RemeGen's Telitacicept and Disitamab Vedotin Enter China's National Reimbursement Drug List for SLE and Gastric Cancer Treatment

YANTAI, China, Dec. 3, 2021 /PRNewswire/ -- RemeGen Co., Ltd. (9995.HK), a commercial-ready biotechnology company, today announced that two of its innovative drugs, a dual-targeted TACI-Fc fusion protein, Telitacicept (RC18) for treating systemic lupus erythematosus (SLE) and a novel antibody-drug conjugate (ADC), Disitamab Vedotin (RC48) for treating locally advanced or metastatic gastric cancer, have been officially included in this year's National Reimbursement Drug List (NRDL).

SLE has one of the highest mortality and disability rates among autoimmune rheumatic diseases. According to Frost & Sullivan, approximately 7.8 million patients will be diagnosed with SLE in 2020, and it is estimated to reach 8.6 million by 2030. There is a substantial unmet medical need for more effective and better-tolerated therapies for the treatment of SLE. Telitacicept is a first-in-class fusion protein product capable of simultaneously inhibiting the binding of two cytokines: a proliferation-inducing ligand (APRIL) and recombinant B lymphocyte stimulator (BLyS) proved with higher efficacy in treating SLE.

"SLE does not only severely affect patients' health but also brings a lot of difficulties in their lives. Telitacicept brings new changes for current SLE treatments in China, to maintain low disease recurrence rate, and reduce the use of glucocorticoids for patients," said Professor Zhao Yan, Director of Rheumatism Branch, Chinese Medical Association, and Chief Physician of the Department of Rheumatology and Immunology in Peking Union Medical College Hospital.

Disitamab Vedotin is China's first domestically made antibody-drug conjugate indicated for HER2-expressing locally advanced or metastatic gastric cancer. According to Frost & Sullivan, gastric cancer is one of the leading causes of cancer deaths globally. Almost one million people are diagnosed annually, and over 700,000 patients die from the disease.

"Gastric cancer has the characteristics of high morbidity and mortality, low early diagnosis rate, and poor prognosis. In the process of drug development, we were pleasantly surprised to find that the range of people benefiting from Disitamab Vedotin was greater than we thought. That is to say, patients with HER2 expressing (IHC++) or high expressing (IHC+++) can benefit regardless of their FISH expression status. This is the first ADC drug in the international gastric cancer field to report this result making it is a breakthrough development, "said Professor Lin Shen, Deputy Director of Peking University Cancer Hospital and Beijing Institute of Cancer Prevention and Treatment and Director of the Department of Gastroenterology.

The prevalence of cancer in China forces heavy burdens onto the shoulders of disease-stricken individuals and their families. The NRDL was formed to alleviate the financial pressures of falling ill. Increasing the availability of therapeutic drugs, such as Telitacicept and Disitamab Vedotin, is also conducive to improving hospital access, establishing the RemeGen brand, and facilitating subsequent business development.

"The inclusion of two of our drugs in the new NRDL serves as recognition and support of their clinical efficacy," said Fang Jianmin, CEO and Chief Scientist of RemeGen. "The company will continue to conduct independent research while innovating new products to solve unmet clinical needs and change the lives of patients."

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.

About Disitamab Vedotin (RC48)

Disitamab Vedotin (RC48) is an anti-HER2 antibody-drug conjugate targeting prevalent cancers with significant unmet medical needs, and is the first domestically developed ADC in China to receive marketing approval. The drug was granted conditional marketing approval in June 2021 by the National Medical Products Administration (NMPA) in China to treat locally advanced or metastatic gastric cancer. In the same month, the company submitted an Investigational New Drug (IND) application for the treatment of HER2-expressing advanced or metastatic urothelial carcinoma with Disitamab Vedotin.

The company is implementing a differentiated development and commercial strategy for Disitamab Vedotin, including: (i) gastric cancer (GC), (ii) urothelial carcinoma (UC), (iii) breast cancer (BC), and (iv) other HER2-expressing cancer.

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.

SOURCE RemeGen Co., Ltd