Kelun and Aosaikang Advance Toward Market Launch of Lenvatinib Mesylate Capsules, a Billion-Dollar Blockbuster

Recently, the methanesulfonate lenvatinib capsule reported by Kelun Pharmaceutical and Aosaikang for generic drug category 4 has entered the administrative approval stage and is expected to be approved for marketing soon. Lenvatinib is a star drug for liver cancer, with sales in the Chinese market reaching 1.178 billion yuan in 2020.

Lenvatinib, a multi-target receptor tyrosine kinase inhibitor developed by Eisai/MSD, targets VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET, and others. It was approved for marketing in China in September 2018 for the treatment of patients with hepatocellular carcinoma.

After its launch, the sales of Lenvatinib continued to rise. According to the financial reports of Eisai and MSD, the global sales of Lenvatinib exceeded 1.8 billion US dollars in 2020. In the Chinese market, the sales of Lenvatinib increased from 189 million yuan in 2018 to 1.178 billion yuan in 2020. In less than three years, Lenvatinib has grown into a blockbuster product with sales of over 1 billion yuan.

Eisai's Lenvatinib Sales in China (Unit: Million Yuan)

Source: MiNeiNet Multinational Listed Companies Sales Database

Currently, 13 Chinese companies have submitted applications for the marketing of lenvatinib generics. On July 20, 2021, Zhengda Tianqing and Simcere Pharmaceutical obtained production licenses, becoming the first domestic generic manufacturers in China; subsequently, Nanjing Zhengda Tianqing, Qilu Pharmaceutical, and Betta Pharmaceuticals also received approval for the product to be marketed.

Approval Status of Lenvatinib Mesylate Capsules

Source: MiNei Network One-Click Search

The registration status of Lenvatinib Mesylate Capsules by Kelun Pharmaceutical and Aosaikang has changed to "under review" on the same day. If approved, it will be considered as passing the evaluation, becoming the 6th domestically produced version in China.

Data source: MiNeiNet database, NMPA