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RemeGen's Telitacicept Demonstrates Positive Results in Phase II Trial in Treatment of Primary Sjögren's Syndrome

Published : Wednesday, January 26, 2022, 10:52 am
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Telitacicept has become the world's first pSS drug to declare Phase II results

YANTAI, China, Jan. 26, 2022 /PRNewswire/ -- RemeGen Co., Ltd. (9995.HK), a commercial-ready biotechnology company, recently announced positive results from the completion of its Phase II trial in China for Telitacicept in the treatment of primary Sjögren's syndrome ("pSS").

A total of 42 patients were enrolled in the Telitacicept study and randomly assigned to one of two treatment groups: 160mg, 240mg, and a placebo group. The 160 mg treatment group showed significant results compared with the baseline versus the placebo group, as measured by better ESSDAI scores in the full set analysis ("FAS"). The per-protocol-set analysis ("PPS") uncovered a statistical difference for both two dosage groups when compared with the placebo group. The ESSDAI is now in use as the gold standard to measure disease activity in pSS clinical studies.

Sjögren's syndrome is an immune system disorder that first attacks the mucous membranes and moisture-secreting glands of the eyes and mouth, decreasing tear and saliva production to cause the two most common symptoms of pSS — dry eyes and mouth. These symptoms present in secondary Sjögren's syndrome, which is distinguished by an accompanying autoimmune disease such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).

According to an analysis by Frost & Sullivan, the number of patients with Sjögren's syndrome worldwide has risen from 3,735,000 in 2016 to 3,897,700 in 2020. This number is projected to reach 4,092,800 by 2025 and 4,275,600 by 2030. 0.29-0.77% of the Chinese population is affected by pSS. As the disease tends to develop during one's 40s and 50s, it is more prevalent in the elderly population, where 3-4% are affected. Females are also more likely to develop pSS with a male-to-female ratio of 1:9 to 1:20. The same analysis revealed that 631,000 people in China were affected by Sjögren's syndrome in 2020. This is projected to reach 641,800 in 2025 and 644,900 in 2030.

Presently, no drug effective for the treatment of Sjögren's syndrome has been approved; existing therapies frequently lead to serious adverse events. As stated in the Frost & Sullivan analysis, symptomatic treatment can be carried out with drugs such as corticosteroids and immunosuppressants, but they also can result in extensive non-specific immunosuppression with disastrous effects.

Jianmin Fang, founder and CEO of RemeGen, is optimistic about the growing list of indications for Telitacicept: "We are very excited to see the positive results from the Phase II clinical trial of Telitacicept for yet another indication following SLE and IgA nephropathy. Telitacicept has the potential to bring a new therapy to the patient population suffering from Sjögren's syndrome, an autoimmune disease, to address an urgent clinical need."

About RemeGen Co. Ltd. 

Founded in 2008, RemeGen (9995.HK) is China's leading biopharmaceutical company committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases.

For more details, please visit the company's website: www.remegen.cn

About Telitacicept (RC18) 

Telitacicept is a proprietary novel fusion protein for the treatment of autoimmune diseases formulated using the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG).

Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-cell lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. RemeGen is currently conducting several Phase II and III clinical studies for Telitacicept to treat other indications within the autoimmune disease area to address significant unmet medical needs in this therapeutic area.

Forward-Looking Statements                    

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to RemeGen, are intended to identify certain of such forward-looking statements. RemeGen does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of RemeGen with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond RemeGen's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, RemeGen's competitive environment and political, economic, legal and social conditions.

RemeGen, the Directors and the employees of RemeGen assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements do not materialize or turn out to be incorrect.



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