On January 8th, RemeGen Co., Ltd. (688331.SH/09995.HK) announced that its independently developed ADC, RC88, has been granted fast track designation (FTD) by the FDA for the treatment of platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

This is another important progress in the development of RemeGen's blockbuster ADC targeting MSLN after receiving approval from US FDA to conduct an international multi-center phase 2 clinical study last month.

Dr. Fang Jianmin, CEO of RemeGen said: “The FDA's FTD accelerates the development and review process of RC88, which affirms our commitment to pioneering treatments that address the urgent needs of those facing challenging disease. Moving forward, RemeGen will continue to accelerate the development of its ADC products, with the aim of bringing more and better solutions to patients globally”.

Fast Track designations are granted to drugs that show promise in treating a serious condition or illness and can expedite the review of therapies to fill an unmet need, and FDA provides policy support to promote development and expedite review. It includes but not limited to:

Get more opportunities for meeting discussions and written communication with FDA, so as to get closer guidance in drug research and development, clinical trial design, etc.

Obtain priority review and accelerate approval when relevant standard conditions are met.

New drug marketing application materials can be submitted through rolling review.

Previously, two innovative drugs of RemeGen, Telitacicept and Disitamab Vedotin have been awarded fast track designation by US FDA four times. And, Telitacicept has been approved for the indication of systemic lupus erythematosus, and Disitamab Vedotin has been approved for gastric cancer and urothelial cancer. Phase 3 clinical trials of Telitacicept for myasthenia gravis are underway.

Epithelial ovarian cancer (including epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer) is one of the leading causes of cancer death in women. Due to the lack of effective screening methods, more than 70% of patients are diagnosed at an advanced stage, and most patients will relapse within 2 years. As the interval between relapses gradually shortens, these patients eventually progress from platinum-sensitive relapses to platinum-resistant relapses. For patients with platinum-resistant recurrent ovarian cancer, once platinum resistance occurs, the currently available treatment methods are non-platinum chemotherapy. The treatment response rate of these regimens is still very low, and more effective treatment regimens are needed to improve the quality of life of patients.

RC88 is a new type of mesothelin-targeting ADC and uses innovative bridging technology independently developed by RemeGen to connect antibodies and drugs. It includes MSLN-targeting antibodies, cleavable linkers, and small molecule cytotoxins (MMAE). By targeting and binding to MSLN-positive tumor cells, it mediates the endocytosis of the antibody, thereby effectively delivering cytotoxins to cancer cells and achieving better tumor killing effects. RC88 is currently in phase 2 clinical trials. On December 19, 2023, RemeGen announced that its application for a Phase II clinical trial of RC88 for gynecological tumors has been approved by US FDA and will soon perform international multi-center clinical trials in the United States, China, the European Union and other countries and regions. In addition, the application for a phase I/II clinical study of RC88 combined with Sintilimab in the treatment of patients with advanced malignant solid tumors was approved by the CDE in March this year.

RemeGen is one of the few Chinese biopharmaceutical companies with a fully integrated ADC platform. Based on this platform, the company continues to improve and optimize its ADC product pipeline, and four products, including RC88, have entered clinical research or been approved for marketing. Among them, China’s first domestically produced ADC drug Disitamab Vedotin has been approved by the NMPA for 2 indications: gastric cancer and urothelial cancer and has been included in the national reimbursement drug list. Clinical trials of RC88 targeting MSLN, RC108 targeting c-Met, and RC118 targeting Claudin18.2 are proceeding steadily.