XKH001 / Kanova Biopharma - LARVOL DELTA

Bridging Study of XKH001 in Healthy Adult Caucasian Participants (clinicaltrials.gov) - P1 | N=2 | Not yet recruiting | Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD

New P1 trial

A Phase Id, Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Bridging Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of XKH001 in Healthy Adult Caucasian Participants (ANZCTR) - P1 | N=16 | Not yet recruiting | Sponsor: MDCECRO AUSTRALIA PTY. LTD.

New P1 trial • Inflammation

A Small-Sample Clinical Study of XKH001 in the Treatment of Moderate to Severe Atopic Dermatitis (ChiCTR) - P2 | N=6 | Sponsor: Affiliated hangzhou first people's hospital, zhejiang university school of medicine; Affiliated hangzhou first people's hospital, zhejiang university

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

Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection (clinicaltrials.gov) - P2 | N=75 | Not yet recruiting | Sponsor: Zhejiang Kanova Biopharmaceutical Co., LTD

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

XKH001 Injection in Healthy Subjects (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Beijing Kanova Biopharmaceutical Co., LTD | Not yet recruiting ➔ Completed | N=40 ➔ 24

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

Late Breaking Abstract - Efficacy of a monoclonal antibody against IL-25 in human allergic asthma: an open-label, single-arm, phase Ic study (ERS 2025) - "This study provides the first clinical evidence supporting IL-25 as a therapeutic target in patients with moderate-to-severe asthma. Table 1. Demographic and Clinical Characteristics of the Patients at Baseline Characteristic XKH001(N=12) Age — yr 31.80 ± 9.81 Male sex — no."

Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases • CCL11 • CXCL8

New hope for moderate to severe chronic obstructive pulmonary disease: XKH001 injection has obtained clinical trial approval! [Google translation] (Sohu.com) - "Recently, the 'XKH001 Injection' jointly applied by Zhejiang Xinkanghe Biopharmaceutical Technology Co., Ltd. and Beijing Xinkanghe Biopharmaceutical Technology Co., Ltd. has obtained implicit approval for clinical trials, which brings new hope to patients with moderate to severe COPD."

New trial • Chronic Obstructive Pulmonary Disease

First-in-human study on tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of XKH001, a recombinant humanized monoclonal antibody against IL-25 in healthy Chinese volunteers. (PubMed, Expert Opin Investig Drugs) - "XKH001 showed favorable safety and pharmacokinetics profiles and a low immunogenicity in its first-in-human study. The data support its further clinical evaluation in patients with type 2 inflammatory diseases."

Clinical • Journal • P1 data • PK/PD data • Inflammation

XKH001 Injection in Healthy Subjects (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: Beijing Kanova Biopharmaceutical Co., LTD | Initiation date: Sep 2023 ➔ Dec 2023

Trial initiation date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CXCL1

XKH001 Injection in Healthy Subjects (clinicaltrials.gov) - P1/2 | N=40 | Not yet recruiting | Sponsor: Beijing Kanova Biopharmaceutical Co., LTD

New P1/2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • CXCL1

Phase I of XKH001Injection in Healthy Adults (clinicaltrials.gov) - P1 | N=35 | Active, not recruiting | Sponsor: Beijing Kanova Biopharmaceutical Co., LTD | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date

Phase I of XKH001Injection in Healthy Adults (clinicaltrials.gov) - P1 | N=35 | Recruiting | Sponsor: Beijing Kanova Biopharmaceutical Co., LTD | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: Jul 2022 ➔ Dec 2022

Enrollment open • Trial completion date • Trial primary completion date