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BioWorld - Tuesday, April 14, 2026
Home » Topics » Regulatory » NMPA

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).
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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.
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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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China NMPA approves Sciwind’s GLP-1 injection for diabetes

Feb. 3, 2026
By Marian (YoonJee) Chu
No Comments
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
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China NMPA approves Sciwind’s GLP-1 injection for diabetes

Feb. 2, 2026
By Marian (YoonJee) Chu
No Comments
Sciwind Biosciences Co. Ltd. said Jan. 30 it won Chinese approval for self-developed glucagon-like peptide-1 (GLP-1) receptor agonist, ecnoglutide (Xianyida), to treat adults with type 2 diabetes.
Read More
Kim Dong-gun (DG), CEO, Elevar

Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib

Jan. 30, 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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Stomach cross section on abstract scientific background

Alphamab’s HER2 bispecific hits phase III gastric cancer endpoints

Jan. 27, 2026
By Tamra Sami
No Comments
Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), combined with chemotherapy has the potential to become a new standard of care for patients with HER2-positive gastric cancer who failed at least one prior line of therapy, according to newly released phase III results that show the combo cut disease progression risk by 75%.
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Cancer

China’s NMPA clears clinical trial of Henlius’ HLX-701

Jan. 22, 2026
No Comments
China’s National Medical Products Administration (NMPA) has cleared Shanghai Henlius Biotech Inc. to initiate a phase Ib/II trial of HLX-701 in combination with cetuximab and chemotherapy for the treatment of patients with advanced RAS/BRAF wild-type colorectal cancer.
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