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

NMPA
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Green and red bispecific antibodies
Dermatologic

China’s NMPA clears HBM-7575 to enter clinic in atopic dermatitis

March 9, 2026
No Comments
Harbour Biomed Ltd. and Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. have announced IND approval by China’s National Medical Products Administration (NMPA) for HBM-7575 (SKB-575) for the treatment of atopic dermatitis.
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3D illustration of RNA
Endocrine/metabolic

China’s NMPA clears China Medical System’s CMS-D008 for clinic

March 6, 2026
No Comments
China Medical System Holdings Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for CMS-D008 injection for overweight or obese individuals.
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Fallopian tubes, ovaries and uterus

China approves first noninvasive therapy for cervical precancer

March 4, 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.
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Red and blue bispecific antibodies

UCB inks $1.1B deal for Antengene’s autoimmune bispecific TCE

March 4, 2026
By Marian (YoonJee) Chu
No Comments
Belgian pharma giant UCB SA is putting skin in the bispecific T-cell engager (TCE) game, announcing a potential $1.1 billion deal to license Antengene Corp.’s ATG-201. ATG-201 is a CD19/CD3 bispecific TCE antibody aimed at autoimmune disorders, though specific indications were not disclosed.
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Cancer tumor in breast illustration

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

March 3, 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

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.
Read More

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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