GSK5784283 / Jiangsu Hengrui Pharma, GSK - LARVOL DELTA

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | N=20 ➔ 70 | Trial completion date: Sep 2026 ➔ Feb 2027 | Trial primary completion date: Apr 2026 ➔ Sep 2026

Enrollment change • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P3 | N=280 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

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

A Study to Investigate the Efficacy and Safety of SHR-1905 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

AI-Guided Design and Development of HXN-1011: A Potent Anti-TSLP Biparatopic Antibody (EADV 2025) - "Furthermore, in an OVA-induced asthma model using hTSLP/hTSLPR transgenic mice, HXN- 1011 effectively reduced lung inflammation, as evidenced by decreased BALF cell counts, eosinophil levels, and CCL17 expression, outperforming both Tezepelumab and GSK5784283. Furthermore, in an MC903+OVA-induced skin and lung inflammation model, HXN-1011 demonstrated superior efficacy across all tested parameters including reductions in epidermal hyperplasia, immune cell infiltration and lung inflammation... HXN-1011 is a next-generation biparatopic antibody exhibiting exceptional potency and holding significant potential to enhance clinical efficacy in the treatment of TSLP-driven inflammatory diseases, including atopic dermatitis, asthma, chronic obstructive pulmonary disease (COPD), and other related indications. Preclinical studies and IND-enabling research for HXN-1011 are currently underway."

Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Dermatitis • Dermatology • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • CRLF2 • IL7R • STAT5 • STAT5AWqe • TSLP

Late Breaking Abstract - AI-guided biparatopic TSLP nanobody based TSLP/IL-4Rα and TSLP/ST2 bispecific antibodies for chronic respiratory diseases (ERS 2025) - " Epitope analysis validated an AI-guided biparatopic TSLP nanobody, exhibiting superior in vitro activity approximately 200-fold better than Tezepelumab, and also surpassing GSK5784283...It exhibited synergistic TARC inhibition in PBMCs and demonstrated superior anti-inflammatory effects in an OVA- induced asthma mouse model compared to Tezepelumab and Dupilumab...Similarly, the TSLP/ST2 BiAb matched the TSLP activity of the biparatopic nanobody and outperformed Astegolimab in ST2 activity of 10 times. The BiAbs derived from a best-in-class biparatopic TSLP nanobody hold significant promise for the treatment of asthma and COPD."

Late-breaking abstract • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • CRLF2 • IL7R • TSLP

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P3 | N=408 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Hengrui initiates Phase III clinical trial of TSLP monoclonal antibody for asthma [Google translation] (163.com) - "On July 30, 2025 , the Drug Clinical Trial Registration and Information Disclosure Platform showed that Hengrui Medicine registered a Phase III clinical study to evaluate the efficacy and safety of SHR-1905 injection in patients with severe uncontrolled asthma. This is also the third indication approved for the drug."

Trial status • Asthma

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P3 | N=408 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P3 | N=280 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

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

AI-Guided Design and Development of HXN-1011: A Potent Anti-TSLP Biparatopic Antibody (EAACI 2025) - "Results Epitope mapping confirmed that HXN-1011 simultaneously binds to both Site I and Site II, while other TSLP antibodies, including Tezepelumab (AstraZeneca), GSK5784283 (GSK/Hengrui), and CM326 (Keymed), bind only to Site I. HXN-1011 exhibited a binding affinity approximately 100-fold higher than Tezepelumab and achieved IC90 values 15- to 100-fold lower in functional assays...HXN-1011 also showed superior efficacy across all tested parameters in OVA+MC903-induced lung and skin inflammation...Conclusion HXN-1011 is a next-generation biparatopic antibody with exceptional potency and significant potential to improve clinical efficacy in treating TSLP-driven inflammatory diseases, such as asthma, COPD, and beyond. Preclinical studies and IND-enabling research for HXN-1011 are currently in progress."

Late-breaking abstract • Dermatitis • Immunology • Inflammation • CRLF2 • IL7R • STAT5 • STAT5AWqe • TSLP

AI-guided Generation and Development of HXN-1011, A Highly Potent Anti-TSLP Biparatopic Antibody (ATS 2025) - " Epitope mapping confirmed that HXN-1011 simultaneously binds to both Site I and Site II, while other TSLP antibodies, including Tezepelumab (AstraZeneca), GSK5784283 (GSK/Hengrui), and CM326 (Keymed), bind only to Site I. HXN-1011's binding affinity is ∼100 times higher than that of Tezepelumab. HXN-1011 is a highly potent biparatopic antibody targeting TSLP. It has great potential to significantly enhance clinical efficacy and expand to other inflammatory diseases beyond asthma/COPD. Preclinical and IND-enabling studies of HXN-1011 are currently underway."

Asthma • Chronic Obstructive Pulmonary Disease • Inflammation • Pneumonia • Respiratory Diseases • CRLF2 • IL7R • STAT5 • STAT5AWqe • TSLP

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study (clinicaltrials.gov) - P2 | N=9 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study (clinicaltrials.gov) - P2 | N=8 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=260 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Trial primary completion date: Oct 2024 ➔ Apr 2025 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Pharmacokinetics, Pharmacodynamics, Safety, and Preliminary Efficacy of Subcutaneous Injection of SHR-1905 in Adolescent Asthmatic Subjects - an Open-label, Single-dose Phase II Clinical Study (clinicaltrials.gov) - P2 | N=8 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

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

A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: GlaxoSmithKline

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

Study to Evaluate the AIO-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Syneos Health | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024 | Trial primary completion date: Dec 2024 ➔ Apr 2024

Trial completion • Trial completion date • Trial primary completion date • Respiratory Diseases

A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma (clinicaltrials.gov) - P1 | N=86 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=62 ➔ 86

Enrollment change • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Hengrui Medicine's innovative drug SHR-1905 injection for the treatment of adolescent asthma has been approved for clinical trials [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Guangdong Hengrui Medicine...received the 'Notice of Approval for Drug Clinical Trials' approved and issued by the National Medical Products Administration, agreeing to conduct clinical trials of SHR-1905 injection for asthma in adolescents aged 12-17 years."

New trial • Asthma

A phase 1 study of SHR-1905, a long-acting anti-TSLP monoclonal antibody, in healthy subjects and patients with asthma (ERS 2024) - P1 | "SHR-1905 showed favorable safety, tolerability, PK and PD profiles. Its long half-life supported extended dosing intervals (every 24 or 12 weeks) compared with clinically available anti-TSLP antibodies. Supporting information: Figure Mean (SD) change of biomarkers (EOS, FeNO, FEV1) from baseline following a single subcutaneous dose in patients with moderate-to-severe asthma"

Clinical • P1 data • Asthma • Immunology • Respiratory Diseases

A phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-1905, a long-acting anti-thymic stromal lymphopoietin antibody, in healthy subjects. (PubMed, Front Pharmacol) - P1 | "SHR-1905 demonstrated a good safety and tolerability profile with a long half-life in healthy subjects after a single administration in the dose range of 50-600 mg. clinicaltrials.gov, identifier NCT04800263."

Clinical • Journal • P1 data • PK/PD data • Stroma • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • TSLP

A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma (clinicaltrials.gov) - P2 | N=248 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Enrolling by invitation ➔ Recruiting

Enrollment status • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of SHR-1905 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=114 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Feb 2026 | Trial primary completion date: Aug 2025 ➔ Feb 2026

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis