a commercial-stage biotechnology company, announced on December 7, 2022, that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company’s fourth, having previously been twice granted ODD for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year.
Self-developed, RC118 is RemeGen’s latest advanced antibody-drug conjugate (ADC) used to treat patients with solid tumors positive for Claudin 18.2 expressions. The product was previously approved by China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) to conduct clinical trials on September 18, 2021. Phase I clinical trials for malignant solid tumors RC118 are currently being developed in Australia and China for the treatment of locally advanced unresectable or metastatic disease in patients with positive Claudin 18.2 expressions and a dose-escalation study is underway, thus far showing good safety and tolerability.
Claudin protein is a tight junction molecule whose function is mainly to regulate the permeability of the cellular barrier structure. 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. Due to specific expression characteristics, Claudin 18.2 has become a popular target that many pharmaceutical companies have been paying close attention to, with no drug for this target so far being approved for marketing globally.
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.
“It is another positive step forward in the biotechnology development for RemeGen. We are very pleased to have received from the FDA the Orphan Drug Designation for gastric cancer and pancreatic cancer, which adds to the designation granted already for the treatment of myasthenia gravis,” said Dr. Jianmin Fang, CEO and Chief Scientific Officer of RemeGen.
RemeGen is one of a handful of Chinese biopharmaceutical companies with a fully integrated ADC platform. Based on this platform, the company has continuously improved and optimized its proprietary ADC product pipeline, with no less than four products, including the latest RC118, entering clinical trials or gaining marketing approval. Among them, China’s first domestically produced ADC drug, Disitamab Vedotin (RC48), with two indications for gastric and urothelial cancers and autoimmune drug Telitacicept (RC18) have been approved by NMPA in China.
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.
Independently developed by RemeGen, RC118 is a novel antibody-drug conjugate (ADC) targeting Claudin 18.2 expressions. It is the fourth ADC product of the Company to enter clinical studies. In July 2021, the product was approved by the Australian Human Research Ethics Committee for Phase I clinical trial approval, and in September of the same year, it further obtained Phase I clinical trial approval from the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE). At the end of 2021, a phase I clinical trial for patients with locally advanced unresectable or metastatic malignant solid tumors with positive expression of Claudin 18.2 was launched in China and Australia.
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