Alteogen said that Qilu Pharmaceutical, its Chinese partner, has received investigational new drug (IND) approval for ALT-02, a Herceptin biosimilar, from the China Food and Drug Administration.
The Korean company licensed out the substance to Qilu in 2017, giving the latter exclusive rights in China, Hong Kong, and Macau.
With the Chinese approval, Alteogen has received its third milestone payment and will also get additional milestones if Qilu completes clinical trials and commercializes the product. The company will receive royalties for 10 years from the product's launch.
Alteogen said it could not disclose the amount of the milestone because of a confidentiality request from Qilu.
“Clinical approval of our Herceptin biosimilar in China can give us a competitive edge in the giant market,” the company said in a news release. “As Qilu plans to launch its phase 3 clinical trials on about 600 patients, we expect that the clinical trial will help us enter the European market.”