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News about "Mabwell "
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.
Mabwell | 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.
Mabwell | 11/05/2026 | By News Bureau
Mabwell Launches Phase 3 Trial of Nectin-4 ADC 9MW2821 for Triple-Negative Breast Cancer
Mabwell launches Phase 3 study of 9MW2821, the world’s first Nectin-4 ADC for TNBC, marking its fourth pivotal clinical trial.
Mabwell | 23/04/2026 | By News Bureau | 131
Mabwell Advances ADC Manufacturing Pipeline With NMPA-Backed Combination Trial Approval
Mabwell, an innovation-driven biopharmaceutical company with fully integrated capabilities spanning research and development, manufacturing, and commercialisation, announced that China’s National Medical Products Administration (NMPA) has approved the initiation of clinical trials for its independently developed B7-H3–targeting antibody–drug conjugate.
Mabwell | 02/01/2026 | By Darshana | 227
Mabwell Adalimumab Biosimilar Wins Marketing Approval in Indonesia
Mabwell’s adalimumab biosimilar 9MW0113, co-developed with Junshi Biosciences, has received marketing approval from Indonesia’s BPOM, becoming the first China-developed adalimumab biosimilar to secure such approval, as the company advances global expansion with partnerships in over 10 countries.
Mabwell | 01/01/2026 | By News Bureau | 135
Mabwell Gets CDE Approval to Initiate Phase III Clinical Trial of 9MW2821
9MW2821 is a novel Nectin-4-targeting ADC independently developed by Mabwell, and it is the first of its kind in China to initiate clinical trials on the same target, with more than 400 subjects enrolled in the clinical studies for multiple indications.
Mabwell | 27/08/2024 | By Aishwarya | 420
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).
Mabwell | 16/07/2024 | By Aishwarya | 276
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