8-KRegulation FDOther EventsExhibits & Filings

BeOne Medicines Ltd. 8-K Report, Regulation FD Disclosure (Jan 10, 2022)

Filed January 10, 2022For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (ONC) announced significant updates regarding the inclusion of its key medicines on China's National Reimbursement Drug List (NRDL), effective January 1, 2022. This inclusion is crucial for market access and patient affordability, as it enables reimbursement through China's public medical insurance system at negotiated payment standards. The NRDL listing impacts Tislelizumab across five approved indications, including its use in first-line non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). Furthermore, BRUKINSA® is now covered for three indications, including Waldenström's macroglobulinemia (WM) and mantle cell lymphoma (MCL). Pamiparib, a PARP inhibitor, is also included for recurrent advanced ovarian cancer with gBRCA mutations. These developments are expected to substantially drive sales and patient uptake for BeiGene's innovative oncology portfolio within China, a critical growth market.

Key Highlights

  • 1Tislelizumab now included in China's NRDL for five approved indications, including first-line NSCLC and HCC.
  • 2BRUKINSA® is now listed on the NRDL for three indications, covering WM, MCL, and CLL/SLL.
  • 3Pamiparib has been added to the NRDL for the treatment of recurrent advanced ovarian cancer in patients with gBRCA mutations.
  • 4The NRDL inclusion effective January 1, 2022, sets specific payment standards for each drug and indication, facilitating broader patient access and reimbursement.
  • 5The company also announced a separate NMPA approval for tislelizumab as a second- or third-line treatment for NSCLC on January 6, 2022.
  • 6These NRDL listings are expected to be significant catalysts for revenue growth and market penetration in China.
  • 7Negotiated NRDL payment standards provide a framework for affordability and widespread use of BeiGene's innovative cancer therapies.

Frequently Asked Questions

Inclusion on China's National Reimbursement Drug List (NRDL) is critical because it means these medicines will be covered by the national public medical insurance system. This significantly reduces the out-of-pocket cost for patients, making the drugs more accessible and is expected to drive substantial increases in sales volume and market penetration for BeiGene in China.

The update affects three key oncology drugs: Tislelizumab, BRUKINSA®, and Pamiparib. Tislelizumab is now covered for five indications, BRUKINSA® for three, and Pamiparib for one specific indication in ovarian cancer. This broadens the market access for a significant portion of BeiGene's innovative product portfolio in China.

The NRDL payment standards are negotiated prices. While these prices are generally lower than list prices, the widespread reimbursement and increased patient access are expected to lead to higher sales volumes that will more than compensate for the reduced price per unit, ultimately boosting overall revenue in China.

Yes, in addition to the NRDL updates, the filing also references a press release from January 6, 2022, announcing that the China National Medical Products Administration (NMPA) approved tislelizumab as a second- or third-line treatment for patients with locally advanced or metastatic non-small cell lung cancer. This represents another key regulatory milestone for the drug in China.