GSK6582701 / Jiangsu Hengrui Pharma, GSK - LARVOL DELTA

Safety and Efficacy of inhaled HRS-9821 suspension, a novel dual PDE3/4 Inhibitor: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients (ERS 2026) - "Clinically significant bronchodilation effects and favorable safety characteristics support further clinical development of HRS-9821 as a potential dual-mechanism therapy for COPD."

Clinical • First-in-human • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Safety, Tolerability and Pharmacokinetics of innovative, dual PDE3 and PDE4 inhibitor HRS-9821 suspension for inhalation in healthy participants (ERS 2026) - "HRS-9821 showed favorable safety and pharmacokinetic profiles, supporting further development of HRS-9821 in COPD patients."

Clinical • First-in-human • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD. (clinicaltrials.gov) - P1 | N=85 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Completed | N=160 ➔ 85 | Trial completion date: Dec 2026 ➔ Aug 2026 | Trial primary completion date: Dec 2026 ➔ Aug 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Trial to Evaluate the Efficacy and Safety of HRS-9821 Inhalation Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-9821 Powder for Inhalation Administered as a Single Dose in Healthy Participants and Multiple Doses in Patients With COPD (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation and Inhalation Suspension Administered in Healthy Subjects and Multiple Doses in Patients With COPD. (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | N=82 ➔ 160 | Trial completion date: Jan 2026 ➔ Dec 2026 | Trial primary completion date: Jan 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Phase I study on the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose administration in healthy subjects and multiple-dose administration in COPD patients of HRS-9821 inhalation powder aerosol (ChiCTR) - P1 | N=82 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; Guangdong Hengrui Medicine Co., Ltd.

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation Administered in Healthy Subjects and Multiple Doses in Patients With COPD (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics for a Single Dose of HRS-9821 Powder for Inhalation Administered in Healthy Subjects and Multiple Doses in Patients With COPD (clinicaltrials.gov) - P1 | N=82 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects and COPD Patients (clinicaltrials.gov) - P1 | N=106 | Completed | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Trial completion date: Sep 2025 ➔ Jun 2025 | Active, not recruiting ➔ Completed

Trial completion • Trial completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Hengrui Pharma and GSK enter agreements to develop up to 12 innovative medicines across Respiratory, Immunology & Inflammation and Oncology (PRNewswire) - "Hengrui Pharma...announced it has entered into agreements with GSK...to develop up to 12 innovative medicines, adding significant value to the globalization strategy of Hengrui and significant new growth opportunities to GSK beyond 2031....GSK will pay $500 million in upfront fees across the agreements. The agreements include an exclusive worldwide license (excluding mainland China, Hong Kong SAR, Macau SAR and Taiwan region) for a potential best-in-class, PDE3/4 inhibitor (HRS-9821) in clinical development for the treatment of chronic obstructive pulmonary disease (COPD) as an add-on maintenance treatment, irrespective of background therapy....The agreements also include a pioneering scaled collaboration to generate up to 11 programmes in addition to HRS-9821, each with its own financial structure. Hengrui Pharma will lead the development of these programmes up to completion of phase I trials, including patients outside of China."

Licensing / partnership • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Oncology

Jiangsu Hengrui Pharmaceuticals Gains Approval for Clinical Trial of New Inhalation Drug (TipRanks) - "Jiangsu Hengrui Pharmaceuticals Co., Ltd. has announced that its subsidiary, Guangdong Hengrui Pharmaceuticals, has received approval from the National Medical Products Administration for a clinical trial of its HRS-9821 inhalation powder. This approval marks a significant step for the company as it aims to advance its product pipeline in treating chronic obstructive pulmonary conditions, potentially strengthening its position in the pharmaceutical market."

New trial • Chronic Obstructive Pulmonary Disease

Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects and COPD Patients (clinicaltrials.gov) - P1 | N=106 | Active, not recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects (clinicaltrials.gov) - P1 | N=134 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | N=80 ➔ 134 | Trial completion date: Sep 2023 ➔ Sep 2025 | Trial primary completion date: Jul 2023 ➔ Jul 2025

Enrollment change • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Study on Single and Multiple Atomization Inhalation of HRS-9821 Suspension for Inhalation in Healthy Subjects (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases