TQC3721 / Sino Biopharm, AstraZeneca - LARVOL DELTA

Late Breaking Abstract - A Randomized, Open-Label, Active-Controlled Phase I Study of Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with Glycopyrronium Bromide in Patients with COPD (ERS 2026) - "Participants were randomized 1:1:1:1 to receive 1mg TQC3721 (once daily, QD) combined with 50μg glycopyrronium bromide (GLY, QD), 1mg TQC3721 (twice daily, BID) combined with 50μg GLY (QD), 1.5mg TQC3721 (QD) combined with 50μg GLY (QD), or indacaterol/glycopyrronium (IND/GLY, 110μg/50μg, QD) for 2 weeks. Combination of TQC3721 DPI and GLY exhibits comparable bronchodilator effects to the dual bronchodilator IND/GLY, and is well tolerated. These findings support the further development of a fixed-dose combination of TQC3721 DPI and GLY."

Clinical • Late-breaking abstract • P1 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients (ERS 2026) - "TQC3721 Dry Powder significantly improved lung function compared to placebo with favorable safety, which supporting further development of TQC3721 Dry Powder."

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

Abstract Title: Late Breaking Abstract - A Randomised, Open-Label, Active-Controlled Phase I Study of the Inhaled Dual PDE3/4 Inhibitor TQC3721 Dry Powder Combined with lycopyrronium Bromide in Patients with COPD (HKEXnews) - "Phase I clinical trial data for TQC3721 dry powder inhaler...presented at ERS 2026....At the time of submission, among the 23 patients who had completed two weeks of treatment, the group receiving 1 mg of TQC3721 (twice daily) combined with 50 μg of glycopyrronium bromide (once daily) demonstrated clinically significant improvements in lung function compared with the IND/GLY group: a 203-mL improvement in trough FEV1 and a 110-mL improvement in peak FEV1 from baseline. Enrolment and follow-up of all 40 subjects have now been completed. The study results are broadly consistent with the published data..."

Late-breaking abstract • P1 data • Trial status • Chronic Obstructive Pulmonary Disease

Abstract Title: Safety and Efficacy of Inhaled TQC3721 (Dual PDE3/4 Inhibitor) Dry Powder: A Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study in COPD Patients (HKEXnews) - "Phase I clinical trial data for TQC3721 dry powder inhaler...presented at ERS 2026....A total of 72 patients were enrolled in the study and randomised into six cohorts to receive escalating doses of TQC3721 DPI or placebo, with the dose-ranging interval spanning from 125 μg to 1.5 mg. On Day 9 of treatment, the mean change from baseline in peak forced expiratory volume in one second (FEV1) following administration of TQC3721 DPI across the various dose groups showed a clear dose-dependent pattern: 300.0 mL in the 125 μg group, 288.9 mL in the 250 μg group, 263.0 mL in the 500 μg group, 344.0 mL in the 750 μg group, 497.0 mL in the 1000 μg group, and 410.0 mL in the 1500 μg group."

P1 data • Chronic Obstructive Pulmonary Disease

A Clinical Study of TQC3721 Inhalation Powder in Patients With Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P1 | N=113 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=72 ➔ 113 | Trial completion date: Sep 2025 ➔ Aug 2026 | Trial primary completion date: Sep 2025 ➔ Aug 2026 | Recruiting ➔ Completed

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

Safety, pharmacokinetics and pharmacodynamics of TQC3721, an innovative, dual PDE3 and PDE4 inhibitor, in healthy subjects and patients with chronic obstructive pulmonary disease: Randomised, double-blind, placebo-controlled phase I and IIa clinical trials. (PubMed, Br J Pharmacol) - "Pharmacokinetic features, significant bronchodilation effects and overall favourable safety characteristics support further clinical development of TQC3721 as a potential dual-mechanism therapy for COPD."

First-in-human • Journal • P1 data • PK/PD data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

AstraZeneca turns to China again, this time for Sino Biopharm's experimental respiratory drug (Firstwordpharma Press Release) - "The deal announced Wednesday is focused on Sino's experimental PDE3/4 inhibitor TQC3721. Under the agreement, AstraZeneca will pay $200 million upfront for exclusive rights to develop, manufacture and commercialise TQC3721 outside of China. In addition, Sino is eligible to receive further milestones, totalling up to $1.9 billion, as well as tiered sales royalties ranging up to double-digit percentages....That formulation is currently being evaluated in a Phase III study in China, while a dry-powder inhaler version is also being advanced in a Phase II trial. Sino said the pact with AstraZeneca will accelerate the global clinical development of TQC3721, whilst maximising its potential clinical and commercial value."

Licensing / partnership • Chronic Obstructive Pulmonary Disease

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

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

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

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

TQC3721: Expanding the Role of Dual Phosphodiesterase 3/4 Inhibition in COPD Management. (PubMed, Chest) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

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

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

Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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. (PubMed, Chest) - "TQC3721 significantly improved lung function and symptoms compared to placebo in COPD patients receiving concomitant single or dual long-acting bronchodilators, with good tolerability. The study supports further development of TQC3721 in COPD."

Journal • P2 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A phase II clinical Trial on the efficacy and safety of TQC3721 inhalation powder (ChiCTR) - P2 | N=195 | Not yet recruiting | Sponsor: West China Hospital, Sichuan University; Chia Tai Tianqing Pharmaceutical Group Co., Ltd

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

A Phase II Clinical Trial on the Efficacy and Safety of TQC3721 Inhalation Powder (clinicaltrials.gov) - P2 | N=195 | 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 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