How Beigene’s PD-1 just can’t crack the west

It was way back in January 2021 that Novartis paid Beigene $650m for ex-China rights to tislelizumab, but over two years later it still can’t get the anti-PD-1 MAb approved in any of its territories. Most notably these include the US and EU, two regions where today’s second-quarter financial update from the Swiss firm brought further disappointments. In the US liver cancer has been abandoned, with Novartis citing portfolio prioritisation, joining nasopharyngeal cancer and metastatic NSCLC as indications where tislelizumab filings would no longer be pursued. A protracted delay to the one US submission that has been made, in oesophageal squamous cell carcinoma, continues, with the companies most recently promising a decision in 2023. In the EU, meanwhile, four initial approvals remain outstanding, despite having been accepted for review by the EMA 15 months ago. It is a different story in China, where Beigene retains rights, and where tislelizumab is approved in 10 indications and awaiting registration in another two. The relationship between Novartis and Beigene has separately come under strain after the Swiss firm last week decided not to opt in to develop the anti-Tigit MAb ociperlimab.

Selected indications for tislelizumab