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BioWorld - Friday, June 12, 2026
Home » Topics » Regulatory » NMPA

NMPA
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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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Antibody-drug conjugate

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

Aug. 21, 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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Red and white blood cells

Ascentage moves BCL-2 inhibitor into fourth phase III

Aug. 20, 2024
By Tamra Sami
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
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Red and white blood cells

Ascentage moves BCL-2 inhibitor into fourth phase III

Aug. 14, 2024
By Tamra Sami
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
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Thyroid anatomy

Visen’s palopegteriparatide hits endpoints in hypoparathyroidism

Aug. 13, 2024
By Tamra Sami
Visen Pharmaceuticals Co. Ltd.’s palopegteriparatide met both primary and secondary endpoints in the phase III Pathway trial conducted in China in adults with chronic hypoparathyroidism, according to top-line data. In the 26-week randomized, double-blind, placebo-controlled Pathway trial, 77.6% of patients treated with palopegteriparatide achieved the primary multicomponent endpoint compared to 0% for placebo.
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