8-KShareholder MattersOther EventsExhibits & Filings

BeOne Medicines Ltd. 8-K Report, Shareholder Vote Results (Nov 20, 2020)

Filed November 20, 2020For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (ONC) filed an 8-K on November 20, 2020, reporting on the outcome of its 2020 Extraordinary General Meeting (EGM) of Shareholders and a significant regulatory approval in China. The EGM saw strong shareholder participation, with over 88% of outstanding shares represented. The primary resolution approved was the grant of an option to Amgen Inc. to subscribe for up to 75,000,000 ordinary shares, allowing Amgen to maintain approximately 20.6% ownership. This approval is crucial for the ongoing strategic collaboration between BeiGene and Amgen. Furthermore, the company announced that the China National Medical Products Administration (NMPA) has approved XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma. This approval expands the therapeutic applications of XGEVA in China, complementing its existing approval for giant cell tumor of the bone, and is a key milestone for BeiGene's oncology portfolio in a major market.

Key Highlights

  • 1Shareholders overwhelmingly approved the grant of an option to Amgen Inc. to subscribe for up to 75,000,000 ordinary shares, enabling Amgen to maintain approximately 20.6% ownership.
  • 2The EGM had a high turnout, with approximately 88.61% of outstanding ordinary shares present and voting.
  • 3The approval of the Amgen option is tied to a strategic collaboration and supports their ongoing partnership.
  • 4The China National Medical Products Administration (NMPA) has approved XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) in China.
  • 5This XGEVA approval covers patients with bone metastases from solid tumors and those with multiple myeloma.
  • 6XGEVA is already approved and marketed in China for unresectable giant cell tumor of the bone (GCTB).
  • 7The NMPA approval signifies an expansion of BeiGene's oncology product offerings in the significant Chinese market.

Frequently Asked Questions

The main purpose of the EGM was to vote on an ordinary resolution to approve the grant of an option to Amgen Inc. to subscribe for additional shares. This option allows Amgen to subscribe for up to 75,000,000 ordinary shares to maintain its ownership at approximately 20.6% of BeiGene's outstanding share capital.

The resolution to approve the grant of the option to Amgen was overwhelmingly approved by shareholders. Out of the 1,042,393,641 ordinary shares voted, 797,273,269 were cast 'For' the resolution, with only 8,391,220 voting 'Against'.

The NMPA approval of XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and multiple myeloma is a significant commercial milestone. It expands the approved indications for XGEVA in China, a key market, and strengthens BeiGene's oncology portfolio by adding another treatment option for critical patient populations.

The filing details a strategic collaboration between BeiGene and Amgen. The shareholder approval at the EGM is to facilitate Amgen's continued investment and ownership in BeiGene through a share subscription option related to this collaboration. Amgen also licensed XGEVA to BeiGene for development and commercialization in China.