On April 2, Rongchang Biopharmaceutical (Yantai) Co., Ltd.(stock code:688331.SH / 09995.HK) announced:The U.S. FDA granted it fast-track qualification for Taitcept to treat Sjogren's syndrome. At the end of 2023, the global multi-center Phase III clinical trial for this indication has been approved by the US FDA.

Primary Sjogren's syndrome (pSS) is a chronic inflammatory autoimmune disease that mainly affects secretory glands such as lacrimal glands and salivary glands. Patients often experience symptoms such as dry mouth, dry eyes, and dry skin. At present, there are no satisfactory treatment measures for pSS. Whether it is dryness, fatigue, pain or damage to internal organs, there is a lack of effective drugs demonstrated by evidence-based medicine. Most of the drugs currently used are empirical treatment or refer to the treatment of similar lesions.

The B cell pathway plays a key role in the pathogenesis of pSS, while B lymphocyte stimulating factor (BLyS) and proliferation inducing ligand (APRIL) play a crucial role in B cell maturation and differentiation. As a new all-human TACI-Fc fusion protein, Tetacecept is prepared by connecting the extracellular segment of B cell surface receptor TACI with the IgG1 Fc segment through recombinant DNA technology. It can simultaneously bind BLyS and APRIL factors, inhibit B cells. Maturity and differentiation, reduce autoantibody secretion, and better control disease activity.

Previously, the results of a randomized, double-blind, placebo-controlled phase II clinical trial of taitcept in the treatment of adult patients with pSS were published in the international authoritative journal RHEUMATOLOGY. The study conclusions show that Taitcept demonstrates good clinical benefits when treating patients with pSS. Compared with placebo, the tetanercept treatment group significantly improved ESSDAI scores and MFI-20 in patients with pSS at weeks 12 and 24, and reduced immunoglobulin levels. It was safely tolerated without serious adverse events. No deaths occurred in each group during the trial.

There are currently no biological drugs approved worldwide for the treatment of Sjogren's syndrome. Tetacecept is expected to become a breakthrough drug for Sjogren's syndrome, filling a gap in this field and bringing hope for cure to more patients.

About Fast Track Certification (FTD)

Fast Track Designation (FTD) is a qualification granted by the U.S. FDA to promote the development of new drugs to treat serious diseases and address unmet clinical needs. After the drug obtains FTD, the new drug research and development company will have more opportunities to communicate with the FDA during the subsequent drug development and review process, which will help accelerate the subsequent drug development and approval for marketing. In addition, new drug research and development companies can submit new drug research data to the FDA on a rolling basis when submitting a marketing application (NDA/BLA). These preferential policies provide favorable guarantees for accelerating the research and development of new drugs.

So far, Rongchang Biotech's three drugs have been granted fast-track qualifications by the U.S. FDA five times. Among them, tataercept has been approved for the indication of systemic lupus erythematosus, vedicizumab gastric cancer and urothelial cancer. Taitcept is undergoing Phase III clinical trials for the indication of myasthenia gravis, and the ADC under development drug RC88 targeting MSLN is in Phase II clinical trials for the indication of ovarian cancer.

About Titaship

Tetacecept is an antibody fusion protein drug molecule invented and designed by Professor Fang Jianmin, CEO and chief scientific officer of the company. It is the world's first new biological drug for dual-target treatment of systemic lupus erythematosus. It treats autoimmune diseases by simultaneously inhibiting the over-expression of two cytokines, BLyS and APRIL, and preventing the abnormal differentiation and maturation of B cells in a "two-pronged" manner. In addition to systemic lupus erythematosus that has been approved for marketing, the indication of tataercept for rheumatoid arthritis has been applied for marketing, and Phase III clinical studies for indications such as IgA nephritis, Sjogren's syndrome, neuromyelitis optica, and myasthenia gravis are underway.