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BioWorld - Sunday, April 12, 2026
Home » Topics » Regulatory » NMPA

NMPA
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3D illustration of tumor
Immuno-oncology

Fosun gains clinical trial approval in China for FXB-0871

April 2, 2026
No Comments
Fosun Pharmaceutical (Group) Co. Ltd. has received the approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of FXB-0871 (TEV-56278) for the treatment of locally advanced or metastatic solid tumors.
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Woman taking Amsler grid eye exam

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

March 31, 2026
By Tamra Sami
No Comments
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
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Monoclonal antibody illustration

Simcere’s rademikibart meets phase III endpoints in atopic dermatitis

March 31, 2026
By Tamra Sami
No Comments
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
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Woman taking Amsler grid eye exam

Innovent’s IBI-302 meets phase III endpoints in neovascular AMD

March 25, 2026
By Tamra Sami
No Comments
Innovent Biologics Inc.’s efdamrofusp alfa (IBI-302) met the primary endpoint in the phase III Star trial in neovascular age-related macular degeneration (nAMD), and the Suzhou, China-based company will submit an NDA to China’s National Medical Products Administration.
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Alopecia - hair loss

Kintor’s KX-826 meets phase III endpoints in alopecia

March 24, 2026
By Tamra Sami
No Comments
Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.
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3D illustration demonstrating antibody-drug conjugate.
Immuno-oncology

Kelun-Biotech’s SKB-103 cleared to enter clinic in China

March 24, 2026
No Comments
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. has announced IND approval by China’s National Medical Products Administration (NMPA) for SKB-103 for the treatment of advanced solid tumors.
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Alopecia - hair loss

Kintor’s KX-826 meets phase III endpoints in alopecia

March 19, 2026
By Tamra Sami
No Comments
Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.
Read More
Illustration of inflamed spine

China’s Qyuns moves IL-17 biologic toward first approval

March 17, 2026
By Tamra Sami
No Comments
Qyuns Therapeutics Co. Ltd. has moved closer to its first commercial product after China’s National Medical Products Administration (NMPA) accepted its NDA for IL-17 antibody crusekitug (QX-002N) for treating ankylosing spondylitis (AS), a chronic inflammatory disease that affects the spine and sacroiliac joints.
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doctor, checklist, apple, prescription bottle and blood glucose meter illustration

Hightide wins China NDA acceptance for oral metabolic therapy

March 17, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Hightide Therapeutics Inc.’s NDA for HTD-1801 for type 2 diabetes, marking the Shenzhen-based company’s first NDA submission and a major step toward commercialization.
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Internal organs: lungs, heart, stomach, diaphragm
Respiratory

CF Pharmtech’s ICF-001 cleared for clinic in China

March 16, 2026
No Comments
CF Pharmtech Inc. has announced IND approval by China’s National Medical Products Administration (NMPA) for ICF-001, a long-acting inhalation powder candidate for the treatment of pulmonary hypertension and related severe pulmonary diseases.
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