China’s Center for Drug Evaluation (CDE) has announced its intention to include Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. (CTFH)’s FHND1002 granules in the patient-centered rare disease drug development pilot program, known as the Care Plan. The official announcement is expected within the coming week.
FHND1002: Focusing on Patient Experience in ALS Research
FHND1002, currently in the pre-Investigational New Drug (pre-IND) stage, is being prepared for a study that will focus on the patient experience of amyotrophic lateral sclerosis (ALS). The patient experience data collected will be utilized to explore the optimization of ALS efficacy indicators, ensuring that the drug development process is more closely aligned with the needs and experiences of those living with the disease. Additionally, digital health technology will be applied in the trials, and the implementation of decentralized clinical trials will be explored to enhance the efficiency and accessibility of the research process.
CDE’s Care Plan Aims to Enhance Rare Disease Drug Development
The Care Plan program, officially launched by CDE in September, is designed to guide and assist research and development entities in fully incorporating patient perspectives throughout the drug development process. The program aims to enhance the scientific, standardized, and rational integration of patient experience data into the clinical research and development of rare disease drugs. This approach is expected to promote high-quality and efficient development and marketing of rare disease drugs. Since its inception, the Care Plan has included drugs such as Pfizer’s marstacimab, China Resources Double-Crane Pharmaceutical Co., Ltd’s (SHA: 600062) hydroxocobalamine, and Sanofi Genzyme’s fitusiran.-Fineline Info & Tech
Leave a Reply