SHR-1819 / Jiangsu Hengrui Pharma - LARVOL DELTA

Hengrui Medicine (600276.SH) SHR-1819 Injection Receives Drug Clinical Trial Approval Notice [Google translation] (Sina Corp) - "Hengrui Medicine...announced that recently, its subsidiary Guangdong Hengrui Medicine Co., Ltd. received the 'Drug Clinical Trial Approval Notice' for SHR-1819 Injection approved and issued by the National Medical Products Administration ('NMPA'), and will conduct clinical trials in the near future...the SHR-1819 injection clinical trial application accepted on January 26, 2025 meets the relevant requirements for drug registration, and it is agreed to conduct clinical trials for allergic rhinitis.'"

New trial • Allergic Rhinitis

Hengrui Medicine's SHR-1819 is approved for clinical trials for the treatment of chronic spontaneous urticaria [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine's subsidiary Guangdong Hengrui Medicine Co., Ltd. received the 'Drug Clinical Trial Approval Notice' approved and issued by the National Medical Products Administration, agreeing to conduct clinical trials of SHR-1819 injection for patients with chronic spontaneous urticaria."

New trial • Chronic Spontaneous Urticaria

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=650 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

SHR-1819-204: A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting | N=36 ➔ 50

Enrollment change • Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase Ib/II Study to Investigate the Safety of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=36 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Hengrui Medicine’s innovative drug SHR-1819 is approved for clinical trials for children and adolescents with atopic dermatitis [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Guangdong Hengrui Medicine Co., Ltd., a subsidiary of 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-1819 injection for children and adolescents aged 6-17 years with atopic dermatitis."

New trial • Atopic Dermatitis

Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis (clinicaltrials.gov) - P2/3 | N=236 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Prurigo Nodularis

Efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of SHR-1819 in patients with moderate-to-severe atopic dermatitis (AD): a multicenter, randomized, double-blind, placebo-controlled phase 2 study (EADV 2024) - "SHR-1819 effectively ameliorated the signs and symptoms of AD, demonstrating a well-tolerated safety profile, favorable PK and PD characteristics. The findings from this study support the development of SHR- 1819 in phase 3 trials for the treatment of AD. Figure 1 ."

Clinical • P2 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus • IL13 • IL4R

Preclinical Development of SHR-1819, a Potent Humanized IL-4Rα Antibody for Treating Type 2 Inflammatory Diseases. (PubMed, J Inflamm Res) - "Moreover, subcutaneous administration of SHR-1819 exhibited favorable bioavailability in mice. The results supported SHR-1819 as a promising preclinical candidate for the treatment of type 2 inflammatory diseases, including asthma, AD and AR."

Journal • Preclinical • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL4 • STAT6

Clinical Study of the Efficacy and Safety of SHR-1819 Injection in Adult Patients With Prurigo Nodularis (clinicaltrials.gov) - P2/3 | N=236 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2/3 trial • Immunology • Prurigo Nodularis

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis (clinicaltrials.gov) - P3 | N=650 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

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

Safety, pharmacokinetics, and pharmacodynamics of anti-IL-4Rα antibody SHR-1819 in healthy subjects: A randomized, controlled phase I study. (PubMed, Clin Transl Sci) - "More than half of the total subjects treated with SHR-1819 were reported antidrug antibody-negative. The preliminary data from this phase I study support further development of SHR-1819 for the treatment of type 2 inflammatory diseases."

Biomarker • Clinical • Journal • P1 data • PK/PD data • Inflammation

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=158 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=240 | Enrolling by invitation | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Extend Efficacy and Safety of SHR-1819 Injection in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

Hengrui Medicine (600276.SH) Subsidiary Obtained Notification of Clinical Trial Approval for "SHR-1819 Injection" [Google translation] (Stockstar) - "Zhitong Finance APP news, Hengrui Medicine...issued an announcement that recently, the company's subsidiary Shanghai Hengrui Medicine Co., Ltd. The 'Notice of Drug Clinical Trial Approval' for the injection will start clinical trials in the near future."

New trial • Asthma • Atopic Dermatitis • Dermatitis • Immunology • Inflammation • Respiratory Diseases

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

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

Efficacy and Safety Study of SHR-1819 Injection in Adult Patients With Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=148 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

A Trial of SHR-1819 in Healthy Subjects (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Atridia Pty Ltd. | Recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Mar 2022

Trial completion • Trial completion date

A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Clinical • New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects (clinicaltrials.gov) - P1; N=62; Recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.; N=42 ➔ 62; Trial primary completion date: Jul 2021 ➔ Oct 2021

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study in Healthy Subjects (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study in Healthy Subjects (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Clinical • New P1 trial • Asthma • Immunology • Respiratory Diseases