batoclimab (HBM9161) / Harbour BioMed, Roivant, Daewoong Pharma, CSPC Pharma, OmniAb, Immunovant, HanAll Biopharma - LARVOL DELTA

Regimen-stratified Bayesian model-based meta-analysis of targeted biologics in generalised myasthenia gravis: efficacy comparison, mechanism-level class contrast, and endpoint sensitivity with model-informed trial design. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "The study was registered with PROSPERO: CRD420261288549. On MG-ADL, zilucoplan led with the highest Emax (4.8 points; 95% CrI: 4.2-5.4) and largest net benefit (2.5; 2.0-3.1)...Efgartigimod achieved the fastest onset on both scales (≤ 1.6 weeks)...For rozanolixizumab on MG-ADL, snapshot week 26 endpoints were underpowered (65%); integrated endpoints recovered power to 94-95%...Across the multi dimensional treatment-selection framework integrating efficacy, safety, tolerability, and convenience, batoclimab emerged as the highest-ranked agent in all eight clinical priority profiles. These findings provide a pharmacodynamic evidence base for mechanism-guided treatment individualisation and endpoint optimisation in generalised myasthenia gravis."

Journal • Retrospective data • CNS Disorders • Immunology • Myasthenia Gravis

HBM Holdings Sets Commercial Path for Core Myasthenia Drug in Greater China (TipRanks) - "The company has provided an update that Batoclimab (HBM9161), its core product for generalized myasthenia gravis, has had its biologics license application accepted by China’s NMPA and is expected, subject to regulatory review, to obtain marketing authorization in the second half of 2026."

China approval • China filing • Myasthenia Gravis

Randomized, Masked, Placebo-Controlled, Multicenter, Phase 3 Study of Batoclimab for Active, Moderate-To-Severe Thyroid Eye Disease (ATA 2026) - No abstract available

Clinical • P3 data • Ophthalmology • Thyroid Eye Disease

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=233 | Terminated | Sponsor: Immunovant Sciences GmbH | Trial completion date: Feb 2027 ➔ Aug 2026 | Active, not recruiting ➔ Terminated; Sponsor Decision

Trial completion date • Trial termination • CNS Disorders • Immunology • Myasthenia Gravis

An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (clinicaltrials.gov) - P2 | N=26 | Terminated | Sponsor: Immunovant Sciences GmbH | N=108 ➔ 26 | Trial completion date: Nov 2028 ➔ Jul 2026 | Enrolling by invitation ➔ Terminated | Trial primary completion date: Nov 2028 ➔ Jul 2026; Sponsor Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP (clinicaltrials.gov) - P2 | N=94 | Terminated | Sponsor: Immunovant Sciences GmbH | N=277 ➔ 94 | Trial completion date: Jan 2027 ➔ Jul 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jan 2026 ➔ Jul 2026; Sponsor Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

New horizons for autoimmune hyperthyroidism with FcRn blockers. (PubMed, Curr Opin Endocrinol Diabetes Obes) - "FcRn blockade is a promising new therapeutic approach for the management of autoimmune hyperthyroidism. Durability, cost-effectiveness and patient selection remain to be defined."

Journal • Endocrine Disorders • Grave’s Disease • Immunology • Ophthalmology • Thyroid Eye Disease

Comparing Efficacy and Safety of Various Monoclonal Antibodies in Myasthenia Gravis: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. (PubMed, Brain Behav) - "ROZ 10 mg/kg ranked best for MG-ADL. BAT 680 mg significantly reduced QMG and ranked best. BAT 340 mg had the highest probability of reducing the MGC score. ECU significantly decreased MG-QoL 15r and ranked best. BEL 10 mg/kg had the highest likelihood of reducing adverse events."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Immunology • Myasthenia Gravis

IMVT-1401-2402: A Phase 2b Study to Assess the Safety and tolerability of Batoclimab in Patients with CIDP (clinicaltrialsregister.eu) - P1/2 | N=35 | Completed | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Completed

Trial completion • Pain

IMVT-1401-2401: Phase 2b Study to Assess Efficacy and Safety of Batoclimab in Adult Participants with Active CIDP. (clinicaltrialsregister.eu) - P1/2 | N=178 | Completed | Sponsor: Immunovant Sciences GmbH | Suspended ➔ Completed

Trial completion • Pain

In April 2026, we announced topline results from the two Phase 3 clinical studies evaluating batoclimab for adults with active, moderate-to-severe thyroid eye disease (TED), neither of which met the primary endpoint. (The Manila Times) - "The safety profile observed in these studies was consistent with prior batoclimab studies. Following these results, we discontinued further development of batoclimab across all indications..."

Discontinued • P3 data: top line • Thyroid Eye Disease

Unveiling the geographical signature of black tea through UHPLC-quadrupole-Orbitrap Exploris HRMS analysis. (PubMed, Anal Methods) - "Binding energy analysis (MM-PBSA) showed favourable interactions dominated by van der Waals forces, with theanine exhibiting a slightly higher binding affinity (-18.72 kcal mol-1) than RVT-1401 (-17.82 kcal mol-1), a therapeutic monoclonal antibody known to inhibit FcRn function. The findings have significant implications for the tea industry in quality control, authentication, traceability, and health benefits, which offer new insights into how territory shapes the chemical and potentially sensory attributes of black tea."

Journal • FCGRT

Comparing Efficacy and Safety of Various Monoclonal Antibodies in Myasthenia Gravis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials (AAN 2026) - "Batoclimab (BAT) 680 mg significantly reduced the Quantitative MG (QMG) score compared to placebo (MD= -5.17; 95%CI:[-6.44, -3.89]; p <0.0001) and was rated the top performer (p-score = 0.96) for this endpoint...Eculizumab (ECU) was ranked best (p-score = 0.93) regarding the 15-item revised MG Quality of Life (MG-QoL 15r) score. Belimumab (BEL) 10 mg/kg was ranked best in terms of adverse events (p-score = 0.87)...ECU significantly decreased MG-QoL 15r and ranked best. BEL 10 mg/kg was ranked best regarding adverse events."

Retrospective data • Review • CNS Disorders • Immunology • Myasthenia Gravis

IMVT-1401-3101: Phase 3 Study to Assess Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG) (clinicaltrialsregister.eu) - P2/3 | N=152 | Completed | Sponsor: Immunovant Sciences GmbH | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Myasthenia Gravis

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=109 | Terminated | Sponsor: Immunovant Sciences GmbH | Accordingly, there was a change to the benefit-risk balance. No new safety findings were observed.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Ophthalmology • Thyroid Eye Disease

Evaluate the Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=111 | Completed | Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Myasthenia Gravis

A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP (clinicaltrials.gov) - P2/3 | N=36 | Completed | Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. | Recruiting ➔ Completed

Trial completion • Hematological Disorders • Immune Thrombocytopenic Purpura • Thrombocytopenia • Thrombocytopenic Purpura

Efficacy and safety of complement inhibitors and FcRn blockers in generalized AChR antibody-positive myasthenia gravis: a meta-analysis. (PubMed, J Neurol) - "In AChR-Ab⁺ gMG, complement inhibitors and FcRn blockers yield clinically meaningful improvements with favourable safety profiles. Complement inhibition additionally confers sustained benefits and corticosteroid-sparing effects in this population over long-term."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Myasthenia Gravis

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=86 | Completed | Sponsor: Immunovant Sciences GmbH | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

IMVT-1401-3202: Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease (clinicaltrialsregister.eu) - P2/3 | N=75 | Completed | Sponsor: Immunovant Sciences GmbH | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (clinicaltrials.gov) - P3 | N=240 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Trial completion date: Apr 2025 ➔ Jan 2027

Trial completion date • CNS Disorders • Myasthenia Gravis

batoclimab (Businesswire) - "Immunovant anticipates sharing topline data from its two Phase 3 studies evaluating batoclimab as a treatment for active, moderate-to-severe thyroid eye disease in the first half of this year."

P3 data: top line • Thyroid Eye Disease

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=180 | Active, not recruiting | Sponsor: Immunovant Sciences GmbH | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

Euthyroidism and Long-Term Remission of Graves' Hyperthyroidism Following Treatment With an FcRn Blocker: A Case Report. (PubMed, Thyroid) - "FcRn blockade may be an effective and potentially disease-modifying treatment for GD."

Journal • Endocrine Disorders • Grave’s Disease

Immunovant anticipates sharing topline data from both of its Phase 3 studies to evaluate batoclimab as a treatment for active moderate to severe thyroid eye disease (TED) in the first half of calendar year 2026. (The Manila Times) - "In calendar year 2027, topline data are expected across potentially registrational trials of IMVT-1402 in GD and MG."

Clinical data • Grave’s Disease • Myasthenia Gravis • Thyroid Eye Disease