News
Company News
DiQi Pharma’s Risperidone Injectable Microspheres (4W) Receives FDA Clinical Trial Approval
Release time: 2021/09/20

On September 16, 2021, DiQi Pharmaceuticals Co., Ltd.'s independently developed modified new drug, Risperidone Microspheres for Injection (4W), received clinical trial approval from the U.S. Food and Drug Administration (FDA). This product had already obtained clinical trial approval from the National Medical Products Administration (NMPA) on April 14, 2021.

Risperidone is a second-generation classic first-line medication for treating schizophrenia. DiQi Pharmaceuticals Co., Ltd developed Risperidone Microspheres for Injection (4W) using risperidone combined with its proprietary biodegradable high-end excipient, poly(lactic-co-glycolic acid) (PLGA). This product is currently the world's first risperidone microsphere formulation requiring administration only once every four weeks. Compared to the imported commercial product Hengde®, DiQi Pharmaceuticals Co., Ltd.'s risperidone microsphere product not only eliminates the three-week delayed release period after administration but also doubles the drug release duration. Not only does this significantly improve patient compliance, but it is also anticipated to substantially reduce relapse rates. The relapse rate may decrease from 32% (with biweekly dosing) to 13% (with quarterly dosing), compared to 56% for oral risperidone.

DiQi Pharmaceuticals Co., Ltd.'s independently developed biodegradable high-end excipients—poly(lactic-co-glycolic acid) copolymers PLGA 8515, PLGA 7525, and PLGA 5050 (for injection)—have been registered with the NMPA and FDA respectively. DiQi Pharmaceuticals Co., Ltd. can customize cGMP-compliant products according to customer requirements and provide relevant technical support.

  • Contact Information
    Address:8 Luoxuan 3rd Road, Guangzhou International BIO-island
    Main telephone number:020-32227031
    Fax:020-32227031
    Email:gzdq@gzdqyy.com
  • Customer Service
    Postal Code:510300
    Business Consulting:18122367150 13602749876
    Complaints Hotline:020-32227031
    Complaint Email:diqiyjx@gzdqyy.com
Official WeChat
Official WeChat
Copyright©2021 Guangzhou DiQi Pharmaceuticals Co., Ltd 粤ICP备2024318179号 粤公网安备44011202002899号 Powered By Vancheer
top