Telitacicept (brand name: 泰愛®) formally granted full approval from conditional approval by NMPA for use in combination with conventional therapy in adult patients with active and auto-antibody positive systemic lupus erythematosus
November 23 , 2023
On November 22, 2023, RemeGen Co., Ltd. (688331.SH/9995.HK) announced that telitacicept (brand name: 泰愛®) has been formally granted full approval from conditional approval by China’s National Medical Products Administration (the “NMPA”) for use in combination with conventional therapy in adult patients with active and auto-antibody positive systemic lupus erythematosus (SLE) who have a high level of disease activity despite the fact that they have been treated with conventional therapy.
This full approval also marks another important milestone following the first conditional approval of the drug in 2021 and its successful inclusion in the 2022 National Reimbursement Drug List (the “NRDL”), which will further accelerate the benefits to a wider range of patients with SLE in China.
Full approval of telitacicept in this indication was based on a randomized, double-blind, placebo-controlled, multicenter, confirmatory Phase III clinical trial enrolling 335 patients in total. The purpose of this study is to evaluate the efficacy and safety of telitacicept in combination with standard therapy versus placebo in combination with standard therapy for the treatment of patients with moderate to severe SLE. Results of the full analysis set (FAS) showed that the response rate of SRI-4 (SLE Response Index 4) at the 52nd week was significantly higher in patients treated with telitacicept than in those given placebo (82.6% versus 38.1%, p < 0.001). Results of all sensitivity analyses showed that the response rate of SRI-4 was significantly higher in patients treated with telitacicept than in patients given placebo (p < 0.001), meeting the primary endpoint of the study.
SLE is a chronic, multi-system and incurable autoimmune disease that can potentially lead to serious organ damage, systemic complications and even death. According to Frost & Sullivan, in 2020, the number of SLE patients in China was about 1.03 million, and about 7.8 million globally. Existing therapies are characterized by high risk of relapse and obvious side effects. Telitacicept, as a new proprietary novel fusion protein, could be considered of significant clinical value in the treatment of SLE patients.
This full approval also marks another important milestone following the first conditional approval of the drug in 2021 and its successful inclusion in the 2022 National Reimbursement Drug List (the “NRDL”), which will further accelerate the benefits to a wider range of patients with SLE in China.
Full approval of telitacicept in this indication was based on a randomized, double-blind, placebo-controlled, multicenter, confirmatory Phase III clinical trial enrolling 335 patients in total. The purpose of this study is to evaluate the efficacy and safety of telitacicept in combination with standard therapy versus placebo in combination with standard therapy for the treatment of patients with moderate to severe SLE. Results of the full analysis set (FAS) showed that the response rate of SRI-4 (SLE Response Index 4) at the 52nd week was significantly higher in patients treated with telitacicept than in those given placebo (82.6% versus 38.1%, p < 0.001). Results of all sensitivity analyses showed that the response rate of SRI-4 was significantly higher in patients treated with telitacicept than in patients given placebo (p < 0.001), meeting the primary endpoint of the study.
SLE is a chronic, multi-system and incurable autoimmune disease that can potentially lead to serious organ damage, systemic complications and even death. According to Frost & Sullivan, in 2020, the number of SLE patients in China was about 1.03 million, and about 7.8 million globally. Existing therapies are characterized by high risk of relapse and obvious side effects. Telitacicept, as a new proprietary novel fusion protein, could be considered of significant clinical value in the treatment of SLE patients.