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BioWorld - Wednesday, June 3, 2026
Home » Topics » Regulatory » NMPA

NMPA
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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.
Read More
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.
Read More
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.
Read More
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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Concept art for targeting cancer
Immuno-oncology

China NMPA clears IND for Akeso’s trispecific antibody

March 16, 2026
No Comments
Akeso Inc.’s first-in-class trispecific antibody, AK-150, has received IND clearance from China’s National Medical Products Administration (NMPA) for clinical trials in patients with advanced solid tumors. Engineered using Akeso’s AI-driven drug discovery platform and its proprietary Tetrabody technology, AK-150 is a humanized anti-CSF-1R, ILT2 and ILT4 trispecific antibody that achieves multipathway blockade of both innate and adaptive immunity.
Read More
Illustration of inflamed spine

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

March 11, 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.
Read More
doctor, checklist, apple, prescription bottle and blood glucose meter illustration

Hightide wins China NDA acceptance for oral metabolic therapy

March 11, 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.
Read More
Fallopian tubes, ovaries and uterus

China approves first noninvasive therapy for cervical precancer

March 10, 2026
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2.
Read More
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