Junshi Biosciences announces approval of the supplemental new drug application for Toripalimab

Following the approval of a new indication, Toripalimab, China's first homegrown PD-1 anti-cancer treatment, has become the first approved perioperative therapy for lung cancer in China and the second worldwide, its developer Shanghai Junshi Biosciences Co Ltd said.

That also meant the drug has expanded the treatment population from late-stage to early-stage cancer patients.

The supplemental new drug application for the drug in combination with chemotherapy as perioperative treatment and subsequently, monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB non-small cell lung cancer (NSCLC) has been approved by the National Medical Products Administration, the company announced Tuesday.

Lung cancer is currently the world's second most prevalent malignant tumor, with the highest mortality rate. According to the World Health Organization, in 2020, the number of new lung cancer cases in China amounted to 816,000, accounting for 17.9 percent of all new cancer cases in China. In the same year, the number of lung cancer deaths in China amounted to 715,000, accounting for 23.8 percent of all cancer deaths in China.

Among lung cancer, NSCLC is a major subtype, accounting for approximately 85 percent of all cases. Among these patients, 20 percent to 25 percent are surgically resectable at first diagnosis, but even after radical surgical treatment, 30 percent to 55 percent of these patients suffer from post-surgical recurrence and death.

Radical surgery in combination with chemotherapy is a way to prevent recurrence, but chemotherapy alone, as preoperative neoadjuvant or postoperative adjuvant therapy, has limited clinical benefits and can only raise patients' 5-year survival rate by approximately 5 percent.

Launched in 2018, the flagship domestic cancer treatment has obtained seven indications. The first six indications, including as a treatment for unresectable or metastatic melanoma after the failure of standard systemic therapy, have been included in the 2023 edition of the national reimbursement drug list.

Toripalimab is also the only anti-PD-1 monoclonal antibody included in the list for the treatment of melanoma.

liuzhihua@chinadaily.com.cn