RemeGen Receives Orphan Drug Designation from the FDA for Telitacicept for the Treatment of Myasthenia Gravis

YANTAI, China, October 12, 2022 /PRNewswire/ — RemeGen Co., Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331), a commercial-stage biotechnology company, announced that the United States Food and Drug Administration (FDA) has obtained orphan drug designation (ODD) for its novel patented fusion protein Telitacicept (RC18) for the treatment of myasthenia gravis (MG).

Myasthenia gravis (MG) is a chronic autoimmune neuromuscular disease that makes patients prone to fluctuating muscle weakness. It can affect eye movements, swallowing, speech and respiratory functions to varying degrees and can even be life-threatening in severe cases. The disease, although rare, is a long-lasting condition that is currently difficult to cure. In 2018, it was added to the National Rare Disease Registry System of China, the first national list of rare diseases published in the country. Currently, the most common treatment options for MG symptom relief include cholinesterase inhibitors, glucocorticoids, immunosuppressants, intravenous immunoglobulin, plasma exchange, anti-CD20 monoclonal antibodies (mAb) and thymectomy. These treatments can have some side effects, while fast-acting treatments such as plasma replacement can impact the immune system due to removal of other macromolecules and poor accessibility. Therefore, a significant unmet clinical need is currently being addressed by RemeGen.

“We are delighted that the FDA has granted ODD the new proprietary Telitacicept fusion protein created by RemeGen,” said Dr. Jianmin Fang, CEO and Scientific Director of RemeGen. “This is an important step in our quest to address the significant global unmet need for myasthenia gravis, and follows our successful Phase II clinical study in patients in China earlier this year.”

In the first quarter of this year, the company announced the completion of a phase II clinical study of Telitacicept for the treatment of generalized myasthenia gravis (gMG) in Chinese patients, which showed positive results.

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 diseases. 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 new proprietary fusion protein from RemeGen to treat autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and modulator calcium receptor and cyclophilin ligand interactor (TACI) and the crystallizable fragment (Fc) domain of human immunoglobulin G (IgG). Telitacicept targets two cell signaling molecules essential for B cell development: B cell stimulator (BLyS) and proliferation-inducing ligand (APRIL), enabling it to effectively reduce autoimmune responses mediated by involved B cells in several autoimmune diseases. It has been granted conditional marketing authorization by China National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in March 2021.

Forward-looking statements

This press 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, with respect to RemeGen, are intended to identify certain of these forward-looking statements. RemeGen does not intend to regularly update these forward-looking statements.

These forward-looking statements are based on RemeGen’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such statements are made. These statements are not guarantees 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. Accordingly, actual results may differ materially from the information contained in the forward-looking statements due to changes or future developments in our business, RemeGen’s competitive environment and political, economic, legal and social conditions.

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SOURCE RemeGen Co.,Ltd

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