Novel Mechanism Targeted Therapy

Dipeptidyl Peptidase 1 (DPP1) Inhibitor

TG-4318

Overview

Bronchiectasis is a chronic respiratory disease characterized by the permanent dilation of the bronchi and the destruction of bronchial wall structures. Non-Cystic Fibrosis Bronchiectasis (NCFBE) accounts for the vast majority of cases. Its etiology is diverse, including recurrent pulmonary infections, immunodeficiency, Chronic Obstructive Pulmonary Disease (COPD), asthma, Allergic Bronchopulmonary Aspergillosis (ABPA), and sequelae of tuberculosis. Clinical symptoms include chronic cough, purulent sputum production, dyspnea, and recurrent respiratory tract infections, which severely impact lung function and quality of life.

Current treatments for NCFBE primarily focus on symptom management—such as airway clearance, anti-infective therapy, and bronchodilators—or long-term antibiotic maintenance for patients with frequent exacerbations. There is a significant lack of specific anti-inflammatory therapies that target the underlying pathogenic mechanism to effectively interrupt the "vicious cycle" of the disease.

TG-4318: Breaking the Inflammatory Cycle at its Source A key pathological mechanism of NCFBE is the over-activation of Neutrophil Elastase (NE), which leads to continuous lung tissue destruction. Dipeptidyl Peptidase 1 (DPP1) is the essential enzyme responsible for activating multiple neutrophil serine proteases. As a highly potent DPP1 inhibitor, TG-4318 effectively blocks the activation pathway of NE, controlling bronchial inflammation at its source, reducing exacerbations and tissue damage, and ultimately improving pulmonary function.
  • Indication under development
  • Non-Cystic Fibrosis Bronchiectasis (NCFBE)

Superiority

  • Novel Mechanism of Action: A small-molecule inhibitor targeting Dipeptidyl Peptidase 1 (DPP1), providing precision therapy directed at key pathological pathways.
  • Best-in-class Potential: Demonstrated superior biochemical activity and selectivity in preclinical studies, showing strong potential to become the leading drug in its class.
  • Addressing Unmet Medical Needs: Provides a proactive therapeutic option for the NCFBE market, where current care is limited to supportive treatments.

Marketplace

Expanding Market Scale: The NCFBE treatment market was valued at approximately USD 2.1 billion in 2023. Driven by improved diagnostic techniques and the introduction of new therapies, the market is projected to reach USD 4.3 billion by 2032, representing a CAGR of 7.9%.

Blockbuster Potential: Due to its clear mechanism of action and the advantage of replacing traditional therapies, the DPP1 mechanism is recognized as one of the top ten most promising innovative therapies globally. Currently, only one drug targeting this mechanism has recently been approved worldwide, leaving substantial market room and growth potential.

Development

  • December 2025: TaiGen Biotechnology licensed the development and commercialization rights of TG-4318 for Mainland China, Hong Kong, and Macau to the Joincare Pharmaceutical Group.
  • R&D Status: At the time of licensing agreement, TG-4318 was in the Pre-clinical Candidate (PCC) evaluation stage. Preparations for various preclinical trials are currently in active progress.