CDE Includes Chiral Tech’s Cerdelga Generic in Rare Disease Care Plan

China’s Center for Drug Evaluation (CDE) announced the inclusion of Beijing Chiral Tech’s generic version of Sanofi Genzyme’s Cerdelga (eliglustat) in the patient-centered rare disease drug development pilot program, known as the Care Plan. The move aims to accelerate access to affordable treatments for rare diseases.

Drug Profile
Eliglustat, a glucosylceramide synthase inhibitor, was first approved in the U.S. in August 2014 for adult patients with Gaucher disease type 1. The drug targets the enzyme responsible for glucosylceramide accumulation, reducing disease symptoms.

Regulatory Background

• March 2021: Eliglustat included in China’s second batch of encouraged generic development drugs.
• October 2022: Chiral Tech’s generic version approved in China, while the originator remains unlisted.
• CDE Care Plan: The program supports rare disease drugs with unmet clinical needs, offering policy incentives for developers.-Fineline Info & Tech