Summary
BeiGene, Ltd. (ONC) has announced significant progress in its regulatory submissions for two key drugs, BRUKINNSA® (zanubrutinib) and tislelizumab. On June 18, 2020, the company revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for BRUKINNSA® for Waldenström’s macroglobulinemia (WM). This validation marks a crucial step towards potential market approval in Europe for this indication. Furthermore, on June 19, 2020, BeiGene announced that China's Center for Drug Evaluation (CDE) has accepted a supplemental new drug application (sNDA) for tislelizumab. This application seeks approval for tislelizumab in combination with chemotherapy for the first-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC) in China. These developments are positive indicators of the company's pipeline advancement and potential for future revenue generation in major markets.
Key Highlights
- 1European Medicines Agency (EMA) validated the marketing authorization application (MAA) for BRUKINNSA® (zanubrutinib) for Waldenström’s macroglobulinemia (WM).
- 2This EMA validation is a key step towards potential European approval for BRUKINNSA®.
- 3China's Center for Drug Evaluation (CDE) accepted a supplemental new drug application (sNDA) for tislelizumab.
- 4The tislelizumab sNDA is for its use in combination with chemotherapy for first-line advanced non-squamous non-small cell lung cancer (NSCLC).
- 5The regulatory acceptance in China pertains to a significant patient population for NSCLC.
- 6Both announcements highlight the company's progress in advancing its drug candidates through the regulatory approval process in key global markets.