CM326 / Keymed Biosciences, CSPC Pharma - LARVOL DELTA

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

Keymed Biosciences Releases 2021 Annual Results (PRNewswire) - "Keymed Biosciences...released 2021 annual results...the Phase III clinical study has been rapidly initiated in the first quarter of 2022....The Company plans to initiate the Phase III study for CRSwNP in the second half of 2022...Core product CM26...Phase Ib/IIa clinical trials of CM326 in adults with moderate to severe AD have been initiated in the first quarter of 2022. Phase Ib/IIa clinical trials in patients with CRSwNP are about to be initiated."

New P1/2 trial • New P3 trial • Atopic Dermatitis • Chronic Rhinosinusitis With Nasal Polyps • Immunology

A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Recruiting

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

The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: Keymed Biosciences Co.Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • IL5 • POSTN

The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=54; Not yet recruiting; Sponsor: Keymed Biosciences Co.Ltd

Clinical • New P1/2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • IL13 • IL5 • POSTN

A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Keymed Biosciences Co.Ltd

Clinical • New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Many firsts in China! Conoya-B (2162.HK) R&D progress is accelerated and the differentiation advantage is significant [Google translation] (Eastmoney.com) - P1, N=44; NCT04842201; Sponsor: Keymed Biosciences Co.Ltd; "CM326....From the research data point of view, CM326 has excellent performance in preclinical data, and the clinical phase I data disclosed in the recent period is also good news, with good safety and tolerability. Specifically, according to preclinical studies, CM326 has higher biological activity than tezepelumab analogs...which has shown the potential of best-in-class. According to clinical trial data, the overall safety and tolerability characteristics of the Phase I clinical study (CM326HV001) of CM326 injection in healthy people are comparable to those of the placebo group. The incidence of adverse events (TEAE)...was similar to that in the placebo group, most of which were Grade 1, which were short-lived and could recover spontaneously without medical intervention..."

P1 data • Preclinical • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Immunology

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

Clinical • Enrollment closed • Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Single Ascending Dose Study of CM326 in Healthy Volunteers (clinicaltrials.gov) - P1; N=44; Recruiting; Sponsor: Keymed Biosciences Co.Ltd; Not yet recruiting ➔ Recruiting

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