TQC3721 / Sino Biopharm - LARVOL DELTA

Late Breaking Abstract - Effects of a Novel Dual Phosphodiesterase 3 and 4 Inhibitor TQC3721 in Patients with COPD in China (PACER-II): a phase 2, multicentre, randomised, double-blind, placebo-controlled trial (ERS 2025) - No abstract available

Clinical • Late-breaking abstract • P2 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

TQC3721 INHALATION SUSPENSION “PDE3/4 INHIBITOR” OBTAINING APPROVAL FOR PHASE III REGISTRATIONAL CLINICAL STUDY FROM CDE (HKEXnews) - "The board of directors (the 'Board') of Sino Biopharmaceutical Limited (the 'Company', together with its subsidiaries, the 'Group') announces that the TQC3721 inhalation suspension 'PDE3/4 inhibitor', the category 1 innovative drug developed by the Group, has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China to commence the phase III registrational clinical study on the maintenance treatment for chronic obstructive pulmonary disease (COPD)....This phase III clinical study will further observe the efficacy and safety of using TQC3721 inhalation suspension under different background treatments (no background, single bronchodilator or dual bronchodilators) in a larger sample of patients with moderate to severe COPD."

New P3 trial • Chronic Obstructive Pulmonary Disease

A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

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

A Phase II Clinical Trial of TQC3721 Suspension for Inhalation (clinicaltrials.gov) - P2 | N=59 | Terminated | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=460 ➔ 59 | Recruiting ➔ Terminated; Per sponsor request. Closure was not prompted by any safety or efficacy concerns.

Enrollment change • Trial termination • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

TQC3721-II-03: A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=240 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Mar 2025

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

A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

TQC3721-II-03: A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

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

Late Breaking Abstract - A Dose-Ranging Study of the Inhaled Dual PDE3/4 Inhibitor TQC3721 in COPD Patients (ERS 2024) - "In this study TQC3721 was well tolerated with rapid onset of action in 3 hours and lasting in 12 hours, supporting the regimen of 3mg and 6mg, twice daily for future trials."

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

Safety, Tolerability and Pharmacokinetics of The Phosphodiesterase 3/4 (PDE3/4) Inhibitor TQC3721 Suspension for Inhalation in Healthy Adult Subjects (ERS 2024) - "TQC3721 showed a favorable safety, tolerability and pharmacokinetic profile. These results support further development of TQC3721 in patients with COPD."

Clinical • PK/PD data • Anemia • Chronic Obstructive Pulmonary Disease • Hematological Disorders • Immunology • Pulmonary Disease • Respiratory Diseases

SINO BIOPHARM To Present Research Results of 2 Innovative Drugs at ERS in Sep [Google translation] (iis.aastocks.com) - "SINO BIOPHARM...announced that the research results of two innovative drugs developed by the Group, 'TQC3721 (PDE3/4 inhibitor) and 'TQC2731 (TSLP monoclonal antibody)', will be presented at the 2024 annual meeting of European Respiratory Society (ERS 2024) to be held on 7-11 September."

Clinical data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

A Phase II Clinical Trial of TQC3721 Suspension for Inhalation (clinicaltrials.gov) - P2 | N=460 | Recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Phase II Clinical Trial of TQC3721 Suspension for Inhalation (clinicaltrials.gov) - P2 | N=460 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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