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BioWorld - Tuesday, February 3, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Chinese flag and pills

China NMPA approves 40 innovative new drugs in 2023

Feb. 29, 2024
By Marian (YoonJee) Chu
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
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Eye illustration

Innovent thyroid eye therapy hits phase III goal, spurs China NDA

Feb. 20, 2024
By Marian (YoonJee) Chu
In a crowded thyroid eye disease (TED) space, Innovent Biologics Inc. reported positive late-stage findings for its TED therapy, IBI-311, spurring the Suzhou, China-based biopharma to file for regulatory approval in China.
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Test tube, dropper
Dermatologic

Fermion’s TYK2 JH2 inhibitor cleared by China NMPA to advance into clinic

Feb. 6, 2024
Guangzhou Fermion Technology Co. Ltd. has received IND approval by China’s National Medical Products Administration (NMPA) for its TYK2 JH2 inhibitor, FZ-007-119.
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Red wooden approved stamp

NMPA approves China’s second homegrown SGLT2 inhibitor janagliflozin

Jan. 23, 2024
By Marian (YoonJee) Chu
Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022.
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China’s NMPA accepts Hutchmed’s sovleplenib NDA for primary immune thrombocytopenia

Jan. 16, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
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China’s NMPA accepts Hutchmed’s sovleplenib NDA for primary immune thrombocytopenia

Jan. 11, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted for review Hutchmed’s NDA for sovleplenib (HMPL-523) for treatment of primary immune thrombocytopenia.
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Back pain
Neurology/Psychiatric

Fermion’s FZ-008-145 for pain relief cleared to enter clinic in China

Jan. 10, 2024
Guangzhou Fermion Technology Co. Ltd. has announced IND clearance by China’s National Medical Products Administration (NMPA) for FZ-008-145 to treat pain.
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Man measuring waist

Innovent’s mazdutide meets endpoints in phase III obesity trial

Jan. 9, 2024
By Tamra Sami
Innovent Biologics Inc. said its glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, met the primary endpoints and all key secondary endpoints in its first phase III trial in Chinese adults who were overweight or obese. The company plans to submit the first mazdutide NDA for weight management to China's NMPA shortly.
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Kidneys
Nephrology

Jemincare obtains approvals to advance five drugs into clinical trials

Dec. 28, 2023
Jiangxi Jemincare Group Co. Ltd. has reported that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co. Ltd., recently received approvals for clinical trials of five of its drugs in the fields of cancer, kidney and infectious diseases.
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China’s NMPA greenlights Jingxin’s dimdazenil for insomnia

Dec. 12, 2023
By Tamra Sami
China’s National Medical Products Administration (NMPA) approved Zhejiang Jingxin Pharmaceutical Co. Ltd.’s dimdazenil (EVT-201) for short-term treatment of insomnia. Jingxin filed the NDA in China in April 2022.
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