ocankitug (CM326) / Keymed Biosciences, CSPC Pharma - LARVOL DELTA

Efficacy and Safety of CM326, a Humanized Anti-Thymic Stromal Lymphopoietin (TSLP) Monoclonal Antibody, in Moderate-to-Severe Asthma: A Phase II Randomized, Double-Blind, Placebo-Controlled Trial (ERS 2026) - P2 | "CM326, especially for Q2W, demonstrated rapid, sustained improvements in asthma exacerbation rates and control, with a safety profile comparable to placebo, supporting phase III evaluation."

Clinical • P2 data • Stroma • Asthma • Immunology • Infectious Disease • Nephrology • Respiratory Diseases • TSLP

Lessons learned from clinical trials of thymic stromal lymphopoietin (TSLP) inhibition. (PubMed, J Allergy Clin Immunol) - "Tezepelumab is currently the only approved anti-TSLP therapy. Other TSLP-targeting agents, including ecleralimab, SHR-1905, bosakitug, verekitug, sunakiment, TAVO101, ocankitug, HBM9378, MG-ZG122, GB-0895, and solrikitug, are in clinical development."

Journal • Review • Allergic Rhinitis • Allergy • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • Urticaria • IL13 • IL5 • TSLP

A Comparative Pharmacokinetic Study of CM326 in Healthy Subjects (clinicaltrials.gov) - P1 | N=192 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

New P1 trial

A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma (clinicaltrials.gov) - P3 | N=230 | Recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis (clinicaltrials.gov) - P3 | N=212 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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

A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P2 | N=318 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

A Phase III Study of CM326 in Subjects With Moderate to Severe Asthma (clinicaltrials.gov) - P3 | N=230 | Not yet recruiting | Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

New P3 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

An anti-TSLP monoclonal antibody for uncontrolled CRSwNP: the DUBHE randomized clinical trial. (PubMed, Nat Commun) - P1/2 | "A baseline plasma TSLP level of 330 fg/mL may serve as a predictive marker for treatment efficacy of CM326. ClinicalTrials.gov Identifier: NCT05324137."

Clinical • Journal • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL13 • IL5 • TSLP

Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. (PubMed, BioDrugs) - P1 | "CM326 improved Th2 inflammation preclinically and demonstrated an acceptable safety profile with linear pharmacokinetics and low immunogenicity in healthy adults."

Journal • P1 data • Preclinical • Inflammation • TSLP

Study of CM326 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Recruiting ➔ Completed

Trial completion

A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P1/2 | N=88 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Active, not recruiting ➔ Completed | Phase classification: P1b/2a ➔ P1/2 | Trial completion date: Aug 2024 ➔ Mar 2024 | Trial primary completion date: Aug 2023 ➔ Mar 2024

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

Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P2 trial • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

A Study of CM326 in Subjects With Moderate to Severe Asthma (clinicaltrials.gov) - P2 | N=207 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting

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

A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P1b/2a | N=113 | Active, not recruiting | Sponsor: Keymed Biosciences Co.Ltd | Trial primary completion date: Aug 2024 ➔ Aug 2023

Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL13 • IL5 • POSTN

A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P1b/2a | N=113 | Active, not recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Active, not recruiting | N=72 ➔ 113 | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: Aug 2023 ➔ Aug 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL13 • IL5 • POSTN

Study of CM326 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

The Study of CM326 in Adult Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Recruiting ➔ Completed

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

Keymed Biosciences Announces 2022 Annual Results: Efficiently Promotes Clinical Progress & Proactively Develops Global Strategic Collaboration (PRNewswire-Asia) - "Core Product CM310 (IL-4Rα antibody): Initiated Phase III registrational clinical trial for adults with moderate to severe AD in 2022 Q1; Completed the patient enrollment in 2022 November; The Company plans to complete this trial and submit the NDA for this indication in 2023....Initiated Phase II/III pivotal clinical trial for moderate to severe asthma in March 2023, led by CSPC. Core Product CM326 (TSLP antibody)...Initiated Phase Ib/IIa clinical trial for patients with CRSwNP in 2022 H2; Completed the patient enrollment in February 2023."

Enrollment closed • NDA • Trial completion date • Trial initiation date • Asthma • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Dermatology • Immunology

A Study of CM326 in Subjects With Moderate to Severe Asthma (clinicaltrials.gov) - P2 | N=207 | Not yet recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of CM326 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=46 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

New P1 trial

The Study of CM326 in Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd

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

The Study of CM326 in Adult Subjects With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd

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

A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P1b/2a | N=72 | Not yet recruiting | Sponsor: Keymed Biosciences Co.Ltd | Trial completion date: May 2023 ➔ Aug 2023 | Initiation date: May 2022 ➔ Aug 2022 | Trial primary completion date: May 2023 ➔ Aug 2023

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

Single Ascending Dose Study of CM326 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Keymed Biosciences Co.Ltd | Active, not recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Sep 2021

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