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.
RemeGen (REGMY) announced significant positive results from its Phase 3 clinical trial of disitamab vedotin (DV) in combination with PD-1 inhibitor toripalimab. The study, evaluating the treatment as a first-line therapy for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC), successfully met its primary endpoints of progression-free survival (PFS) and overall survival (OS).
The trial, involving 484 patients across 74 sites in China, demonstrated statistically significant improvements in both PFS and OS compared to standard chemotherapy, regardless of cisplatin eligibility or HER2 expression levels. The treatment showed a manageable safety profile with tolerable adverse reactions. RemeGen plans to file a Biologic License Application (BLA) with China's NMPA, with detailed data to be presented at upcoming international conferences.
RemeGen (REGMY) has announced breakthrough Phase 3 clinical trial results for Telitacicept in treating generalized myasthenia gravis (gMG). The trial, presented at the American Academy of Neurology Annual Meeting 2025, showed remarkable efficacy with 98.1% of patients in the Telitacicept 240 mg group achieving ≥3-point reduction in MG-ADL score and 87% showing ≥5-point reduction in QMG score at Week 24.
The multicenter, randomized, double-blind study involved 114 gMG patients, demonstrating significant improvements in clinical outcomes with a favorable safety profile. At Week 24, the Telitacicept group showed MG-ADL score changes of -5.74 versus -0.91 in the placebo group. The drug's Biologics License Application has been accepted by China's regulatory authorities, with approval expected in Q2 2025.
RemeGen presented promising Phase II clinical trial results for Disitamab Vedotin (DV) combined with Toripalimab in treating HER2-expressing muscle-invasive bladder cancer (MIBC) at ASCO GU 2025. The study (NCT05297552) showed a pathological complete response (pCR) rate of 63.6%, nearly double the traditional neoadjuvant chemotherapies (36%-42%).
The trial included 47 patients, with 33 undergoing radical cystectomy. Key findings include: 75.8% pathological response rate, 85.7% pCR rate in T2N0 stage patients, and 84.6% pCR rate in HER2 IHC 3+ patients. The 12-month event-free survival rate was 92.5%, with 18-month rate at 85.9%. Grade 3 or higher adverse events were reported in 27.7% of cases, lower than traditional chemotherapy (40%-50%).
RemeGen's phase 1b/2 clinical trial results for Disitamab Vedotin (DV) combined with Toripalimab in treating locally advanced or metastatic urothelial carcinoma (la/mUC) were published in Annals of Oncology. The nearly three-year follow-up data showed impressive results with a 73.2% objective response rate (ORR) and 33.1 months median overall survival (OS).
The study enrolled 41 patients between August 2020 and December 2021. Key findings include: 9.8% complete response rate, 63.4% partial response rate, 90.2% disease control rate (DCR), 9.3 months median progression-free survival (PFS), and 8.6 months median duration of response (DOR). The 36-month OS rate was 49.2%.
Notably, patients with HER2 expression (IHC 1+/2+/3+) showed better outcomes with 76.3% ORR compared to 33.3% in HER2 IHC 0 patients. The therapy demonstrated efficacy across various subgroups, including chemotherapy-naïve patients (76.0% ORR) and those who progressed on platinum-based chemotherapy (68.8% ORR).
RemeGen presented groundbreaking results from its Phase III study of Disitamab Vedotin (DV) for HER2-positive advanced breast cancer with liver metastasis at the 47th San Antonio Breast Cancer Symposium. The study, involving 104 patients, compared DV against Lapatinib plus Capecitabine in patients previously treated with Trastuzumab and Taxanes.
Key findings showed DV significantly improved progression-free survival (9.9 months vs. 4.9 months), with a hazard ratio of 0.56. The overall survival data, while not yet mature, showed a positive trend favoring DV. This marks the first global prospective randomized Phase III study demonstrating significant efficacy of a HER2-targeting ADC in this patient population, where the 5-year survival rate is typically only 8% to 12%.
The Biologics License Application for DV has been accepted by China's National Medical Products Administration with priority review status.
RemeGen announced that its drug Taicercept® for treating generalized myasthenia gravis (gMG) has been accepted for marketing application by China's Center for Drug Evaluation (CDE) and included in priority review. The drug targets a rare chronic autoimmune disease affecting an estimated 217,000 patients in China, with global cases expected to reach 1.5 million by 2025. Telitacept, a dual target antibody fusion protein, completed Phase III clinical trials in China in August 2024, showing continuous and effective improvement in gMG patients. The drug has received orphan drug and fast track status from the FDA and breakthrough therapy status from China's NMPA.
RemeGen Co. (9995.HK, SHA:688331) has announced the first patient enrollment in the U.S. for its global phase III clinical trial of telitacicept, a BLyS/APRIL dual targeting fusion protein, for treating generalized myasthenia gravis (gMG). This milestone marks a significant step in telitacicept's worldwide clinical development. The trial aims to recruit 180 patients globally to evaluate the drug's efficacy and safety.
Telitacicept has received orphan drug and fast track status from the FDA and breakthrough therapy designation from China's NMPA. Since its approval in China in March 2021, telitacicept has treated over 40,000 patients with excellent efficacy and safety. The global myasthenia gravis patient population is expected to reach 1.15 million by 2025, highlighting the significant market potential for this innovative treatment.
