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News about "NMPA Approval "
Mabwell's 9MW5211 Gains NMPA IND Clearance for Inflammatory Bowel Disease
Mabwell’s 9MW5211 has received IND clearance from China’s NMPA for the treatment of Inflammatory Bowel Disease (IBD). As the first drug candidate globally targeting this novel mechanism to enter clinical development, 9MW5211 represents a significant advancement in the search for innovative therapies for IBD patients.
NMPA Approval | 08/06/2026 | By News Bureau
Mabwell Secures FDA Clearance for 9MW5211 Clinical Trial Application
Mabwell receives US Food and Drug Administration (FDA) IND clearance for 9MW5211, a novel antibody therapy being developed for Inflammatory Bowel Disease (IBD) clinical studies.
NMPA Approval | 11/05/2026 | By News Bureau
National Medical Products Administration approves IND application for HBM7575/SKB575, a long-acting bispecific antibody developed by Harbour BioMed and Kelun-Biotech for treating atopic dermatitis.
NMPA Approval | 10/03/2026 | By News Bureau | 117
Mabwell Gets NMPA Approval for Clinical Trial of Nectin-4 Targeting ADC in TNBC
Mabwell has announced that its novel Nectin-4 targeting ADC has been approved by the NMPA to enter Phase II clinical trial as monotherapy or in combination with a PD-1 inhibitor for the treatment of triple-negative breast cancer (TNBC).
NMPA Approval | 16/07/2024 | By Aishwarya | 276
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