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BioWorld - Tuesday, May 12, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Endocrine/Metabolic

CSPC Pharmaceutical’s SYH-2053 receives NMPA clearance for clinical studies in China

Nov. 30, 2023
CSPC Pharmaceutical Group Ltd.’s SYH-2053 injection has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
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3D illustration and light micrograph of lung cancer.

Innovent on a roll: China accepts two new NDAs for lung cancer

Nov. 28, 2023
By Tamra Sami
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
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Cancer

CSPC Pharmaceutical’s SOS-1 inhibitor cleared to enter clinic in China for solid tumors

Nov. 28, 2023
CSPC Pharmaceutical Group Ltd.’s selective son of sevenless homolog 1 (SOS-1) inhibitor SYH-2038 has received clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
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3D illustration and light micrograph of lung cancer.

Innovent on a roll: China accepts two new NDAs for lung cancer

Nov. 27, 2023
By Tamra Sami
In less than one week, Innovent Biologics Inc. has seen two NDAs for non-small-cell lung cancer accepted for review by China’s National Medical Products Administration, and both are firsts for China. The NDA for IBI-351 under priority review marks China’s first NDA for a KRAS G12C inhibitor, and the NDA for taletrectinib is the first global submission for the ROS1 inhibitor.
Read More

Apollomics gets China NMPA nod for lung cancer drug vebreltinib

Nov. 17, 2023
By Marian (YoonJee) Chu
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
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Apollomics gets China NMPA nod for lung cancer drug vebreltinib

Nov. 17, 2023
By Marian (YoonJee) Chu
The U.S. and China biotech Apollomics Inc. on Nov. 16 gained the NMPA’s conditional approval for its cellular mesenchymal-epithelial transcription inhibitor for lung cancer called vebreltinib (APL-1010) through its Beijing-based partner, Avistone Biotechnology Co. Ltd.
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Scientist, microscope and dropper
Immuno-oncology

Abbisko's CD73 inhibitor ABSK-051 cleared for clinic in China

Nov. 9, 2023
Abbisko Therapeutics Co. Ltd. has received clearance from China's National Medical Products Administration (NMPA) to conduct clinical trials in China of ABSK-051, a novel small-molecule CD73 inhibitor, for advanced solid tumors.
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Antibodies attacking cancer cell
Immuno-oncology

CSPC Pharmaceutical’s SYS-6011 cleared to enter clinic in China for solid tumors

Nov. 6, 2023
CSPC Pharmaceutical Group Ltd.’s SYS-6011 has been cleared by China’s National Medical Products Administration (NMPA) to enter clinical trials in China for solid tumors.
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Cancer

HLX-42 is EGFR-targeting ADC with activity in several cancer models

Oct. 31, 2023
Researchers from Shanghai Henlius Biotech Inc. presented the discovery and preclinical characterization of HLX-42, a next-generation EGFR-targeting antibody-drug conjugate (ADC) being developed for the treatment of cancer.
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Antibody-drug conjugate illustration
Immuno-oncology

HLX-43, a next-generation PD-L1-targeting antibody-drug conjugate

Oct. 27, 2023
There is a need for new agents targeting PD-1/PD-L1 because many patients either do not respond or develop resistance to treatment.
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