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<title>Remegen Co. Ltd. A — News on 6ix</title>
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<title>Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/telitacicept-achieved-primary-endpoint-reducing-164500001</link>
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<pubDate>Sat, 08 Nov 2025 16:45:00 GMT</pubDate>
<description>Treatment with telitacicept for 39 weeks resulted in a rapid, clinically meaningful, and statistically significant reduction in proteinuria, with a favorable safety profile Telitacicept demonstrated a 55% reduction in 24-hour urine protein-to-creatinine ratio (24h-UPCR) at 39 weeks compared with placebo; statistically significant benefits also achieved across all key secondary endpoints Data presented as late-breaking oral presentation at American Society of Nephrology’s Kidney Week 2025 BOSTON,</description>
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<title>Telitacicept Demonstrates Sustained Efficacy and Favorable Safety Profile in 48-Week China Phase 3 Open-Label Extension Generalized Myasthenia Gravis Data</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/telitacicept-demonstrates-sustained-efficacy-favorable-150100567</link>
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<pubDate>Wed, 29 Oct 2025 15:01:00 GMT</pubDate>
<description>Telitacicept delivered consistent quality-of-life improvement across both treatment and placebo crossover arms 100% of patients on telitacicept for 48 weeks achieved ≥2-point Myasthenia Gravis Activities of Daily Living (MG-ADL) improvement, with a mean reduction of -7.5 points Sustained efficacy and favorable safety extension data support potential global best-in-disease profile in generalized myasthenia gravis (gMG) BOSTON, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-st</description>
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<title>ESMO Congress 2025 Presidential Symposium Oral Presentation | Disitamab Vedotin Achieves Major Breakthrough as First-Line Treatment for Urothelial Carcinoma</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/esmo-congress-2025-presidential-symposium-065700600</link>
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<pubDate>Mon, 20 Oct 2025 06:57:00 GMT</pubDate>
<description>At the 2025 European Society for Medical Oncology (ESMO) Congress, a Phase III clinical study on disitamab vedotin plus toripalimab versus chemotherapy as first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (RC48-C016) sponsored by RemeGen Co., Ltd. was presented at the Presidential Symposium by Professor Jun Guo from Beijing Cancer Hospital. It's the first time a research led by Chinese scholars in the field of urological oncology has ever been selected</description>
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<title>Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/telitacicept-demonstrates-clinically-meaningful-statistically-120000745</link>
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<pubDate>Tue, 14 Oct 2025 12:00:00 GMT</pubDate>
<description>Telitacicept met primary and all secondary endpoints, demonstrating clinically meaningful improvements in disease activity versus placebo ~71.8% of patients receiving telitacicept 160mg achieved ≥3-point ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) reduction vs 19.3% on placebo at 24 weeks Sustained efficacy and favorable safety profile through 48 weeks support potential best-in-disease profile in primary Sjögren’s disease (pSD) Company evaluating timing of global Phase 3 clinical st</description>
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<title>2025 ACR Abstract Released! Exciting Data from Telitacicept's Phase III Clinical Study in Sjögren's Syndrome in China</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/2025-acr-abstract-released-exciting-054400676</link>
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<pubDate>Tue, 14 Oct 2025 05:44:00 GMT</pubDate>
<description>On October 14, RemeGen (688331.SH/09995.HK) announced that the results of the Phase III clinical study of Telitacicept for Sjögren's Syndrome in China have been published in an abstract on the 2025 ACR website. The study met its primary endpoint of change from baseline in ESSDAI at week 24, as well as all key secondary endpoints, with the telitacicept 160mg dose achieving highly significant p values (p<0.0001) for every endpoint at week 24 and 48 compared to placebo. The results will be presente</description>
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<title>Results of China Phase III Clinical Study of Telitacicept for Generalized Myasthenia Gravis Selected for Oral Presentation at 2025 AANEM Annual Meeting</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/results-china-phase-iii-clinical-010000675</link>
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<pubDate>Thu, 18 Sep 2025 01:00:00 GMT</pubDate>
<description>RemeGen (688331.SH/09995.HK) announced that the 48-week open-label extension (OLE) data from China Phase III clinical study of telitacicept (RC18, brand name: 泰爱®, a BLyS/APRIL dual-target fusion protein innovative drug independently developed by RemeGen) for the treatment of generalized myasthenia gravis (gMG) was selected as an oral presentation at the 2025 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. The meeting will be held from October 29 to Nov</description>
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<title>Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/telitacicept-achieved-primary-endpoint-phase-120000955</link>
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<pubDate>Wed, 27 Aug 2025 12:00:00 GMT</pubDate>
<description>Results reinforce telitacicept’s potential across multiple autoimmune diseases Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its collaborator, RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in a</description>
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<title>RemeGen and Santen Enter into Exclusive Licensing Agreement for Ophthalmic Innovative Drug RC28-E in Greater China and Asian countries</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/remegen-santen-enter-exclusive-licensing-000000068</link>
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<pubDate>Tue, 19 Aug 2025 00:00:00 GMT</pubDate>
<description>RemeGen Co., Ltd. (Stock Code: 688331.SH/09995.HK, "RemeGen"), a leading Chinese biopharmaceutical company, announced today that it has entered into an agreement with Santen Pharmaceutical (China) Co., Ltd. ("Santen China"), a wholly-owned subsidiary of Santen Pharmaceutical Co., Ltd. ("Santen"). Under the agreement, Santen China has obtained exclusive rights to develop, manufacture, and commercialize RC28-E in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) as well as in</description>
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<title>Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for Primary Sjögren's Disease with Telitacicept, a Dual BAFF/APRIL Inhibitor</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/telitacicept-achieved-primary-endpoint-phase-123000480</link>
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<pubDate>Wed, 13 Aug 2025 12:30:00 GMT</pubDate>
<description>Phase 3 results position telitacicept as potential best-in-disease profile in primary Sjögren's disease Telitacicept demonstrated a favorable safety profile Vor evaluating timing of global Phase 3 clinical study in primary Sjögren's disease Data anticipated to be presented at an upcoming medical conference CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that its co</description>
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<title>Telitacicept Meets Primary Endpoint in Phase III Trial for Primary Sjögren's Syndrome in China</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/telitacicept-meets-primary-endpoint-phase-095700267</link>
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<pubDate>Wed, 13 Aug 2025 09:57:00 GMT</pubDate>
<description>On August 13th, Remegen (688331.SH/09995.HK) announced that its global first-in-class BLyS (BAFF)/APRIL dual-target fusion protein drug, Telitacicept, met the primary endpoint in its Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) in China, as per the pre-specified study protocol. The company will promptly submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and plans to present</description>
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<title>RemeGen's Independently-Developed Bispecific Antibody RC148 Approved to Proceed Phase II Clinical Trial in US by FDA</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/remegens-independently-developed-bispecific-antibody-095000657</link>
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<pubDate>Fri, 08 Aug 2025 09:50:00 GMT</pubDate>
<description>On August 8th, RemeGen Co., Ltd. (688331.SH/09995.HK) announces clearance of IND application by Food and Drug Administration (FDA) for phase II clinical trials for its independently-developed bispecific antibody, RC148, for the treatment of multiple advanced malignant solid tumors in the US.</description>
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<title>RemeGen's Telitacicept (RC18) Received Orphan Drug Designation from EMA for Myasthenia Gravis</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/remegens-telitacicept-rc18-received-orphan-151600738</link>
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<pubDate>Tue, 17 Jun 2025 15:16:00 GMT</pubDate>
<description>On June 16, 2025, RemeGen Co., Ltd. ("RemeGen", stock symbols: 688331.SH/09995.HK) announced that telitacicept (RC18; brand name: 泰爱®) has received Orphan Drug Designation (ODD) from European Medicines Agency (EMA) for the treatment of Myasthenia Gravis (MG), marking a key milestone achieved in its global development. Telitacicept now is the first dual-target biologic drug for MG with ODD from both FDA and EMA worldwide.</description>
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<title>2025 ASCO ｜Oral Presentation: Disitamab Vedotin Achieves Stellar Efficacy as First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Gastric Cancer</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/2025-asco-oral-presentation-disitamab-010000685</link>
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<pubDate>Tue, 03 Jun 2025 01:00:00 GMT</pubDate>
<description>On June 2 (Chicago time), in an oral presentation at the 2025 ASCO Annual Meeting, Dr. Lin Shen from Beijing Cancer Hospital presented the results of a Phase 2 clinical study conducted in China evaluating the efficacy and safety of disitamab vedotin (DV), developed by Remegen Co., Ltd., and toripalimab (PD-1) combined with CAPOX or trastuzumab as the first-line therapy for HER2-expressing patients with locally advanced or metastatic (la/m) gastric cancer. Comparing to the control group who recei</description>
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<title>RemeGen: Telitacicept for the Treatment of Generalized Myasthenia Gravis Approved in China</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/remegen-telitacicept-treatment-generalized-myasthenia-083000110</link>
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<pubDate>Tue, 27 May 2025 08:30:00 GMT</pubDate>
<description>On May 27, RemeGen Co., Ltd.(688331.SH / 09995.HK) announced that Telitacicept has officially been approved for marketing in China by the National Medical Products Administration (NMPA) for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in combination with conventional therapies. As the world's first innovative biologic drug targeting both BLyS and APRIL for the treatment of myasthenia gravis (MG), Telitacicept's appr</description>
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<title>Poised to Reshape Treatment Landscape: The Phase 3 Clinical Trial of Disitamab Vedotin as a First-Line Therapy for HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma Reached its Primary Endpoints of PFS and OS</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/poised-reshape-treatment-landscape-phase-082900474</link>
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<pubDate>Mon, 12 May 2025 08:29:00 GMT</pubDate>
<description>On May 12th, 2025, RemeGen Co., Ltd. ("RemeGen", stock symbols: 688331.SH/09995.HK) announced that its phase 3 clinical trial (Study ID: RC48-C016) on disitamab vedotin (DV, brand name: 爱地希®), the first domestically approved antibody-drug conjugate (ADC) in China, in combination with the PD-1 inhibitor toripalimab versus the standard chemotherapy as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC) has reached its two primary endpoints of pro</description>
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<title>Remegen Announces Exciting Results of Telitacicept Phase 3 Clinical Trial for Patients with Generalized Myasthenia Gravis</title>
<link>https://6ix.com/company/remegen-co-ltd-a/news/remegen-announces-exciting-results-telitacicept-020700211</link>
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<pubDate>Wed, 09 Apr 2025 02:07:00 GMT</pubDate>
<description>On April 8, 2025 (UTC-7), impressive results of the Phase 3 clinical trial (NCT05737160) evaluating the efficacy and safety of Telitacicept (synonym: RC18; brand name: 泰爱®) in patients with generalized myasthenia gravis (gMG) were presented during the Late-Breaking Science Session at the American Academy of Neurology (AAN) Annual Meeting 2025 in San Diego, CA.</description>
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