Vor Bio (VOR) drug telitacicept gains China NMPA nods in IgAN and Sjögren’s
Rhea-AI Filing Summary
Vor Bio reported that its partner RemeGen has received decisions from China’s National Medicinal Products Administration for telitacicept in two autoimmune kidney and rheumatologic diseases. Telitacicept gained conditional approval for treating adult patients with IgA nephropathy and full approval for adult patients with Sjögren’s disease in China.
The IgA nephropathy decision is based on Phase 2 and Phase 3 data, including a 59% reduction in urinary protein-to-creatinine ratio at Week 39 with telitacicept 240 mg and a favorable safety profile. Telitacicept is described as the first and only BAFF/APRIL-targeting therapy approved for IgA nephropathy.
For Sjögren’s disease, a Phase 3 study showed statistically significant improvements in the ESSDAI disease activity score and clinically meaningful gains in the ESSPRI patient-reported index across 160 mg and 80 mg doses with sustained benefit to Week 48. Telitacicept is the first approved therapy for Sjögren’s disease in China. RemeGen controls development and commercialization in China, while Vor Bio holds exclusive rights outside Greater China and is advancing global Phase 3 programs.
Positive
- Multiple NMPA approvals validate telitacicept: Conditional approval in IgA nephropathy and full approval in Sjögren’s disease, backed by Phase 3 data, strengthen clinical and regulatory proof for this dual BAFF/APRIL inhibitor and support Vor Bio’s global Phase 3 development outside Greater China.
Negative
- None.
Insights
China approvals validate telitacicept across multiple autoimmune indications but commercial benefit for Vor Bio depends on ex-China execution.
The NMPA’s conditional approval in IgA nephropathy and full approval in Sjögren’s disease give telitacicept four and five approved indications respectively in China. These decisions rest on randomized Phase 3 data showing strong reductions in proteinuria and disease activity, plus favorable safety signals.
For Vor Bio, which holds rights outside Greater China, the immediate commercial upside from these China approvals is indirect. The value lies in clinical and regulatory validation of dual BAFF/APRIL inhibition and in telitacicept’s first-in-class and only-therapy positioning in these diseases.
Impact ultimately hinges on Vor Bio’s global Phase 3 programs in generalized myasthenia gravis and Sjögren’s disease, and on its ability to secure approvals in the United States, Europe, and Japan. The company also notes that key trial data come from RemeGen and have not been independently verified by Vor Bio.
8-K Event Classification
Key Figures
Key Terms
BAFF/APRIL-targeting therapy medical
IgA nephropathy medical
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) medical
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) medical
conditional approval regulatory
Phase 3 TELIGAN trial medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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Item 7.01 Regulation FD Disclosure.
On June 8, 2026, Vor Biopharma Inc. (the “Company”) announced that RemeGen Co., Ltd. received conditional approval from the National Medicinal Products Administration (“NMPA”) for telitacicept for the treatment of adult patients with IgA nephropathy and approval from the NMPA for telitacicept for the treatment of adult patients with Sjögren’s disease, in each case in China. A copy of the Company's press releases are furnished as Exhibits 99.1 and 99.2.
The information contained in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, attached hereto, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. |
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99.1 |
Telitacicept Receives NMPA Conditional Approval for the Treatment of IgA Nephropathy in China |
99.2 |
Telitacicept Receives NMPA Approval for the Treatment of Sjögren’s Disease in China |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Vor Biopharma Inc. |
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June 8, 2026 |
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/s/ Jean-Paul Kress |
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Jean-Paul Kress |
Telitacicept Receives NMPA Conditional Approval for the Treatment of IgA Nephropathy in China
First and only approved BAFF/APRIL-targeting therapy for IgA nephropathy (IgAN)
Approval based on positive interim Phase 3 TELIGAN results generated by collaborator RemeGen and recently published in The New England Journal of Medicine
IgAN marks the fourth indication approval for telitacicept
BOSTON, Mass., June 8, 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 conditionally approved telitacicept for the treatment of adult patients with IgAN.
The conditional approval is supported by positive efficacy and safety data from RemeGen's completed Phase 2 trial (18C014) and Phase 3 TELIGAN trial (18C021 Part A) in IgAN. 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 delighted to see telitacicept receive NMPA conditional approval in IgA nephropathy, representing an important achievement for the field and the first regulatory approval of a BAFF/APRIL-targeting therapy for IgAN,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. “We congratulate our collaborator RemeGen on the successful development, regulatory submission, and approval of telitacicept in China. Together with the positive Phase 3 TELIGAN results recently published in The New England Journal of Medicine, this milestone further validates the potential of dual BAFF/APRIL inhibition to address the underlying immunopathology of IgAN and supports our belief that telitacicept has the potential to become a foundational therapy across multiple autoimmune diseases globally.”
The NMPA approval was supported by positive results from the Phase 3 TELIGAN trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating telitacicept in adults with IgAN. The primary endpoint was change from baseline in urinary protein-to-creatinine ratio (UPCR) at Week 39.
In the primary analysis, patients treated with telitacicept 240 mg achieved a 59% reduction in UPCR from baseline at Week 39, corresponding to a 55% placebo-adjusted reduction. The study met its primary efficacy endpoint and demonstrated a favorable safety profile.
As previously reported in The New England Journal of Medicine, telitacicept treatment was also associated with encouraging preservation of kidney function. Estimated glomerular filtration rate (eGFR) remained largely stable through 39 weeks of treatment, while greater declines were observed in the placebo arm. Additional findings included reductions in circulating CD19+ B cells and serum immunoglobulin levels, including IgA, consistent with telitacicept's mechanism of action.
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 IgA Nephropathy
IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide and a leading cause of chronic kidney disease (CKD) and end-stage renal disease (ESRD). It is characterized by IgA-containing immune complex deposition in the kidney, leading to inflammation, proteinuria, hypertension, and progressive loss of renal function. Up to 40% of patients progress to ESRD within 20 years of diagnosis, underscoring the significant unmet need for effective therapies. Current treatment approaches, including optimized blood pressure control, renin-angiotensin system blockade, and SGLT2 inhibitors, primarily slow disease progression but do not address the underlying immunopathology.
The prevailing scientific consensus is that overproduction of galactose-deficient IgA1 (Gd-IgA1) is a central driver of IgAN. BAFF and APRIL, two cytokines critical to B-cell survival and function, promote the production of Gd-IgA1 and its pathogenic antibodies.
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 dual BAFF/APRIL inhibition to address the underlying immunopathology of IgAN; telitacicept’s potential to become a foundational therapy across multiple autoimmune diseases globally potential for telitacicept to become a best-in-class dual BAFF/APRIL therapy across autoimmune diseases and to deliver meaningful benefit for patients globally; Vor Bio’s development and commercialization plans for telitacicept; 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
Telitacicept Receives NMPA Approval for the Treatment of Sjögren’s Disease in China
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, Mass., June 8, 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