Telitacicept Receives NMPA Approval for the Treatment of Sjögren’s Disease in China

Vor Bio (Nasdaq: VOR)/b) and partner RemeGen announced that China’s NMPA has approved for adult patients with Sjögren’s disease (SjD), the first and only approved SjD therapy in China.

Rhea-AI Summary

Vor Bio (Nasdaq: VOR)/b) and partner RemeGen announced that China’s NMPA has approved for adult patients with Sjögren’s disease (SjD), the first and only approved SjD therapy in China.

The decision is based on a Phase 3 trial showing statistically significant ESSDAI and clinically meaningful ESSPRI improvements, with a favorable safety profile. This is the fifth approved indication for telitacicept.

Positive

• NMPA approval for telitacicept in adult Sjögren’s disease in China
• First and only approved therapy for Sjögren’s disease in China
• Phase 3 study met primary ESSDAI endpoint at Week 24
• Sustained efficacy in both 160 mg and 80 mg groups through Week 48
• Clinically meaningful ESSPRI improvements and favorable safety profile
• Fifth indication approved for telitacicept across autoimmune diseases
• Vor Bio holds exclusive telitacicept rights outside Greater China

Negative

• None.

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Details

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On Jun 8, the day this news came out, VOR closed 0.99% above the previous close.

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Key Figures

Trial phase: Phase 3 Primary endpoint timepoint: Week 24 Efficacy duration: Week 48 +5 more

Trial phase

Phase 3

Pivotal Sjögren’s disease program supporting NMPA approval

Primary endpoint timepoint

Week 24

Change from baseline in ESSDAI score at Week 24

Efficacy duration

Week 48

Efficacy sustained through Week 48 in Phase 3 study

Dose level

160 mg

Telitacicept treatment group with significant ESSDAI reduction

Dose level

80 mg

Lower telitacicept dose also showing efficacy vs placebo

Indication count

5 indications

Sjögren’s disease marks fifth approved indication for telitacicept

Regulatory approval

First and only

First and only approved therapy for Sjögren’s disease in China

Adult population

Adult patients

Approval covers adult patients with Sjögren’s disease in China

Historical Context

5 past events · Latest: Jun 01

5 events

1. Jun 01

   Inducement grants

   24h Move

   -6.3%

   Equity awards to new hires under 2023 Inducement Plan.

2. May 28

   Conference participation

   24h Move

   -3.3%

   Jefferies Global Healthcare Conference corporate update fireside chat.

3. May 14

   Clinical data update

   24h Move

   -5.3%

   NEJM interim Phase 3 TELIGAN IgA nephropathy data for telitacicept.

4. May 13

   Earnings and pipeline

   24h Move

   -3.4%

   Q1 2026 results and ongoing global Phase 3 UPSTREAM trials update.

5. May 04

   Inducement grants

   24h Move

   +5.5%

   Stock options and RSUs granted to six new employees.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 3, randomized, double-blind, placebo-controlled, +2 more

6 terms

phase 3 medical

"based on positive Phase 3 results generated by collaborator RemeGen"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized medical

"nationwide multicenter, randomized, double-blind, placebo-controlled Phase 3 study"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

double-blind medical

"nationwide multicenter, randomized, double-blind, placebo-controlled Phase 3 study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"nationwide multicenter, randomized, double-blind, placebo-controlled Phase 3 study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

eular medical

"EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 24"

A leading professional organization for doctors and researchers focused on arthritis and other rheumatic diseases; it sets clinical guidance, organizes major scientific meetings, and publishes research that shapes practice across Europe and beyond. Think of it like a respected trade association whose recommendations and conference announcements can change how quickly new drugs and diagnostics are adopted, which in turn affects sales, pricing, and investment prospects in related healthcare companies.

nmpa regulatory

"China’s National Medicinal Products Administration (NMPA) has approved telitacicept"

China’s National Medical Products Administration is the government agency that reviews and approves medicines, medical devices and cosmetics, and enforces safety and quality rules. Think of it as a gatekeeper or traffic controller: its approvals and inspections determine whether a product can be sold, how quickly it reaches patients, and what safety or labeling rules apply—factors that directly affect a healthcare company’s sales, costs and regulatory risk for investors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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First regulatory approval for Sjögren’s disease (SjD)

First and only approved therapy for SjD in China

Approval based on positive Phase 3 results generated by collaborator RemeGen demonstrating statistically significant and clinically meaningful improvements in both ESSDAI and ESSPRI

SjD marks the fifth indication approval for telitacicept

BOSTON, June 08, 2026 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, and RemeGen Co., Ltd., (HKEX: 9995, SHA: 688331) today announced that China’s National Medicinal Products Administration (NMPA) has approved telitacicept for the treatment of adult patients with SjD.

The approval is supported by positive efficacy and safety data from RemeGen's Phase 3 clinical program in Sjögren's disease. RemeGen independently developed telitacicept and is responsible for its development, regulatory approvals, and commercialization in China. Vor Bio holds exclusive rights to develop and commercialize telitacicept outside of Greater China.

“We are thrilled to see telitacicept become the first and only approved therapy for Sjögren's disease in China, marking the first regulatory approval ever for this indication,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. “The approval represents a landmark moment for patients who have long lacked approved treatment options and reflects the strength of the clinical evidence supporting telitacicept. Notably, telitacicept is the only therapy to demonstrate statistically significant and clinically meaningful improvements in both ESSDAI and ESSPRI, underscoring its potential to address both systemic disease manifestations and the symptoms that matter most to patients. We congratulate RemeGen on this achievement and believe this fifth approved indication for telitacicept further reinforces its potential to become a foundational therapy across autoimmune diseases.”

The NMPA approval was supported by a nationwide multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating telitacicept in patients with SjD. The primary endpoint was change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 24.

In the primary analysis, patients treated with telitacicept achieved statistically significant reductions in ESSDAI score compared with placebo, with efficacy observed in both the 160 mg and 80 mg treatment groups and sustained through Week 48. Telitacicept also demonstrated clinically meaningful improvements in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), supporting benefit across both systemic disease activity and symptoms important to patients. The study met its primary efficacy endpoint and demonstrated a favorable safety profile.

About Telitacicept
Telitacicept is a novel recombinant fusion protein designed to treat autoimmune diseases through dual inhibition of BLyS (BAFF) and APRIL - two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology.

Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG).

Vor Bio is advancing telitacicept in global Phase 3 trials in gMG and SjD to support potential regulatory approvals in the United States, Europe, and Japan.

About Sjögren’s Disease (formerly known as Sjögren’s Syndrome)
Sjögren’s disease is a chronic autoimmune condition in which overactive B cells drive inflammation, damaging moisture-producing glands and, in many cases, other organs. Hallmark symptoms include dry eyes and dry mouth, alongside fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system. About one-third of patients develop significant extraglandular involvement, and the disease carries an elevated lymphoma risk, often leading to substantial impairment in daily life.

One of the most common rheumatic autoimmune diseases, Sjögren’s remains underdiagnosed, with roughly half of cases unrecognized and women comprising the vast majority of patients. Despite its prevalence and burden, no systemic disease-modifying therapies exist; current care focuses on symptom management with incomplete relief.

About Vor Bio
Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions worldwide. For more information visit www.vorbio.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding the potential of telitacicept to address both systemic disease manifestations and the symptoms that matter most to patients; telitacicept’s potential to become a foundational therapy across autoimmune diseases; and other statements that are not historical fact.

Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including the data for our product candidates may not be sufficient for obtaining regulatory approval to commercialize products; we may not be able to execute our business plans, including meeting our planned clinical and regulatory milestones and timelines, and possible limitations of financial and other resources. The results of the clinical trial described in this press release are based on information reported by RemeGen; Vor Bio has not independently verified this data. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission.

Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law. 

Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Vor Bio (VOR) announce about telitacicept approval for Sjögren’s disease in China?

Vor Bio reported NMPA approval of telitacicept for adult Sjögren’s disease (SjD) patients in China. According to Vor Bio, this is the first regulatory approval worldwide for SjD and makes telitacicept the first and only approved SjD therapy in the Chinese market.

Why is the NMPA approval of telitacicept for Sjögren’s disease important for Vor Bio (VOR) investors?

The approval validates telitacicept’s efficacy and safety in Sjögren’s disease, supporting its broader autoimmune potential. According to Vor Bio, this represents the fifth approved indication for telitacicept, which Vor Bio has exclusive rights to develop and commercialize outside Greater China.

What Phase 3 clinical results supported telitacicept’s NMPA approval in Sjögren’s disease?

The approval was based on a randomized, double-blind, placebo-controlled Phase 3 study in Sjögren’s disease. According to Vor Bio, telitacicept achieved statistically significant ESSDAI score reductions versus placebo and clinically meaningful ESSPRI improvements, with efficacy in both 160 mg and 80 mg groups and a favorable safety profile.

How did telitacicept perform on the ESSDAI and ESSPRI endpoints in Sjögren’s disease?

Telitacicept met the primary ESSDAI endpoint, showing significant disease activity reduction at Week 24. According to Vor Bio, it also delivered clinically meaningful ESSPRI improvements, indicating benefit on both systemic manifestations and patient-reported symptoms, with effects sustained through Week 48 in the Phase 3 trial.

What rights does Vor Bio (VOR) hold for telitacicept following the Sjögren’s disease approval in China?

RemeGen handles telitacicept development, approvals, and commercialization within China. According to Vor Bio, the company holds exclusive rights to develop and commercialize telitacicept outside Greater China, so China’s approval may support future ex-China autoimmune development strategies.

How many indications has telitacicept been approved for, including Sjögren’s disease?

With the new NMPA approval in Sjögren’s disease, telitacicept now has five approved indications. According to Vor Bio, this growing indication portfolio supports the view that telitacicept could become a foundational therapy across multiple autoimmune diseases.