San Diego, CA – October 3, 2025 – Mabwell Therapeutics, a U.S.-based biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for MWTX-4611, authorizing the initiation of clinical trials in patients with mild cognitive impairment (MCI) and mild to moderate dementia due to Alzheimer’s disease, one of the most prevalent, burdensome and fatal neurodegenerative disorders worldwide.
In parallel, the National Medical Products Administration (NMPA) in China has approved the IND application for MWTX-4611 injection for the same indication on September 11, 2025. These dual regulatory milestones mark a major step forward in the global development of MWTX-4611.
MWTX-4611 is a fully human monoclonal antibody that selectively targets Aβ protofibrils, the neurotoxic form of amyloid beta implicated in Alzheimer’s disease. In preclinical studies, MWTX-4611 significantly reduced protofibril levels and plaque burden in a dose-dependent manner.
Importantly, MWTX-4611 is clearly differentiated from currently approved anti-Aβ therapies such as Leqembiâ (lecanemab). The antibody exhibits approximately 5-fold higher selectivity for Aβ protofibrils over monomers, effectively mitigating the “peripheral sink” effect associated with systemic administration and potentially enabling lower effective doses and extended dosing intervals.
About Mabwell Therapeutics
Mabwell Therapeutics is a U.S.-based biotechnology company focused on developing innovative antibody-based therapies for serious and rare diseases. It is a wholly owned subsidiary of Mabwell (Shanghai) Bioscience Co., Ltd. (688062.SH).