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On April 19, the CDE official website showed that Yangtze River's 4-category generic drug "Rigofinil Tablets" was declared for listing (acceptance number: CYHS2101075), which was the first generic drug reported for listing in China
.
Its indications are: colorectal cancer, gastrointestinal stromal tumor, liver cancer
Data source: CDE official website
Regorafenib is a new type of oral multi-kinase inhibitor, which is a new generation of oral multi-target tyrosine kinase inhibitor developed by Bayer after Sorafenib
.
In addition to inhibiting KIT and PDGFRA kinase targets, regorafenib can also act on RET, BRAF, RAF1, VEGFR, FGFR, PDGFRP and other targets
On September 27, 2012, the FDA approved it for the treatment of metastatic chemotherapy, anti-VEGF therapy, and anti-EGFR therapy (if KRAS wild-type) previously received or based on fluorouracil, oxaliplatin, and irinotecan.
Patients with colorectal cancer (CRC)
On February 25, 2013, the FDA approved it for locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) patients who had previously been treated with imatinib and sunitinib
.
On April 28, 2017, the FDA approved it for the second-line treatment of hepatocellular carcinoma (HCC) patients who have previously used Nexavar® (Sorafenib)
.
On March 24, 2013, the original CFDA approved its listing for the treatment of metastatic colorectal cancer (mCRC) that had previously received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy and anti-EGFR treatment (RAS wild-type).
) Patients, and locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) patients who have previously been treated with imatinib mesylate and sunitinib malate
In May 2017, the original CFDA approved it for the treatment of metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumor (GIST)
.
On December 12, 2017, the original CFDA approved it for the treatment of liver cancer
.
According to the Insight database, the global sales of Rigofinil have been increasing year by year since its listing in 2012 (except for 2016), and its sales in 2019 reached 458 million U.
S.
dollars
Data source: insight database
At present, in addition to the original research company Bayer, there are 21 pharmaceutical companies that have deployed rigorfenib.
The companies involved include CSPC, CP Tianqing, Shuanglu, Qilu Pharmaceutical, Kelun, etc.
; among them, 5 companies are conducting BE experiments.
Companies, 15 companies have applied for clinical trials
