{"id":4319,"date":"2026-06-14T10:09:50","date_gmt":"2026-06-14T17:09:50","guid":{"rendered":"https:\/\/xpharma.com.cn\/?p=4319"},"modified":"2026-06-14T10:09:52","modified_gmt":"2026-06-14T17:09:52","slug":"jj%ef%bc%9acomplete-data-for-nipocalimab-were-announced","status":"publish","type":"post","link":"https:\/\/xpharma.com.cn\/index.php\/news\/jj%ef%bc%9acomplete-data-for-nipocalimab-were-announced\/","title":{"rendered":"J&J\uff1aComplete data for Nipocalimab\u00a0were announced."},"content":{"rendered":"\n
Johnson & Johnson (J&J) Presents Full Data from Phase 2b JASMINE Study of Nipocalimab in Systemic Lupus Erythematosus (SLE) at EULAR 2026<\/h5>\n\n\n\n
I. Introduction: The SLE Treatment Landscape is Being Reshaped<\/strong><\/strong><\/h6>\n\n\n\n

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting 3-5 million patients worldwide. For decades, treatment relied on steroids and immunosuppressants until belimumab (GSK’s Benlysta\u00ae) became the first approved biologic in over 50 years in 2011, followed by anifrolumab (AZ’s Saphnelo\u00ae) in 2021.<\/p>\n\n\n\n

However, the current standard of care remains far from ideal\u2014a considerable proportion of patients have inadequate responses, and long-term steroid use carries significant metabolic, bone, and infection risks. Against this backdrop, the FcRn blocker Nipocalimab brings a novel mechanism of action to SLE treatment with its JASMINE Phase 2b data.<\/p>\n\n\n\n

II. Nipocalimab: What Makes Its Mechanism Different?<\/strong><\/strong><\/h6>\n\n\n\n

Target:<\/strong> Neonatal Fc receptor (FcRn)<\/p>\n\n\n\n

Mechanism:<\/strong> FcRn normally protects IgG from lysosomal degradation, prolonging IgG half-life. Nipocalimab blocks FcRn \u2192 accelerated clearance of pathogenic IgG autoantibodies \u2192 reduced immune complex deposition and inflammation. The advantage is immunoselectivity<\/strong>\u2014it does not broadly suppress the immune system, only clears IgG autoantibodies.<\/p>\n\n\n\n

III. JASMINE Phase 2b Data: Core Interpretation<\/strong><\/strong><\/h6>\n\n\n\n

Trial Design:<\/strong> N=228 patients with active moderate-to-severe SLE, 52 weeks, multicenter RCT, dose-finding (15 mg\/kg vs placebo). Primary endpoint:<\/strong> SRI-4 response rate at Week 24.<\/p>\n\n\n\n

3.1 Overall Population Data<\/strong><\/strong><\/h6>\n\n\n\n
Endpoint<\/td>Nipocalimab<\/td>Placebo<\/td>Difference<\/td><\/tr>
Week 24 SRI-4<\/td>57.9%<\/td>51.1%<\/td>+6.8% (statistically significant)<\/td><\/tr>
Week 52 SRI-4<\/td>65.4%<\/td>51.5%<\/td>+13.9%<\/td><\/tr>
Week 52 LLDAS<\/td>42.3%<\/td>25.3%<\/td>+17.0%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Interpretation:<\/strong> The 6.8% difference in the overall population at Week 24 may not be dramatic, but statistical significance was achieved. More importantly, efficacy deepened over time\u2014by Week 52, the SRI-4 difference expanded from +6.8% to +13.9%, and the LLDAS difference reached 17%.<\/p>\n\n\n\n

3.2 Autoantibody-Positive Subgroup<\/strong><\/strong><\/h6>\n\n\n\n
Subgroup<\/td>Difference in Efficacy<\/td><\/tr>
Autoantibody-positive (~80% of SLE patients)<\/td>+22%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Interpretation:<\/strong> In the ~80% of SLE patients with autoantibodies (anti-dsDNA, anti-Smith, or ANA positive), the efficacy difference jumped to 22%. This clearly defines the precision patient profile for Nipocalimab\u2014truly IgG-mediated SLE, which aligns with the mechanism of an FcRn blocker.<\/p>\n\n\n\n

3.3 Safety<\/strong><\/strong><\/h6>\n\n\n\n

The safety profile was consistent with previous Phase 2 studies, with no new safety signals identified. The most common AEs included nasopharyngitis, headache, UTI, and nausea. No typical safety issues associated with broad-spectrum immunosuppressants were observed.<\/p>\n\n\n\n

IV. Comparative Efficacy of Approved SLE Biologics (Indirect Comparison)<\/strong><\/strong><\/h6>\n\n\n\n
Drug<\/td>Mechanism<\/td>Key Endpoint Difference vs Placebo<\/td>LLDAS Difference<\/td><\/tr>
Belimumab<\/strong> (BLISS Ph3)<\/td>anti-BLyS<\/td>SRI-4: ~14-16%<\/td>\u2014<\/td><\/tr>
Anifrolumab<\/strong> (TULIP pooled)<\/td>anti-IFNAR<\/td>BICLA: ~16% (SRI-4 not met in TULIP-1)<\/td>~17%<\/td><\/tr>
Nipocalimab<\/strong> (JASMINE Ph2b)<\/td>anti-FcRn<\/td>SRI-4 (W52): 13.9%; AutoAb+ subgroup: 22%<\/td>17% (W52)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Key Conclusions<\/strong><\/p>\n\n\n\n

Nipocalimab’s overall population efficacy in SRI-4 and LLDAS is comparable to existing biologics.<\/p>\n\n\n\n

In the autoantibody-positive subgroup, its effect may be superior to current standards of care.<\/p>\n\n\n\n

V. Emerging Competitors: The Disruptive Potential of CAR-T and TCE<\/strong><\/strong><\/h6>\n\n\n\n

The most exciting developments in SLE treatment are not just iterative improvements in traditional monoclonal antibodies, but the entry of entirely new therapeutic modalities.<\/p>\n\n\n\n

5.1 Autologous CD19 CAR-T<\/strong><\/strong><\/h6>\n\n\n\n

Representative pipelines:<\/strong><\/p>\n\n\n\n

KYV-101 (Kyverna Therapeutics):<\/strong> Fully human CD19 CAR-T, entered Ph2\/3. Demonstrates deep B cell depletion and reduced disease activity in SLE, with some patients achieving drug-free remission.<\/p>\n\n\n\n

GC012F (Gracell, now under AstraZeneca):<\/strong> CD19\/BCMA dual-target CAR-T, received SLE IND, Ph1 enrolling.<\/p>\n\n\n\n

Erlangen\/German study:<\/strong> Mackensen’s team (Nature Medicine 2022) reported long-term drug-free remission in the first 5 SLE patients treated with CAR-T.<\/p>\n\n\n\n

CAR-T aims to achieve “immune reset”<\/strong> \u2192 long-term drug-free remission or even “functional cure.” However, the cost is high: autologous manufacturing, bridging chemotherapy, CRS\/ICANS risks. Currently, it is only for refractory SLE.<\/p>\n\n\n\n

5.2 CD19 T Cell Engagers (TCEs)<\/strong><\/strong><\/h6>\n\n\n\n

CLN-978 (Cullinan Therapeutics):<\/strong> CD19\u00d7CD3 TCE, subcutaneous administration. At EULAR 2026 this week, Ph1 OUTRACE SLE data were presented with the headline “induces robust B cell depletion.” Subcutaneous dosing and simple manufacturing position it as an “off-the-shelf alternative to CAR-T.”<\/strong><\/p>\n\n\n\n

Genrix Bio:<\/strong> Initiated SLE Ph1 enrollment in China.<\/p>\n\n\n\n

Velinotamig (Cullinan):<\/strong> BCMA\u00d7CD3 TCE, also advancing.<\/p>\n\n\n\n

TCEs pursue deep B cell depletion but face challenges including CRS and infection risks.<\/p>\n\n\n\n

5.3 In Vivo CAR-T \u2014 The Cutting Edge<\/strong><\/strong><\/h6>\n\n\n\n

In September 2025, NEJM reported that a team from The First Affiliated Hospital of University of Science and Technology of China used lipid nanoparticle (LNP)-delivered mRNA to generate CD19 CAR-T in vivo<\/strong>, without ex vivo modification. After treating refractory SLE patients, B cell depletion and reduced disease activity were observed, with no severe adverse events.<\/p>\n\n\n\n

This represents the most aggressive next-generation immunotherapy direction\u2014if the balance of safety and durability is confirmed, it could be a disruptive shock to the entire SLE treatment landscape.<\/p>\n\n\n\n

Overall perspective:<\/strong> TCEs, ex vivo CAR-T, and in vivo CAR-T represent different implementation forms of the B cell clearance mechanism. Fundamentally, after B cell clearance, pathogenic antibodies can still circulate for some time. Therefore, Nipocalimab’s mechanism of reducing pathogenic IgG may still have potential for complementarity with B cell clearance therapies.<\/p>\n\n\n\n

Buy Nipocalimab<\/strong> <\/strong>from China and save up to 80% on costs . no insurance needed . compare prices from a certified HongKong pharmacy .with fast shipping. Contact us now on WhatsApp to get the latest prices.<\/p>\n","protected":false},"excerpt":{"rendered":"

Johnson & Johnson (J&J) Presents Full Data from Phase 2b JASMINE Study of Nipocalimab in Systemic Lupus Erythematosus (SLE) at EULAR 2026 I. Introduction: The SLE Treatment Landscape is Being Reshaped Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting 3-5 million patients worldwide. For decades, treatment relied on steroids and immunosuppressants until belimumab […]<\/p>\n","protected":false},"author":3,"featured_media":3095,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-4319","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"blocksy_meta":[],"yoast_head":"\nJ&J\uff1aComplete data for Nipocalimab\u00a0were announced. - Xpharma China<\/title>\n<meta name=\"description\" content=\"J&J\uff1aComplete data for Nipocalimab\u00a0were announced. - Xpharma China\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/xpharma.com.cn\/index.php\/news\/jj\uff1acomplete-data-for-nipocalimab-were-announced\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"J&J\uff1aComplete data for Nipocalimab\u00a0were announced. - 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