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BioWorld - Friday, February 20, 2026
Home » Topics » Regulatory » NMPA

NMPA
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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).
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Close-up of nasal drug spraying
Immune

Diff Biotech’s DIFF-flu influenza vaccine cleared to enter clinic

Feb. 10, 2026
No Comments
Zhejiang Difference Biological Technology Co. Ltd. (Diff Biotech)’s proprietary nasal spray influenza attenuated live vaccine, DIFF-flu, has received clinical trial approval from China’s National Medical Products Administration (NMPA).
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Vaccine vial and syringe
Immune

Delonix gains clinical trial clearances for MenB vaccine DX-104

Feb. 9, 2026
No Comments
Delonix Bioworks Ltd. has obtained IND clearance from China’s National Medical Products Administration (NMPA) for its group B meningococcal (MenB) vaccine candidate, DX-104. This follows the successful completion last month of clinical trial notification (CTN) procedures and ethics committee approval in Australia.
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Art concept for molecular glue degradation
Immune

Innocare’s VAV1 degrader ICP-538 cleared for clinic in China

Feb. 9, 2026
No Comments
Beijing Innocare Pharma Tech Co. Ltd. has gained IND clearance in China to conduct clinical trials of ICP-538, an orally administered molecular glue degrader targeting VAV1, which is a key protein downstream of T-cell and B-cell receptors. ICP-538 is being studied for the treatment of autoimmune diseases, such as inflammatory bowel disease, systemic lupus erythematosus and multiple sclerosis.
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Insight Lifetech IPO ceremony

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

Feb. 6, 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
Gavel and block with Chinese flag

China amends drug rules to enforce lifecycle accountability

Feb. 4, 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.
Read More
Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer.
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