#China #Beijing #Jacobio Pharma #BET Inhibitor #JAB-8263

Jacobio Pharma's EARLY BREAKTHROUGHS IN AUTOIMMUNE DISEASES

In a significant development for the treatment of autoimmune disorders, Jacobio Pharma has announced the acceptance of its Phase I/II Investigational New Drug (IND) application for JAB-8263, a novel BET inhibitor. The application, submitted to the Center for Drug Evaluation (CDE) in China, is part of the company's strategic effort to broaden its therapeutic portfolio beyond oncology into the realm of autoimmune diseases.

Impact of Autoimmune Diseases

Autoimmune diseases are known to affect approximately 5% to 9% of the global population, leading to a variety of health complications and impacting the quality of life. Current treatment options are largely focused on monoclonal antibodies administered intravenously, with oral alternatives being relatively scarce. Jacobio aims to change this landscape by introducing JAB-8263 as a promising oral treatment option.

Jacobio's CEO, Dr. Yinxiang Wang, emphasized the commitment to improving patient outcomes and expanding treatment options. "Through our internal translation research and discovery efforts, we are looking to enhance the therapeutic value of our BET inhibitor for a wider array of autoimmune diseases," stated Dr. Wang.

Previous Successes with JAB-8263

Before the recent IND acceptance, JAB-8263 had already undergone initial Phase I clinical trials that targeted solid tumors and hematological malignancies in both China and the United States. Noteworthy data presented at the 2024 American Society of Hematology (ASH) Annual Meeting demonstrated that the drug exhibited a favorable safety profile and good tolerability in human trials.

These early successes are critical as the drug transitions into the next stages of clinical testing, focusing on autoimmune diseases. The acceptance of the IND signifies that the CDE recognizes the potential benefits of JAB-8263 and is dedicated to evaluating it in a timely manner, with the review process expected to conclude within 30 working days.

Understanding JAB-8263

JAB-8263 is an orally administered, potent BET inhibitor that Jacobio Pharma has independently developed. Extensive studies have already evaluated its safety and pharmacokinetics during early-phase trials in both China and the United States, confirming its well-tolerated status. The favorable pharmacokinetic profile exhibited by JAB-8263 may play a critical role in its efficacy as a treatment for various diseases, including autoimmune conditions and cancers.

Jacobio Pharma's Vision

Jacobio Pharma has positioned itself as a forward-thinking entity in the biopharmaceutical sector, explicitly focusing on breakthrough treatments for patients suffering from complex health issues. Utilizing an induced allosteric drug discovery platform, the company primarily targets the KRAS pathway, aiming for significant advancements in the realm of drugs that combat previously undruggable targets.

With R&D centers located in key global cities such as Beijing, Shanghai, and Boston, Jacobio Pharma is strategically placed to undertake extensive clinical trials. Currently, clinical trials for the company's candidate drugs are being implemented at over 180 sites across China, more than 30 sites in the United States, and over 10 sites throughout Europe. This extensive network reinforces Jacobio's commitment to research and innovation in the pharmaceutical landscape.

Conclusion

As Jacobio Pharma moves forward with its JAB-8263 clinical trial, the company's dedication to tackling the challenges presented by autoimmune diseases may soon lead to revolutionary changes in treatment protocols. With regulatory acceptance and previous trial successes as a foundation, there is hope for enhanced treatment options for the millions affected by autoimmune conditions, further solidifying Jacobio Pharma’s promise in innovative healthcare solutions.