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BeOne Medicines Ltd. 8-K Report, Agreement Terminated (Dec 20, 2018)

Filed December 20, 2018For Securities:ONCBEIGF

Summary

BeiGene, Ltd. (the Company) announced a significant strategic step in its drug development and commercialization efforts. The Company has repurchased the commercialization option for its investigational PARP inhibitor, pamiparib (BGB-290), in China from Merck KGaA. This termination of the License Agreement, effective December 31, 2018, means BeiGene will regain full control over pamiparib's commercialization in China and is relieved of future milestone obligations to Merck KGaA under that agreement. While the payment for this option buy-back is undisclosed, this move signifies BeiGene's intent to manage its key assets independently in a crucial market. In parallel, the Company provided positive updates on its lead anti-PD-1 antibody, tislelizumab. Updated clinical data from a Phase 1A/1B trial were presented at the ESMO Immuno-Oncology Congress. Furthermore, BeiGene announced the enrollment of the first patients in two global Phase 3 clinical trials for tislelizumab. These trials are evaluating tislelizumab in combination with chemotherapy as a first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma and advanced esophageal squamous cell carcinoma, marking a critical advancement in the drug's development pathway for significant cancer indications.

Key Highlights

  • 1BeiGene repurchased the China commercialization option for pamiparib (BGB-290) from Merck KGaA.
  • 2The License Agreement with Merck KGaA for pamiparib in China will terminate effective December 31, 2018.
  • 3BeiGene regains full control of pamiparib's commercialization in China.
  • 4Updated clinical data for tislelizumab (anti-PD-1 antibody) were presented at the ESMO-IO Congress.
  • 5Two global Phase 3 clinical trials for tislelizumab have initiated enrollment.
  • 6These Phase 3 trials evaluate tislelizumab in combination with chemotherapy for first-line treatment of gastric and esophageal cancers.

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