On December 28, 2019, BeiGene announced that 百泽安 (generic name: tislelizumab injection), an anti-PD-1 antibody drug, had been approved by the National Medical Products Administration (NMPA) on December 27 for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (R/R cHL) who have received at least second-line systemic chemotherapy. Prior to this approval, the new drug application for tislelizumab had been granted priority review by the NMPA.
百泽安 is BeiGene’s first independently developed anticancer drug approved in China, following the U.S. Food and Drug Administration (FDA) approval of BRUKINS (zanubrutinib), its self-developed BTK inhibitor.
About Classical Hodgkin Lymphoma
Hodgkin lymphoma is a malignant tumor affecting the lymph nodes and lymphatic system, among which classical Hodgkin lymphoma is the most prevalent subtype, accounting for approximately 95% of all Hodgkin lymphoma cases. It has the highest incidence in young adults aged 15–30 and adults over 55 years old. Lymph node enlargement is usually the initial symptom, and in advanced stages, the tumor may invade the liver, spleen, bone marrow and other organs¹.
First-line radiotherapy and chemotherapy have significantly improved the survival of patients with classical Hodgkin lymphoma. Nevertheless, approximately 5–10% of patients present with primary refractory disease, and 10–30% experience relapse after achieving initial disease remission². These patients have a poor prognosis, and traditional salvage therapies show limited efficacy, leaving a substantial unmet clinical need.
About 百泽安 (Tislelizumab)
百泽安 (tislelizumab) is a humanized IgG4 monoclonal antibody against programmed death receptor 1 (PD-1), engineered to minimize binding to FcγR receptors on macrophages. Preclinical data demonstrate that binding to FcγR receptors on macrophages triggers antibody-dependent cellular cytotoxicity against T cells, which reduces the antitumor activity of PD-1 antibodies.
As the first candidate drug developed from BeiGene’s immuno-oncology biological platform, tislelizumab is currently being evaluated in monotherapy and combination therapy clinical trials to develop a broad range of indications for solid tumors and hematological malignancies.
百泽安 has been approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma who have received at least second-line systemic chemotherapy. Another new drug application for 百泽安 in patients with previously treated locally advanced or metastatic urothelial carcinoma has been granted priority review by the Center for Drug Evaluation (CDE) of the NMPA and is currently under review.
百泽安 is being developed as a monotherapy and in combination regimens for multiple indications in solid tumors and hematological malignancies. A total of 15 registration clinical trials are ongoing in China and globally, including 11 Phase 3 clinical trials and four pivotal Phase 2 clinical trials.
