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RemeGen Releases Phase II Clinical Study Data for Treatment of Myasthenia Gravis in Chinese Patients

RemeGen Releases Phase II Clinical Study Data for Treatment of Myasthenia Gravis in Chinese Patients

YANTAI, China, Nov.1, 2022 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, recently released data from the Phase II clinical study of its proprietary novel fusion protein Telitacicept for the treatment of myasthenia gravis (MG) in Chinese patients, showing positive results.

For the multicenter, randomized, open-label Phase II clinical study, the subjects were adult patients diagnosed with myasthenia gravis (MG), who had tested positive for acetylcholine receptor antibodies, and were receiving standardized medical therapy. With a dosing cycle of once per week for 24 weeks, a total of 41 patients were recruited, where 29 of which were randomly assigned in the trial (14 assigned to the Telitacicept 160mg group and 15 in the 240mg group), and all completed the full duration. The primary efficacy endpoint of the study was the change in the Quantitative Myasthenia Gravis (QMG) test score at week 24 compared to the baseline.

The study showed a mean reduction of 7.7 points in the Telitacicept 160mg group and 9.6 points in the Telitacicept 240mg group (an improvement of 3 points in the QMG score is clinically significant, with an improvement of more than 5 points representing significant curative effects). It showed that Telitacicept can significantly improve the condition of patients and demonstrated good safety in the treatment of myasthenia gravis (MG).

"As a fully-integrated biopharmaceutical company committed to the discovery, development and commercialization of innovative and differentiated biologics for the treatment of autoimmune, oncology and ophthalmic diseases, our vision to become a leading player in the global biopharmaceutical industry is rapidly being realized," said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen.

"Leveraging our strong research and development platforms, we have discovered and developed a robust pipeline of more than ten drug candidates, among which, seven are in clinical development stage targeting over twenty indications. The latest Phase II clinical study results show the use of our proprietary novel fusion protein Telitacicept in the treatment of MG in Chinese patients has the potential to profoundly address the unmet clinical needs of countless patients in China and around the globe," added Fang.

Currently, the most common treatment options for myasthenia gravis (MG) include cholinesterase inhibitors, glucocorticoids, immunosuppressants, where a large number of unmet clinical demands need to be addressed. RemeGen will continue to invest in the research and development of innovative drugs and provide solutions to the unmet clinical needs of patients suffering from life-threatening illnesses.

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 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.

In September 2022, RemeGen received preliminary results from a Phase III validation study of Telitacicept for the treatment of systemic lupus erythematosus (SLE) in China, showing results consistent with earlier phase studies. The Company is now conducting Phase II or Phase III clinical trials of Telitacicept for multiple other indications in the treatment of autoimmune diseases to address a significant unmet or undermet medical need 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 does not materialize or turn out to be incorrect.

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