- BeiGene ( NASDAQ: BGNE ) on Friday said China's drug regulator had accepted its supplemental biologics license application (sBLA) for its inhibitor tislelizumab for the treatment of the most common type of liver cancer.
- The sBLA was accepted by the Center for Drug Evaluation of the China National Medical Products Administration, BGNE said in a statement .
- The exact indication for tislelizumab under the sBLA is for the treatment of patients with first-line unresectable or metastatic hepatocellular carcinoma, the most common type of primary liver cancer.
- BGNE said the sBLA was supported by data from a clinical trial that enrolled more than 600 patients.
- Tislelizumab was earlier approved by China's drug regulator as a treatment for nine indications.
- U.S.-listed shares of BeiGene ( BGNE ) were marginally higher at $224.06 after the opening bell.
For further details see:
China accepts BeiGene's supplemental license application for treatment of liver cancer