RemeGen Reiterates Commitment to Its Battle Against Autoimmune Disease on World Strengthened Immunity Day 2021

Rhea-AI Summary

RemeGen Co., Ltd. celebrates World Strengthened Immunity Day by reaffirming its commitment to developing innovative biological drugs for autoimmune diseases, focusing on systemic lupus erythematosus (SLE). Its dual-target drug Telitacicept is highlighted as a significant advancement in treating SLE by inhibiting key cytokines BLyS and APRIL. The drug was recently added to China's National Reimbursement Drug List, enhancing RemeGen's confidence in its R&D efforts. Phase III trials are planned in the US for 2022, expanding treatment options for several autoimmune conditions.

Positive

• Telitacicept has been officially included in China's National Reimbursement Drug List, increasing market access.
• The drug targets key cytokines, showing promise in treating systemic lupus erythematosus and potentially other autoimmune diseases.
• Planned Phase III clinical trials in the US for Telitacicept indicate expansion into international markets and further development.

Negative

• None.

YANTAI, China, Dec. 14, 2021 /PRNewswire/ -- To celebrate World Strengthened Immunity Day, RemeGen Co., Ltd. (9995.HK), a commercial-ready biotechnology company, reiterated its commitment to discovering, developing, and producing best-in-class biological drugs for autoimmune diseases, to create clinical value, and meet the major unmet clinical needs of the world.

Since 1988, December 15 has been marked as World Strengthened Immunity Day, established by the World Health Organization (WHO) to raise awareness in the battle against disorders of the immune system. Today, this day remains to serve as a reminder that immunity stands as the "world's best doctor" for the body's well-being. World Strengthened Immunity Day symbolizes the elimination of diseases for the betterment of quality of life. RemeGen strives to uphold this, continually innovating as part of the battle against autoimmune diseases, in particular systemic lupus erythematosus (SLE).

RemeGen's Telitacicept (RC18) is a self-developed dual-target innovative fusion protein drug that can be considered a milestone in the treatment of SLE. Following the pathogenesis of SLE closely, targeted inhibition of the signaling pathways that lead to abnormal B cells has become the focus of scientific research and exploration. Studies have found that BLyS and APRIL are the key factors for the maturation and differentiation of abnormal B cells. Inhibiting these two cytokines has been shown to completely block the signal pathway of abnormal B cells and effectively reduce the body's autoimmune response.

As is the nature of a dual-target biological agent, Telitacicept can simultaneously bind to BLyS and APRIL, doing so with high affinity due to the fusion protein technology employed in the drug. This two-pronged treatment effect increases effectiveness and improves the drug's safeness.

"World Strengthened Immunity Day is important to observe every year and we are proud that our decades of research and development is bringing new treatment opportunities for more patients with autoimmune diseases, especially as this year happens to coincide with a very important milestone for RemeGen," said Jianmin Fang, founder, CEO and CSO of RemeGen. " In November, Telitacicept was officially included in the updated National Reimbursement Drug List (NRDL) in China. This news has boosted our confidence that RemeGen will continue to invest in R&D, promote clinical trials for more indications, and strive to bring new treatment opportunities for more patients with autoimmune diseases," added Fang.

Phase III clinical trials for Telitacicept are expected to be held in the US in the first half of 2022. RemeGen is also actively promoting Phase II and III trials where the drug is used for the treatment of other autoimmune diseases such as rheumatoid arthritis, neuromyelitis optica spectrum disorder, IgA nephropathy, myasthenia gravis, Sjogren's syndrome and multiple sclerosis.

SLE is one of the more common autoimmune diseases which mostly occurs in women aged 15 to 45 for which there is currently no cure. Over one million patients suffer from it in China alone. Symptoms are diverse, from facial erythema, joint swelling and pain, to photosensitivity, oral ulcers, and more. As it progresses, the disease starts to attack the kidneys and cardiovascular system and can lead to multiple organ failure, posing a serious threat to life.

The traditional treatment has strong side effects. According to the Guidelines for Diagnosis and Treatment of Systemic Lupus Erythematosus in China (2020), the treatment drugs for SLE mainly include glucocorticoids, immunosuppressants, and antimalarials. However, approximately 60% of patients still have active disease or repeated recurrences. The use of long-term high-dose glucocorticoids and immunosuppressive agents cause irreversible damage to patients' organs and even induce serious adverse reactions such as infection and bone marrow suppression.

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

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 does not materialize or turn out to be incorrect.

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SOURCE RemeGen Co., Ltd

FAQ

What is RemeGen's focus on World Strengthened Immunity Day?

RemeGen is committed to developing innovative biological drugs for autoimmune diseases, particularly systemic lupus erythematosus (SLE).

What is Telitacicept and its significance?

Telitacicept is a dual-target drug that inhibits key cytokines to reduce autoimmune responses in patients with SLE.

When are Phase III clinical trials for Telitacicept planned?

Phase III clinical trials for Telitacicept are expected to begin in the US in the first half of 2022.

How does the inclusion in the National Reimbursement Drug List impact RemeGen?

Inclusion in the National Reimbursement Drug List enhances market access and confidence in RemeGen's R&D investments.

What autoimmune diseases is RemeGen targeting with Telitacicept?

RemeGen is targeting systemic lupus erythematosus, rheumatoid arthritis, neuromyelitis optica spectrum disorder, IgA nephropathy, myasthenia gravis, Sjogren's syndrome, and multiple sclerosis.