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BioWorld - Monday, December 29, 2025
Home » Topics » Regulatory » NMPA

NMPA
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ESMO 2024: Immvira’s MVR-T3011 shows early efficacy in bladder cancer

Sep. 16, 2024
By Tamra Sami
Immvira Group Co.’s oncolytic herpes simplex virus product, MVR-T3011, showed early efficacy via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer.
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Autoinjectors on pink background

China biotechs rise to challenge Ozempic, Wegovy

Sep. 12, 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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China flag and autoinjector pen

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

Sep. 11, 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. China represents the world’s largest population of diabetes and obesity patients. Its GLP-1 market, valued at about $1.7 billion in 2023 according to Clarivate, is expected to grow as the number of obesity patients is projected to exceed 500 million by 2033.
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Bio Hong Kong 2024
Bio Hong Kong 2024

Chapter 18A entices biotechs to list on Hong Kong exchange

Sep. 11, 2024
By Marian (YoonJee) Chu
The Stock Exchange of Hong Kong is “all ears” to foster local biotech IPOs, speakers said at the Bio Hong Kong 2024 conference Sept. 11, and more than 60 companies have jumped on board since the introduction of the Chapter 18A listing regime in 2018.
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Jacobio chairman, CEO Yinxiang Wang (right) and Allist chairman and general manager Jinhao Du at a signing ceremony Aug. 30

Jacobio, Allist shake on ¥900M China deal for lung cancer combo

Sep. 3, 2024
By Marian (YoonJee) Chu
Jacobio Pharmaceuticals Group Co. Ltd. out-licensed rights for two lung cancer assets in China to Shanghai Allist Pharmaceuticals Co. Ltd. through a potential ¥900 million (US$126.4 million) deal. Beijing-headquartered Jacobio said Aug. 30 that it signed off development, regulatory and commercial milestone rights to both glecirasib, a KRAS G12C inhibitor first targeting non-small-cell lung cancer, and a SHP2 inhibitor called JAB-3312.
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3D illustration of T cells fighting cancer
Immuno-oncology

Highfield Biopharmaceuticals files IND in China for immunoliposome HF-50 for solid tumors

Sep. 3, 2024
Highfield Biopharmaceuticals Inc. has filed an IND application with China’s National Medical Products Administration (NMPA) to conduct a clinical trial of HF-50, an immunoliposome that directs T cells to attack solid tumors and enhances anticancer activity with an immune modulator.
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Antibody-drug conjugate

Adcendo licenses Multitude’s phase I-ready ADC for $1B+

Aug. 27, 2024
By Tamra Sami
Adcendo ApS has inked a deal with Multitude Therapeutics Inc. and is licensing Multitude’s phase I-ready antibody-drug conjugate (ADC), ADCE-T02, which targets tissue factor. Under the deal, Copenhagen, Denmark-based Adcendo gains exclusive development and commercialization rights for the ADC globally, excluding greater China (mainland China, Hong Kong, Macao and Taiwan) where Multitude retains all rights.
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Seegene Novaplex MPXV OPXV Assay

Asia med-tech stocks rise as WHO moves to contain mpox outbreak

Aug. 27, 2024
By Marian (YoonJee) Chu
Shares of Chinese and South Korean med-tech companies continued to rise after the World Health Organization declared mpox a public health emergency of international concern Aug. 14 after recent outbreaks.
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Scientist looking in microscope, chemical structure concept image
Cancer

Simcere’s POLθ inhibitor to enter clinic in China for advanced solid tumors

Aug. 23, 2024
Simcere Zaiming Pharmaceutical Co. Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SIM-0508, a small-molecule inhibitor of DNA polymerase θ (POLθ), allowing initiation of clinical trials in locally advanced or metastatic solid tumors.
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Innovent wins nod for China’s first KRAS G12C lung cancer drug

Aug. 22, 2024
By Marian (YoonJee) Chu
The National Medical Products Administration (NMPA) has approved Innovent Biologics Inc.’s Dupert (fulzerasib) as the first KRAS G12C inhibitor in China to treat select patients with non-small-cell lung cancer (NSCLC).
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