SHANGHAI, China, November 28, 2024 — Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that four new indications of the company’s product toripalimab injection (trade name: TUOYI®, product code: JS001) were successfully included in Category of the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2024) (the “NRDL”). The new edition of the NRDL will be officially come into effect on 1 January 2025.

Up till now, ten approved indications of TUOYI® in Chinese mainland were all included in the NRDL and it is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of non-small cell lung cancer (“NSCLC”), treatment of renal carcinoma and treatment of triple-negative breast cancer (“TNBC”).

Indications:

1. Treatment for unresectable or metastatic melanoma after failure of standard systemic therapy;
2. Treatment for locally advanced or metastatic urothelial carcinoma that failed platinum containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum containing chemotherapy;
3. Treatment for patients with recurrent/metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy;
4. First-line treatment for patients with locally recurrent or metastatic NPC;
5. First-line treatment for patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma;
6. First-line treatment for patients with EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous NSCLC;
7. The product in combination with chemotherapy as perioperative treatment and subsequently, monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
8. The product in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma;
9. The product in combination with etoposidein plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
10. The product in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic TNBC with a well-validated test to evaluate PD-L1 positive (CPS ≥ 1).

Items 7 to 10 are new indications included in the NRDL.

In addition, the successful inclusion of the 4 new indications of TUOYI® in the NRDL is the first time that the NRDL included immunotherapy for perioperative NSCLC, renal carcinoma, small cell lung cancer and TNBC.