HLB Life Science, which owns rights to market Jiangsu Hengrui Medicine’s anticancer drug pyrotinib in Korea, said it would expand new pipelines on the back of the recent success of a phase 3 pyrotinib trial.
Jiangsu Hengrui announced that the phase 3 clinical trial of pyrotinib met the primary endpoint as the first-line treatment for breast cancer.
According to Jiangsu Hengrui, the phase 3 study of pyrotinib in combination with trastuzumab and docetaxel showed a statistically significant improvement in progression-free survival (PFS) on 590 patients with HER2 positive breast cancer.
In China, pyrotinib sales have been growing rapidly since it won Chinese approval in 2020 as a second-line treatment for breast cancer.
Should it be approved as the first-line treatment, pyrotinib will become more marketable, HLB Life Science said.
The Chinese drugmaker plans to disclose the full results of the phase 3 study at a cancer society’s meeting.
HLB Life Science signed an exclusive licensing agreement with Jiangsu Hengrui for pyrotinib in September 2020.
In December 2020, HLB Life Science received the local approval for a phase 3 clinical trial to treat non-small cell lung cancer (NSCLC).
On July 29, the company submitted a plan for a phase 3 bridging trial of pyrotinib as the third-line treatment for breast cancer.
A bridging trial is a study of a drug authorized in other countries on Koreans to assess the efficacy and safety in different ethnicities.