8-KOther EventsExhibits & Filings

BeOne Medicines Ltd. 8-K Report, Corporate Update (Oct 16, 2018)

Filed October 16, 2018For Securities:ONCBEIGF

Summary

BeOne Medicines Ltd. (ONC), now identified as BeiGene, Ltd. in this filing, announced updated results from a Phase 1 clinical trial of its investigational Bruton's tyrosine kinase (BTK) inhibitor, zanubrutinib. These results pertain to patients with Waldenström’s Macroglobulinemia and were presented at the 10th International Workshop on Waldenström’s Macroglobulinemia (IWWM). The primary purpose of this 8-K filing is to incorporate by reference a corrected press release detailing these clinical trial findings. The correction involves a minor adjustment in the reported percentage of patients who discontinued treatment due to disease progression, changing from 3% to 5%. Investors should note that this filing does not include new financial statements or other significant operational updates beyond the dissemination of these updated clinical trial results.

Key Highlights

  • 1BeiGene, Ltd. (formerly BeOne Medicines Ltd.) announced updated Phase 1 clinical trial results for zanubrutinib.
  • 2The results focus on patients with Waldenström’s Macroglobulinemia.
  • 3The data was presented at the 10th International Workshop on Waldenström’s Macroglobulinemia (IWWM).
  • 4A press release detailing these updated results is filed as Exhibit 99.1.
  • 5A correction was made to the press release regarding the percentage of patients discontinuing treatment due to disease progression (updated from 3% to 5%).
  • 6This filing primarily serves to disseminate updated clinical data, not new financial or operational information.

Frequently Asked Questions

Zanubrutinib is an investigational Bruton's tyrosine kinase (BTK) inhibitor being developed by BeiGene. BTK inhibitors are a class of drugs that have shown efficacy in treating certain B-cell blood cancers, including Waldenström’s Macroglobulinemia. The updated results indicate progress in understanding its effectiveness and safety profile for this specific indication.

The correction pertains to the description of patients discontinuing treatment due to disease progression. The percentage was revised from 3% to 5% of the study participants. This is a minor adjustment to the reported data within the press release.

No, this 8-K filing does not contain new financial statements, updates to financial guidance, or other significant operational disclosures. Its primary purpose is to report updated clinical trial results for zanubrutinib through the incorporation of a press release.

Waldenström’s Macroglobulinemia is a rare, slow-growing type of non-Hodgkin's lymphoma that affects a specific type of white blood cell called B-cells. It involves an abnormal protein (monoclonal immunoglobulin M) that can cause symptoms and complications.