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BioWorld - Saturday, June 20, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Jiuyuan seeks approval of Wegovy biosimilar in China

March 3, 2026
By Marian (YoonJee) Chu
No Comments
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
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Primary myelofibrosis (PMF) cells in blood flow

China clears first JAK/ROCK drug for myelofibrosis

March 3, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rovadicitinib, branded as Anxu, for first-line treatment of adults with intermediate- or high-risk primary myelofibrosis, as well as post polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.
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Cancer tumor in breast illustration

Systimmune’s iza-bren hits phase III breast cancer goals in China

Feb. 27, 2026
By Marian (YoonJee) Chu
No Comments
In a boon for licensee Bristol Myers Squibb Co., Systimmune Inc.’s next-generation cancer drug, izalontamab brengitecan (iza-bren), hit both progression-free survival and overall survival endpoints in a phase III trial of Chinese patients with advanced triple-negative breast cancer.
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Jiuyuan seeks approval of Wegovy biosimilar in China

Feb. 26, 2026
By Marian (YoonJee) Chu
No Comments
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
Read More
Lungs with alveoli
Respiratory

CF Pharmtech’s ICF-004 cleared for clinical trials in China

Feb. 26, 2026
No Comments
CF Pharmtech Inc. has announced approval from China’s National Medical Products Administration (NMPA) of an IND application filed by subsidiary Changfeng Suyue Pharmaceutical (Guangzhou) Co. Ltd. for ICF-004.
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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 24, 2026
By Marian (YoonJee) Chu
No Comments

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.


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Hands holding pink paper kidneys
Nephrology

NMPA clears Gensci-136 for trials in immunoglobulin A nephropathy

Feb. 16, 2026
No Comments
Changchun Genescience Pharmaceutical Co. Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to start clinical trials with Gensci-136 for injection, a dual APRIL/BAFF antagonist in development for the treatment of immunoglobulin A nephropathy.
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Takeda’s oral narcolepsy drug steps closer to FDA approval

Feb. 11, 2026
By Marian (YoonJee) Chu
No Comments

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.


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Gavel and block with Chinese flag

China amends drug rules to enforce lifecycle accountability

Feb. 10, 2026
By Tamra Sami
No Comments
China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.
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Insight Lifetech IPO ceremony

Heart intervention device-maker Insight lands $143M SSE IPO

Feb. 10, 2026
By Marian (YoonJee) Chu
No Comments
Insight Lifetech Co. Ltd. listed on the Shanghai Stock Exchange’s STAR market via an unprofitable biotech track reinstated last year, with the Feb. 5 IPO raising ¥998.64 million (US$143.93 million).
Read More
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