What happened
BeiGene's (BGNE 6.15%) shares were up by more than 13% on Tuesday at 2:50 p.m. ET thanks to a regulatory body in China accepting one of the company's supplemental biologics licensing application filings for a new indication for its drug tislelizumab.
The Center for Drug Evaluation (CDE) will now evaluate whether tislelizumab is sufficiently safe and effective to treat metastatic gastric junction adenocarcinoma in conjunction with chemotherapy for patients whose tumors express the PD-1 biomarker, potentially giving BeiGene the green light for an expansion of its commercialization in China.
So what
If regulators ultimately opt to approve the company's application, it'll be the 10th indication for tislelizumab in China, which speaks to its versatility as a cancer medicine as well as its money-making potential.
The medicine isn't currently approved anywhere outside China, but both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are currently evaluating its merits for treating post-chemotherapy metastatic epidural spinal cord compression (ESCC).
Now what
Today's acceptance is a step toward realizing more revenue from research and development (R&D) investments in tislelizumab. Investors can expect the company to continue to invest in exploring new use cases for the drug, which is currently being investigated in late-stage clinical trials for at last five other indications.
It's unclear precisely when the CDE will weigh in on whether or not to approve the application for a new indication, but based on past activity, it could be a few months. Expect BeiGene's shares to pop again if regulators in any country give it a thumbs-up.
