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Remegen - REGMY STOCK NEWS

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.

News

RemeGen's Telitacicept (RC18) Granted Fast Track Designation by United States FDA for Treatment of Primary Sjögren's Syndrome

Rhea-AI Summary
RemeGen Co. receives Fast Track Designation from the FDA for its innovative drug Telitacicept to treat primary Sjögren's syndrome. Telitacicept is a dual-target fusion protein drug that inhibits B-cell overexpression, addressing autoimmune diseases. Phase III clinical trials are ongoing in China.
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RemeGen Presents Oral Presentation on Evaluation of Its Proprietary Disitamab Vedotin (RC48) for Cervical Cancer at ESGO 2024

Rhea-AI Summary
RemeGen Co. Ltd. presented positive interim data on Disitamab Vedotin for HER2-expressing cervical cancer patients at ESGO 2024 Congress. The Phase II study showed an ORR of 36.4% and a manageable safety profile. RC48 demonstrates promise as a new treatment option for HER2-expressed cervical cancer.
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World Cancer Day 2024: RemeGen Announces Three Significant Developments in the Global Fight Against Cancer, Narrowing the Care Gap

Rhea-AI Summary
RemeGen Co. Ltd. has announced three major developments in the fight against cancer, including advancements in cancer drug research and new treatment options for cervical cancer, advanced malignant entities, and HER2-expressing advanced gastric cancer. These developments aim to provide more effective and safer treatment options for cancer patients around the world.
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RemeGen's RC88 Obtained FDA Fast Track Designation, Heralds New Hope for Ovarian Cancer Patients

Rhea-AI Summary
RemeGen Co. Ltd. (9995.HK, 688331.SH) announced that its mesothelin-targeting antibody-drug conjugate, RC88, has been granted Fast Track Designation by the FDA for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers. RC88 has shown promising results in terminating tumor cells with various expression levels of MSLN, offering a novel approach to this challenging medical condition.
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RemeGen Announces Continued Inclusion of Telitacicept and Disitamab Vedotin in China National Reimbursement Drug List, Ensuring Continuous Accessibility of Innovative Drugs for More Patients

Rhea-AI Summary
RemeGen Co. Ltd. (9995.HK, SHA: 688331) has confirmed the inclusion of Telitacicept and Disitamab Vedotin on the National Reimbursement Drug List (NRDL) under the 2023 simple renewal mechanism of China National Healthcare Security Administration (NHSA). This achievement signifies a significant milestone for RemeGen in the innovative pharmaceutical industry and highlights its prominent position in the market. Sales of these drugs surged by 1780% and 1513% for Telitacicept and Disitamab Vedotin, respectively, compared to the preceding year, showcasing their growing popularity and effectiveness among patients.
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RemeGen Announces Publication of Results from Two Phase II Studies for Disitamab Vedotin in Latest Issue of Journal of Clinical Oncology (JCO)

Rhea-AI Summary
RemeGen Co. Ltd. (9995.HK, SHA: 688331) announced positive results from two Phase II trials of Disitamab Vedotin for HER2-positive locally advanced or metastatic urothelial carcinoma. The drug demonstrated consistent efficacy and manageable safety profiles, leading to its conditional approval in China.
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RemeGen to Present Telitacicept Phase III Clinical Trial Results for Rheumatoid Arthritis Patients in a Late-Breaking Abstract Oral Presentation Session at the American College of Rheumatology

Rhea-AI Summary
RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) is set to present telitacicept Phase III Clinical Trial Results for Rheumatoid Arthritis Patients at the American College of Rheumatology (ACR) Convergence 2023. The study demonstrated the efficacy and safety of telitacicept 160 mg group compared to the placebo group in RA patients with inadequate responses to MTX. This follows positive results in a Phase III clinical study in China for the innovative drug telitacicept, which independently developed by RemeGen, targeting B-cell lymphocyte stimulation and proliferation inducing ligands (BLyS/APRIL) to treat various immunology diseases mediated by B cells.
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Remegen's Innovative New Drug Telitacicept(RC18) Obtains Positive Phase III Results, Submitted for Second Indication for Treatment of Rheumatoid Arthritis

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RemeGen's Telitacicept shows positive results in Phase III study for rheumatoid arthritis treatment in China
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RemeGen's Telitacicept Shows Significant Promise in Phase II Trial for Primary Sjogren's Syndrome: Findings Published in Prestigious Rheumatology Journal

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RemeGen Co., Ltd. (HKG: 9995, SHA: 688331) has announced the publication of their Phase II clinical study of telitacicept (RC18) for the treatment of Primary Sjögren's Syndrome (pSS) in adults in the top international medical journal Rheumatology. The study, led by Professor Zeng Xiaofeng, demonstrated significant improvements in disease activity index scores, promising clinical benefits, and well-tolerated treatment. Telitacicept shows great potential as a breakthrough treatment for pSS.
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RemeGen and Innovent Collaborate on Clinical Trials to Evaluate the Potential of RC88 and RC108 Combined with PD-1 Therapy for Advanced Solid Tumors

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Research and Development in Biotechnology
Professional, Scientific, and Technical Services
China (Mainland)