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On October 17, 2022, Remegen Biopharmaceutical (Yantai) Co.
, Ltd.
(688331.
SH/09995.
HK) announced that Tetacept (trade name: Taiai ®).
The global multicenter phase III clinical trial for the treatment of systemic lupus erythematosus (SLE) was approved
by the European Union and the National Medical Products Administration on September 26 and September 28, respectively.
These are two milestones in the internationalization journey after the completion of the first patient enrollment in the global multicenter phase III clinical trial in the United States in the first half of the year
.
As the world's first dual-target biological new drug for the treatment of systemic lupus erythematosus, the lyophilized dosage form of tetacept, tetacept for injection, was conditionally approved for marketing
in China in March 2021.
In September this year, Remegen announced that the phase III confirmatory study of tetacept in China had reached the preset clinical endpoint, and the results showed that the SRI-4 response rate of 52 weeks of treatment with tetacept (160 mg) was significantly higher than that of placebo group (82.
6% vs.
38.
1%), and the safety was good
.
In order to facilitate patients' self-administration, improve the convenience of clinical medication, and the compliance of patients, Remegen has developed the liquid preparation of tetacept - tetacept injection (study code: RC18-L, prefilled injection), and carried out the global multicenter clinical trial
of this liquid dosage form for the treatment of systemic lupus erythematosus.
This study is a multicenter, randomized, double-blind, placebo-controlled two-phase trial to evaluate the efficacy and safety of tetacept in patients with moderately to severely active systemic lupus erythematosus, and is expected to participate in more than 100 research centers located in North America, Central/South America, Europe, Asia and other countries around the world
.
The approval of clinical trials by the European Union and the National Medical Products Administration (NMPA) marks the beginning of the acceleration of the globalization of tatacept
.
Tetacept is an antibody fusion protein drug molecule invented and designed by Professor Fang Jianmin, CEO and Chief Scientific Officer of the company, which prevents the abnormal differentiation and maturation of B cells by simultaneously inhibiting the overexpression of BLyS and APRIL cytokines, thereby treating a series of immune diseases
such as B cell-mediated systemic lupus erythematosus 。 In addition to systemic lupus erythematosus, a number of clinical studies of tetacept in the treatment of neuromyelitis optica spectrum disease, rheumatoid arthritis, IgA nephropathy, primary Sjogren's syndrome, myasthenia gravis, multiple sclerosis and other immune diseases have entered the phase II/III clinical research stage
.
