Narlumosbart Injection

On September 6, 2023, the application for indication of Naruxobimab (trade name: Jinlitai), a national Class 1.1 new drug independently developed by Shijiazhuang Pharmaceutical Group and the first IgG4 RANKL inhibitor, was officially approved by the National Medical Products Administration for use in adult patients with giant cell tumor of bone who cannot be surgically removed or whose surgical removal may cause severe functional impairment.
Naruxobimab is a RANKL inhibitor. The JMT103CN03 study is a single-arm, open, multicenter, Phase Ib/II clinical study to evaluate the efficacy and safety of Naruxobimab in the treatment of patients with giant cell tumor of bone who cannot be removed or have difficult surgery. The study included 135 patients with giant cell tumor of bone who were unresectable (unresectable means that the tumor cannot be completely removed by surgery) or difficult to operate (difficult to operate means that the tumor can be completely removed by surgery, but complete resection may cause severe functional impairment or complications) from more than 30 centers across the country, including Beijing Jishuitan Hospital, Peking University Third Hospital, Chinese People’s Liberation Army General Hospital, West China Hospital of Sichuan University, and Fudan University Affiliated Cancer Hospital.

The results of the study showed that the tumor response rate of naruxobimab in patients with unresectable or difficult-to-operate giant cell tumor of bone was as high as 93.3% in 12 weeks. The disease control rate (DCR) of the efficacy-evaluable analysis set population evaluated by the independent review committee (IRC) based on the ICDS standard reached 100%, and the objective response rate (ORR) was 85.8%.

Naruxobimab has a rapid onset of action, and the median time to tumor response based on imaging assessment by IRC is only 0.95 months. In the study, 81.5% of those with difficult surgery received surgical treatment after drug treatment, and the median time from the first dose to surgical resection was 2.92 months. After treatment with naruxobimab, the tumor boundary became clear, which brought a lot of convenience to the surgical operation. In terms of safety, no serious adverse reactions occurred and the patient tolerated it well.