Collaboration and Regulatory Submission - Orion's collaboration partner Bayer has submitted an application to China's NMPA for the use of darolutamide in combination with ADT for metastatic hormone-sensitive prostate cancer (mHSPC) [1] - The submission is based on positive Phase III ARANOTE trial results showing a 46% reduction in the risk of radiological progression or death compared to placebo plus ADT in mHSPC patients [1] Market Approvals and Global Presence - Darolutamide, marketed as Nubeqa®, is already approved for mHSPC in combination with ADT and docetaxel in over 80 markets, including China [2] - The compound is also approved for non-metastatic castration-resistant prostate cancer (nmCRPC) in over 85 countries, including China [2] Company Overview - Orion is a globally operating Finnish pharmaceutical company with a focus on oncology and pain [3] - The company develops, manufactures, and markets human and veterinary pharmaceuticals, with a portfolio including proprietary and generic medicines and consumer health products [3] - Orion's net sales in 2023 amounted to EUR 1,190 million, with approximately 3,600 employees at the end of the year [3]
Orion's collaboration partner Bayer submits application in China for third indication of darolutamide