Is Tevimbra (Tislelizumab-jsgr) on the market?

Tevimbra (Tislelizumab-jsgr) is a humanized monoclonal IgG4 antibody directed against programmed death receptor-1 (PD-1). It was designed to have an inactive Fc portion, thereby minimizing binding to FcγRs on macrophages and limiting treatment resistance through antibody-dependent phagocytosis. By blocking PD-L1/PD-L2-mediated cell signaling, tislelizumab restores T cell function through cytokine production, resulting in an immune-mediated anti-tumor response. Tislelizumab is generally well tolerated, with manageable mild to moderate side effects.

Tislelizumab, which is marketed under the brand name Tevimbra, was approved for medical use in China in December 2019, in the European Union in September 2023, and in the United States in March 2024.

In China,Tevimbra is indicated for the treatment of patients with classic Hodgkin lymphoma who have received at least two prior lines of therapy; and for the treatment of people with locally advanced or metastatic urothelial cancer with high PD-L1 expression whose disease has progressed during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In the EU,Tevimbra is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy. In the United States, Tevimbra is indicated for the treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma following prior systemic chemotherapy that does not include a PD-(L)1 inhibitor.

Tevimbra is effective in improving survival and slowing progression of non-small cell lung cancer. It is also effective in improving survival in patients with advanced or metastatic squamous esophageal cancer who have previously received platinum-based chemotherapy. The drug's side effects are considered manageable and comparable to similar cancer drugs. Therefore, Tevimbra's benefits outweigh its risks and it can be authorized for use.

Reference materials:https://go.drugbank.com/drugs/DB14922

https://fanyi.sogou.com/text?keyword=&transfrom=auto&transto=zh-CHS&model=general