Rongchang Bio-Tetacept was approved, the second new drug for systemic lupus erythematosus in 60 years

On March 9th, Rongchang Bio-Taltazep (trade name: Tai'ai®) was approved by China's NMPA to be combined with conventional treatments to be used in systems with high disease activity and autoantibody positive on the basis of conventional treatments.
Adult patients with sexual lupus erythematosus (SLE).

SLE is a systemic autoimmune disease.
Its main clinical features are multi-system and multi-organ involvement, repeated recurrence and remission, and the presence of a large number of autoantibodies in the body.
If not treated in time, it will cause irreversible damage to the involved organs.
Cause the patient's death.

The cause of SLE is complex, and it is related to the excessive proliferation of B cells in the patient's body caused by the interaction of multiple factors such as genetics, sex hormones, and environment (such as viral and bacterial infections).

At present, the prevalence of SLE in mainland China is 30-70/100,000, and the ratio of male to female is 1:10-12.
The global SLE population is about 7.
7 million, and it is expected to reach 8.
6 million by 2030.

In the past 60 years, the US FDA has only approved belimumab, a drug for the treatment of systemic lupus erythematosus, which is difficult to meet the huge clinical needs at home and abroad.

Taltazep is a dual-targeting fusion protein developed by Rongchang Biological.
It is fused with the BLyS/APRIL binding domain of a transmembrane activator and a calmodulin ligand interaction molecule (TACI) and a human immunoglobulin Fc fragment.
Become.

BLyS and APRIL are the key factors for the differentiation and maturation of B lymphocytes.
Overexpression of these factors is an important cause of systemic lupus erythematosus (SLE) and other autoimmune diseases related to B lymphocytes.

Taltazep prevents BLyS and APRIL from binding to BAFF-R, BCMA and TACI receptors expressed on the surface of B cells, inhibits BLyS and APRIL signal transduction, and inhibits the development and survival of mature B cells and plasma cells, thereby achieving systemic treatment The purpose of lupus erythematosus.

According to the key clinical research results published by Rongchang Biological, the systemic lupus erythematosus response index (SRI) of the high-dose Taltazep group for 48 weeks was significantly higher than that of the placebo control group (79.
2% vs 32.
0%).
The degree of improvement is significantly better than that of belyumumab currently on the market (61.
4% vs 48.
4%), and tytacept is also excellent in terms of safety and well tolerated by patients.
It is expected to become the best-in-class in the treatment of SLE Biological therapy.

The details of Telitacicept and the competitive landscape of biopharmaceuticals targeting BlyS are shown in the figure below: (click to enlarge) You can click the link below to get more details of new batches of drugs and related target competition landscape information https://data.
pharmacodia.
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