong Drug Trading Center has issued a critical update on preparations for the centralized volume-based procurement (VBP) of Apixaban Tablets and related medications under the Guangdong Alliance framework. This initiative, aligned with provincial healthcare policies (Yue Medical Insurance Letter [2025] No. 49), mandates streamlined logistics and supply chain coordination…
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China Unveils 2025 Medical Device Inspection Strategy to Tighten Quality Control
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China’s National Medical Products Administration (NMPA) convened a pivotal conference in Chengdu on March 24 to outline its 2025 medical device inspection agenda. The meeting highlighted achievements from 2024, including enhanced product quality and public safety, while emphasizing stricter compliance frameworks to address evolving industry risks. 2024 Progress and 2025…
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Eisai Transfers Pariet Rights in China to CBC Group-Controlled Peak Pharma
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Japan-based Eisai (TYO: 4523) announced a strategic decision to transfer the rights of its proton pump inhibitor (PPI) Pariet (rabeprazole) in China to Peak Pharmaceutical, a company controlled by CBC Group. Pariet’s Market PresencePariet, with rabeprazole as its active ingredient, has been a leading prescription drug for gastrointestinal disorders such…
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Sinovac Biotech’s SNA02-48 Gains Clinical Approval for Tetanus Prevention
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Beijing Sinovac Biotech Co., Ltd’s (NASDAQ: SVA) subsidiary Sinovac Life Sciences Co., Ltd. and its partner Synermore Biologics announced that their Category I new drug, SNA02-48 injection, has received clinical approval from the National Medical Products Administration (NMPA). This recombinant fully human monoclonal antibody targets tetanus toxin and offers a…
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Shanghai Designates Backup Suppliers and Specialized Drug Formulations in GY-YD2024-2 Procurement
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Shanghai has finalized its list of second-tier backup suppliers and manufacturers for specialized drug formulations under the 10th National VBP (Volume-Based Procurement) Program (GY-YD2024-2). The move aims to stabilize supply chains, address market shortages of irregular drug specifications, and ensure cost-effective access to critical medications. Key suppliers include domestic pharmaceutical…
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Abbott Laboratories’ Volt PFA System Receives EU CE Mark for Atrial Fibrillation Treatment
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US-based Abbott Laboratories (NYSE: ABT) has announced the receipt of the CE mark in the European Union (EU) for its Volt PFA System, a novel therapy for patients with atrial fibrillation (AFib). This approval marks a significant advancement in treatment options for AFib, particularly for those with complex conditions. Technology…
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Alcon Laboratories Acquires Majority Stake in Aurion Biotech to Advance Eye Disease Cell Therapy
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US-based eye care firm Alcon Laboratories, Inc. has announced the acquisition of a majority stake in Aurion Biotech, Inc., a clinical-stage cell therapy specialist focused on eye diseases. This strategic move aims to enhance Alcon’s portfolio in innovative ophthalmic treatments. Aurion Bio’s Leading TherapyAurion Bio’s flagship product, AURN001, is an…
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Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
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Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour and Welfare for its Tivdak (tisotumab vedotin) to treat advanced or recurrent cervical cancer that has progressed on or after chemotherapy. Drug Profile and TechnologyTivdak is an antibody-drug conjugate (ADC) comprising Genmab’s human monoclonal antibody…
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CStone Pharmaceuticals Reports 2024 Results with License Fee Growth Offsetting Drug Sales Decline
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China-based CStone Pharmaceuticals (HKG: 2616) reported its 2024 financial results and recent business highlights. Revenues reached RMB 407.2 million (USD 56.1 million), a 12.2% year-on-year (YOY) decrease. This consisted of RMB 175 million (USD 24.1 million) in pharmaceutical product sales and RMB 232 million (USD 32 million) in license fee…
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TransThera and Akeso Biopharma Collaborate on HCC Study with Tinengotinib and Bispecific Antibodies
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Chinese companies TransThera Sciences (Nanjing) Inc. and Akeso Biopharma (HKG: 9926) have formed a strategic research collaboration to advance an open, multi-center Phase II study combining TransThera’s tinengotinib (TT-00420) with Akeso’s cadonilimab or ivonescimab for advanced hepatocellular carcinoma (HCC). The National Medical Products Administration (NMPA) has granted clearance for the…
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NMPA Approves Qingfeng’s Suraxavir Marboxil for Influenza A and B Treatment
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China’s National Medical Products Administration (NMPA) has approved suraxavir marboxil, a Category 1 drug developed by Qingfeng Pharmaceutical Group Co. Ltd’s subsidiary Jiangxi Kerui Pharmaceutical Co., Ltd, for the treatment of influenza A and B. The drug is intended for adolescents aged 12 and above as well as adults with…
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Medtronic Launches Digital Innovation Base in Beijing’s BioPark
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US-Irish firm Medtronic (NYSE: MDT) has inaugurated its digital medical innovation base at the BioPark in Beijing, marking the company’s first such facility in China. This strategic move underscores Medtronic’s commitment to leveraging advanced technologies in the Chinese healthcare sector. Facility Details and FocusThe new base will concentrate on developing…
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Huadong Medicine Gains NMPA Approval for HDM3019 Rheumatoid Arthritis Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its HDM3019 in rheumatoid arthritis (RA). This marks a significant step forward for the company in expanding its portfolio in autoimmune diseases. Drug Profile and Preclinical ResultsHDM3019…
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Lee’s Pharmaceutical Holdings Ltd Reports 32.9% Revenue Growth in 2023
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) released its 2023 financial report, recording HKD 1.4 billion (USD 193 million) in revenues, up 32.9% year-on-year (YOY). Licensed products continued to yield significant sales growth with HKD 553 million (USD 76 million), accounting for 39.5% of the total revenue. Patented and generic…
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RemeGen’s 2024 Revenue Soars 58.54% on Strong Product Sales and R&D Growth
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China-based biotech RemeGen Co., Ltd (HKG: 9995, SHA: 688331) released its 2024 financial report, recording RMB 1.717 billion (USD 236.3 million) in revenues, a 58.54% year-on-year (YOY) increase. Product sales reached RMB 1.699 billion (USD 233.9 million), up 61.9% YOY. The annual loss decreased by 2.8% YOY to RMB 1.468…
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JW Therapeutics Sees 9% Revenue Decline in 2024 Amid Commercial Strategy Shift
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China-based JW Therapeutics (HKG: 2126) released its 2024 financial report, recording RMB 158.2 million (USD 21.8 million) in revenue, a 9% year-on-year (YOY) decline. This decrease was primarily due to the implementation of a commercial activity optimization strategy in the second half of 2024 and a business personnel organizational efficiency…
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Ascentage Pharma’s Revenue Soars 342% in 2024 on Strong Drug Sales and Partnerships
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China-based Ascentage Pharma Group International (NASDAQ: AAPG, HKG: 6855) unveiled its 2024 financials, showing revenues skyrocketing 342% year-on-year (YOY) to RMB980 million (USD135 million). This remarkable growth was primarily driven by an option payment from Japanese partner Takeda and robust sales of olverembatinib, the novel BCR-ABL1 tyrosine kinase inhibitor (TKI),…
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Shanghai Pharmaceuticals Reports 5.75% Revenue Growth in 2024 with Innovation Initiatives
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China’s Shanghai Pharmaceuticals (SPH; SHA: 601607, HKG: 2607) released its 2024 financial results, showing total revenues up 5.75% year-on-year (YOY) to RMB 275.251 billion (USD 37.9 billion). Pharmaceutical industry and business sales reached RMB 22.731 billion (USD 3.3 billion) and RMB 251.5 billion (USD 34.6 billion) respectively, with the latter…
