Ono Pharma Braftovi approval in South Korea will strengthen oncology portfolio but with limited sales potential, says GlobalData

Ono Pharmaceutical’s Braftovi (encorafenib) was recently approved in South Korea as a combination therapy with cetuximab to treat BRAF V600E mutant in previously treated metastatic colorectal cancer (mCRC) patients. However, the limited potential population of BRAF V600E mCRC patients in South Korea is expected to impact its overall sales potential, says GlobalData, a leading data and analytics company.

Braftovi is the first targeted therapy to treat mCRC patients with BRAF V600E mutation, and is not indicated for mCRC patients with wild type BRAF . South Korea became the second country within the Asia-Pacific, following Japan to approve Braftovi in mCRC. Ono Pharmaceutical is responsible for the commercialization of Braftovi in Japan and South Korea, and gained rights from Array BioPharma (now Pfizer) in May 2017.

According to GlobalData’s Pharma Intelligence Center, the number of incident cases in South Korea for BRAF V600E mutant CRC is estimated to grow at a compound annual growth rate of 3.34% from 2,229 in 2021 to 2,700 in 2028.

Mr. Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Braftovi is a highly needed therapy for BRAF V600E mutant mCRC patients in South Korea. However, the overall sales potential for Braftovi will be dependent on diagnosis rate and the mCRC patients with a history of previous treatments, which will further limit the potential population available, considering the number of incident cases observed in South Korea.”

Ono Pharmaceuticals launched its marketing in South Korea in 2015 and gained experience in marketing a diverse portfolio. The company has partnerships within oncology with global majors like BMS and Amgen to market their leading drugs like Opdivo, Yervoy and Kryprolis in South Korea. Braftovi is the first drug in its portfolio to target CRC patients and is still in Phase III for metastatic melanoma in South Korea.

Mr. Khadayate concludes: “Taiwan and South Korea are the only two countries in Asia beyond Japan where Ono Pharmaceuticals have established wholly-owned subsidiaries and marketing products. Therefore, South Korea is a key market for Ono Pharmaceuticals and the launch of new products like Braftovi will further strengthen its overall presence. However, considering the limited potential for Braftovi within mCRC, the company would need to expedite Phase III trials completion in metastatic melanoma and get the approval in South Korea to expand the sales potential for Braftovi.”

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