JKN2403: World’s First Oral PREP Inhibitor for COPD Enters Clinical Development Through Joint Effort by Livzon and Bayer

About JKN2403

JKN2403 is the world's first oral PREP inhibitor for COPD, which effectively prevents the production of COPD inflammatory mediators by inhibiting PREP activity, thereby controlling acute exacerbations of COPD.In March 2024, Joincare Pharmaceutical Group Industry Co., Ltd. and Bayer signed an agreement for the exclusive license for the development, commercialization, and production of JKN2403 in China.This is also the first time that Joincare has introduced an innovative drug pipeline in the respiratory field from a globally leading multinational company.

Non-clinical studies and Phase I clinical trials conducted in Europe with healthy subjects have both fully demonstrated its good safety profile in human clinical trials. In terms of efficacy, this product shows potential advantages in reducing the frequency of acute exacerbations in COPD patients and slowing overall disease progression.

About PREP Inhibitors

PREP is an important serine protease that can hydrolyze peptide bonds at the carboxyl terminus of proline residues in polypeptide chains. PREP is widely distributed in the human body, present in both brain and peripheral tissues; among these, the highest PREP activity levels are found in the cortical regions of the frontal, parietal, and occipital lobes of the brain, while the lowest activity is observed in the cerebellum. Additionally, PREP activity has also been detected in alveoli, bone marrow cells, and germ cells.

PREP's most important physiological function is to participate in the metabolic inactivation of various hormones and peptide neurotransmitters (such as angiotensin I and II, thyrotropin-releasing hormone, bradykinin, etc.), thereby regulating emotions, sensations, and cognitive functions. So far,Only five products targeting this point have been queried, and the indications are mainly concentrated in the field of neurodegenerative diseases except for COPD.。

About COPD

COPD is a common respiratory system disease characterized by airflow limitation, with high prevalence, disability, and mortality rates, as well as long disease duration and treatment cycles. Its three main symptoms are dyspnea, chronic cough, and sputum production. According to the World Health Organization's forecast, COPD will become the third leading cause of death worldwide by 2030; it is projected that over 54 million people will die from COPD by 2060.

According to Frost & Sullivan statistics, the global COPD patient base was approximately 457 million in 2019, and it is expected to reach about 528 million by 2024, with a CAGR of approximately 3.0% from 2019 to 2024; in China, the number of COPD patients was about 104 million in 2019, and it is projected to reach around 108 million by 2024, with a CAGR of approximately 0.7% from 2019 to 2024.

Large Global Base of COPD Patients (100 Million People)

The Number of COPD Patients in China Continues to Increase (in billions)

According to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)" by the Chinese Medical Association, the main drugs used clinically in China for COPD treatment include bronchodilators and inhaled corticosteroids (ICS). Bronchodilators include β2 agonists (short-acting SABA or long-acting LABA), anticholinergic drugs (short-acting SAMA and long-acting LAMA), and xanthine drugs. Clinical studies have shown that combination therapy with bronchodilators of different mechanisms of action is superior to single bronchodilator therapy; however, existing treatment regimens mainly focus on alleviating disease symptoms, and high dosing frequency leads to poor patient compliance.

With the global aging population and the叠加流行趋势 of e-cigarettes, the COPD market is expanding rapidly. Annual COPD-related expenditures in the U.S. reach $40 billion, with the current maintenance therapy market alone accounting for $10 billion. The global drug market is projected to reach $25.4 billion by 2030, with a CAGR of nearly 5% from 2022 to 2030.

About Joincare

Joincare is an innovative research-oriented comprehensive pharmaceutical group that has currently established several R&D platforms for complex formulations with high barriers to innovation.

As a leading innovative pharmaceutical company in the field of inhaled preparations, Joincare has always regarded the inhaled preparations segment as one of its strategic priorities. In addition to strengthening its self-developed product pipeline, Joincare has also introduced several innovative drugs. Apart from JKN2403, at the end of January 2024, the company announced two strategic drug collaborations primarily targeting respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). These include a strategic collaboration with Quanxin Biologics on the TSLP antibody QX008N and a partnership with Boan Biotech for the exclusive rights in China to the long-acting anti-IL-4Rα monoclonal antibody BA2101 injection. The three collaborations have expanded Joincare’s portfolio from injectables to oral medications, further enriching its R&D pipeline and product range in the respiratory field.