Takeda Announces Topline Results of Phase 3 ADMIRE-CD II Trial of Alofisel® (darvadstrocel) in Complex Crohn’s Perianal Fistulas
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Telitacicept Phase III Clinical Trial Results for Rheumatoid Arthritis Patients

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YANTAI, China, Nov. 15, 2023. RemeGen Co., Ltd. (“RemeGen” or “the Company”), a commercial-stage biotechnology company, is invited to present telitacicept Phase III Clinical Trial Results for Rheumatoid Arthritis Patients in a Late-Breaking Abstract Oral Presentation Session by the American College of Rheumatology(RA). According to the abstract, this Phase III, randomized, double-blind study evaluated the efficacy and safety of telitacicept 160 mg group versus the placebo group in RA patients with inadequate responses to MTX. The study met all its primary endpoints and showed comparable safety profile of telitacicept group vs. control group. Interested parties are welcome to attend Remegen’s presentation session on Wednesday, November 15 from 7:30 a.m. to 9:00 a.m.(PST) at ACR Convergence 2023 at the San Diego Convention Center in California.The invitation to present at ACR Convergence 2023 follows a recent announcement that the Company’s cutting-edge drug telitacicept (RC18) obtained positive results in a Phase III clinical study in the treatment of patients with rheumatoid arthritis in China. 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 immunology diseases mediated by B cells.

About RemeGen Co. Ltd.

Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to discovering, developing, and commercializing innovative and differentiated biologic drugs for significant unmet medical needs in the key therapeutic areas including autoimmune, oncology, and ophthalmic diseases. RemeGen has research laboratories and offices throughout China and the United States. For more details, please visit: www.remegen.com

About Telitacicept (RC18)

Telitacicept is RemeGen’s proprietary novel fusion protein for the treatment of 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.

SOURCE RemeGen Co., Ltd

Posted: November 2023

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