Shyndec Pharma subsidiary gets approval for new drug strengths

Shanghai Shyndec Pharmaceutical (SSE:600420) announced that its holding subsidiary, Guoyao Yixin Pharmaceutical, has received approval from the National Medical Products Administration for supplementary applications concerning its fluorouracil injection product. This approval adds two new strengths (10ml:0.25g and 20ml:0.5g) to the existing 10ml:0.5g strength, granting corresponding drug approval numbers. Fluorouracil injection is primarily used in treating digestive tract tumors and other cancers. According to Yaozhi data, the sales of fluorouracil injection in public hospitals in 2024 were CNY 539 million. As of now, Guoyao Yixin's cumulative R&D investment for this project is approximately CNY 4,797,600. While the new strengths are expected to enhance market reach, the company cautions that sales could be influenced by industry policies and market conditions.