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Global New Drug R&D express:brexpiprazole,A166, BI 456906,mazdutide

1 Otsuka and Lundbeck Announce U.S. Food and Drug Administration (FDA) Approval of Supplemental New Drug Application (sNDA) for REXULTI® (brexpiprazole) for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease

Otsuka and Lundbeck announce the U.S. FDA has approved the sNDA of brexpiprazole for use in the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval was based on two Phase 3, 12-week, randomized, double-blind, placebo-controlled fixed-dose studies that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer’s disease based on the CMAI total score. The data showed brexpiprazole patients with agitation associated with dementia due to Alzheimer’s disease achieved a 31% greater reduction from baseline in frequency of agitation symptoms vs. placebo.

2 Kelun Pharmaceutical Announced the NDA of A166(HER2-ADC) for the Treatment of HER2-Positive Breast Cancer was Accepted by China NMPA

Kelun Pharmaceutical announced that the NDA of A166 for the Treatment of HER2-positive unresectable locally advanced, recurrent, or metastatic breast cancer that has previously failed second-line or above anti-HER2 therapy was accepted by NMPA in China. A166, a HER2-ADC, is the first ADC drug of Kelun-Biotech to be submitted for marketing authorization.

3 Boehringer Ingelheim and Zealand Pharma announce phase II trial showed 14.9% weight loss in people living with obesity or overweight

Boehringer Ingelheim and Zealand Pharma announced the phase 2 trial (NCT04667377) of different doses of BI 456906 in people living with obesity or overweight without type 2 diabetes met its primary endpoint. Patients treated with BI 456906 achieved up to 14.9% weight loss after 46 weeks, using the planned maintenance dose.

4 Innovent Announces Phase 2 Clinical Study of Higher dose 9 mg Mazdutide (IBI362) in Chinese Adults with Obesity Achieved the 24-Week Primary Endpoint

Innovent Biologics announced that the phase 2 clinical study (NCT04904913) of 9 mg mazdutide in Chinese adults with obesity. The data showed the treatment difference of the mean change in body weight from baseline versus placebo was -14.7 kg(95%CI:-17.9 kg, -11.5 kg),p<0.0001, meeting the 24-week primary endpoint. Meanwhile, 81.7%、65.0%、31.7% and 21.7% of the subjects in the mazdutide 9 mg group achieved 5% or more,10% or more, 15% or more and 20% or more weight loss from baseline, respectively, while no subject in the placebo group lost 5% or more of body weight from baseline.

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