ZhiKang Hongyi and AstraZeneca Dose First Patient in Phase Ib/II Trial of TIM-3 Antibody BC3402 Combined with PD-L1 Inhibitor Imfinzi for Advanced Hepatocellular Carcinoma

Liver cancer is one of the most common cancers in China, with 410,000 new cases each year (accounting for 50% of the global total) and 390,000 deaths, posing a serious threat to the lives and health of the Chinese people. Over the past few decades, the incidence and mortality rates of liver cancer in China have shown a downward trend, but the five-year survival rate for liver cancer patients remains at only 7%.

Studies have shown that TIM-3 is highly expressed in drug-resistant tumors such as liver cancer and lung cancer after PD-1/PD-L1 treatment. Simultaneously inhibiting PD-1/PD-L1 and TIM-3 can prevent T-cell exhaustion and enhance anti-tumor effects. BC3402 has demonstrated strong synergistic effects with PD-1 or CTLA-4 in preclinical and translational medicine research. Combined with the positive performance of previous and ongoing clinical trials, BC3402 shows great potential to become a BIC molecule.

With the extensive clinical development experience in oncology from Wuxi Zhikang Hongyi Biotechnology Co., Ltd. and AstraZeneca, as well as the excellent molecular advantages of BC3402, both parties will work together with researchers to rapidly advance this clinical study. The aim is to better address the urgent needs of liver cancer treatment and benefit patients worldwide as soon as possible.

BC3402 is a highly differentiated TIM-3 inhibitory humanized IgG4 subtype TIM-3 monoclonal antibody with high affinity. By optimizing protein epitopes, BC3402 can function in various solid tumors and hematological malignancies, offering broad clinical application scenarios and the potential to meet diverse clinical needs.

BC3402 has completed the Phase I clinical study for advanced solid tumors, demonstrating good safety and certain anti-tumor activity. It is currently conducting a Phase Ib/II clinical study in combination with Durvalumab for the treatment of advanced hepatocellular carcinoma, as well as a Phase Ib/II clinical study in combination with Azacitidine for the treatment of malignant hematological diseases.

"Better Medicine for Better Life" is the noble mission of Wuxi Zhikang Hongyi Biotechnology Co., Ltd.

Wuxi Zhikang Hongyi Biotechnology Co., Ltd. was founded in December 2017. The company focuses on patients and diseases, highly values the fundamental role of disease biology in new drug development, and prioritizes the research, clinical trials, and commercialization of "BIC/FIC" innovative drugs for diseases such as cancer and nephropathy.

Since its establishment, the company has laid out pipelines in various technological fields such as small molecule chemistry, monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADC). With an efficient R&D and operational model, seven novel drugs are currently in Phase I/II clinical trials, all led by top experts in the field as clinical principal investigators (PIs). The quality and progress of the clinical trials continue the advantages demonstrated during preclinical development, placing them at a globally leading level. BC3195, an antibody-drug conjugate targeting CDH3 exclusively developed by the company, has entered clinical trials simultaneously in China and the United States, further strengthening the company's oncology pipeline on a global scale. Additionally, the company has several first-in-class (FIC) ADCs and bispecific antibody products in preclinical development and Pre-IND stages.

Wuxi Zhikang Hongyi Biotechnology Co., Ltd. has assembled a core management team with a multidisciplinary background to lead the company’s full lifecycle R&D operations. It also has an operational team familiar with the market environments of both China and the United States, systematically ensuring the quality and efficiency of the company’s entire R&D process. The company will further strengthen the layout of new technologies and global commercialization to consolidate its leading comprehensive R&D capabilities and support the expansion into overseas markets.

Wuxi Zhikang Hongyi Biotechnology Co., Ltd. is striving to become "a rapidly growing leading biopharmaceutical company in China, with continuous innovation capabilities, core combination products, diversified innovative therapies, and deep commercialization capabilities" as its goal. It is committed to benefiting more patients worldwide and contributing to the new round of development in China's biopharmaceutical industry.