Jiabao Yaoyin Founder Academician Yuquan Wei Unveils Latest Progress in Novel Drug JDB0131 for Drug-Resistant Tuberculosis, Addressing High Cost and Toxicity Challenges

Tuberculosis is one of the top ten causes of death worldwide and the leading cause of death from a single infectious agent. According to the WHO’s Global Tuberculosis Report 2020, nearly 2 billion people globally had latent tuberculosis infection in 2019, with approximately 9.96 million new cases of tuberculosis. In China, the population with latent tuberculosis infection is estimated at around 300 million, with 833,000 new tuberculosis cases, ranking third worldwide.

For years, scientists in China have been actively exploring more efficient methods for the diagnosis and clinical treatment of tuberculosis. To further enhance China’s capacity for tuberculosis prevention and control, the Chinese Medical Association’s Branch of Tuberculosis held the 2021 National Academic Conference on Tuberculosis in Chengdu from July 21 to 25, 2021. Themed “Learning from History to Inform the Present: Prevention and Control of Tuberculosis,” the conference brought together numerous experts in the field to exchange insights on the diagnosis, treatment, prevention, control, and research advancements of tuberculosis.

On the 23rd, Professor Wei Yuquan, an academician of the Chinese Academy of Sciences and Director of the State Key Laboratory of Biotherapy at West China Hospital, Sichuan University, delivered a keynote address at the conference.

In his report, Professor Wei Yuquan first outlined the negative impact of the COVID-19 pandemic on tuberculosis prevention and control, as well as the latest translational achievements in COVID-19 vaccines. He then provided an in-depth analysis of the challenges in medication management for tuberculosis patients and shared the research and development outcomes from the “Major New Drug Creation” project during the 13th Five-Year Plan period, focused on drug-resistant tuberculosis.

Meanwhile, Professor Wei Yuquan, as the founder of Chengdu Jiabao Yaoyin Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Jiabao Yaoyin”), introduced the relevant details and latest progress on JDB0131, a drug for drug-resistant tuberculosis currently under development by Jiabao Yaoyin.

Participating experts highly praised the safety and efficacy of JDB0131, stating that this drug will address the long-standing lack of domestically produced medications for drug-resistant tuberculosis in China, effectively improve clinical access to treatments for drug-resistant tuberculosis, and benefit more patients.

On the occasion of the 2021 National Tuberculosis Academic Conference, VCBeat conducted an exclusive interview with Professor Wei Yuquan.

Drug-resistant tuberculosis is one of the major challenges to achieving the WHO’s End TB Strategy goals. Data show that in 2019, approximately 3.3% of new tuberculosis cases and 17.7% of previously treated patients worldwide had multidrug-resistant/rifampicin-resistant tuberculosis.

China faces a more severe situation in the diagnosis and treatment of drug-resistant tuberculosis than the global average. Due to factors such as antibiotic misuse and pathogen lineages (Lineage 2 strains, which are predominant in China, are more prone to developing drug resistance),In 2019, 7.1% of newly diagnosed tuberculosis (TB) cases in China were drug-resistant TB, with the proportion of new drug-resistant pulmonary TB cases exceeding the global average by 115%.

The number of patients with drug-resistant tuberculosis remains high, and China’s funding for tuberculosis prevention and control has increased year by year. In the face of a growing funding gap, eight ministries and commissions jointly issued the Action Plan to Curb Tuberculosis (2019–2022), with a particular focus on the research and development of new drugs for drug-resistant tuberculosis.

According to Professor Wei Yuquan, poor safety profiles are a common global issue with tuberculosis (TB) drugs. All currently marketed TB medications have significant side effects, including hepatotoxicity, cardiotoxicity, reproductive toxicity, bone marrow suppression, and nephrotoxicity. Commonly used drugs such as rifampicin and isoniazid have been in use for over 50 years, and drug resistance has become extremely severe. In the past four decades, only four new drugs for drug-resistant TB have been approved globally. However, these drugs all suffer from two major drawbacks: poor safety and high cost.

The large number of patients with drug-resistant tuberculosis (DR-TB) poses a significant challenge to tuberculosis prevention and control efforts in China. To address this issue, the team at Jiabao Yaoyin, under the leadership of Professor Wei, adhered to the principle of clinical need-driven R&D and conducted in-depth interviews with frontline healthcare providers and patients involved in tuberculosis control. They gained firsthand insight into the desperation faced by patients who, after developing resistance to first-line drugs, are forced to endure severe side effects from alternative medications, only to develop further resistance and face a lack of effective treatment options. They also recognized the helplessness felt by physicians when their patients cannot afford the high costs of imported drug regimens. Consequently, there is an urgent clinical need for domestically produced, affordable, safe, and reliable new drugs for the treatment of drug-resistant tuberculosis.

In response to the urgent clinical need for safe, effective, and affordable drugs for drug-resistant tuberculosis, Professor Wei Yuquan led Jiabao Yaoyin in the development of JDB0131, an innovative anti-tuberculosis agent.

In terms of safety, JDB0131 is currently one of the safest investigational drugs for drug-resistant tuberculosis in clinical development.In the ongoing Phase I clinical trial, JDB0131 has also demonstrated an excellent safety profile, with no drug-related adverse events reported among enrolled subjects.

In terms of efficacy, animal studies demonstrated that JDB0131 has higher oral bioavailability than delamanid. In acute infection models in animals, JDB0131 effectively cleared the pathogenic bacteria.

Professor Wei Yuquan revealed: “JDB0131 is expected to enter pivotal clinical trials in 2022., applying for breakthrough therapy designation, it is poised to become China’s first independently developed and marketed drug for drug-resistant tuberculosis."Notably, preclinical data indicate that JDB0131 has the potential for broad-spectrum anti-tuberculosis therapy and a high safety profile, positioning it as a candidate for first-line treatment."

Jiabao Yaoyin is a Chinese innovative drug R&D enterprise committed to developing National Class I innovative drugs that are urgently needed in clinical practice, with a clinical orientation and the goal of addressing practical clinical issues. In addition to novel drugs for drug-resistant tuberculosis, its pipeline also includes therapies capable of rescuing patients who have failed PD-1 treatment.World’s First Tumor Immunotherapy + Anti-Tumor Angiogenesis DrugJDB153，Highly Selective BTK Inhibitor with Excellent Blood-Brain Barrier PenetrationJDB175，The World's Only Colony-Stimulating Factor Inhibitor Validated by PDX ModelsJDB383, among others. In the future, Jiabao Yaoyin will continue to deepen its focus on the fields of infectious diseases, oncology, and autoimmune disorders. Leveraging the extensive drug development expertise and efficient clinical translation experience of its core team, the company will rapidly advance its various drug pipelines to deliver high-quality therapeutics to patients.