Lenvatinib Generic Approvals Imminent: Qilu Pharma and Chengdu Better Biopharma Enter Final Review Stage

On September 10, two additional generic lenvatinib products are expected to receive approval. Qilu Pharmaceutical (Acceptance No.: CYHS2000144) and BRILLIANT PHARMACEUTICALS (Acceptance No.: CYHS2000156) have both entered the “Under Review” stage. Together with the three previously approved manufacturers, the number of generic lenvatinib producers in China will soon reach five.

Source: NMPA Official Website

Lenvatinib is a first-line targeted therapy for liver cancer. It was approved by the NMPA in September 2018 and launched commercially in November of the same year under the trade name Lenvima.

China has the largest population of liver cancer patients globally, with approximately 466,000 new cases annually, accounting for 55% of the global total, and 422,000 deaths, representing 45%–50% of the worldwide figure. This substantial clinical demand has driven rapid sales growth for lenvatinib in China. In its first year on the market, sales revenue reached RMB 199 million; in 2019, sales surged to RMB 853 million, with a year-on-year growth rate as high as 328.64%; and in 2020, sales in China had surpassed RMB 1 billion.

During the national medical insurance negotiation in December 2020, lenvatinib was included in the National Reimbursement Drug List with an 80% price reduction, and the policy took effect starting in March this year. According to the Insight database, its latest winning bid price is 108 RMB per 4 mg tablet, significantly alleviating the financial burden on patients. Furthermore, since late July, multiple domestically produced generic versions have been successively approved, which will further benefit patients.

According to the Insight database, the three currently approved generic versions of lenvatinib are from Chia Tai Tianqing, Simcere Pharmaceutical, and Nanjing Chia Tai Tianqing, respectively. Qilu Pharmaceutical and BRILLIANT PHARMACEUTICALS have recently entered the administrative approval stage and will soon become the fourth and fifth companies. Meanwhile, seven other enterprises, including Askat Pharmaceutical, Kelun Pharmaceutical, CSPC Pharmaceutical Group, and Yangzijiang Pharmaceutical, are following closely behind. Based on the submission dates, Askat Pharmaceutical filed its application only one month after Qilu Pharmaceutical, and Kelun Pharmaceutical submitted theirs just three months later. Both are also expected to receive approval within this year.

Source: Insight database (http://db.dxy.cn/v5/home/)