On October 16, 2022, Rongchang Bio-Pharmaceutical (Yantai) Co., Ltd. (688331.SH/09995.HK) announced that Taitacept (trade name: Taiai®) was used for the treatment of systemic lupus erythematosus (SLE). The global multi-center phase III clinical trial was approved by EU and State Drug Administration on September 26 and September 28, respectively. These are two milestones that Tetacept has ushered in on its internationalization journey after the completion of the first subject in the global multi-center Phase III clinical trial in the United States in the first half of the year.
, as the world's first dual-targeted new biological drug for the treatment of systemic lupus erythematosus , the freeze-dried dosage form of Taitacept, Taitacept for injection, was approved for marketing in China with conditions in March 2021 . In September of this year, Rongchang Bio announced that the domestic phase III confirmatory study of tetacept reached the pre-set clinical endpoint, and the results showed that the SRI-4 response rate of the tetacept (160 mg) group after 52 weeks of treatment was significantly higher than that of the placebo group (82.6% vs 38.1%), and the safety is good.
In order to facilitate self-administration of patients, improve the convenience of clinical medication, and the compliance of patients, Rongchang Bio has developed a liquid preparation of tacitarcept - tacitarcept injection (research code: RC18-L, pre-filled Seal injection), and to conduct a global multi-center clinical trial of this liquid formulation in the treatment of systemic lupus erythematosus. This study is a multicenter, randomized, double-blind , placebo-controlled, two-phase trial evaluating the efficacy and safety of tetacept in patients with moderately to severely active systemic lupus erythematosus, expected to be located in North America, More than 100 research centers around the world, including /South America, Europe, and Asia, will participate in this study. The clinical trial was approved by the European Union and the National Medical Products Administration (NMPA), marking the acceleration of the globalization of tetacept.
Taitacept is an antibody fusion protein drug molecule invented and designed by the company's CEO and chief scientific officer, Professor Fang Jianmin. By simultaneously inhibiting the overexpression of two cytokines, BLyS and APRIL, , "two-pronged" prevents B cells from . Abnormal differentiation and maturation to treat a series of immune diseases such as B cell-mediated systemic lupus erythematosus. In addition to systemic lupus erythematosus, tetacept is used in the treatment of neuromyelitis optica spectrum disorders, rheumatoid arthritis, IgA nephropathy, primary Sjögren's syndrome, myasthenia gravis, , multiple sclerosis and other immune diseases. The clinical research has entered the phase II/III clinical research stage.
Lightning News reporter Liu Yuliang reports
