REMEGEN CO LTD UNSP/ADR - REGMY STOCK NEWS

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.

RemeGen Co., Ltd. (9995.HK) announced positive outcomes from its Phase II trial of Telitacicept for treating primary Sjögren's syndrome, with 42 patients enrolled. The 160mg group showed significant improvement in ESSDAI scores compared to the placebo. The number of Sjögren's syndrome patients globally is projected to rise to 4.27 million by 2030. No approved drugs exist for this condition, making Telitacicept a promising new therapy that could fulfill unmet medical needs. RemeGen aims to expand indications for Telitacicept beyond this trial.

RemeGen Co., Ltd. celebrates World Strengthened Immunity Day by reaffirming its commitment to developing innovative biological drugs for autoimmune diseases, focusing on systemic lupus erythematosus (SLE). Its dual-target drug Telitacicept is highlighted as a significant advancement in treating SLE by inhibiting key cytokines BLyS and APRIL. The drug was recently added to China's National Reimbursement Drug List, enhancing RemeGen's confidence in its R&D efforts. Phase III trials are planned in the US for 2022, expanding treatment options for several autoimmune conditions.

RemeGen announced the inclusion of two innovative drugs, Telitacicept (RC18) for systemic lupus erythematosus and Disitamab Vedotin (RC48) for gastric cancer, in China's National Reimbursement Drug List. This recognition highlights their clinical efficacy and aims to improve patient access to effective treatments. Telitacicept offers a first-in-class approach for SLE, while Disitamab Vedotin targets HER2-expressing gastric cancer. The drugs address critical unmet medical needs and are expected to bolster RemeGen's market presence and business development.