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BioWorld - Saturday, June 6, 2026
Home » Topics » Regulatory » NMPA

NMPA
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Illustration of knee joint, giant cell tumor of bone

China approves Abbisko/Merck’s CSF-1R inhibitor pimicotinib

Dec. 23, 2025
By Tamra Sami
No Comments
Abbisko Therapeutics Co. Ltd. and its partner Merck KGaA got an early Christmas present from China’s National Medical Products Administration (NMPA) with the approval of pimicotinib (ABSK-021), the first domestically developed systemic therapy for tenosynovial giant cell tumor (TGCT).
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Infection

CSPC’s SYH-2085 cleared for clinic in China to treat influenza

Dec. 22, 2025
No Comments
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2085 tablets for the treatment of uncomplicated influenza A and B in adults and adolescents age 12 years and older.
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Tape measure wrapped around scale
Endocrine/metabolic

Sanegenebio’s SGB-7342 cleared to enter clinic for obesity

Dec. 17, 2025
No Comments
Sanegenebio has obtained clinical trial clearance in China for SGB-7342, an siRNA medicine targeting inhibin β E (INHBE) for the treatment of obesity. A phase I trial is scheduled to begin early next year.
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KRAS protein

D3 Bio raises $108M series B to move KRAS G12C into phase III

Dec. 16, 2025
By Marian (YoonJee) Chu
No Comments
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
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China in red on globe

China introduces new reimbursement list for innovative drugs

Dec. 16, 2025
By Tamra Sami
No Comments
China unveiled its first Commercial Health Insurance Innovative Drug List (CIIDL), reimbursing 19 high-value innovative drugs, including all five domestically developed CAR T therapies as well as treatments for rare diseases and Alzheimer's disease.
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Opportunity compass with Chinese flag

China eclipses Europe for clinical trial starts: LEK report

Dec. 16, 2025
By Tamra Sami
No Comments
China’s clinical trial volume has surged to nearly U.S. scale and now tops Europe, sitting at about 80% of U.S. levels and roughly 10% above the EU in 2024.
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Opportunity compass with Chinese flag

China eclipses Europe for clinical trial starts: LEK report

Dec. 15, 2025
By Tamra Sami
No Comments
China’s clinical trial volume has surged to nearly U.S. scale and now tops Europe, sitting at about 80% of U.S. levels and roughly 10% above the EU in 2024.
Read More
China in red on globe

China introduces new reimbursement list for innovative drugs

Dec. 11, 2025
By Tamra Sami
No Comments
China unveiled its first Commercial Health Insurance Innovative Drug List (CIIDL), reimbursing 19 high-value innovative drugs, including all five domestically developed CAR T therapies as well as treatments for rare diseases and Alzheimer's disease.
Read More
KRAS protein

D3 Bio raises $108M series B to move KRAS G12C into phase III

Dec. 10, 2025
By Marian (YoonJee) Chu
No Comments
D3 Bio Inc. secured $108 million in a series B financing round Dec. 9 to support its planned phase III program of lead oral KRAS G12C inhibitor, elisrasib (D3S-001).
Read More

Subcutaneous biologics maker Bao Pharma prices $128M IPO

Dec. 2, 2025
By Marian (YoonJee) Chu
No Comments
Bao Pharmaceuticals Co. Ltd., a developer of subcutaneous biologic drugs, priced its IPO at HK$26.38 on Dec. 2, aiming to raise about HK$1 billion (US$128 million). Bao expects net proceeds of HK$921.5 million after expenses, which will fund its “two-anti” strategy – developing both antibody and antibiotic drugs worldwide, mainly in China, the U.S. and Europe.
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