8-KOther EventsExhibits & Filings

BeOne Medicines Ltd. 8-K Report, Corporate Update (Jan 23, 2023)

Filed January 23, 2023For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (ONC) announced two significant positive developments impacting its key drug franchises. On January 18, 2023, China's National Reimbursement Drug List (NRDL) was updated to include four new indications for tislelizumab, a PD-1 inhibitor. Notably, KYPROLIS®, a proteasome inhibitor licensed from Amgen, was added to the NRDL for the first time, and XGEVA®, another Amgen asset, successfully renewed its inclusion. These changes are effective March 1, 2023, and are expected to enhance market access and affordability for these important therapies in China. Furthermore, on January 19, 2023, BeiGene received FDA approval for its Bruton's tyrosine kinase inhibitor, BRUKINSA (zanubrutinib), for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This U.S. approval marks a significant milestone for BRUKINSA, expanding its therapeutic reach and solidifying its position in the oncology market. Both announcements are expected to be positive catalysts for the company's growth and revenue prospects.

Key Highlights

  • 1China's NRDL will include four new indications for BeiGene's PD-1 inhibitor, tislelizumab, effective March 1, 2023.
  • 2KYPROLIS®, a proteasome inhibitor licensed from Amgen, has been added to China's NRDL for the first time.
  • 3XGEVA®, a RANKL inhibitor and another Amgen asset, has successfully renewed its inclusion on China's NRDL.
  • 4The FDA approved BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • 5The FDA approval for BRUKINSA in CLL/SLL is a significant market expansion for the drug in the U.S.
  • 6These developments are expected to improve market access and affordability for key BeiGene therapies in major markets.

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