RemeGen Announces Two Indications for Anti-HER2 Antibody-Drug Conjugate, Disitamab Vedotin for Injection, Included in China's National Reimbursement Drug List for 2023

YANTAI, China, Jan. 20, 2023 /PRNewswire/ -- RemeGen Co., Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, is pleased to announce that as of January 18, 2023, two indications for the Company's proprietary anti-HER2 antibody-drug conjugate (ADC), Disitamab Vedotin (RC48), have been successfully included in the new version of national reimbursement drug list (NRDL) in China. Specifically, the indication of HER2-expressing patients with locally advanced or metastatic urothelial carcinoma (UC), was first included in the new NRDL this year.

The previous indication for Disitamab Vedotin in patients with HER2-expressing locally advanced or metastatic gastric cancer (including gastroesophageal junction (GEJ) adenocarcinoma) was first included on the list by the end of 2021. Further at that time, the National Medical Products Administration (NMPA) of China conditionally approved Disitamab Vedotin for the treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma (UC), and this indication had since been obtained breakthrough therapy designations issued by China Center for Drug Evaluation (CDE) and U.S. Food and Drug Administration (FDA).

"In China, the high incidence of cancer imposes a heavy financial burden on individual patients and their families," said Dr. Fang Jianmin, RemeGen's CEO and Chief Scientist. "The purpose of the national reimbursement drug list is to reduce the economic pressure on patients and their families. The new indications included on the list represent further recognition of the clinical efficacy of RemeGen's Disitamab Vedotin. We will continue to carry out independent research and development of innovative drugs to meet clinical needs that have the possibility of changing the fate of patients."

China's medical insurance scheme has a large patient base and massive coverage with the number of people participating in basic medical insurance in China in 2020 exceeding 1.36 billion. It provides full reimbursement for some drugs on the list and partial reimbursement for others. Patients must pay the full price for drugs not on the list, which can cause huge financial stress. Disitamab Vedotin has expanded the selection of anti-tumor drugs within the scope of medical insurance, allowing more patients with gastric cancer and urothelial carcinoma to use higher-quality tumor-targeted drugs at lower prices, and reducing the burden on more patients and bringing hope.

Urothelial carcinoma is one of the most common malignancies, with morbidity and mortality both ranking first in male genitourinary system tumors. According to World Health Organization (WHO) data, in 2020, the incidence rate of bladder cancer ranked sixth among male malignant tumors in the world, with mortality rate ranking ninth, meaning there is an unmet clinical demand.

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.cn

About Disitamab Vedotin (RC48)

Disitamab Vedotin for injection (RC48), an anti-HER2 antibody-drug conjugate (ADC) targeting a common carcinoma with a large unmet medical need, is the first to obtain approval in China and is the first batch of ADC products independently developed by a domestic Chinese company on the market. The product was officially approved for conditional marketing by the National Medical Products Administration (NMPA) in China on June 9, 2021, for the treatment of locally advanced or metastatic gastric cancer (including adenocarcinoma of the gastroesophageal junction (GEJ). On December 31 of the same year, the National Medical Products Administration (NMPA) formally and conditionally approved the new drug marketing application for the injection of Disitamab Vedotin for the treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma.

Disitamab Vedotin for injection has been granted Breakthrough Therapy and Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial carcinoma. It has also been approved by the China National Medical Products Administration (NMPA) for advanced HER2-positive breast cancer patients with liver metastases and patients with HER2-expressing locally advanced or metastatic urothelial carcinoma.

The company is implementing differentiated development and commercial strategies for the injection of Disitamab Vedotin for common HER2 expression indications that currently lack treatment, including (i) gastric cancer (GC), (ii) urothelial carcinoma (UC) (iii) breast cancer (BC), and (iv) other cancer indications of HER2 expressions.

Forward-Looking Statements 

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to RemeGen, are intended to identify certain of such forward-looking statements. RemeGen does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of RemeGen with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond RemeGen's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, RemeGen's competitive environment and political, economic, legal and social conditions.

RemeGen, the Directors and the employees of RemeGen assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

SOURCE RemeGen Co., Ltd