Korean-based Alteogen reports that China’s Qilu Pharmaceutical has received IND approval for ALT-02, a Herceptin biosimilar, from the China Food and Drug Administration.
The Korean company (Alteogen) licensed out the substance to Qilu Pharmaceutical in 2017 granting the latter exclusive rights in China, Hong Kong, and Macau.
What are the Implications of Chinese FDA Approval?
Alteogen has received its third milestone payment and will receive additional milestone payments. Moreover, the company will receive royalties for 10 years from the product’s launch.
How Much Money Is Involved?
Alteogen cannot disclose.
Clinical approval of our Herceptin biosimilar in China can give us a competitive edge in the giant market.
Next Stop: Clinical Trials in China
Qilu plans on launching a Phase 3 trial on about 600 patients and the hope is that it will help the group enter Europe reports Korean Biomedical Review.