RemeGen Announces Preliminary Results of Phase III Confirmatory Study of Telitacicept for Treatment of Systemic Lupus Erythematosus (SLE) in China

YANTAI, China, Sept. 19, 2022 /PRNewswire/ — RemeGen Co., Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331), a commercial-stage biotechnology company, recently announced the preliminary results of the Phase III confirmatory study of its proprietary novel fusion protein Telitacicept for the treatment of systemic lupus erythematosus (SLE) in China.

The study included 335 patients who were randomized to weekly subcutaneous injections of Telitacicept (160 mg) or placebo in combination with standard therapy for 52 weeks. Preliminary results from the full analysis set (FAS) showed that at week 52, patients who received Telitacicept had a significantly higher rate of SRI-4 (The Systemic Lupus Erythematosus Responder Index 4) response than those who received placebo (82.6% vs. 38.1%, p<0.001). These figures apply multiple imputation for missing data. Imputing missing data as ‘non-response’ also reveal a significantly higher rate of SRI-4 response in the Telitacicept treated group compared to placebo (67.1% vs. 32.7%, p<0.001). This result is consistent with that of early-stage studies in China.

SLE is a chronic, multi-system, incurable autoimmune disease that can potentially lead to serious organ damage, systemic complications and even death. The drugs currently used to treat SLE can be associated with significant risks and adverse effects. Telitacicept could be considered of significant clinical value in the treatment of SLE.

2022 has been another landmark year for RemeGen. These latest Phase III confirmatory study preliminary results are a continuation of the strong momentum that the Company has been building since the beginning of the year with regards to Telitacicept, among many other clinical-stage drug candidates and selected IND-enabling stage candidates in RemeGen’s rich product pipeline. Milestones for the year thus far include:

In February, the company completed a Phase II clinical study of Telitacicept for the treatment of myasthenia gravis (MG) in China and is now speaking with the Center for Drug Evaluation (CDE) for the phase III study plan. In April, RemeGen’s Investigational New Drug (IND) application for Telitacicept for the treatment of childhood systemic lupus erythematosus (cSLE) was approved by CDE for clinical trials. In the first half of the year, the company launched a Phase III clinical study of Telitacicept in SLE in the U.S. and achieved first patient enrollment. In June, the company submitted an application for the Phase III clinical trial of Telitacicept in the treatment of immunoglobulin A nephropathy (IgAN) to CDE. Also in June 2022, the National Medical Products Administration (NMPA) in China granted an approval for a Phase III clinical trial for Telitacicept in primary Sjögren’s syndrome (pSS). In July, Telitacicept’s Investigational New Drug (IND) application for the treatment of lupus nephritis (LN) was officially accepted by CDE.

“We are delighted with the news of the preliminary results of the Phase III confirmatory study of our proprietary novel fusion protein Telitacicept for the treatment of SLE in China,” said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen. “Our focus has always been the prioritization of indications with high unmet medical needs and sizeable patient populations that can be addressed in the global market. IgAN, pSS and MG have been a major part of this focus and our portfolio of other indications for which Telitacicept could potentially be the first biologic therapy is expanding rapidly.”

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.

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About Telitacicept (RC18) 

Telitacicept (RC18, Brand Name: 泰爱®) is a proprietary novel fusion protein of us 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 the China’s National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in March, 2021. We are currently conducting a number of phase II or III clinical studies for telitacicept to treat other indications within the autoimmune disease area, in an attempt to address the significant unmet or underserved 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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