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Home » Topics » Regulatory » NMPA

NMPA
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Illustration of knee joint, giant cell tumor of bone

Abbisko’s pimicotinib meets endpoints in phase III

Nov. 12, 2024
By Tamra Sami
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor inhibitor, pimicotinib, met both primary and secondary endpoints in the phase III Maneuver global study evaluating pimicotinib for treatment of tenosynovial giant cell tumor.
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Brain tumor illustration
Cancer

Chipscreen Biosciences’ IND application for CS-231295 accepted by China’s NMPA

Oct. 18, 2024
Shenzhen Chipscreen Biosciences Co. Ltd. has submitted an IND application for CS-231295 tablets for the treatment of tumors, and the application has been accepted by the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA).
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Innocare’s TYK2 inhibitor meets psoriasis endpoints in phase II

Oct. 15, 2024
By Tamra Sami
Innocare Pharma Ltd.’s tyrosine kinase 2 (TYK2) inhibitor, ICP-488, met the primary endpoint in a phase II trial in Chinese patients with moderate to severe plaque psoriasis, and the results clear the way to accelerate clinical development in psoriasis and other autoimmune diseases.
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Wooden stamp with China flag

China’s NMPA approves Junshi’s PCSK9 ongericimab

Oct. 15, 2024
By Tamra Sami
China’s National Medical Products Administration has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, marking the third PCSK9 inhibitor to be cleared in China.
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Wooden stamp with China flag

China’s NMPA approves Junshi’s PCSK9 ongericimab

Oct. 14, 2024
By Tamra Sami
China’s National Medical Products Administration has given the thumbs up to Junshi Biosciences Co. Ltd.’s NDA for ongericimab, a recombinant humanized anti-PCSK9 monoclonal antibody, marking the third PCSK9 inhibitor to be cleared in China.
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Innocare’s TYK2 inhibitor meets psoriasis endpoints in phase II

Oct. 10, 2024
By Tamra Sami
Innocare Pharma Ltd.’s tyrosine kinase 2 (TYK2) inhibitor, ICP-488, met the primary endpoint in a phase II trial in Chinese patients with moderate to severe plaque psoriasis, and the results clear the way to accelerate clinical development in psoriasis and other autoimmune diseases.
Read More

Wuhan YZY, CTTQ ink $143M China bispecific antibody deal

Oct. 8, 2024
By Tamra Sami
Wuhan YZY Biopharma Co. Ltd. is out-licensing lead candidate M-701, a CD3/EpCAM bispecific antibody, to Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ) for China rights in a deal worth up to $143 million. Under the deal, Sino Biopharmaceutical Ltd. subsidiary CTTQ is granted an exclusive license to develop, register, manufacture and commercialize M-701 within mainland China.
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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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