On Rare Disease Day 2023 RemeGen Highlights Its Social Responsibility and Rare Disease Advocacy

YANTAI, China — RemeGen Co., Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331), a commercial-stage biotechnology company, continues to strengthen its social responsibility and rare disease advocacy in unison with Rare Disease Day 2023’s message of continuing to increase visibility and generate change for the millions of people globally living with a rare disease, their families and carers.

Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen, said, “Rare Disease Day 2023 is a highly important day that marks a global celebration to raise awareness among the public and decision-makers regarding the challenges faced by over 25 million Americans and nearly 300 million people globally who are impacted by rare diseases, and those without a diagnosis. Individuals and families affected by the type of rare diseases that we target should know they are not alone. RemeGen takes immense pride in observing this special day and will be there to help and support all those living with rare diseases.”

Rare Disease Day is a global movement focused on rare diseases that pushes for equity in social opportunity, healthcare, and access to diagnosis and therapies for people living with a rare disease. During the past six months, RemeGen has had two innovative new drugs, Telitacicept (RC18) and RC118, approved by the U.S. Food and Drug Administration (FDA) for three rare disease indications and is currently conducting Phase I/III clinical trial research.

Myasthenia gravis (MG) is a rare, chronic autoimmune disease caused by autoantibodies against acetylcholine receptors, muscle-specific kinases, or other acetylcholine receptor-related proteins on the postsynaptic membrane, leading to neuromuscular junction Impaired transmission that can affect eye movement, swallowing, speech, activity, and respiratory function to varying degrees. RemeGen’s proprietary novel fusion protein for the treatment of myasthenia gravis (MG), Telitacicept (RC18), was granted orphan-drug designation (ODD) by the U.S. Food and Drug Administration (FDA) in October 2022 and in November 2022 the product was granted breakthrough drug designation by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration for this indication. Prior to this, the phase II clinical study of Telitacicept in the treatment of generalized myasthenia gravis (gMG) in China was completed with positive results obtained. Currently, Phase III clinical trial research is being launched in the country.

Orphan drugs, also known as rare disease drugs, are used for the prevention, treatment, and diagnosis of rare diseases. The ODD granted by the US FDA is applicable to drugs and biologics for rare diseases with less than 200,000 patients in the United States each year. The drugs that have been certified can potentially enjoy tax incentives in the United States, a seven-year market exclusivity period after listing, as well as other policy incentives.

Additionally, RemeGen’s self-developed innovative antibody-drug conjugate (ADC) RC118 was granted two orphan drug designations by the US Food and Drug Administration (FDA) in December 2022, targeting the treatment of gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. RC118 is currently conducting a Phase I clinical trial for the treatment of locally advanced unresectable or metastatic malignant solid tumors in patients with a positive Claudin 18.2 expression. Claudin protein is a tight junction molecule whose function is mainly to regulate the permeability of the epithelial layer. As a member of the Claudin protein family, Claudin 18.2 is a highly tissue-specific protein that is mainly expressed in gastric epithelial cells and is also highly expressed in primary malignant tumors such as gastric, breast, colon, liver, and pancreatic cancers.

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