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On September 23, the CDE official website showed that Qilu Pharmaceutical's 4 generic generic drug "Rigofinil Tablets" was declared for listing (acceptance number: CYHS2101768)
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
On September 27, 2012, the FDA approved it for the treatment of metastatic patients who have previously received or based on fluorouracil, oxaliplatin, and irinotecan chemotherapy, anti-VEGF therapy, and anti-EGFR therapy (if KRAS wild-type) 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 that has previously received fluorouracil, oxaliplatin and irinotecan-based chemotherapy and anti-EGFR treatment (RAS wild-type) ( mCRC) 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
Regorafenib entered the medical insurance category B list through negotiations in 2018, and the medical insurance payment standard is 196 yuan (40mg/tablet); renewal negotiations will be carried out in 2020, and the contract will be renewed at 172.
According to the Insight database, the global sales of Rigofinil have been increasing year by year since it was listed in 2012 (except for 2016), and the sales in 2020 will reach 545 million US dollars
Regofinil global sales
From: Insight database (http://db.
At present, in addition to the original research company Bayer, there are 21 pharmaceutical companies deploying regorafenib
Regofinil domestic competition
From: Insight database (http://db.
