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BioWorld - Monday, December 15, 2025
Home » Topics » Regulatory » NMPA

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3D map of China

China’s NMPA finalizes rule for novel device classification

Oct. 3, 2024
By Mark McCarty
China’s National Medical Products Administration wrapped up a revision of its device classification procedures, providing entries into one of the world’s largest markets a mechanism for obtaining means for determining the risk of a novel device type.
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Transdermal patch on arm

China approves Sino Biopharm’s patch for Alzheimer’s disease

Oct. 1, 2024
By Tamra Sami
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
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Green approved stamp

Akeso scores two new China approvals

Oct. 1, 2024
By Tamra Sami
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
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Transdermal patch on arm

China approves Sino Biopharm’s patch for Alzheimer’s disease

Sep. 26, 2024
By Tamra Sami
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
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3D illustration demonstrating antibody-drug conjugate.

ESMO 2024: Innovent’s IBI-354 shows promise across tumor types

Sep. 24, 2024
By Tamra Sami
Innovent Biologics Inc. unveiled for the first time safety and efficacy data of IBI-354, an HER2 monoclonal antibody-camptothecin derivative conjugate that shows promising efficacy signals across a range of advanced solid tumors, during the European Society of Medical Oncology (ESMO) 2024 Congress. An HER2-targeted antibody-drug conjugate developed using Innovent's topoisomerase inhibitor NT3 platform, IBI-354 combines a hydrophilic linker design with a hydrophobic payload to enhance the bystander effect, targeting adjacent antigen-low or negative tumor cells.
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Leung Chun-ying, vice chairperson of the Chinese People’s Political Consultative Conference (CPPCCC) at Bio Hong Kong 2024

Hong Kong’s role grows as China moves to up, reform bio sector

Sep. 24, 2024
By Marian (YoonJee) Chu
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
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Leung Chun-ying, vice chairperson of the Chinese People’s Political Consultative Conference (CPPCCC) at Bio Hong Kong 2024

Hong Kong’s role grows as China moves to up, reform bio sector

Sep. 23, 2024
By Marian (YoonJee) Chu
Both the biotech industry and Hong Kong have become strategic points for China as the People’s Republic of China works to lay a biotech “belt and road” through Asia to expand global influence.
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3D illustration demonstrating antibody-drug conjugate.

ESMO 2024: Innovent’s IBI-354 shows promise across tumor types

Sep. 18, 2024
By Tamra Sami
Innovent Biologics Inc. unveiled for the first time safety and efficacy data of IBI-354, an HER2 monoclonal antibody-camptothecin derivative conjugate that shows promising efficacy signals across a range of advanced solid tumors, during the European Society of Medical Oncology (ESMO) 2024 Congress. An HER2-targeted antibody-drug conjugate developed using Innovent's topoisomerase inhibitor NT3 platform, IBI-354 combines a hydrophilic linker design with a hydrophobic payload to enhance the bystander effect, targeting adjacent antigen-low or negative tumor cells.
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China flag and autoinjector pen

Big pharma eyes China ‘at forefront of GLP-1 revolution’

Sep. 17, 2024
By Marian (YoonJee) Chu
Two leading glucagon-like peptide-1 (GLP-1) receptor agonists for obesity and type 2 diabetes – Novo Nordisk A/S’s semaglutide (Wegovy/Ozempic) and Eli Lilly and Co.’s tirzepatide (Mounjaro/Zepbound) – are advancing in China after taking the U.S. market by storm.
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Autoinjectors on pink background

China biotechs rise to challenge Ozempic, Wegovy

Sep. 17, 2024
By Marian (YoonJee) Chu
Chinese pharmaceutical and biotech companies are leading development of glucagon-like peptide-1 receptor agonists as Novo Nordisk A/S and Eli Lilly and Co. edge closer to launching blockbuster therapies in China. At the heart of the GLP-1 boom is a nationwide obesity problem driven by a confluence of factors, including the rise of a modern, sedentary lifestyle, according to Clarivate. Despite the rising prevalence of obesity and type 2 diabetes, the gap in obesity therapeutics is “substantial and leaves a solid market opportunity for weight loss drugs,” Karan Verma, principal analyst of healthcare research & data analytics at Clarivate, said.
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