Innovative cancer therapy developed by Pudong pharma receives conditional approval in China
HUTCHMED (China) Limited, an innovative pharmaceutical company based in Zhangjiang Science City in Shanghai's Pudong New Area, and Innovent Biologics Inc, a world-class biopharmaceutical company, jointly announced on Dec 3 that the new drug application for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.
This approval follows the priority review status and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China, recognizing its potential in treating severe diseases with no effective treatment options and the significant clinical advantages over existing therapies.
Developed independently by HUTCHMED, fruquintinib achieved this milestone in just five years. It became the first innovative targeted therapy approved for the treatment of metastatic colorectal cancer in the United States, European Union, and Japan in over a decade. Furthermore, it is the first original drug from Shanghai to enter these three major global markets.
HUTCHMED (China) Limited based in Zhangjiang Science City in Shanghai's Pudong New Area. [Photo/WeChat ID: pdnews]
By the third quarter of 2024, global sales of fruquintinib reached $203 million, triggering a $20-million milestone payment and indicating strong market potential, suggesting that it will become Shanghai's first globally recognized innovative drug.
As an innovative pharmaceutical company that established a presence in Zhangjiang Science City in 2002, HUTCHMED has evolved over the course of more than 20 years to become a leader in independent innovative drugs. The company's commitment to "going global" has demonstrated robust market demand and commercial appeal.