8-KRegulation FDOther EventsExhibits & Filings

BeOne Medicines Ltd. 8-K Report, Regulation FD Disclosure (Oct 21, 2021)

Filed October 21, 2021For Securities:ONCBEIGF

Summary

BeOne Medicines Ltd. (likely a typo and referring to BeiGene, Ltd. given the filing content) filed an 8-K on October 21, 2021, primarily announcing two key pieces of information relevant to investors. Firstly, the company has scheduled its financial results announcement for the third quarter and first nine months of 2021 for November 4, 2021, after market close. This provides investors with a date to anticipate crucial financial updates, including revenue, profitability, and operational performance metrics. Secondly, and of significant strategic importance, is the announcement regarding BRUKINSA® (zanubrutinib). The drug has received approval from the Russian Ministry of Health for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This approval marks an expansion of BRUKINSA's market access into Russia, facilitated by an exclusive distribution agreement with Nanolek. This development is a positive step for BeiGene, indicating continued global commercial progress for its key oncology asset and potential for increased revenue generation from this new territory.

Key Highlights

  • 1BeiGene Ltd. announced its Q3 and YTD 2021 financial results are scheduled for release on November 4, 2021.
  • 2BRUKINSA® (zanubrutinib) received approval from the Russian Ministry of Health.
  • 3The Russian approval is for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • 4BeiGene has entered into an exclusive distribution agreement with Nanolek for BRUKINSA in the Russian Federation.
  • 5This filing indicates progress in global market expansion for BRUKINSA.

Frequently Asked Questions

BeiGene is scheduled to announce its financial results for the three and nine months ended September 30, 2021, after the close of U.S. financial markets on Thursday, November 4, 2021.

The approval of BRUKINSA (zanubrutinib) by the Russian Ministry of Health for mantle cell lymphoma (MCL) represents an expansion of the drug's market access into Russia. This approval, coupled with the distribution agreement with Nanolek, opens up a new revenue stream and market for BeiGene's key oncology product.

In Russia, BRUKINSA is approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Nanolek is a biopharmaceutical company specializing in drug production in Russia. They have entered into an exclusive distribution agreement with BeiGene to commercialize BRUKINSA within the Russian Federation.