telikibart (GR1802) / Zhixiang (Shanghai) Pharma - LARVOL DELTA

Restoring the Sense of Smell: A Systematic Review and Meta-Analysis of Biologic Therapies for Chronic Rhinosinusitis with Nasal Polyps. (PubMed, Curr Allergy Asthma Rep) - "In single RCTs, benralizumab showed large effect (1.03, 0.55-1.51), tezepelumab (0.56, 0.46-0.67), telikibart (0.35, 0.11-0.59), and omalizumab (0.27, 0.15-0.40) yielded modest but significant improvements. Mepolizumab showed no effect (0.1330 (95% CI -0.2490-0.5150)...The cohort studies supported the findings (SMD = 1.20, 95% CI = 0.99-1.42), though most data were derived from studies of dupilumab. Overall, biologics substantially improve psychophysically measured olfactory function in CRSwNP. Future head-to-head trials are warranted to delineate comparative efficacy of smell recovery."

Clinical • Journal • Retrospective data • Review • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study of GR1802 Injection in Patients With Seasonal Allergic Rhinitis. (clinicaltrials.gov) - P3 | N=144 | Not yet recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P3 trial • Allergic Rhinitis • Immunology • Inflammation

A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P3 trial • Allergic Rhinitis • Immunology • Inflammation

The third domestically produced IL-4Rα monoclonal antibody was approved for production [Google translation] (CPHI.cn) - "The author speculates that the application for telikibart is for moderate to severe atopic dermatitis."

China filing • Atopic Dermatitis

Zhixiang Jintai has completed the EOP2 (end of Phase II clinical trial/before launch of Phase III clinical trial) meeting with the Center for Drug Evaluation (CDE ) of the National Medical Products Administration [Google translation] (new.qq.com)

New P3 trial • Allergic Rhinitis

A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps (clinicaltrials.gov) - P3 | N=228 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Zhixiang Jintai: GR1802 injection is currently in Phase III clinical trials for moderate to severe atopic dermatitis. [Google translation] (Sohu.com) - "Zhixiang Jintai...stated on the investor interaction platform on August 1 that the GR1802 injection for moderate to severe atopic dermatitis indication completed enrollment in the Phase III clinical trial in August 2024 and is currently in the Phase III clinical trial stage."

Enrollment closed • Atopic Dermatitis

A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR). (clinicaltrials.gov) - P2 | N=240 | Active, not recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | N=90 ➔ 240 | Trial completion date: Dec 2024 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ May 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Allergic Rhinitis • Immunology • Inflammation

The Phase II clinical results of Zhixiang Jintai GR1802 injection for the treatment of moderate to severe atopic dermatitis were published in the International Dermatology... [Google translation] (163.com) - P2 | N=120 | "A total of 120 patients with moderate to severe AD were included in the study and randomly assigned to the GR1802 injection 300 mg group, GR1802 injection 150 mg group and placebo group in a 1:1:1 ratio. They received subcutaneous injections every 2 weeks for 16 weeks....The results of the study showed that the EASI-75 response rate of the GR1802 injection 300mg group reached 75.0% at week 16, which was significantly higher than that of the placebo group (p=0.0002), and it also showed significant advantages in multiple secondary endpoints such as EASI-50 and EASI-90, and performed well in reducing the severity of skin lesions and itching. In terms of safety, the incidence of adverse events of the GR1802 injection and placebo groups was comparable, and no serious adverse events occurred, showing good tolerability and safety."

P2 data • Atopic Dermatitis

Zhixiang Jintai: GR1802 injection starts Phase III clinical trial for chronic spontaneous urticaria [Google translation] (Sohu.com) - "Securities Daily Network reported on the evening of February 13 that Zhixiang Jintai issued an announcement stating that the company had recently completed the meeting communication with the National Drug Administration's Drug Review Center (CDE) EOP2 (end of Phase II clinical trial/before the start of Phase III clinical trial)....The company will officially launch the Phase III clinical trial."

New P3 trial • Chronic Spontaneous Urticaria

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trail Evaluating the Efficacy and Safety of GR1802 Injection in Patients with Moderate to Severe Asthma (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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

The Study of GR1802 in Patients with Chronic Rhinosinusitis with Nasal Polyps (clinicaltrials.gov) - P2 | N=70 | Active, not recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study of GR1802 in Participants With Chronic Sinusitis With Nasal Polyps (clinicaltrials.gov) - P3 | N=228 | Not yet recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P3 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study of IL4Rα Monoclonal Antibody in Patients With Seasonal Allergic Rhinitis(SAR). (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Combination therapy • New P2 trial • Allergic Rhinitis • Immunology • Inflammation

Phase III Study of GR1802 Injection in Patients With Atopic Dermatitis (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

New P3 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Zhixiang Jintai: Phase III clinical trial of GR1802 injection for indications of moderate and severe atopic dermatitis will be officially launched [Google translation] (jrj.com) - "Zhixiang Jintai announced that recently, the company has conducted a randomized, double-blind, placebo-controlled, multi-center Phase III study to evaluate the effectiveness, safety and immunogenicity of GR1802 injection in patients with moderate and severe atopic dermatitis. 'Clinical Trial' has been carried out and the meeting and communication with the Drug Evaluation Center of the State Drug Administration has been completed, and the company will officially launch the Phase III clinical trial."

New P3 trial • Atopic Dermatitis • Immunology

The Study of Long-term Outcomes of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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

The Study of GR1802 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd.

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