YANTAI, China, May 24, 2022 /PRNewswire/ -- RemeGen Co., Ltd. (9995.HK, SHA: 688331), a commercial-stage biotechnology company, today announced that three abstracts for disitamab vedotin (RC48) have been selected for poster discussions by the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting that will be held from June 3 to June 7 2022 in Chicago, USA. Disitamab vedotin is a novel antibody-drug conjugate (ADC) directed to HER2 and it has been approved by National Medical Products Administration (NMPA) in China for the treatment of gastric and urothelial cancers.
The clinical studies described in the three abstracts were conducted or sponsored by RemeGen and will be presented at a poster discussion session, constituting a topical discussion on the treatment of metastatic urothelial carcinoma (mUC). The session is scheduled on June 4 and will include all related clinical studies to be presented by RemeGen. These abstracts highlight the emerging role of disitamab vedotin in the potential management of mUC.
In abstract #4518, entitled, "Preliminary Results of a Phase Ib/II Combination Study of Disitamab Vedotin in Combination with Toripalimab in Locally Advanced or Metastatic Urothelial Carcinoma," investigators report updated data that continue to demonstrate a manageable safety profile and promising efficacy of disitamab vedotin. The earlier data from this study were previously presented at the 2022 ASCO Genitourinary Cancers Symposium (ASCO-GU) held earlier this year in February 2022.
The other two abstracts are entitled, "A phase II study of RC48-ADC in HER2-negative patients with locally advanced or metastatic urothelial carcinoma" and "RC48-ADC for Metastatic Urothelial Carcinoma with HER2-positive: combined analysis of RC48-C005 and RC48-C009 trials." These studies further highlight the potential clinical efficacy of disitamab vedotin in mUC patients.
"We are delighted that our research has been recognized and selected for the upcoming ASCO meeting," said Fang Jianmin, CEO and Chief Scientific Officer of RemeGen. "RemeGen has performed a number of clinical trials for disitamab vedotin in the treatment of HER2-expressing advanced gastric, urothelial, and breast cancers. Disitamab vedotin has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for use in second-line treatment of patients with HER2-expressing, locally advanced or metastatic urothelial cancer (mUC) who have previously received platinum-containing chemotherapy. The data presented in this ASCO meeting will provide additional support that disitamab vedotin may play a unique role in meeting unmet medical needs for the patients of urothelial cancer."
In China, disitamab vedotin has been granted conditional approval by the NMPA for locally advanced or metastatic urothelial carcinoma after at least 2 prior systemic chemotherapy treatments, opening a new chapter in the treatment of urothelial carcinoma in China. In addition, disitamab vedotin has been included in the Chinese Society of Clinical Oncology (CSCO) guidelines in 2021.
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 (RC48) is an investigational anti-HER2 antibody-drug conjugate targeting prevalent cancers with significant unmet medical needs and is the first domestically developed ADC to receive marketing approval in China. The drug was granted conditional marketing approval in June 2021 by the National Medical Products Administration (NMPA) in China to treat locally advanced or metastatic gastric cancer. In the same month, the company submitted an Investigational New Drug (IND) application for the treatment of HER2-expressing advanced or metastatic urothelial carcinoma with disitamab vedotin. In 2021, RemeGen and Seagen Inc. entered into an exclusive worldwide licensing agreement to develop and commercialize disitamab vedotin.
The company is implementing a differentiated development and commercial strategy for disitamab vedotin, including (i) gastric cancer (GC), (ii) urothelial carcinoma (UC), (iii) breast cancer (BC), and (iv) other HER2-expressing cancers.
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 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 concerning 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.
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Source: RemeGen Co., Ltd Related Stocks: HongKong:9995 OTC:REGMY Shanghai:688331
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