AN01 / Haisco, AirNexis Therapeutics - LARVOL DELTA

Late Breaking Abstract - A Dose-Ranging Study of the Novel PDE3/4 Inhibitor HSK39004 in Patients with COPD Receiving Maintenance Single or Dual Bronchodilators (ERS 2026) - P2 | "These results support further clinical development of HSK39004 for COPD. It is expected to become the first marketed PDE3/4 DPI, offering a new therapeutic option for a wider population of patients."

Clinical • Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of HSK39004 Inhalation Suspension in Patients With COPD (clinicaltrials.gov) - P3 | N=387 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study of HSK39004 Inhalation Powder for the Treatment of COPD (clinicaltrials.gov) - P3 | N=376 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Active, not recruiting ➔ Recruiting

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

Long-Term Safety and Efficacy of HSK39004 Inhalation Suspension in COPD (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase III Study of HSK39004 Inhalation Powder for the Treatment of COPD (clinicaltrials.gov) - P3 | N=376 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

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

Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Trial completion date: Aug 2025 ➔ Aug 2026

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

Long-Term Safety and Efficacy of HSK39004 Dry Powder Inhaler in COPD: A Multicenter, Single-Arm, Open-Label Study (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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

Haisco Grants Global Rights of Innovative Drug HSK39004 to AirNexis in Deal Exceeding USD 1 Billion (PRNewswire) - "Under the agreement, Haisco grants AirNexis the rights to develop, manufacture, and commercialize its independently developed innovative drug HSK39004 globally, excluding Greater China. The total deal value reaches up to USD 1.063 billion, including an upfront payment of USD 108 million (USD 40 million in cash and USD 68 million in AirNexis equity), up to USD 955 million in development, regulatory, and commercial milestone payments, and tiered royalties on post‑launch net sales reaching the mid-teens percentage."

Licensing / partnership • Chronic Obstructive Pulmonary Disease • Immunology

A Clinical Study Evaluating the Pharmacokinetics and Pharmacodynamics of HSK39004 Inhalation Suspension in COPD Patients (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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

Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler and HSK39004 Inhalation Suspension in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2 | N=50 | Active, not recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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

Evaluation of the Safety and Efficacy of HSK39004 Dry Powder Inhaler in Chinese Patients With Chronic Obstructive Pulmonary Disease (COPD) (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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

Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HSK39004 Dry Powder Inhalation (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1 trial