Toripalimab Drug News

In December 2018, toripalimab was approved by the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic melanoma after failure of prior standard therapy.

In February 2021, toripalimab was approved by the NMPA for the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC) after failure of second- or later-line systemic therapy.

In April 2021, toripalimab was approved by the NMPA for the treatment of locally advanced or metastatic urothelial carcinoma following prior therapy.

In November 2022, toripalimab was approved by the NMPA for the first-line treatment of locally recurrent or metastatic nasopharyngeal carcinoma (in combination with cisplatin and gemcitabine).

In December 2022, toripalimab was approved by the NMPA for the first-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (in combination with paclitaxel and cisplatin).

In January 2023, toripalimab was approved by the NMPA for the first-line treatment of non-squamous non-small cell lung cancer (in combination with pemetrexed and platinum-based chemotherapy).

In April 2023, toripalimab was approved by the NMPA for perioperative treatment of resectable stage IIIA‑IIIB non-small cell lung cancer.

In April 2024, toripalimab was approved by the NMPA for the first-line treatment of intermediate‑high risk unresectable or metastatic renal cell carcinoma (in combination with axitinib).

In December 2024, toripalimab was approved by the NMPA for two indications:

First-line treatment of extensive‑stage small cell lung cancer (in combination with etoposide and platinum-based chemotherapy);

First-line treatment of recurrent or metastatic triple-negative breast cancer with PD-L1 positivity (CPS ≥ 1) confirmed by a fully validated assay (in combination with paclitaxel for injection [albumin-bound]).

In January 2025, toripalimab received full approval from the NMPA for the second- or later-line treatment of unresectable or metastatic melanoma (converted from conditional approval).

In March 2025, toripalimab was approved by the NMPA for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (in combination with bevacizumab).

In April 2025, toripalimab was approved by the NMPA for the first-line treatment of unresectable or metastatic melanoma.