RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, announced recently that its independently developed mesothelin (MSLN)-targeting antibody-drug conjugate (ADC), RC88, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.

RC88 consists of a recombinant humanized anti-MSLN monoclonal antibody linked to the microtubule inhibitor monomethyl auristatin E (MMAE), which acts as a microtubule inhibitor. It has a high affinity for MSLN, which can specifically bind to overexpressing MSLN tissues, and has clearly displayed a terminating effect on tumor cells with various expression levels of MSLN.

Epithelial ovarian cancer (EOC) is the leading cause of cancer-related deaths in women, often diagnosed late and prone to relapse within two years, with their disease evolving from platinum-sensitive to resistant. The later the stage and the more aggressive the ovarian cancer, the higher the expression rate of MSLN, and current treatment options are limited. RC88 uniquely targets MSLN, offering a novel approach to this challenging medical condition.

FTD is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose behind this is to get important new drugs to the patient earlier.

Reflecting on this process, Dr. Jianmin Fang, 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."

The Company is poised to initiate international multicenter phase II clinical studies across the United States, China, the European Union, and other regions, aiming to further clarify the optimal dosage, effectiveness, and safety of RC88 monotherapy.