Welcome to our dedicated page for Remegen news (Ticker: REGMY), a resource for investors and traders seeking the latest updates and insights on Remegen stock.
RemeGen Co., Ltd. (REGMY) is a global biotechnology innovator developing advanced therapies for autoimmune disorders and oncology. This page aggregates official announcements, clinical trial updates, and strategic developments from the company.
Investors and researchers will find curated news about RemeGen's fusion protein therapies and antibody-drug conjugates (ADCs), including regulatory milestones for candidates like telitacicept and Disitamab Vedotin. Content spans trial phase results, partnership agreements, and market expansion initiatives.
Key updates include progress on B-cell modulation therapies for autoimmune conditions and targeted ADC treatments for solid tumors. All information is sourced directly from company filings and verified channels to ensure accuracy.
Bookmark this page for streamlined access to RemeGen's latest developments in precision medicine and biopharmaceutical innovation. Check regularly for updates on therapies addressing primary Sjögren's syndrome, myasthenia gravis, and HER2-expressing cancers.
On February 27, 2023, RemeGen Co., Ltd. highlighted its commitment to rare disease advocacy in conjunction with Rare Disease Day. The company emphasizes the challenges faced by over 25 million Americans and nearly 300 million globally suffering from rare diseases. RemeGen announced two FDA-approved innovative drugs, Telitacicept (RC18) and RC118, for three rare disease indications. Telitacicept, targeting myasthenia gravis, is moving into Phase III trials in China. RC118 aims at treating gastric and pancreatic cancers and is in Phase I trials. RemeGen is dedicated to addressing unmet clinical needs in the rare disease sector.
RemeGen Co., Ltd. (9995.HK, SHA: 688331) announced on December 7, 2022, that its antibody-drug conjugate (ADC), RC118 for injection, has received two orphan drug designations from the FDA for treating gastric and pancreatic cancers. This marks the company's fourth ODD, adding to prior designations for Disitamab Vedotin and Telitacicept. Currently undergoing Phase I trials in Australia and China, RC118 targets Claudin 18.2, a protein prevalent in certain solid tumors. The FDA's designation provides potential market exclusivity and tax incentives.
RemeGen Co., Ltd. has released positive data from its Phase II clinical study of Telitacicept for myasthenia gravis (MG) treatment in Chinese patients. The study included 41 participants, with significant improvement observed: a mean reduction of 7.7 points in the 160mg group and 9.6 points in the 240mg group on the Quantitative Myasthenia Gravis (QMG) test. The results highlight Telitacicept's safety and efficacy, addressing unmet clinical needs in MG. RemeGen continues to develop innovative therapies for autoimmune diseases.
RemeGen Co., Ltd. announced that the U.S. FDA has granted orphan-drug designation for its novel fusion protein Telitacicept (RC18) to treat myasthenia gravis (MG), a rare autoimmune disease. This designation follows positive results from a Phase II clinical study in China. MG leads to fluctuating muscle weakness, necessitating effective treatments due to existing options having limited efficacy and side effects. RemeGen aims to address this unmet need globally through Telitacicept, which targets critical signaling molecules in B-cell development. The company strives to develop solutions for life-threatening conditions.
RemeGen Co., Ltd. announced preliminary results from its Phase III study of Telitacicept for treating systemic lupus erythematosus (SLE) in China. The study involved 335 patients, revealing a significantly higher SRI-4 response rate for Telitacicept (82.6%) compared to placebo (38.1%) after 52 weeks. This aligns with earlier studies and suggests Telitacicept's potential as a valuable treatment option for SLE. 2022 has been pivotal for RemeGen, marked by various milestones in clinical research and drug applications for Telitacicept across multiple autoimmune conditions.
On July 24, 2022, RemeGen emphasized self-care for wellness on International Self Care Day. The biotechnology firm has made significant progress in developing treatments for systemic lupus erythematosus (SLE) and Sjögren's syndrome. The global phase III trial for telitacicept, aimed at treating SLE, has completed patient enrollment. A study on telitacicept's efficacy in childhood-onset SLE shows promising results. The company's domestic phase II study for Sjögren's syndrome has also yielded positive outcomes, highlighting the need for effective treatments in these autoimmune diseases.
RemeGen Co., Ltd. announced the selection of three abstracts on disitamab vedotin (RC48) for the ASCO Annual Meeting in Chicago, scheduled for June 3-7, 2022. Disitamab vedotin, an antibody-drug conjugate targeting HER2, has been approved in China for gastric and urothelial cancers. Two abstracts focus on its efficacy in metastatic urothelial carcinoma, while one explores its combination with Toripalimab. The drug has received Breakthrough Therapy Designation from the FDA for advanced urothelial cancer treatments, demonstrating its potential impact on patient care in this field.
