Yangtze River Pharmaceutical Submits China's First Generic Regorafenib Tablets for Marketing Approval

On April 19, the CDE website showed that Yangtze River Pharmaceutical Group's Class 4 generic drug "Regorafenib Tablets" was submitted for market approval (acceptance number: CYHS2101075), making it the first generic drug to be reported for marketing in China. Its indications are: colorectal cancer, gastrointestinal stromal tumors, and liver cancer.

Data Source: CDE Official Website

Regorafenib is a novel oral multi-kinase inhibitor and a new-generation oral multi-target tyrosine kinase inhibitor developed by Bayer following sorafenib. In addition to inhibiting the kinase targets KIT and PDGFRA, regorafenib also acts on RET, BRAF, RAF1, VEGFR, FGFR, PDGFRβ, and other targets. Regorafenib blocks multiple enzymes that promote tumor growth, thereby inhibiting tumorigenesis, angiogenesis, and the formation of the tumor microenvironment through its effects on multiple kinases in tumor cells, endothelial cells, and peripheral cells.

On September 27, 2012, the FDA approved it for the treatment of patients with metastatic colorectal cancer (CRC) who had previously received chemotherapy based on fluorouracil, oxaliplatin, and irinotecan, anti-VEGF therapy, and anti-EGFR therapy (if KRAS wild-type).

On February 25, 2013, the FDA approved its use for patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumors (GIST) who had previously been treated with imatinib and sunitinib.

On April 28, 2017, the FDA approved it for second-line treatment of patients with hepatocellular carcinoma (HCC) who had previously been treated with Nexavar® (sorafenib).

On March 24, 2013, the former China Food and Drug Administration (CFDA) approved its marketing authorization for the treatment of patients with metastatic colorectal cancer (mCRC) who had previously received chemotherapy based on fluorouracil, oxaliplatin, and irinotecan, as well as anti-EGFR therapy (for RAS wild-type tumors); and for patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumors (GIST) who had previously been treated with imatinib mesylate and sunitinib malate.

In May 2017, the former China Food and Drug Administration (CFDA) approved it for the treatment of metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumors (GIST).

On December 12, 2017, the former China Food and Drug Administration (CFDA) approved it for the treatment of liver cancer.

According to the Insight database, global sales of regorafenib have increased year by year since its market launch in 2012 (except for 2016), reaching $458 million in 2019.

Data Source: Insight Database

Currently, in addition to the originator Bayer AG, 21 other pharmaceutical companies have entered the regorafenib market. These companies include CSPC Pharmaceutical Group, Chia Tai Tianqing Pharmaceutical Group, Double-Crane Pharmaceutical, Qilu Pharmaceutical, and Kelun Pharmaceutical. Among them, five companies are conducting bioequivalence (BE) studies, and 15 companies have submitted clinical trial applications.