- Vor Bio's collaborator, RemeGen, announced **positive 48-week open-label extension (OLE) data** from a Phase 3 study in China for **telitacicept in generalized myasthenia gravis (gMG)** on **October 29, 2025**.  **[1817229_2de7ce651aa641dba6e07f12fb57a6d6_0]** 
- The data demonstrated **sustained efficacy**, with **100% of patients on telitacicept for 48 weeks achieving at least a 2-point improvement in MG-ADL** (Myasthenia Gravis Activities of Daily Living scale), showing a **mean reduction of -7.5 points**.  **[1817229_2de7ce651aa641dba6e07f12fb57a6d6_0]**  Continuous telitacicept patients also achieved a **-9.8 mean QMG change** (Quantitative Myasthenia Gravis) at week 48.  **[1817229_2de7ce651aa641dba6e07f12fb57a6d6_1]** 
- Telitacicept exhibited a **favorable safety profile comparable to placebo**, with **no new safety signals observed**.  **[1817229_2de7ce651aa641dba6e07f12fb57a6d6_1]** 
- Telitacicept is already **approved in China for gMG**, and a **global Phase 3 clinical trial is currently underway** across 14 countries to support potential approvals in the United States, Europe, and Japan.  **[1817229_2de7ce651aa641dba6e07f12fb57a6d6_0]** **[1817229_2de7ce651aa641dba6e07f12fb57a6d6_2]**

Vor Bio's Telitacicept Shows Sustained Efficacy and Favorable Safety in 48-Week China Phase 3 gMG Data

- VOR Biopharma Inc. presented **positive 48-week Phase 3 clinical trial data from China for telitacicept in primary Sjögren’s disease** on October 28, 2025.  **[1817229_0001193125-25-253636_vor-20251028.htm:0]** 
- Telitacicept demonstrated **statistically significant and clinically meaningful improvements** in disease activity, with the 160mg dose achieving a **-4.4 point reduction in ESSDAI score** and a **-1.9 point reduction in ESSPRI score** at Week 24 compared to placebo.  **[1817229_0001193125-25-253636_vor-ex99_1.htm:1]** 
- The trial showed a **consistent and favorable safety profile**, with no new safety signals or opportunistic infections reported.  **[1817229_0001193125-25-253636_vor-ex99_1.htm:1]** 
- Over **half of the patients (55.0%)** receiving 160mg telitacicept achieved low disease activity (ESSDAI <5) through 48 weeks, significantly higher than the 12.2% in the placebo group.  **[1817229_0001193125-25-253636_vor-ex99_1.htm:4]** 
- Telitacicept, a dual BAFF/APRIL inhibitor, is positioned as a **potential best-in-disease therapy** for pSD, building on its existing commercial approvals in China for other autoimmune conditions.  **[1817229_0001193125-25-253636_vor-ex99_1.htm:0]** **[1817229_0001193125-25-253636_vor-ex99_1.htm:2]**

VOR Biopharma Inc. discusses 48-week Phase 3 clinical trial data for telitacicept in primary Sjögren’s disease

- VOR announced positive results from the primary Sjögren's disease Phase 3 study in China for **telitacicept**, a fusion protein therapy targeting BAF and APRIL.  **[0001817229_2209206_1]** 
- The study met its primary and all secondary endpoints, demonstrating statistically significant and clinically meaningful efficacy with a **placebo-adjusted ESSDAI reduction of 3.8** and **ESSPRI reduction of 1.5**.  **[0001817229_2209206_1]** 
- Telitacicept's safety profile was consistent with previous clinical trials and vast commercial experience.  **[0001817229_2209206_1]** **[0001817229_2209206_10]** 
- The company believes the Sjögren's opportunity is substantial, with **over 800,000 diagnosed patients** in key global markets and no currently approved therapies, and plans a global Phase 3 study, likely with a **160 mg dose**.  **[0001817229_2209206_11]** **[0001817229_2209206_13]** 
- Telitacicept is already approved in China for lupus, rheumatoid arthritis, and myasthenia gravis, having treated tens of thousands of patients in real-world settings.  **[0001817229_2209206_2]**

VOR Announces Positive Phase 3 Results for Telitacicept in Sjögren's Disease

- Vor Bio's telitacicept met primary and all secondary endpoints in a **Phase 3 study in China** for primary Sjögren’s disease, demonstrating statistically significant and clinically meaningful efficacy with a favorable safety profile.  **[0001817229_2213229_1]** 
- In the Sjögren's study of **380 adults**, telitacicept **160mg** achieved a placebo-adjusted ESSDAI reduction of **3.8** and ESSPRI reduction of **1.5** at week 24, without the use of DMARDs or steroids.  **[0001817229_2213229_1]** **[0001817229_2213229_8]** 
- Telitacicept also showed deep sustained improvement through **48 weeks** in generalized myasthenia gravis, with a **two-fold improvement** on the MG ADL scale compared to competitors.  **[0001817229_2213229_1]** **[0001817229_2213229_11]** 
- The company plans to use **160mg** as the single active dose for future studies and sees a significant market opportunity in Sjögren’s disease, with over **800,000 diagnosed patients** in key global markets.  **[0001817229_2213229_11]** **[0001817229_2213229_13]** 
- Telitacicept, which targets both BAF and APRIL, is already commercially approved in China for lupus, rheumatoid arthritis, and myasthenia gravis.  **[0001817229_2213229_2]**

Vor Bio Announces Positive Phase 3 Results for Telitacicept in Sjögren’s Disease and Myasthenia Gravis

- Vor Bio announced positive results from its **primary Sjögren’s disease phase III study in China** for **telitacicept**, a fusion protein therapy targeting BAFF and APRIL.  **[0001817229_2213313_1]** 
- The study met its primary and all secondary endpoints, demonstrating **statistically significant and clinically meaningful efficacy**, with a **placebo-adjusted ESSDAI reduction of 3.8** and **ESSPRI reduction of 1.5**.  **[0001817229_2213313_1]** 
- The safety profile of telitacicept was **consistent with previous clinical trials**.  **[0001817229_2213313_1]** **[0001817229_2213313_11]**  The trial was conducted with only hydroxychloroquine as background therapy, allowing for a clear assessment of the drug's effect.  **[0001817229_2213313_1]** **[0001817229_2213313_8]** 
- By week 24, patients on **telitacicept 160 mg showed an ESSDAI improvement of more than four points versus 1.4 for placebo**, with this benefit deepening through week 48.  **[0001817229_2213313_8]**  Over **half of patients on telitacicept achieved low disease activity (below ESSDAI 5 points) by week 48**, compared to 12% on placebo.  **[0001817229_2213313_9]** 
- The company highlighted a significant market opportunity, with **over 800,000 diagnosed Sjögren’s patients in key global markets** and no currently approved therapies.  **[0001817229_2213313_11]**  Vor Bio plans to advance telitacicept into a global phase III study, likely utilizing a **single active dose of 160 mg**.  **[0001817229_2213313_13]**

Vor Bio Announces Positive Phase III Results for Telitacicept in Sjögren’s Disease

- Vor Biopharma's telitacicept demonstrated **statistically significant and clinically meaningful improvement in primary Sjögren's disease (pSD)** in China Phase 3 results, with a **-4.4 change in ESSDAI score** and **-1.9 change in ESSPRI score** from baseline at Week 24 for the 160mg dose.  **[0001817229_2208999:4]** 
- The company filed two Biologics License Application (BLA) submissions in China in **2025** for **Primary Sjögren's Disease (pSD)** and **IgA Nephropathy (IgAN)**.  **[0001817229_2208999:6]** 
- Telitacicept has already received **three commercial approvals in China**: Systemic Lupus Erythematosus (SLE) in **2021**, Rheumatoid Arthritis (RA) in **2024**, and Generalized Myasthenia Gravis (gMG) in **2025**.  **[0001817229_2208999:6]** 
- In generalized myasthenia gravis (gMG), 48-week OLE results showed **deep, sustained duration of response** and **significant MG-ADL and QMG score reduction**, with consistent safety and tolerability.  **[0001817229_2208999:4]** 
- Telitacicept maintains a **favorable safety profile** across indications, with no new safety signals reported in pSD trials and comparable adverse event rates to placebo.  **[0001817229_2208999:4]** **[0001817229_2208999:6]** **[0001817229_2208999:20]**

Vor Biopharma Provides Updates on Telitacicept Clinical Trials and Commercial Progress

- Vor Bio's collaborator, RemeGen Co., Ltd, will present **clinical data** from Stage A of a Phase 3 study evaluating **telitacicept** in adults with IgA nephropathy (IgAN) at American Society of Nephrology’s (ASN) Kidney Week 2025 on **November 8, 2025**.  **[1817229_a7f28953db8b425c8093ad031ceeb5ca_0]** 
- The study achieved its primary endpoint, demonstrating a **55% reduction** in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared with placebo (p<0.0001), and telitacicept showed a **favorable safety profile**.  **[1817229_a7f28953db8b425c8093ad031ceeb5ca_0]** 
- RemeGen has submitted a Biologics License Application (BLA) in China for telitacicept in IgAN, which, if approved, would become its **fifth approved indication** in the country.  **[1817229_a7f28953db8b425c8093ad031ceeb5ca_0]**

Vor Bio Announces Late-Breaking Presentation of Positive Phase 3 IgAN Data and BLA Submission in China

- Vor Bio announced the publication of **positive Phase 3 study results** for its drug, telitacicept, in systemic lupus erythematosus (SLE) in The New England Journal of Medicine.  **[1817229_2f96d9e7fcb0494d8990d24b3fe893c7_0]** 
- The trial met its primary endpoint, demonstrating a **statistically significant improvement in disease activity**, with **67.1% of patients responding to telitacicept** compared to **32.7% with placebo** at week 52.  **[1817229_2f96d9e7fcb0494d8990d24b3fe893c7_0]** 
- The company highlighted telitacicept's potential as a **disease-modifying therapy** for SLE, with its dual inhibition of BAFF and APRIL validated as a transformative B-cell approach.  **[1817229_2f96d9e7fcb0494d8990d24b3fe893c7_0]** 
- Safety findings were consistent with previous studies, showing **fewer serious adverse events** with telitacicept (**7.2%**) compared to placebo (**14.3%**).  **[1817229_2f96d9e7fcb0494d8990d24b3fe893c7_2]**

Vor Bio Announces Publication of Positive Phase 3 Telitacicept Results for SLE in NEJM

- Vor Bio's collaborator, RemeGen, reported **positive 48-week results** from a China Phase 3 study of telitacicept in primary Sjögren’s disease, which met its primary and all secondary endpoints.  **[1817229_45a8a19d67d2488baf056e26aa18cb35_0]** 
- The study demonstrated that **71.8%** of patients receiving telitacicept 160mg achieved a **≥3-point ESSDAI reduction** at 24 weeks, compared to **19.3%** on placebo, indicating clinically meaningful improvements.  **[1817229_45a8a19d67d2488baf056e26aa18cb35_0]** **[1817229_45a8a19d67d2488baf056e26aa18cb35_1]** 
- Telitacicept exhibited **sustained efficacy and a favorable safety profile** through 48 weeks.  **[1817229_45a8a19d67d2488baf056e26aa18cb35_0]** **[1817229_45a8a19d67d2488baf056e26aa18cb35_1]** 
- Vor Bio is currently **evaluating the timing of a global Phase 3 clinical study** for telitacicept in primary Sjögren's disease.  **[1817229_45a8a19d67d2488baf056e26aa18cb35_0]**

Vor Bio's Telitacicept Shows Positive Phase 3 Results in Primary Sjögren’s Disease

- Vor Bio (Vor 2.0) has been rebuilt around **telitacicept**, a dual **BAFF/APRIL inhibitor** licensed from RemeGen in **late June**, securing global rights ex-China.  **[1817229_2144716_0]** 
- Telitacicept is the most advanced BAFF/APRIL inhibitor globally, with **over 70,000 patients treated in China** and proven efficacy in **three indications** there.  **[1817229_2144716_0]** 
- The company is prioritizing global Phase 3 development for **Myasthenia Gravis (MG)**, with its global trial expected to read out in **H1 2027**, and **Sjögren's disease**, where RemeGen recently reported Phase 3 success.  **[1817229_2144716_2]** **[1817229_2144716_3]** **[1817229_2144716_5]** 
- Vor Bio reported a cash balance of **$190 million as of June**, providing a runway into **Q1 2027**.  **[1817229_2144716_7]** 
- Upcoming catalysts include **48-week MG long-term data** at AANEM and **Sjögren's Phase 3 data** at a major rheumatology conference, both expected around the **end of October**.  **[1817229_2144716_4]** **[1817229_2144716_5]** **[1817229_2144716_7]**

Vor Biopharma (VOR)