Remegen’s Innovative New Drug Telitacicept(RC18) Obtains Positive Phase III Results, Submitted for Second Indication for Treatment of Rheumatoid Arthritis

YANTAI, China, Sept. 27, 2023 /PRNewswire/ — RemeGen Co., Ltd. (“RemeGen” or “the Company”) (HKG: 9995, SHA: 688331), a fully-integrated commercial-stage biotechnology company, recently announced that Telitacicept(RC18) for injection obtained positive results in a Phase III clinical study in the treatment of patients with rheumatoid arthritis(RA) in China. A new drug application(NDA) was also submitted to China’s National Medical Products Administration(NMPA). This is the second indication for Telitacicept after being approved for systemic lupus erythematosus(SLE) in March 2021.

This recent NDA is based on a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial, which saw a total of 479 patients with rheumatoid arthritis enrolled. At week 24, according to the results of the full analysis set(FAS), the ACR20 response rate of patients who received 160mg of Telitacicept combined with methotrexate was significantly higher than that of patients who received methotrexate monotherapy, with main efficacy endpoints successfully reached. Relevant research and development results will be published in academic journals and academic conferences in the coming months.

Telitacicept is an innovative B-cell lymphocyte stimulator/proliferation inducing ligand(BLyS/APRIL) dual-target fusion protein drug independently developed by RemeGen that can prevent abnormal differentiation of B cells by simultaneously inhibiting the overexpression of two cytokines, BLyS and APRIL, thereby treating a variety of immune diseases mediated by B cells.

“Rheumatoid arthritis(RA) is a chronic autoimmune disease, mainly characterized by erosive arthritis, that unfortunately affects a huge number of people globally,” said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen. “In the early stages of the disease, joint symptoms include morning stiffness, swelling, and pain and eventually, joint deformity and loss of normal joint function may occur, seriously affecting the quality of life of patients. It is expected that our recent successful application for Telitacicept, a new therapy for the treatment of RA, will provide new options for RA patients around the world.”

According to a Frost & Sullivan Report, the number of patients with rheumatoid arthritis worldwide is expected to reach 42.2 million people in 2025 (including 6.2 million people in China) and reach 45 million people (including 6.4 million people in China) in 2030. Current standard treatments for rheumatoid arthritis mainly include anti-inflammatory drugs, glucocorticoids, traditional immunosuppressants, and TNF-α inhibitors. For patients who are ineffective or intolerant to the above therapies, there are unmet clinical needs which are being directly addressed by RemeGen.

In March 2021, the first indication of Telitacicept was conditionally approved by the National Medical Products Administration(NMPA) for the treatment of systemic lupus erythematosus (SLE), making it the world’s first dual-target drug for the treatment of the disease. This drug was conditionally approved for marketing by China’s NMPA on March 9, 2021, and will be mainly used to treat adult SLE patients. In October 2022, the U.S. FDA granted Telitacicept orphan drug designation for the treatment of myasthenia gravis(MG). The drug is currently in Phase III clinical trials. In addition to SLE and RA, Phase III clinical studies of Telitacicept for IgA nephropathy(IgAN), neuromyelitis optica spectrum disorders(NMOSD), primary Sjögren’s syndrome(pSS), and multiple sclerosis(MS) are also underway.

About RemeGen Co. Ltd.

Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China 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: www.remegen.cn

About Telitacicept (RC18) 

Telitacicept(RC18, Brand Name: 泰爱®) is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases. It is constructed with 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. It was granted conditional marketing approval by China’s National Medical Products Administration(NMPA) to treat systemic lupus erythematosus(SLE) in March 2021.

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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