Fifth subcutaneous PD-1 could be Junshi's

Having surprised last November with the revelation that it was developing a subcutaneous version of toripalimab, Shanghai Junshi has moved swiftly to get this to market. The phase 3 study that was at the time toplined positive, testing chemo combos of the SC versus the IV formulation in first-line non-squamous non-small cell lung cancer, has been filed with China’s NMPA, Junshi said on Monday, suggesting that toripalimab could soon become the fifth anti-PD-(L)1 drug to come to market globally in a SC formulation. As with Roche’s Tecentriq Hybreza, Bristol Myers Squibb’s Opdivo Qvantig and Merck & Co’s Keytruda Qlex, which are SC versions of existing IV drugs, the filing for SC toripalimab (JS001sc) seeks approval for all (12) indications for which the IV drug is already greenlit. This of course differs from Alphamab’s envafolimab, a novel drug developed specifically for SC use, and thus approved in China on an indication-by-indication basis. The same will go for Pfizer’s sasanlimab – whenever that’s filed for non-muscle invasive bladder cancer. IV toripalimab is awaiting Chinese approval for a 13th indication, urothelial carcinoma in combination with disitamab vedotin, and if this is approved it’s not clear whether a SC nod would encompass it too.

Regulatory status of IV toripalimab in China

Source: OncologyPipeline.