Boji Biopharma Files for IPO, Highlighting Two Dual-Targeted Oncology Candidates Approved for Clinical Trials in Both China and the U.S.

“The oncology treatment market is enormous, but this field is also crowded. There are numerous anti-tumor drug projects, with even more monoclonal antibody (mAb) projects; according to Clarivate’s database, there are approximately 1,400 mAb candidates and over 600 bispecific antibody (BsAb) candidates.”Dr. Zhang Haizhou, Co-founder and CEO of Boji BioSo it was said.

According to Frost & Sullivan data, the global market size for anti-tumor drugs grew from $110.6 billion in 2017 to $143.5 billion in 2019, and is projected to reach $199.2 billion by 2022. In 2020, the market size for anti-tumor drugs in China also reached RMB 145.874 billion, indicating substantial market potential.

“Bispecific antibodies,” which target two distinct antigens, offer multiple advantages over monoclonal antibodies in certain diseases and therapeutic areas, and are therefore regarded as the second generation of antibody therapies. Due to the rapid advancement of genetic engineering technologies in recent years, bispecific antibodies have become a focal point in the development of treatments for numerous conditions, including cancer, inflammation, viral infections, and autoimmune diseases.

Dr. Zhang Haizhou stated, “We started our venture in 2017, when no PD-1 inhibitors had yet been launched in China. Although we had antibodies targeting PD-1/PD-L1, LAG3, and TIGIT, we abandoned the development of monoclonal antibodies in favor of differentiated bispecific antibodies, including bifunctional antibodies and bispecific antibodies, after considering product differentiation as well as future market and commercialization prospects.”

Boji Biopharmaceuticals is a biotechnology company dedicated to the research and development of innovative drugs. Adhering to the philosophy of developing globally competitive, independently innovated pharmaceuticals, and leveraging its proprietary high-throughput screening platform for macromolecular drugs, the company is committed to developing novel biologics for the treatment of immune-related diseases, providing patients with cancer, autoimmune disorders, and infectious diseases with cutting-edge and highly effective therapeutic solutions.

The core team members of Boji Bio possess extensive experience across all stages of new drug development, offering highly complementary skill sets and industrialization expertise. The primary scientific and management teams have many years of experience in R&D and management of antibody-based therapeutics at domestic and international R&D companies and national key research institutions, particularly within multinational corporations in Europe and the United States.

Co-founder and CEO Dr. Haizhou Zhang is a senior expert in the field of drug R&D, with extensive experience in both preclinical and clinical drug development. Dr. Zhang holds a Bachelor of Medicine and a Master of Medicine from Beijing Medical University, as well as a Ph.D. in Toxicology from Indiana University, USA. He previously served as a core member of the management team at Roche R&D (China) Ltd. and as a member of its Product Pipeline Management Committee, while also concurrently serving on Roche’s Global Non-Clinical Drug Safety Committee.

Over more than two decades in drug development, Dr. Haizhou Zhang has led and participated in the regulatory submissions of multiple clinical-stage and marketed products. He has extensive experience engaging with regulatory authorities in various countries, including the U.S. FDA and China’s CFDA, particularly in the area of drug safety assessment.

Zhang Haizhou is also an expert in the National Major Project for New Drug Innovation and Development Expert Database. He has participated in multiple reviews of major new drug projects, serves as an expert for the Center for Drug Evaluation (CDE) guidelines, and has contributed to the drafting of several domestic guidelines. He possesses extensive knowledge of China’s drug R&D capabilities and overall development trends.

In 2017, Boji Biologics was registered in Yuhang District, Hangzhou. With a global R&D vision and robust capital support, Boji Biopharmaceuticals adopted a global R&D layout from its inception, establishing two research laboratories in San Francisco, USA, and Hangzhou, China. This strategy enabled the company to integrate talent, technology, management, and capital markets comprehensively during its early stages, laying a solid foundation for its global positioning and development.

Zhang Haizhou stated that in the field of immuno-oncology R&D, a large number of products are in clinical development globally, and combination therapy represents the prevailing trend in this area.The company’s two products currently in clinical development, BJ-001 and BJ-005, also demonstrate excellent synergistic effects in antitumor therapy.

BJ-001 is the world’s first tumor-targeted IL-15 fusion protein independently developed by the company., its domains contain targeting molecules that bind to integrins such as αvβ3, αvβ5, and/or αvβ6, enabling targeted therapy for tumors with high expression of these integrins. Its IL-15/IL-15Rα sushi domain can bind to the IL-2/15Rβγc receptor complex expressed on immune cells (particularly NK cells), thereby activating the immune system and exerting anti-tumor effects.

This design of BJ-001 enables its accumulation in the tumor microenvironment, thereby holding the potential to reduce systemic toxicity and enhance anti-tumor 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 commonly used immunotherapies such as anti-PD-1 antibodies, into responsive “hot tumors.” This would significantly improve the efficacy of existing cancer immunotherapy drugs and benefit a larger number of patients. Therefore, Boji Biopharma’s tumor-targeted IL-15 is poised to emerge as another promising candidate in cancer immunotherapy.

Zhang Haizhou stated, “This is our first product. It entered clinical trials in December 2019 and has currently completed the highest clinical dose originally designed. The pharmacological effects met expectations, and preliminary clinical efficacy was observed. Safety and tolerability were better than anticipated, so we amended the protocol to add three higher dose levels, thereby providing greater dosing flexibility for subsequent clinical development. This is the current status of the project.”

The Company's Second Self-Developed ProductBJ-005 received clinical approval from the U.S. FDA in June 2021 and obtained clinical approval in China in September of the same year.

BJ-005 is a recombinant bifunctional fusion protein composed of a humanized anti-programmed death-ligand 1 (PD-L1) IgG1 monoclonal antibody fused to a portion of the extracellular domain of human transforming growth factor-beta (TGF-β) receptor II. It simultaneously targets PD-L1 and TGF-β, inhibiting tumor growth by targeting immune checkpoints and modulating cytokine pathways involved in tumor cell proliferation, for the treatment of patients with cancer.

Zhang Haizhou stated, “Our second product was developed primarily with the aim of being used in combination with the first product to achieve enhanced therapeutic efficacy. Since PD-L1 is mainly expressed on tumor cells, BJ-005 also exhibits tumor-targeting properties. This product primarily acts on T cells within the tumor microenvironment, whereas BJ-001 primarily targets NK cells.”When both molecules are present within the tumor microenvironment, they exert enhanced antitumor effects through synergistic interaction., our animal experiments also demonstrated this.”

Boji Biologics selects diverse targets and employs varied modalities and mechanisms for projects at different stages of development to mitigate R&D risks and enhance success rates.Enhancing efficacy and reducing toxicity through a proprietary bispecific antibody platform, for which a PCT patent application has been filed.

The development of bispecific antibody drugs in China is booming, with rapid technological iteration.In Zhang Haizhou’s view, the biggest challenge in the development of bispecific antibody drugs lies not in technology, but in biology.“It is not the case that any combination of two antibodies is inherently beneficial. Critical considerations include how to select targets and whether the complementarity between the targets and mechanisms of action offers superior efficacy compared with the combined use of two separate antibodies. Only bispecific antibodies that effectively address issues related to mechanisms of action and target selection can be considered truly effective.”

Zhang Haizhou explained that bispecific antibody designs currently available on the market face at least two major challenges. First, once the two antibody components are determined, it is difficult to further adjust their biological activity. Second, although bispecific antibodies, as artificially engineered functional antibodies, offer more advantages than monoclonal antibodies, their design and production present greater difficulties compared with natural antibodies. In particular, chain mispairing issues often arise during the chemistry, manufacturing, and controls (CMC) phase, resulting in low yields.

The company’s unique bispecific antibody platform can address challenges in both areas. ThroughSpecific Mechanisms Address Activity Modulation After Antibody Determination, thereby enhancing the binding ratio of bispecific antibodies in tumor versus normal tissues to increase efficacy and reduce toxicity. SecondlyThe production process is relatively simple, with no mismatch issues, resulting in higher yields and lower production costs.

During the interview, Zhang Haizhou referred to Boji Biopharma as an “outlier” company.

“First, the ‘oddity’ lies inOur primary goal is to become a profitable company.Biopharmaceutical R&D is a capital-intensive process. We not only emphasize cost control but also strive to accelerate the progression of our products from development to market launch, with the goal of becoming a profitable biotechnology company. The second “unique aspect” is that, apart from the angel round of financing, the company has not raised any additional funds. Since commencing formal operations in 2018, we have sustained our business for over three years solely through loans from angel investors. This demonstrates the confidence our angel investors place in us and further underscores our strong belief in our products. We are confident in licensing partial rights of our projects to larger companies, and such revenue streams represent one of the pathways toward achieving our goal of profitability.

Zhang Haizhou also revealed the company’s future plans. “We are preparing for an initial public offering (IPO) on China’s STAR Market. The fifth set of listing criteria of the STAR Market aligns closely with our philosophy, as core competitiveness, innovation capability, and profitability have been our fundamental priorities since inception. We are now initiating fundraising efforts to lay the groundwork for our subsequent IPO on the STAR Market.”

“As a company that prioritizes profitability as its ultimate goal, we place greater emphasis on how to reward investors and the capital market during our fundraising process. Therefore, we will continue to adhere to the principle of living within our means and controlling costs in our operations. This could be considered another aspect of our ‘unconventional’ approach.”

In 2022, Boji Biopharma plans to relocate its R&D headquarters to the Lingang Blue Bay Industrial Park in Shanghai, where it will establish its own pilot-scale and R&D facilities. In the future, the company intends to build an international R&D headquarters and production base. Leveraging its proprietary dual-specific antibody technology platform, Boji Biopharma aims to advance at least one to two bispecific antibodies into clinical trials by 2023, pursue an initial public offering (IPO) on the STAR Market in 2024, and submit a Biologics License Application (BLA) to achieve product commercialization. By 2026, the company plans to launch its second product, striving to secure approval or market launch of one product every two years, thereby advancing toward its ultimate goal of becoming a sustainably profitable enterprise with international competitiveness while being based in China.