RemeGen's RC88 Obtained FDA Fast Track Designation, Heralds New Hope for Ovarian Cancer Patients

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RemeGen Co. Ltd. (9995.HK, 688331.SH) announced that its mesothelin-targeting antibody-drug conjugate, RC88, has been granted Fast Track Designation by the FDA for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. RC88 has shown promising results in terminating tumor cells with various expression levels of MSLN, offering a novel approach to this challenging medical condition.

YANTAI, China, Jan. 12, 2024 /PRNewswire/ -- 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. This marks another significant development following the FDA's approval to RC88's international multicenter Phase II clinical trials last month.

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.

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.com

About RC88

RC88 is a novel antibody drug conjugate (ADC) independently developed by RemeGen targeting mesothelin (MSLN). It uses the company's independently developed innovative bridging technology to connect antibodies and drugs. The structure includes MSLN-targeting antibodies, cleavable connections and a small fraction of cytotoxins (MMAE) can mediate the endocytosis of antibodies by binding to MSLN-positive tumor cells, thereby effectively delivering cytotoxins to cancer cells and achieving improved tumor killing effects.

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SOURCE RemeGen Co., Ltd

FAQ

What is the Fast Track Designation granted by the FDA for?

The Fast Track Designation was granted for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.

What is RC88 and how does it work?

RC88 is a mesothelin-targeting antibody-drug conjugate consisting of a recombinant humanized anti-MSLN monoclonal antibody linked to the microtubule inhibitor MMAE. It has a high affinity for MSLN and has shown promising results in terminating tumor cells with various expression levels of MSLN.

What is the significance of the FDA's Fast Track Designation for RC88?

The Fast Track Designation accelerates the development and review process of RC88, affirming RemeGen's commitment to pioneering treatments that address urgent medical needs.

What are the next steps for RemeGen and RC88?

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