The development of subcutaneously delivered anti-PD-(L)1 antibodies has so far delivered four approved drugs, and there could soon be a fifth, with Shanghai Junshi this week toplining the success of a phase 3 study of a SC form of toripalimab. The trial tested chemo combos of a SC version (JS001sc) versus the IV form in first-line non-squamous non-small cell lung cancer, and was said to have shown comparable efficacy and safety, and non-inferior pharmacokinetics. Junshi says the data will back a Chinese filing across all indications where the IV form, Tuoyi, is approved; these presently number 12 cancer settings. In the US toripalimab is licensed to Coherus, and approved IV in two nasopharyngeal carcinoma settings as Loqtorzi, but it’s unclear whether Coherus holds specific rights to a SC version. With Tecentriq Hybreza, Opdivo Qvantig and Keytruda Qlex not approved in China, JS001sc’s local SC competition is limited to Alphamab’s envafolimab, an anti-PD-L1/Fc fusion protein with high solubility. Pfizer’s sasanlimab is awaiting approval in the EU for non-muscle invasive bladder cancer, but a US filing hasn’t yet been publicly disclosed. Subcutaneously delivered anti-PD-(L)1 MAbsProjectCompanyIV drugStatusEnvafolimabAlphamab OncologyNoneApproved in China for 2nd-line MSI-H/dMMR tumoursTecentriq HybrezaRocheTecentriqApproved in all IV indications, based on Imscin-001Opdivo QvantigBristol Myers SquibbOpdivoApproved in all IV solid tumour indications, based on Checkmate-67TKeytruda QlexMerck & CoKeytrudaApproved in most IV solid tumour indications, based on Keynote-D77SasanlimabPfizerNoneTo be filed in US for non-muscle invasive bladder cancer, based on CrestJS001scShanghai JunshiTuoyi/LoqtorziTo be filed in China for all IV indications, based on NCT06505837TevimbraBeOneTevimbraPh3 trial for gastric/GEJ cancer started in Aug 2025Source: OncologyPipeline.
The development of subcutaneously delivered anti-PD-(L)1 antibodies has so far delivered four approved drugs, and there could soon be a fifth, with Shanghai Junshi this week toplining the success of a phase 3 study of a SC form of toripalimab. The trial tested chemo combos of a SC version (JS001sc) versus the IV form in first-line non-squamous non-small cell lung cancer, and was said to have shown comparable efficacy and safety, and non-inferior pharmacokinetics. Junshi says the data will back a Chinese filing across all indications where the IV form, Tuoyi, is approved; these presently number 12 cancer settings. In the US toripalimab is licensed to Coherus, and approved IV in two nasopharyngeal carcinoma settings as Loqtorzi, but it’s unclear whether Coherus holds specific rights to a SC version. With Tecentriq Hybreza, Opdivo Qvantig and Keytruda Qlex not approved in China, JS001sc’s local SC competition is limited to Alphamab’s envafolimab, an anti-PD-L1/Fc fusion protein with high solubility. Pfizer’s sasanlimab is awaiting approval in the EU for non-muscle invasive bladder cancer, but a US filing hasn’t yet been publicly disclosed.
Subcutaneously delivered anti-PD-(L)1 MAbs
