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RemeGen Co. Ltd. is a commercial-stage biotechnology company based in Yantai, China. Established in 2008, the company is a leader in providing solutions for patients with life-threatening illnesses through innovative biologic drugs. RemeGen focuses on therapeutic areas such as autoimmune diseases, oncology, and ophthalmic conditions, with a commitment to research, development, and commercialization.
RemeGen has gained recognition for its proprietary antibody-drug conjugates (ADCs), including Disitamab Vedotin (RC48) and RC88, targeting various solid tumors with high unmet medical needs. These innovative drugs have shown promising results in clinical trials, offering new hope for patients worldwide.
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.
RemeGen showcased significant research results at the ASCO 2024 Annual Meeting in Chicago, held from May 31 to June 4, 2024. The company highlighted its innovative antibody drug conjugates (ADCs), Disitamab Vedotin (RC48) and RC88, through various presentations. This included one Clinical Science Symposium, five Poster presentations, and ten online Abstracts covering multiple cancer types such as gastric, bladder, and gynecological tumors.
Key presentations featured:
1. A Phase II trial on Disitamab Vedotin combined with Toripalimab and oral fluoropyrimidine S-1 for HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma.
2. A Phase II study on neoadjuvant treatment with Disitamab Vedotin plus Toripalimab in muscle-invasive bladder cancer (MIBC), showing promising anti-tumor activity and manageable safety profiles.
Additional studies included Disitamab Vedotin for high-risk non-muscle invasive bladder cancer and advanced penile cancer, along with ten other abstracts on bladder, breast, and GI cancers.
RemeGen presented results from a Phase I/II clinical study of RC88, an antibody-drug conjugate targeting mesothelin (MSLN) in advanced solid tumors. The study included 170 patients with ovarian cancer, non-squamous non-small cell lung cancer, and cervical cancer who had failed standard therapies.
Key findings include:
- Ovarian cancer cohort: 45.2% overall response rate (ORR) and a median duration of response (DoR) of 8.02 months.
- Non-squamous non-small cell lung cancer cohort: 31.3% ORR and a median progression-free survival (PFS) of 6.87 months.
- Cervical cancer cohort: 33.3% ORR with a median DoR of 9.13 months.
These promising results suggest RC88's potential in improving outcomes for MSLN-expressing tumors.
RemeGen has announced the completion of patient enrollment for two Phase III clinical trials in China using Telitacicept for IgA nephropathy and primary Sjögren's syndrome (pSS). The trials enrolled 318 and 381 patients, respectively, aiming to evaluate the efficacy and safety of Telitacicept. The IgA nephropathy trial focuses on patients at risk of end-stage kidney disease, using pre-filled injections to simplify administration. The pSS trial measures changes in the EULAR Sjögren's syndrome disease activity index (ESSDAI) at week 24. These trials mark significant progress in RemeGen's efforts to provide more effective treatment options.
RemeGen Co. is celebrating World Lupus Day 2024 by sharing updates on its revolutionary fusion protein drug Telitacicept, offering hope to systemic lupus erythematosus (SLE) patients worldwide. Telitacicept, the world's first approved dual-target new fusion protein drug, has shown significant efficacy in treating SLE, offering a breakthrough in the global treatment of the disease. RemeGen's commitment to raising awareness about lupus and improving treatments underscores its mission to change the lives of millions affected by this autoimmune disease.
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