Beijing Time, November 28 – Junshi Biosciences (1877.HK, [688180.SH](688180.SH)) announced that four new indications of toripalimab (brand name: 拓益), an anti-PD-1 monoclonal antibody independently developed by the company, have been successfully included in the National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance Drug List (2024 Edition) (National Reimbursement Drug List). The updated National Reimbursement Drug List will take effect on January 1, 2025.
To date, all 10 approved indications of 拓益 in China have been incorporated into the National Reimbursement Drug List, making it the only anti-PD-1 monoclonal antibody in the list for the treatment of melanoma, perioperative non-small cell lung cancer, renal cell carcinoma and triple-negative breast cancer.
Indications of Toripalimab
The indications of 拓益 included in the 2024 updated National Reimbursement Drug List are as follows:
Existing Indications
Treatment of unresectable or metastatic melanoma after failure of prior systemic therapy;
Treatment of locally advanced or metastatic urothelial carcinoma that progressed within 12 months following failure of platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy;
Treatment of recurrent/metastatic nasopharyngeal carcinoma after failure of at least two lines of prior systemic therapy;
First-line treatment of locally recurrent or metastatic nasopharyngeal carcinoma;
First-line treatment of unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma;
First-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with negative epidermal growth factor receptor (EGFR) gene mutation and negative anaplastic lymphoma kinase (ALK) rearrangement.
Newly Added Indications
Perioperative treatment in combination with chemotherapy, followed by monotherapy as adjuvant treatment, for adult patients with resectable Stage IIIA–IIIB non-small cell lung cancer (NSCLC);
First-line treatment in combination with axitinib for intermediate- or high-risk unresectable or metastatic renal cell carcinoma;
First-line treatment in combination with etoposide and platinum-based chemotherapy for extensive-stage small cell lung cancer (ES-SCLC);
First-line treatment in combination with paclitaxel injection (albumin-bound) for recurrent or metastatic triple-negative breast cancer (TNBC) with PD-L1-positive status (CPS ≥ 1) assessed by a fully validated assay.
As one of the company’s core products, toripalimab adopted a differentiated superior-efficacy strategy during development. It features a unique binding site, high affinity, and potent induction of PD-1 receptor internalization.
In 2018, toripalimab (拓益) was officially approved for marketing in China, becoming the first domestically developed anti-PD-1 monoclonal antibody approved in China. In October 2023, toripalimab’s marketing application was approved by the U.S. Food and Drug Administration (FDA), making it the first and currently the only drug approved for nasopharyngeal carcinoma in the United States, as well as the first innovative biologic independently developed and manufactured in China to gain FDA approval.
To date, toripalimab has been officially approved for marketing in more than 35 countries and regions including China, the United States, the European Union, the United Kingdom and India. Over 40 clinical studies covering more than 15 indications have been conducted globally, and its global commercialization network has been deployed in more than 50 countries or regions. It is the first domestically developed anti-PD-1 monoclonal antibody recommended by three major authoritative guidelines worldwide: NCCN, ESMO and CSCO.
