TQC3721 / Sino Biopharm - LARVOL DELTA

A Phase II Clinical Trial on the Efficacy and Safety of TQC3721 Inhalation Powder (clinicaltrials.gov) - P2 | N=195 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Zhengda Tianqing TQC3721 inhalation powder has started Phase II clinical trials for moderate to severe chronic obstructive pulmonary disease [Google translation] (Sina Corp) - "The clinical trial registration number is CTR20253974, and the first public disclosure date is October 10, 2025...Currently, the experiment is in progress (not yet recruited), with a target enrollment of 195 participants."

Trial status • Chronic Obstructive Pulmonary Disease • Immunology

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) - " TQC3721 significantly improved lung function and symptoms compared to placebo with good tolerability. The study supports the further development of TQC3721."

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

DATA FROM FOUR STUDIES OF “TQC3721 (PDE3/4 INHIBITOR)”, “TQC2731 (TSLP MONOCLONAL ANTIBODY)” AND “TQC3403 (UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE POWDER FOR INHALATION)” PRESENTED AT ERS 2025 (Sino Biopharm Press Release) - "In addition to the inhalation suspensions, the inhaled dry powder formulation of cis set to commence the Phase II clinical trial in anticipation of further enhancement of the efficacy and patient compliance....The Group has overcome challenges in multiple key core technologies and is the first party in China to complete equivalence studies on dry powder formulation as dual bronchodilators, which is expected to obtain approval for marketing in the first half of 2026, and become the first marketed generic drug of the umeclidinium bromide and vilanterol trifenatate powder for inhalation."

China approval • Clinical data • New P2 trial • Asthma • Chronic Obstructive Pulmonary Disease

Evaluation of the Clinical Trial of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=666 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • CXCL8

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