8-KOther Events

BeOne Medicines Ltd. 8-K Report, Corporate Update (Jun 11, 2021)

Filed June 11, 2021For Securities:ONCBEIGF

Summary

Beigene, Ltd. (ONC) has filed a Form 8-K detailing significant progress across its oncology pipeline and strategic partnerships. Key developments include the acceptance of a supplemental Biologics License Application (sBLA) in China for tislelizumab, an anti-PD-1 antibody, for the treatment of specific solid tumors (MSI-H/dMMR). This regulatory step in a major market signifies a potential expansion for a key asset. Furthermore, the company announced a significant strategic collaboration with Shoreline Biosciences to develop and commercialize next-generation NK-based cell therapeutics utilizing Shoreline's iPSC NK cell technology. This partnership aims to leverage BeiGene's R&D and clinical capabilities to create innovative cell therapies for various malignancies. The report also highlights positive clinical data presented at the EHA2021 Virtual Congress, showcasing long-term efficacy and safety results for tislelizumab in classical Hodgkin's lymphoma and for its BTK inhibitor BRUKINSA® (zanubrutinib) in mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. Notably, the ALPINE Phase 3 trial results demonstrated superiority of BRUKINSA® over ibrutinib in a head-to-head comparison for relapsed/refractory CLL/SLL, including key efficacy and safety endpoints.

Key Highlights

  • 1China's NMPA accepted a supplemental BLA for tislelizumab in MSI-H/dMMR solid tumors.
  • 2Exclusive worldwide collaboration established with Shoreline Biosciences to develop iPSC NK cell therapies.
  • 3Long-term follow-up results for tislelizumab in classical Hodgkin's lymphoma presented at EHA2021.
  • 4Pivotal Phase 2 trial results for BRUKINSA® (zanubrutinib) in R/R mantle cell lymphoma and CLL/SLL presented at EHA2021.
  • 5Phase 3 ALPINE trial results show BRUKINSA® superior to ibrutinib in R/R CLL/SLL for overall response rate and atrial fibrillation.
  • 6The Alpine trial results also indicate potential safety advantages for BRUKINSA® compared to ibrutinib.

Frequently Asked Questions

The acceptance of the supplemental Biologics License Application (sBLA) by China's NMPA is a crucial step towards potential market approval for tislelizumab in a significant oncology market. This filing targets patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, indicating an expanded indication for this key anti-PD-1 antibody.

BeiGene has entered into a worldwide strategic collaboration with Shoreline Biosciences to develop and commercialize a portfolio of Natural Killer (NK) cell-based therapeutics. This partnership leverages Shoreline's induced pluripotent stem cell (iPSC) NK cell technology and BeiGene's extensive research and clinical development capabilities to advance novel cell therapies for various types of cancer.

The presentations at EHA2021, particularly the ALPINE Phase 3 trial results, demonstrate that BRUKINSA® (zanubrutinib) achieved superiority over ibrutinib in treating relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This superiority was observed in the primary endpoint of investigator-assessed overall response rate (ORR) and a key secondary endpoint of atrial fibrillation or flutter, suggesting both efficacy and a potentially improved safety profile.

Yes, the filing announces the acceptance of a supplemental Biologics License Application (sBLA) in China for tislelizumab for the treatment of patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors. This indicates potential for an expanded use of tislelizumab beyond its currently approved indications.