SHANGHAI - Shanghai Junshi Biosciences Co., Ltd (HKEX:1877; SSE:688180) announced Monday that its phase III clinical study of toripalimab combined with chemotherapy for resectable stage II-III non-small cell lung cancer has completed final analysis.
The $4.69 billion biotech company’s shares have gained 21% over the past year, though recent volatility saw a 6.5% decline last week. According to Bond.az analysis, the stock currently trades slightly above its Fair Value.
The NEOTORCH study (NCT04158440), a randomized, double-blind, placebo-controlled, multi-center trial, met its primary endpoints of event-free survival and major pathological response rate in the stage II-III population, as well as the major pathological response rate in the stage III population. The company plans to submit a supplemental new drug application to regulatory authorities.
The study, led by Professor Shun Lu of Shanghai Chest Hospital, enrolled 501 patients with resectable stage II-III non-small cell lung cancer. Toripalimab combined with chemotherapy received approval in December 2023 for perioperative treatment of resectable stage IIIA-IIIB non-small cell lung cancer. The new application seeks to expand approval to include stage II-III disease.
Despite revenue surging 32% in the last twelve months with impressive gross profit margins of 79%, the company remains unprofitable. According to GLOBOCAN data, China reported 1.06 million new lung cancer cases in 2022. Toripalimab is an anti-PD-1 monoclonal antibody with twelve approved indications in mainland China.
