On October 21, 2025, the Class 3 generic drug pyridostigmine bromide extended‑release tablet, independently developed by SPH Zhongxi Pharmaceutical Co., Ltd., was officially approved for marketing, becoming the first approved extended‑release formulation of this drug in China. Chengdu West China Clinical Research Center Co., Ltd. (hereinafter referred to as “WCCR”) served as the full‑cycle clinical trial technical service provider. From human experience evaluation to regulatory pathway design, from IND dossier preparation to CDE registration communication, WCCR leveraged scientific strategy optimization and efficient trial execution to help accelerate the approval of this drug, providing patients with a valuable treatment option.
With professional competence and innovative thinking, WCCR contributed to the first generic approval of pyridostigmine bromide extended‑release tablets, demonstrating the critical role of our medical decision‑making, expert advisory support, and clinical research practice experience in drug development. Moving forward, we will continue to collaborate with partners to drive the development of more innovative drugs and benefit patients.
WCCR’s Core Technical Service Contributions to This Study:
1. Data‑Driven Registration Strategy
• Comprehensively reviewed clinical practice data and integrated authoritative expert advice to build an evidence system meeting CDE registration requirements.
• Conducted multiple in‑depth communications to clarify the registration pathway and shorten the review cycle.
2. Efficient, Full‑Service Process Compliance
• Provided seamless support from IND technical document preparation and clinical trial application to final drug approval document acquisition.
• Optimized clinical trial design and implemented pivotal trials with rigorous standards, ensuring data quality and compliance.
3. Patient Benefit as a Priority
• The approval of the extended‑release formulation significantly improves patient medication experience by reducing dosing frequency and enhancing quality of life.
• The rapid market entry of this product fills a gap in the treatment of myasthenia gravis in China, offering patients a better therapeutic option.
