LP-003 / Longbio Pharma - LARVOL DELTA

A Study to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Longbio Pharma (Suzhou) Co., Ltd.

New P2 trial • Allergy • Food Hypersensitivity • Immunology

Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Longbio Pharma (Suzhou) Co., Ltd.

New P2 trial • Allergy • Food Hypersensitivity • Immunology

LongBio Pharma…is pleased to announce that the biologics license application ('BLA') for LP-003 for the indication of seasonal allergic rhinitis ('SAR') has been accepted by the National Medical Products Administration of the People’s Republic of China ('NMPA') (HKEXnews)

China filing • Allergic Rhinitis

A phase I, randomized, dose-escalation clinical trial of the anti-IgE humanized monoclonal antibody LP-003 in healthy subjects. (PubMed, Comb Chem High Throughput Screen) - "LP-003 demonstrated a favorable safety profile and a superior PK advantage characterized by an extended half-life, supporting its development as a long-acting therapeutic option for allergic conditions."

Clinical • Journal • Inflammation

LONGBIO-B (01779.HK) LP-003 Phase III Clinical Trial for Allergic Rhinitis Meets Primary Endpoint (iis.aastocks.com) - "The trial results demonstrated high statistical and clinical significance....A total of 546 patients with moderate-to-severe disease inadequately controlled by standard therapy were enrolled in the study. The primary endpoint evaluated the clinical efficacy of the product in treating moderate-to-severe seasonal allergic rhinitis inadequately controlled by standard therapy."

P3 data • Allergic Rhinitis • Immunology

LP-003 Injection for the treatment of H1 Antihistamine-Inadequately Controlled Chronic Spontaneous Urticaria (CSU): A Multicenter, Randomized, Double-Blind, Controlled Phase Ⅱ Study (EAACI 2026) - P2 | "TEAEs were mostly mild or moderate, with no treatment-related serious events. Conclusion LP-003 provided robust, rapid and sustained symptom control in CSU with a superior activity over omalizumab and favorable safety profile, offering a promising treatment alternative for participants with uncontrolled CSU."

Clinical • Immunology

Results of a Multicenter, Randomized, Double-Blind, Controlled Phase ? Study of LP-003 Injection in H1 Antihistamine-Inadequately Controlled Chronic Spontaneous Urticaria (CSU) (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

LP-003 Significantly Decreases Chronic Spontaneous Urticaria Disease Activity and is Well Tolerated: Top Line Results from a Phase 2 Trial (AAD 2026) - P2 | "The study met its efficacy endpoint. LP-003 at 200 mg Q8W and 200 mg group (Q8W + Q4W) demonstrated clinically meaningful and statistically significant improvement in UAS7 compared with Omalizumab at 12 weeks in patients with refractory CSU. LP-003 was also well tolerated with a favorable safety profile."

P2 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

LP-003 Significantly Decreases Chronic Spontaneous Urticaria Disease Activity and is Well Tolerated: Top Line Results from a Phase 2 Trial (AAAAI 2026) - P2 | "Conclusions The study met its efficacy endpoint. LP-003 at 200 mg Q8W and 200 mg group (Q8W + Q4W) demonstrated clinically meaningful and statistically significant improvement in UAS7 compared with Omalizumab in patients with refractory CSU, in addition to a favorable safety profile, which warrants its further development in this setting."

Late-breaking abstract • P2 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Superior Efficacy and Long-acting: LongBio Announces Positive Topline Results from Phase II CSU Trial of Next-Generation Anti-IgE Therapy, LP-003 in Head-to-Head Comparison with Xolair (PRNewswire) - "The data was presented as a late-breaking poster at the 2026 AAAAI Annual Meeting.....A total of 202 patients were enrolled and randomly assigned to one of three LP-003 treatment groups....For the primary endpoint, at Week 12, the proportions of patients achieving UAS7=0 were 44.4%, 66.7%, 57.5%, 43.6% and 10.8% in the LP-003 100 mg Q8W, 200 mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0405). For the second key efficacy endpoint, LS mean changes from baseline in UAS7 at Week 12 were -23.15, -26.63, -24.74, -21.85 and -13.98 in the LP-003 100 mg Q8W, 200mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0137)."

Late-breaking abstract • P2 data • Chronic Spontaneous Urticaria • Immunology

A Study of Single Dose of LP-003 in Adolescent Subjects (clinicaltrials.gov) - P1/2 | N=6 | Active, not recruiting | Sponsor: Longbio Pharma | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Allergy

Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Longbio Pharma

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Longbio Pharma

New P2 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=546 | Active, not recruiting | Sponsor: Longbio Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergic Rhinitis • Immunology • Inflammation

Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=251 | Recruiting | Sponsor: Longbio Pharma

New P3 trial • Allergic Rhinitis • Immunology • Inflammation

A Study of Single Dose of LP-003 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Longbio Pharma | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy and Safety of LP-003 in Moderate-to-severe Seasonal Allergic Rhinitis Adult (clinicaltrials.gov) - P2 | N=180 | Completed | Sponsor: Longbio Pharma | Recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Immunology • Inflammation

Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment (clinicaltrials.gov) - P2 | N=202 | Completed | Sponsor: Longbio Pharma | Recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Nov 2025

Trial completion • Trial completion date • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Longbio Pharma | Active, not recruiting ➔ Completed

Trial completion • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study of Single Dose of LP-003 in Adolescent Subjects (clinicaltrials.gov) - P1/2 | N=6 | Not yet recruiting | Sponsor: Longbio Pharma

New P1/2 trial • Allergic Rhinitis • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Urticaria

LP-003, a novel high-affinity anti-IgE antibody for inadequately controlled seasonal allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial. (PubMed, Clin Transl Allergy) - "These findings support LP-003 as a promising add-on option to the SoC for patients with moderate to severe SAR. Fixed dosage regimen and extensive suppression of free-IgE render it a cutting-edge advantage."

Clinical • Journal • P2 data • Allergic Rhinitis • Immunology • Inflammation

Breakthrough! Exciting interim Phase II Data of LP-003 in CSU released by Longbio at AAAAI 2025 (PRNewswire) - P2 | N=200 | NCT06228560 | Sponsor: Longbio Pharma | "This is a multi-center, double-blind, placebo-controlled Phase II clinical study, randomized to receive 100 mg Q8W, 200 mg Q8W or 200 mg Q4W of LP-003 or 300mg Omalizumab or placebo (n=40/group)....Comparing to the first-generation anti-IgE antibody, omalizumab, LP-003 shows: superior improvement in mean change of UAS7 from baseline at week 12 as well as the percentage% of patients with UAS7=0 at week 4 and week 12; rapid and sustained relief in CSU symptoms in a dose-dependent manner; favorable safety profile, no statistically significant difference in adverse events were found between LP-003 and placebo groups...In addition, LP-003's efficacy result was also comparable to barzolvolimab without raising any new safety concerns."

P2 data • Chronic Spontaneous Urticaria

An interim analysis of Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for CSU (AAAAI-WAO 2025) - "A new anti-IgE antibody, LP-003 developed by Longbio, of even higher IgE binding affinity, stronger FcεRI inhibition and much longer half-life compared to Omalizumab and Ligelizumab, was investigated in refractory CSU patients. Conclusions These interim-analysis results indicated that 200mg Q4W and 200mg Q8W LP-003 demonstrated potentially superior improvement and 100 mg Q8W LP-003 shows non-inferiority compared to Omalizumab group. LP-003 was also well-tolerated with a favorable safety profile."

P2 data • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Study of Single Dose of LP-003 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Longbio Pharma

New P1 trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Phase II study of LP-003, a novel high-affinity, long-acting anti-IgE antibody for allergic rhinitis (EAACI 2024) - "Omalizumab was the only approved anti-IgE antibody for several allergic diseases. In patients with moderate to severe SAR not well controlled despite SoC, LP-003 added to SoC demonstrated better efficacy in improving symptoms and was well tolerated. These results indicate that LP-003 renders a promising therapeutic option for AR."

P2 data • Allergic Rhinitis • Immunology • Inflammation