Phase II Clinical Trial of JDB0131 Benzenesulfonate Tablets, a Class 1 Innovative Anti-TB Drug Developed in China, Launched at Beijing Chest Hospital

On April 14, 2023, the Phase II clinical trial of JDB0131 Besylate Tablets, a Class 1 innovative drug independently developed by Jiabao Yaoyin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Jiabao Yaoyin”) for the treatment of tuberculosis, was officially launched at Beijing Chest Hospital, Capital Medical University. Led by Beijing Chest Hospital, Capital Medical University, and jointly conducted with West China Hospital, Sichuan University, and Wuhan Pulmonary Hospital, this Phase II clinical trial targets patients with pulmonary tuberculosis. Given the scarcity of independently developed drugs for tuberculosis worldwide, JDB0131 Besylate Tablets, distinguished by their high safety profile, were selected for the “13th Five-Year” Major New Drug Creation Special Project and have garnered significant attention from both the healthcare industry and patients.

The meeting was presided over by Professor Chu Naihui, Director of the Tuberculosis Department at Beijing Chest Hospital, Capital Medical University, who also introduced the attendees. Distinguished guests included President Li Xiaobei of Beijing Chest Hospital, Capital Medical University; Professor Chu Naihui, Director of the First Tuberculosis Department; Professor Lu Yu, Director of the Pharmacology Research Laboratory; Professor Jiang Guanglu from the National Clinical Laboratory for Tuberculosis; Professor He Jianqing from the Department of Respiratory and Critical Care Medicine/Tuberculosis at West China Hospital, Sichuan University; Professor Du Juan, Director of the Tuberculosis Department at Wuhan Pulmonary Hospital; as well as researchers involved in the project.

First, President Li Xiaobei delivered an opening address. President Li stated that the Phase II clinical trial of JDB0131 besylate tablets holds significant importance for the treatment of pulmonary tuberculosis in China. The hospital attaches great importance to this project and will provide strong support and full cooperation to ensure its completion with high quality and high standards. By working together with the enterprise, the hospital aims to contribute to the prevention and control of tuberculosis in China and even globally.

Academician Wei Yuquan, founder of Jiabao Yaoyin, expressed heartfelt gratitude on behalf of the company to the hospital leaders, project investigators, and researchers from relevant departments present at the event. He noted that in recent decades, very few new drugs have been launched globally for tuberculosis (TB), and independently developed anti-TB novel agents in China are particularly rare. The development of JDB0131 besylate tablets is poised to help address the current challenges in China characterized by low treatment and cure rates for drug-resistant TB. He also extended his best wishes for the smooth progress and complete success of the project through the concerted efforts of all parties involved.

Dr. Zhang Qi, Head of Medicine at Jiabao Yaoyin, provided an overview of the company, the development background of JDB0131 benzenesulfonate tablets, preclinical data, and results from the completed Phase I clinical study. He then presented a detailed introduction to the study protocol, including the trial design, inclusion and exclusion criteria, evaluation endpoints, and criteria for trial termination. The investigators, clinical trial staff, and representatives from relevant departments actively discussed the study protocol and offered valuable insights.

Finally, Professor Chu Naihui, the Principal Investigator of the lead site, expressed her gratitude to the attending guests. Professor Chu stated that drug-resistant tuberculosis (DR-TB) represents a key focus and significant challenge in China’s tuberculosis prevention and control efforts. Given the high mortality rate among patients with DR-TB, there is an urgent need for new anti-tuberculosis drugs that are highly efficacious, safe, and affordable. She expressed hope that, through the joint efforts of pharmaceutical companies and medical professionals, the development of domestically innovated anti-tuberculosis drugs in China will be actively promoted, thereby bringing hope to patients with drug-resistant and extensively drug-resistant tuberculosis.

Jiabao Yaoyin was established in 2019, dedicated to medical research and clinical development of innovative drugs. Led by an academician of the Chinese Academy of Sciences and an expert in tumor biological therapy, the company is guided by clinical needs and aims to address practical clinical challenges. It focuses on developing Class I national innovative drugs that are either best-in-class or first-in-class globally and are urgently needed in clinical practice. Currently, Jiabao Yaoyin has built a core team in Chengdu and Shanghai, comprising overseas-returning talents and expert professors from Fortune 500 companies, globally renowned pharmaceutical enterprises, and research institutions.

Our current key R&D pipeline includes: the drug-resistant tuberculosis medication with the highest clinical safety profile globally; a first-in-class combination therapy integrating tumor immunotherapy and anti-angiogenic agents, designed to rescue patients who have failed PD-(L)1 inhibitors; a highly selective BTK inhibitor with exceptional blood-brain barrier penetration; and colony-stimulating factor inhibitors validated through a world-first PDX model. Jiabao is committed to understanding patients’ unmet needs, adopting a clinical-oriented approach to address real-world clinical challenges, and continuously deepening its expertise across multiple therapeutic areas.

JDB0131 Besylate Tablets are a novel nitroimidazole compound independently developed in China. They exert their therapeutic effect by interfering with the metabolism of the Mycobacterium tuberculosis cell wall and represent one of the few Class 1 innovative drugs in the field of tuberculosis, with a proposed indication for drug-resistant pulmonary tuberculosis. Preclinical studies have demonstrated potent inhibitory effects against laboratory standard strains, clinically isolated drug-susceptible strains, and drug-resistant strains of M. tuberculosis in vitro. Furthermore, the compound showed significant efficacy in suppressing M. tuberculosis in both acute and chronic infection animal models. Given that anti-tuberculosis therapy requires prolonged treatment courses, adverse drug reactions are a critical factor influencing medication adherence and utility. The completed Phase I clinical trial of JDB0131 Besylate Tablets, involving nearly 100 subjects, has preliminarily demonstrated an excellent safety profile and high tolerability. Consequently, JDB0131 Besylate Tablets stand out as one of the most promising candidates in the field of tuberculosis treatment.