Eisai, a Japanese pharmaceutical company, intends to apply in China as soon as October for marketing approval for its new liver cancer drug Lenvima, which the company only just submitted in Japan in June and will submit in Western nations later this month.
Including China among the first target markets for a new drug is a first for Eisai and a rarity among foreign drug companies because of the regulatory hurdles there. But China appears ready to change its rules on the use of multiregional clinical data, and that has the drug companies speeding up their efforts to tap into the huge and growing Chinese market.
Eisai is developing Lenvima for the treatment of hepatocellular carcinoma, which accounts for some 80% of the 800,000 global cases of liver cancer each year and is concentrated in Asia, home to four out of five patients with this type.
Eisai conducted multiregional phase III clinical trials on Lenvima on 954 subjects, including 100 from China. It will use that data when submitting the drug to the Chinese regulators for approval.
Up until now, most drugs submitted for marketing approval in China by multinational drug companies have been accompanied by data from clinical trials conducted inside China. That is because the only way to use data from multiregional trials has been to apply ahead of time for an exemption, which takes nearly 20 months to receive.
But now China is considering doing away with the exemption requirement and letting drug companies use the data from their multiregional trials, provided that the trials include a certain number of Chinese patients. Eisai is acting on the assumption that the new policy will soon come into effect.