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Rongchang BioTatisip's first biopharmaceutical for Sjogren's syndrome market application was accepted by CDE

2025-09-19 05:15:52 healthy

Rongchang BioTatisip's first biopharmaceutical for Sjogren's syndrome market application was accepted by CDE

Recently, Rongchang Biopharma (Yantai) Co., Ltd. (hereinafter referred to as "Rongchang Biopharma") announced that its independently developed innovative biopharmaceutical Tatecip (RC18) for the treatment of Sjogren's syndrome (SS) application has been accepted by the Drug Review Center (CDE) of the State Drug Administration. This is the world's first biopharmaceutical application for Sjogren's syndrome, marking a major breakthrough in the treatment model in this field.

1. The current treatment status of Sjogren's syndrome and the breakthrough of Tetarcept

Rongchang BioTatisip's first biopharmaceutical for Sjogren's syndrome market application was accepted by CDE

Sjogren's syndrome is a chronic autoimmune disease that mainly affects the exocrine glands, causing symptoms such as dry mouth and dry eyes. In severe cases, it can cause multiple system damage. At present, there are no special drugs for this disease worldwide, and clinical treatment is mainly used to relieve symptoms. As the world's first dual-target fusion protein targeting B lymphocyte stimulator (BLyS) and proliferation-induced ligand (APRIL), tetacept is expected to fundamentally improve disease progression by regulating B cell function.

Global epidemiological data for Sjogren's syndromeValue
Number of patients around the worldAbout 5 million
Number of patients in ChinaAbout 1 million
Female proportionMore than 90%

2. Clinical data and advantages of tetacept

The results of Phase III clinical trial of tetacept showed that it significantly improved the patient's symptoms and immune indicators, and was safe. The following are the key clinical data:

Clinical trial indicatorsresult
ESSPRI score improvement rate68.5% (vs placebo 29.4%)
Increased saliva flow rate≥50% of patients
Adverse reaction rateEquivalent to the placebo group

3. Rongchang Bio's R&D pipeline and market prospects

Tetarcept is one of Rongchang Bio's core products and has been approved in China for the treatment of systemic lupus erythematosus (SLE). The advancement of indications for Sjogren's syndrome has further broadened its market potential. According to forecasts, if approved for listing, Tetarcept is expected to become a major product with annual sales of over 2 billion yuan.

Progress in Rongchang Bio's R&D Pipeline (partial)state
Tatasip (SLE)Already on the market
Tedasip (SS)Listing application acceptance
Vidicitumab (gastric cancer)Phase III clinical

4. Reactions between the industry and the capital market

After the news was announced, Rongchang Bio's stock price rose by more than 5% on the same day, reflecting the market's confidence in innovative biopharmaceuticals. Many analysts pointed out that Tetarcept's differentiated advantages and first-mover position will help Rongchang Bio to occupy a leading position in the field of autoimmune diseases.

5. Future Outlook

With the expansion of Tetacipep indications, Rongchang Bio is expected to become an important player in the treatment of autoimmune diseases worldwide. The acceptance of CDE is a key step, and the subsequent approval process and commercialization performance deserve continuous attention.

This article is based on public data and aims to convey industry information and does not constitute investment advice.

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