HSK44459 / Haisco - LARVOL DELTA

Late Breaking Abstract - A Phase II Clinical Study of HSK44459 in Patients with Idiopathic Pulmonary Fibrosis (ERS 2026) - P2 | "HSK44459 demonstrated excellent safety and tolerability. HSK44459 8 mg and 12 mg, with or without background antifibrotic therapy, effectively slowed lung function decline in patients with IPF, with HSK44459 12 mg showing potential for greater efficacy."

Clinical • Late-breaking abstract • P2 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Trial of HSK44459 Cream for the Management Plaque Psoriasis (clinicaltrials.gov) - P1/2 | N=180 | Active, not recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1/2 trial • Dermatology • Immunology • Psoriasis

HSK44459-201: Evaluating the Efficacy and Safety of of HSK44459 in People With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=186 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Completed | N=120 ➔ 186 | Trial completion date: Jul 2026 ➔ Mar 2026

Enrollment change • Trial completion • Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=420 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PPF: Evaluating the Efficacy and Safety of of HSK44459 in People With Progressive Pulmonary Fibrosis (clinicaltrials.gov) - P3 | N=378 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P3 trial • Immunology • Pulmonary Disease • Respiratory Diseases

A Study for HSK44459 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: Xizang Haisco Pharmaceutical Co., Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

First-in-Human Phase I Trial: the Safety, Tolerability, and Pharmacokinetics of HSK44459 in Healthy Subjects (ERS 2025) - "HSK44459 was safe and well tolerated in healthy subjects. The encouraging PK and PD profiles support its further development."

Clinical • First-in-human • P1 data • PK/PD data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

A Phase II Efficacy and Safety Study of HSK44459 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Dermatology • Immunology • Psoriasis

A Long-term Study of HSK44459 Tablets in Participants With Bechet's Disease (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial

Long-term Safety and Efficacy Study of HSK44459 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Study for HSK44459 in Participants With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Xizang Haisco Pharmaceutical Co., Ltd

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

Evaluating the Efficacy and Safety of of HSK44459 in Patients With Behçet's Disease (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Immunology • Rare Diseases

Clinical trial of HSK44459, a new drug of Hiseco's subsidiary, was approved [Google translation] (Eastmoney.com) - "March 12, Haisike(002653) announced that its subsidiary Shanghai Hisuno Pharmaceutical Technology Co., Ltd. recently obtained the 'Drug Clinical Trial Approval Notice' issued by the National Medical Products Administration, approving its new drug HSK44459 tablets for clinical trials of psoriasis and atopic dermatitis."

New trial • Atopic Dermatitis • Psoriasis