As the world celebrates Rare Disease Day 2023, RemeGen Co., Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331) stands in solidarity with the millions of people living with a rare disease, their families and carers. As a commercial-stage biotechnology company, RemeGen continues to strengthen its social responsibility and rare disease advocacy, aiming to increase visibility and create positive change for all affected by rare diseases.
For Rare Disease Day 2023, RemeGen is proud to stand alongside the over 25 million Americans and nearly 300 million people worldwide facing the challenges of rare diseases. Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen, shares his commitment to supporting those living with rare diseases and their families, “We understand the pain and confusion of living with a rare disease, and we are here to provide help and support.” On this special day, RemeGen will be there to show solidarity and spread awareness of the major impact that rare diseases have on individuals, families, and society.
In honor of Rare Disease Day, RemeGen is proud to have had two groundbreaking new drugs, Telitacicept (RC18) and RC118, approved by the U.S. Food and Drug Administration (FDA) for three rare disease indications in the past six months. We are also actively conducting Phase I/III clinical trial research to ensure that those living with a rare disease have access to diagnosis and therapies. Let’s come together to push for equity in social opportunity, healthcare, and access to treatment options!
Myasthenia gravis (MG) is a rare, chronic autoimmune disorder that affects the transmission of signals between the nerves and muscles. Symptoms of the disease can range from difficulty in eye movement, swallowing, speech, activity, and respiratory function. RemeGen’s Telitacicept (RC18), a novel fusion protein for the treatment of myasthenia gravis, has been granted an Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) and Breakthrough Drug Designation (BDD) by the Center for Drug Evaluation (CDE) of the State Food and Drug Administration. The positive results obtained in a Phase II clinical study of Telitacicept in the treatment of generalized myasthenia gravis (gMG) in China has resulted in the launch of a Phase III clinical trial research.
Orphan drugs, also known as rare disease drugs, are a special type of medication used to combat rare conditions. The US Food and Drug Administration (FDA) grants a special designation, called the Orphan Drug Designation (ODD), for treatments for diseases that affect fewer than 200,000 people in the United States each year. The ODD provides several incentives for drug developers, including tax breaks, a seven-year market exclusivity period, and other policy incentives. These drugs are essential for the prevention, treatment, and diagnosis of rare diseases.
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 for the treatment of gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. Currently, RC118 is undergoing a Phase I clinical trial to treat locally advanced unresectable or metastatic malignant solid tumors in patients with a positive Claudin 18.2 expression. 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. By targeting this molecule, RemeGen hopes to revolutionize the treatment of these hard-to-treat cancers.
About RemeGen Co. Ltd.
RemeGen is a pioneering biopharmaceutical company that has been leading the way in providing cutting-edge solutions for those suffering from life-threatening illnesses since 2008. With research and offices in both China and the United States, the company has been dedicated to discovering, developing, and commercializing biologic drugs with a focus on autoimmune, oncology, and ophthalmic diseases. RemeGen strives to make a lasting impact on the lives of patients by producing innovative and differentiated treatments that address unmet clinical needs.