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 ChinaIndicationRegimenSupporting trialStatus1st-line Her2+ve urothelial carcinomaDisitamab vedotin comboRC48-C016Awaiting NMPA approval (filing accepted Aug 2025)1st-line melanomaMonotherapyMelatorchApproved Apr 20251st-line liver cancerAvastin comboHepatorchApproved Mar 20251st-line PD-L1 +ve (≥1%) triple-negative breast cancerAbraxane comboTorchlightApproved Jun 20241st-line ES-SCLCChemo comboExtentorchApproved Jun 20241st-line renal cell carcinomaInlyta comboRenotorchApproved Apr 2024Neoadjuvant + adjuvant stage III NSCLCChemo combo, followed by monotherapyNeotorchApproved Jan 20241st-line non-squam NSCLCChemo comboChoice-01Approved Sep 20221st-line oesophageal squamous cell carcinomaChemo comboJupiter-06Approved May 20221st-line nasopharyngeal carcinomaChemo comboJupiter-02Approved Nov 20212nd-line urothelial carcinomaMonotherapyPolaris-03Approved Apr 20212nd-line nasopharyngeal carcinomaMonotherapyPolaris-02Approved Feb 20212nd-line melanomaMonotherapyUnclearApproved Dec 2018Source: OncologyPipeline.