By Fineline Cube 
China-based CStone Pharmaceuticals (HKG: 2616) has announced that it has received approval from the National Medical Products Administration (NMPA) to locally manufacture its Gavreto (pralsetinib tablets, 100mg) instead of importing the drug from overseas. This milestone is expected to enhance supply flexibility and improve patient access in China, with domestic production set to commence next year.
Approval Details
The NMPA’s approval for local manufacturing represents a significant step forward for CStone Pharmaceuticals in expanding its capabilities within the Chinese market. By producing Gavreto domestically, the company aims to streamline its supply chain and ensure consistent availability of this critical therapy for patients with RET-related cancers.
Gavreto Overview
Gavreto is an oral, once-daily, highly selective RET inhibitor that was in-licensed from US-based biotech Blueprint Medicines in June 2018. The drug has been approved for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer in multiple markets, including mainland China, Hong Kong, Taiwan, and the United States.
Commercialization Partnership
In November 2023, CStone Pharmaceuticals partnered with Allist Pharmaceuticals Co., Ltd. for the commercialization of Gavreto in China. This collaboration is designed to maximize the drug’s market reach and ensure that patients have access to this innovative therapy.
Significance of Local Manufacturing
The shift to local production underscores CStone Pharmaceuticals’ commitment to strengthening its presence in the Chinese market while addressing potential supply chain challenges. By manufacturing Gavreto domestically, the company aims to enhance its ability to meet patient demand and support broader healthcare initiatives in China.
Conclusion
CStone Pharmaceuticals’ NMPA approval for local manufacturing of Gavreto marks a pivotal moment in its journey to expand access to life-saving therapies in China. As domestic production begins next year, the company is poised to play a key role in improving patient outcomes and solidifying its position as a leader in oncology innovation.-Fineline Info & Tech