Nhwa：NHL35700 initiates its first Phase III clinical trial.
On June 2, the official website of the Drug Clinical Trial Registration and Information Disclosure Platform showed that NHWA Pharmaceutical and Shujing Biomedical have registered a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (Registration No.: CTR20262177) evaluating the efficacy and safety of NHL35700 for the treatment of adult schizophrenia. The primary objective of this study is to evaluate the efficacy of NHL35700 in the treatment of adult schizophrenia versus placebo. The secondary objectives are to evaluate the safety and pharmacokinetic (PK) profile of NHL35700 in adult patients with schizophrenia. The study plans to enroll 516 subjects, who will be randomized to receive NHL35700 tablets or placebo. The primary endpoint is the change from baseline in PANSS score at 8 weeks of treatment. Secondary endpoints include the change from baseline in PANSS positive symptom subscale and negative symptom subscale scores at 8 weeks of treatment, as well as the proportion of patients achieving a ≥30% or ≥50% reduction from baseline in PANSS score, among others.
NHL35700 is a Category 1 innovative drug that NHWA Pharmaceutical in-licensed through an exclusive license agreement with Lundbeck Pharmaceutical in November 2021. It targets dopamine receptors, serotonin receptors, and adrenergic receptors. Compared with existing antipsychotic drugs, NHL35700 has a unique pharmacological mechanism characterized by higher affinity for the dopamine D1 receptor than for the D2 receptor, which is expected to achieve antipsychotic efficacy while reducing the incidence of side effects such as extrapyramidal symptoms (EPS) and hyperprolactinemia. In addition, NHL35700 features rapid onset of action and low fluctuation in plasma drug concentration. Therefore, NHL35700 has the potential to improve schizophrenia symptoms while reducing adverse reactions and enhancing medication adherence.
Buy NHL35700 online from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.
