Boji Biopharma Announces FDA Clearance for Global First-in-Class Tumor-Targeted IL-15 Fusion Protein BJ-001 to Enter Clinical Trials

VCBeat (WeChat ID: vcbeat) has learned that Boji Biopharmaceutical Technology (Hangzhou) Co., Ltd. recently announced that its independently developed and globally patented world’s first tumor-targeted IL-15 fusion protein (product code: BJ-001) received notification from the U.S. FDA just 28 days after submission, granting approval to conduct clinical trials in the United States.

IL-15 is a pleiotropic cytokine that plays a central role in the development, survival, and activation of NK, T, and B cells. IL-15 not only increases the numbers of NK cells and T cells but also activates NK cells and cytotoxic CD8+ T cells, thereby enabling them to kill tumors and other pathogens. Consequently, IL-15 holds significant therapeutic potential in the fields of oncology and infectious diseases. It ranked first among the 20 tumor immunotherapy drugs recommended by the U.S. National Cancer Institute (NCI) in 2008, a list that included PD-1 inhibitors.

Although recombinant IL-15 has demonstrated antitumor effects in animal studies and shown efficacy in pulmonary metastases of melanoma in first-in-human trials, its short half-life and other drawbacks remain major obstacles to its druggability. BJ-001, the world’s first tumor-targeted IL-15 fusion protein, independently developed and globally patented by Boji Biopharmaceuticals, not only overcomes the limitation of the short half-life of recombinant IL-15 but, more importantly, leverages its tumor-targeting capability to enable IL-15 enrichment in tumors with high target expression, thereby reducing systemic toxicity and enhancing therapeutic efficacy.

Furthermore, IL-15’s ability to promote lymphocyte proliferation within the tumor microenvironment holds the potential to convert “cold tumors,” which are unresponsive to currently common immunotherapies such as anti-PD-1 antibodies, into responsive “hot tumors.” This would significantly enhance the efficacy of existing cancer immunotherapy drugs, benefiting a larger patient population. Therefore, Boji Biopharma’s tumor-targeted IL-15 is poised to emerge as a promising new candidate in cancer immunotherapy. The fact that the U.S. FDA granted early clearance for clinical trials upon initial application further underscores its recognition of the product’s quality and safety.

Regarding the FDA’s accelerated approval of BJ-001, Dr. Zhang Haizhou, Co-founder and CEO of Boji Biopharmaceuticals, stated: “The entry of BJ-001 into clinical trials in the United States marks our company’s transition into the clinical development stage, representing a significant milestone for us. As a biotechnology company based in China, oriented toward the global market, and centered on independent innovation, our goal is to advance one fully innovative product into clinical research every one to two years, thereby providing more innovative therapeutic options for patients in China and around the world.”

Dr. Zhang Haizhou, Co-founder and CEO of Boji Biologics

Although it has been in operation for less than two years, Boji Biopharma, adhering to its philosophy of developing only globally original innovative drugs, has begun to lay out its portfolio in oncology and infectious diseases by leveraging its biologic drug R&D platform protected as trade secrets. BJ-001, which has recently received approval to enter clinical trials, is one of the many innovative products in its R&D pipeline. Prior to this, Boji Biopharma had already initiated collaborations with partners to establish an immunohistochemistry (IHC) assay for BJ-001 and develop a companion diagnostic kit, aiming to provide more precise treatments for cancer patients through the means of precision medicine.

Boji Biopharmaceuticals is a biotechnology company dedicated to the research and development of innovative drugs. It was founded by overseas-returning experts with extensive experience in innovative drug R&D both in China and abroad, including review experts from the National Science and Technology Major Project for "Major New Drug Creation." The company possesses an antibody discovery platform protected by trade secrets and boasts top-tier technologies both domestically and internationally. Currently, its primary focus is on developing biologics for the treatment of cancer and infectious diseases.

The company’s core scientific research and management teams possess many years of experience in antibody drug development and management, gained at R&D companies and key national research institutions both domestically and internationally, particularly within multinational corporations in Europe and the United States. With a global perspective on R&D and backed by strong capital support, Boji Biopharmaceuticals established a global R&D layout from its inception. By operating two R&D laboratories—one in San Francisco, USA, and the other in Hangzhou, China—the company has achieved comprehensive integration of talent, technology, management, and capital markets during its early stages, laying a solid foundation for its global positioning and future development.