HER2-expressing Gastric Adenocarcinoma

YANTAI, China, Feb. 2, 2024 /PRNewswire/ -- RemeGen Co. Ltd.("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, with a mission that is closely aligned with the Close the Care Gap theme of World Cancer Day 2024 which falls on February 4, has announced three major developments that will further the global fight against cancer and forge new paths in tumor treatments. The Company not only endeavors to contribute to the field of anti-cancer treatments, but also provide much-improved medical opportunities and increased hope to all patients. Dr. Jianmin Fang, CEO of RemeGen, commented, "Cancer is the common enemy of mankind, and at RemeGen we feel a strong sense of responsibility and mission to continue to provide more effective and safer treatment options for cancer patients around the world through our cutting-edge innovation and research. On World Cancer Day 2024, we are proud to announce more advances in cancer drug research through drug discovery and collaboration with our partners. We are celebrating the progress of scientific research and working for a more just and healthier future. Our time is now, and our mission is clear. Let's act together for a world without cancers." RemeGen's three major recent developments On January 12, RemeGen announced that it enrolled its first patient on a Phase II study of Disitamab Vedotin combined with Zimberelimab to treat cervical cancer patients who have failed at least one first-line platinum-containing standard treatment. Preliminary data show that Disitamab Vedotin can significantly improve treatment efficiency and its safety is controllable. Zimberelimab, compared with the data of PD-1/PD-L1 single drugs approved for this indication (not head-to-head), displayed excellent long-term efficacy with a higher objective response rate (ORR) of 27.8%, a median progression-free survival (mPFS) of 3.7 months, a median overall survival (mOS) of 16.8 months, and a 2-year duration of response (DoR) rate of 55%. This study is a new combination treatment strategy that is expected to provide better options for cervical cancer patients and bring new hope. On January 15, RemeGen announced its RC88 combined with Sintilimab injection to treat advanced malignant entities in cooperation with Innovent Biologics was approved by the State Food and Drug Administration's for Center for Drug Evaluation (CDE). The Phase I/IIa clinical study in tumor patients approved by the CDE is an open, multi-center Phase I/IIa clinical study in patients with advanced malignant solid tumors expressing mesothelin (MSLN). It includes, but is not limited to, pleural mesothelioma, peritoneal mesothelioma, ovarian cancer, pancreatic cancer, and lung adenocarcinoma, gastric adenocarcinoma, triple-negative breast cancer, among other cancer types that may benefit to evaluate the efficacy, safety, tolerability, PK characteristics, immunogenicity, and preliminary results of RC88 combined with Sintilimab injection administered every three weeks. Also recently, a national multi-center clinical study of RemeGen's Disitamab Vedotin (RC48) combined with monoclonal antibody, Toripalimab, in the treatment of HER2-expressing advanced gastric cancer and other solid tumors, led by Professor Shen Lin from Peking University Cancer Hospital, was published in The Lancet sub-journal eClinicalMedicine. This study is the first to explore the safety and efficacy of antibody drug conjugates (ADC) combined with immunotherapy in patients with HER2-positive and HER2-low-expressing gastric cancer. The study results show that Disitamab Vedotin combined with Toripalimab has a controllable safety profile and is effective in patients with HER2-positive and HER2-low-expressing gastric cancer or gastroesophageal junction (G/GEJ) cancer, displaying encouraging efficacy. About World Cancer Day World Cancer Day is a leading international awareness day held every February 4 and is the global uniting initiative led by the Union for International Cancer Control (UICC). By raising worldwide awareness, improving education and catalyzing personal, collective and government action, organizers all work together to reimagine a world where millions of preventable cancer deaths are saved and access to life-saving cancer treatment and care is equitable for all - no matter who you are or where you live. 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: SOURCE RemeGen Co., Ltd

YANTAI, China, Dec. 18, 2023 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, SHA: 688331), a commercial-stage biotechnology company, has recently confirmed that under the 2023 simple renewal mechanism of China National Healthcare Security Administration (NHSA), on January 1, 2024, the updated National Reimbursement Drug List (NRDL) will continue to include Telitacicept (RC18) and Disitamab Vedotin (RC48) for the next two-year agreement. This achievement represents a significant milestone for RemeGen in the innovative pharmaceutical industry and reinforces its prominent position in the market. The successful renewal also underscores the effectiveness of RemeGen's business strategy and highlights positive strides in enhancing the accessibility of innovative drugs within the Chinese market. "The simplified renewal provides a solid foundation for the sustainable development of innovative drug companies such as RemeGen and allows for the continuous improvement of patient access to innovative drugs, meaning patients can truly benefit from healthcare innovations." said Dr. Jianmin Fang, CEO of RemeGen. Telitacicept, RemeGen's proprietary novel fusion protein for the treatment of autoimmune diseases and the world's first innovative dual-target biological agent for treating systemic lupus erythematosus (SLE), received approval from China's National Medical Products Administration (NMPA) in March 2021 and subsequently entered the market. By December of the same year, the product was first added to the updated National Reimbursement Drug List (NRDL) to treat adult patients with SLE. Upon conditional marketing approval from the NMPA on March 9, 2021, it received full marketing approval on November 22 this year. The results of the Phase III study of Telitacicept showed the SRI-4 Telitacicept group response rate to be significantly higher than that of the placebo group (82.6% vs 38.1%), with positive effects. Disitamab Vedotin, an investigational anti-HER2 antibody-drug conjugate targeting prevalent solid cancers with significant unmet medical needs, obtained marketing approval in June and December 2021, respectively, for treating patients with HER2-expressing locally advanced or metastatic gastric cancer (GC) and advanced urothelial cancer (mUC). In December 2021, the HER2-expressing GC indication was successfully included in the updated NRDL. Furthermore, in January 2023, related urothelial cancer indication was also added to the same NRDL. As per the information presented in RemeGen's 2022 annual report, the inclusion of Telitacicept and Disitamab Vedotin on the NRDL at the close of 2021 had a substantial impact on product production and sales in 2022. Notably, sales witnessed a remarkable surge, escalating by 1780 percent and 1513 percent for Telitacicept and Disitamab Vedotin, respectively, compared to the preceding year. This not only underscores the effectiveness and growing popularity of these drugs among patients but also signifies a substantial rise in drug demand, attributed to the alleviation of financial burdens on patients through medical insurance. The successful renewal by RemeGen not only showcases its robust competitiveness in the Chinese market but also mirrors the rapid development of medical care in China while serving as a positive example of China's pharmaceutical industry on the global stage. Looking ahead, RemeGen is poised to maintain a pivotal role in the global pharmaceutical market. 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: About Telitacicept (RC18) Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatments of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator(BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. It was granted conditional marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in March 2021. About Disitamab Vedotin (RC48) Disitamab Vedotin (RC48) is an investigational anti-HER2 antibody-drug conjugate targeting prevalent solid 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. 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 do not materialize or turn out to be incorrect. Company Codes: HongKong:9995, OTC-PINK:REGMY, Shanghai:688331