bosakitug (BSI-045B) / Biosion, Sino Biopharm, Aclaris - LARVOL DELTA

Aclaris completes enrollment in phase 2 trial of Bosakitug for atopic dermatitis (MSN News) - "The company said the randomized, double-blind, placebo-controlled study enrolled 109 patients and is designed to evaluate both the efficacy and safety of bosakitug, also known as ATI-045, in adults with moderate-to-severe disease."

Enrollment closed • P2 data • Atopic Dermatitis

ATI-045 Versus Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=110 | Active, not recruiting | Sponsor: Aclaris Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aclaris Therapeutics Completes Enrollment in Phase 2 Trial of Bosakitug (ATI-045) in Atopic Dermatitis (Aclaris Press Release) - "Top line results are expected in the fourth quarter of 2026."

Enrollment closed • P2 data • Atopic Dermatitis

ATI-045-AD-201: Study to Evaluate the Efficacy and Safety of ATI-045 in Atopic Dermatitis (clinicaltrialsregister.eu) - P1/2 | N=54 | Sponsor: Aclaris Therapeutics Inc.

New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Fourth Quarter 2025 Highlights and Recent Updates (The Manila Times) - "Confirmed Expectation of Top Line Results in the Second Half of 2026 from Ongoing Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug: This randomized, double-blind, placebo-controlled Phase 2 trial is designed to evaluate bosakitug in approximately 96 patients with moderate-to-severe AD...Aclaris intends to file an IND for ATI-9494 in the second half of 2026."

IND • P2 data • Atopic Dermatitis • Immunology

Beyond inhaled medications: precision medicine and biologic therapies targeting the IL-33/TSLP/type 2 axis in COPD. (PubMed, Front Immunol) - "Emerging drugs such as JKN2401, TQC2731, and tezepelumab demonstrate promising therapeutic potential by modulating these specific inflammatory mediators. This review comprehensively summarizes the pathophysiological roles of these cytokines in COPD, the current progress in biologic drug development targeting these molecules, and the outcomes of recent clinical trials. By elucidating these novel therapeutic avenues, the article aims to provide a theoretical foundation and clinical guidance for precision medicine approaches in COPD management beyond conventional inhaled treatments."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL33 • IL4R • IL5 • TSLP

TQC2731-Ⅱ-04: A Clinical Study of TQC2731 Injection in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=258 | Active, not recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. | Recruiting ➔ Active, not recruiting

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

A Extension Clinical Study of TQC2731 Injection in the Treatment of Chronic Sinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=59 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Feb 2026 ➔ Oct 2025 | Trial primary completion date: May 2025 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma. (clinicaltrials.gov) - P2 | N=205 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Mar 2025 | Trial primary completion date: Oct 2024 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Top Line Results Expected in the Second Half of 2026 from Phase 2 Trial of Investigational Anti-TSLP Monoclonal Antibody Bosakitug (GlobeNewswire) - "Patient enrollment is ongoing in the randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate bosakitug in approximately ninety (90) patients with moderate-to-severe AD."

Enrollment status • P2 data • Atopic Dermatitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQC2731 Injection in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) (ChiCTR) - P3 | N=200 | Not yet recruiting | Sponsor: Eye & ENT hospital of Fudan University; Eye & ENT hospital of Fudan University

New P3 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps (clinicaltrials.gov) - P3 | N=246 | Recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Dose Optimization and Exposure-Response Analyses to Support the Dose Selection of TQC2731, a Novel Anti-TSLP Monoclonal Antibody, in Patients with Severe Asthma (ERS 2025) - P1 | "Integrated PK/PD-E-R analyses support 420 mg as the clinically optimal dose for sustained suppression of type 2 inflammatory biomarkers in severe asthma, providing mechanistic rationale for dose selection in late-phase trials."

Clinical • Asthma • Immunology • Respiratory Diseases • IL13 • IL5 • POSTN

Phase 1 study of TQC2731 targeting thymic stromal lymphopoietin in Chinese healthy adults and asthma patients (ERS 2025) - P1 | "The integrated data from Part 1 and Part 2 support the continued development of TQC2731, with 420mg identified as the recommended Phase 2 dose (P2RD)."

Clinical • P1 data • Stroma • Asthma • Immunology • Respiratory Diseases • IL13 • IL5 • TSLP

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

Second Quarter 2025 and Year-to-Date 2025 (Aclaris Press Release) - "Research and development (R&D) expenses were $11.4 million and $23.0 million for the quarter and six months ended June 30, 2025, respectively, compared to $8.8 million and $18.6 million for the corresponding prior year periods. The increases were primarily driven by product candidate manufacturing costs, preclinical development activities, and clinical development expenses associated with the Phase 2 trial in AD for bosakitug and the Phase 1a/1b program for ATI-052. For the six-month comparison period, clinical development expenses associated with the Phase 2a trial in AD for ATI-2138 also contributed to the increase."

Commercial • Alopecia • Atopic Dermatitis

Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

New P3 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Aclaris Therapeutics Initiates Phase 2 Trial of Bosakitug (ATI-045) in Atopic Dermatitis (GlobeNewswire) - "Aclaris Therapeutics...announced that it has initiated a randomized, double-blind, placebo-controlled Phase 2 trial of bosakitug (ATI-045) in patients with moderate-to-severe atopic dermatitis (AD)...'We expect to provide top line results from this trial in the second half of 2026.'....This randomized, double-blind, placebo-controlled global Phase 2 trial is designed to evaluate the efficacy and safety of bosakitug in approximately 90 patients with moderate-to-severe atopic dermatitis."

P2 data • Trial status • Atopic Dermatitis

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Human Monoclonal Antibody TQC2731 Targeting Thymic Stromal Lymphopoietin (TSLP) in Health Chinese Adults (ATS 2025) - "TQC2731 was well tolerated at all doses administered during the study in healthy Chinese adults. Our results support further clinical development of TQC2731 for asthma and other related diseases mediated by Th2 inflammation."

Clinical • PK/PD data • Stroma • Asthma • Immunology • Infectious Disease • Inflammation • Otorhinolaryngology • Respiratory Diseases • TSLP

Aclaris Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Based on the potency of bosakitug observed in preclinical and clinical studies to date, including the compelling results of the Phase 2a single arm trial in AD, Aclaris intends to initiate a two-arm placebo-controlled Phase 2 trial of bosakitug in approximately 90 patients with moderate-to-severe AD in the second quarter of 2025...Results from CTTQ’s Phase 2 Trials in Respiratory Indications Support Further Development....Aclaris Intends to Seek Partners to Develop Bosakitug in Respiratory Indications."

Commercial • New P2 trial • Pipeline update • Asthma • Atopic Dermatitis • Inflammation • Respiratory Diseases

Shanghai Zhengda Tianqing Pharmaceutical Technology Development Co., Ltd.'s application for implied license for clinical trials of drugs has been accepted [Google translation] (new.qq.com) - "On May 6, according to the official website of CDE, Shanghai Zhengda Tianqing Pharmaceutical Technology Development Co., Ltd. jointly applied for the drug 'TQC2731 Injection' and obtained implicit approval for clinical trials, acceptance number CXSL2500184....Public information shows that the indications of the drug 'TQC2731 Injection' are: intended for use in adolescents aged 12 years and above with severe asthma."

New trial • Asthma

A Clinical Study of TQC2731 Injection in the Treatment of Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Mar 2025 | Trial primary completion date: Jul 2025 ➔ Feb 2025

Trial completion • Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

TQC2731-III-01: TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection (clinicaltrials.gov) - P3 | N=660 | Recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Aclaris Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Confirmed Expectation of Phase 2 Data in the First Half of 2025 for Bosakitug in Chinese Patients with Certain Pulmonary Disorders:..Data from trials in severe asthma and CRSwNP expected in first half of 2025 to inform internal development programs. Initiated Clinical Trial Activities for a Phase 2b Trial of Bosakitug in Atopic Dermatitis (AD); Enrollment Expected to Begin in the First Half of 2025...Confirmed Expectation of Top Line Results in the First Half of 2025 for Phase 2a Trial in AD of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor...Announced Plan to File an Investigational New Drug (IND) Application for ATI-052 in the First Quarter of 2025..."

IND • New P2b trial • P2 data • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Pulmonary Disease • Ulcerative Colitis

TQC2731 Clinical Trial for the Treatment of Severe Asthma With Injection (clinicaltrials.gov) - P3 | N=660 | Not yet recruiting | Sponsor: Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases