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BeOne Medicines Ltd. 8-K Report, Agreement Terminated (Jul 11, 2023)

Filed July 11, 2023For Securities:ONCBEIGF

Summary

BeOne Medicines Ltd. (ONC) announced a significant strategic shift regarding its investigational TIGIT inhibitor, ociperlimab. Effective immediately as of July 10, 2023, the company's subsidiary, BeiGene Switzerland, has mutually terminated its Option, Collaboration and License Agreement with Novartis Pharma AG. This termination restores full, global rights for the development, manufacturing, and commercialization of ociperlimab back to BeOne Medicines. This strategic move is accompanied by a modification to the company's clinical development plans. BeOne Medicines will continue enrollment in its Phase 3 AdvanTIG 302 trial for ociperlimab in combination with tislelizumab for first-line treatment of certain NSCLC patients. However, the company will discontinue the AdvanTIG 301 trial, citing a changing treatment paradigm. Investors should monitor how BeOne Medicines plans to leverage its regained global rights and the future development strategy for ociperlimab.

Key Highlights

  • 1BeOne Medicines regains full, global rights to its investigational TIGIT inhibitor, ociperlimab, following mutual termination of the agreement with Novartis.
  • 2The Option, Collaboration and License Agreement with Novartis has been terminated effective July 10, 2023.
  • 3BeOne Medicines will continue enrollment in the Phase 3 AdvanTIG 302 trial for ociperlimab in combination with tislelizumab for first-line NSCLC treatment.
  • 4The company will discontinue the Phase 3 AdvanTIG 301 trial of ociperlimab due to a changing treatment paradigm in NSCLC.
  • 5The termination allows BeOne Medicines to independently control and direct the future development and commercialization of ociperlimab globally.

Frequently Asked Questions

The mutual termination of the agreement with Novartis results in BeOne Medicines regaining full, global rights to develop, manufacture, and commercialize its investigational TIGIT inhibitor, ociperlimab.

The company is discontinuing the AdvanTIG 301 trial due to a changing treatment paradigm in the therapeutic area for which the trial was designed.

BeOne Medicines will continue the enrollment for the Phase 3 AdvanTIG 302 trial, which is evaluating ociperlimab in combination with tislelizumab for first-line treatment of specific NSCLC patients.

Regaining global rights means BeOne Medicines now has the sole authority to decide on the future strategy for ociperlimab, including its development, manufacturing, and commercialization across all territories without needing Novartis's consent or sharing future profits from these activities.