News about "National Medical Products Administration "

Akeso's B7-H3 ADC AK157D1 Cleared for Phase I Clinical Trial in China

Akeso has received NMPA clinical trial clearance for AK157D1, a next-generation B7-H3-targeting ADC, paving the way for a Phase I study in patients with advanced solid tumours in China.

National Medical Products Administration | 24/08/2026 | By News Bureau

Harbour BioMed Secures China IND Approval for HBM7004 in Advanced Solid Tumours

NMPA clearance advances the B7H4xCD3 bispecific antibody toward clinical development, following promising preclinical efficacy and safety results and recent US FDA clearance.

National Medical Products Administration | 19/08/2026 | By News Bureau

ArkBio's AK0406 Influenza Prophylaxis Drug Receives China IND Approval

ArkBio has secured China IND approval for AK0406, a long-acting antiviral Fc conjugate for influenza prophylaxis, marking the first influenza AFC candidate to enter clinical development in China.

National Medical Products Administration | 14/08/2026 | By News Bureau

Laekna's LAE002 Breast Cancer Drug Application Accepted by China's NMPA

Laekna has advanced LAE002 toward potential commercialisation in China after the NMPA accepted its NDA for afuresertib in patients with advanced HR+/HER2- breast cancer.

National Medical Products Administration | 12/08/2026 | By News Bureau |  110

China Grants Priority Review to Leads Biolabs' Opamtistomig for Advanced Neuroendocrine Carcinoma

NMPA accepts biologics license application under expedited review pathway for investigational PD-L1/4-1BB bispecific antibody targeting advanced extrapulmonary neuroendocrine carcinoma after multiple prior therapies.

National Medical Products Administration | 13/07/2026 | By News Bureau |  107

NMPA Reviews QMS for Vaccine and Drug GMP Compliance

China's NMPA has completed a QMS management review to strengthen vaccine and drug Good Manufacturing Practice (GMP) compliance, supporting WHO WLA standards and PIC/S regulatory requirements.

National Medical Products Administration | 13/07/2026 | By News Bureau

China Approves Hengrui Pharma's Water-Free Cyclosporine Eye Drop for Dry Eye Disease

China's drug regulator has approved Hengrui Pharma's Heng Yi, the country's first water-free 0.1 percent cyclosporine ophthalmic solution, expanding treatment options for patients with dry eye disease through Novaliq's EyeSol technology.

National Medical Products Administration | 03/07/2026 | By News Bureau |  101

Junshi Biosciences Secures China Approval for Toripalimab Combination Therapy in Advanced Urothelial Cancer

Junshi Biosciences expands toripalimab’s treatment footprint in China with regulatory approval for a new urothelial carcinoma indication, strengthening immunotherapy options for patients with advanced bladder cancer.

National Medical Products Administration | 25/05/2026 | By News Bureau |  127

Chance Pharma Secures NMPA Acceptance for CXG87 Respiratory Drug NDA

Chance Pharma secures National Medical Products Administration acceptance of NDA for CXG87, marking its first filing and a key step toward commercialisation of a novel respiratory therapy.

National Medical Products Administration | 08/05/2026 | By News Bureau |  113

GSK plc Secures China Approval for Blenrep Combination Therapy in Multiple Myelom

National Medical Products Administration approves Blenrep with bortezomib and dexamethasone for relapsed or refractory patients, backed by strong phase III trial outcomes.

National Medical Products Administration | 21/04/2026 | By News Bureau |  137