Rongchang Biotech's first original innovative drug, Tai'ai®, was approved to start the "dual target" era of systemic lupus erythematosus

As the only dual-target biological agent approved for the treatment of SLE in the world, Tai Ai® can simultaneously inhibit the two cytokines BLyS and APRIL, and the breakthrough use of fusion protein technology makes the drug and the two cytokines have a stronger affinity , To achieve more effective inhibition, so as to achieve a "two-pronged" treatment effect, which not only increases the effectiveness but also enhances the safety of the drug
.

A phase IIb clinical study involving 249 patients with SLE showed that SRI4 (SLE response index) was 77.
8% and 79%, respectively, in SLE patients who received Tai'ai® 160 mg and 240 mg for 48 weeks, which were significantly better.
In 50% of the placebo group, the disease activity of the patients decreased after treatment and the condition remained stable for a long time
.

As the person in charge of this clinical research, Professor Zhang Fengchun, former head of the Department of Internal Medicine of Peking Union Medical College Hospital, said: “Taiai® is a Class 1 innovative drug with completely independent intellectual property rights for Chinese biopharmaceutical companies.
It has not only achieved encouraging results in terms of efficacy”.
As a result, the performance in terms of safety is also excellent
.
Its approval reflects the contribution of Chinese innovative drugs in the field of rheumatism, and hopes to lead the treatment practice in the field of systemic lupus erythematosus in China and even the world
.
"

Actively pioneer and innovate

Rongchang Biotechnology leads China's innovative drugs to the world

The characteristics of the new target, new structure and new mechanism of Tai Ai® have enabled its invention patents to be authorized by China, the United States, Europe, Russia, South Korea, Japan, etc.
, and the R&D project has also won the national "Eleventh Five-Year" and "Twelfth Five-Year Plan" During the 5th and 13th Five-Year Plan period, "Major new drug creation" special science and technology projects are supported
.

Professor Zeng Xiaofeng, chairman of the National Clinical Research Center for Dermatology and Immune Diseases and director of the Department of Rheumatology and Immunology of Peking Union Medical College Hospital, said: “The approval of Tai Ai® is of epoch-making significance
.
As a result of a major national major science and technology project for the creation of new drugs, it opens The "dual target era" of systemic lupus erythematosus treatment will bring significant clinical benefits to countless patients suffering from recurrence of "lupus", effectively improve the prognosis of patients and enhance their quality of life
.
"

Dr.
Jianmin Fang, founder and CEO of Rongchang Biotech, said: "Taltazep has experienced more than 12 years of research and development.
The approval this time demonstrates Rongchang Biotech's innovative research and development capabilities in macromolecular drugs.
It is not only an affirmation of Rongchang Biotech.
Encouragement is also an important milestone for Rongchang Bio to achieve commercialization.
I hope that the approval of Tai Ai® will bring new treatment opportunities to more SLE patients
.
"

In addition to targeting local patients, the commercialization process of Taltazep overseas is also accelerating
.
The U.
S.
FDA has granted the fast-track approval channel for tytacept and is launching phase III clinical trials in an effort to promote the drug's listing in many foreign countries as soon as possible, so that this innovative dual-target biologic can benefit SLE patients worldwide
.

Rongchang Bio is currently rapidly advancing the clinical trials of Tai Ai® in other diseases, including rheumatoid arthritis, neuromyelitis optica spectrum disorder, IgA nephropathy, myasthenia gravis, Sjogren’s syndrome and multiple sclerosis
.
In the future, it is expected that more patients will benefit from this innovative drug
.

references

1.
Chinese Medical Association Rheumatology Branch.
2020 Chinese Systemic Lupus Erythematosus Diagnosis and Treatment Guidelines[J].
Chinese Journal of Internal Medicine, 2020, 59(3): 172-185.

2.
Carter EE, Barr SG, Clarke A E.
Nature Reviews Rheumatology, 2016, 12(10): 2.
605.

3.
China Systemic Lupus Erythematosus Development Report, the 10th China Systemic Lupus Erythematosus Research Collaborative Group (CSTAR)/National Rheumatism Data Center (CRDC) Forum and China Rheumatism and Immunology Medical Association (CRCA) Annual Meeting

4.
Stohl W & Hilbert DM.
Nature Biotechnology.
2012; 30(1):69-77.

5.
Mok CC & Lau CS.
J Clin Pathol 2003;56:481–490.

6.
Zhu Wencai, et al.
Chinese Journal of Misdiagnosis.
2007; 7(14):3191-3193.

7.
Cogollo E, et al.
Drug Design, Development and Therapy 2015:9 1331–1339.

8.
Samy E, et al.
INTERNATIONAL REVIEWS OF IMMUNOLOGY.
2017; 36(1):3-19

9.
Wu D, Li J, Xu D, et al.
A Human Recombinant Fusion Protein Targeting B Lymphocyte Stimulator (BlyS) and a Proliferation-Inducing Ligand (APRIL), Telitacicept (RC18), in Systemic Lupus Erythematosus (SLE): Results of a Phase 2b Study[C]//ARTHRITIS & RHEUMATOLOGY.
111 RIVER ST, HOBOKEN 07030-5774, NJ USA: WILEY, 2019, 71.