Hanx Biopharmaceuticals Begins Phase 1 Trial with First HX044 Patient Dosed

Hanx Biopharmaceuticals, a pioneering biotech firm based in Wuhan, China, has taken a significant step in its mission to develop cutting-edge immunotherapies. On December 30, 2024, the company dosed its first patient in Australia as part of a Phase 1 clinical trial for its novel drug candidate, HX044. This trial is aimed at patients with advanced solid tumors, marking a crucial progression in Hanx Biopharmaceuticals' research and development endeavors.

HX044 is an innovative bispecific antibody created by Hanx Biopharmaceuticals. It represents a new class of immune-checkpoint inhibitors tailored to tackle a broad spectrum of malignant tumors, particularly those resistant to PD-1 treatments. This includes cancers such as non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and various gastrointestinal cancers. As a next-generation CTLA-4 immunotherapy, HX044 seeks to widen the therapeutic window while enhancing safety and boosting antitumor immune responses, presenting a significant advancement in CTLA-4-focused therapies.

Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals, expressed enthusiasm about the initiation of the clinical study with the first patient. He emphasized that this milestone is a testament to the company's robust research and development capabilities and their dedication to addressing critical unmet medical needs. The company is committed to furthering this project with diligence, reflecting its dedication to advancing therapeutic options for patients.

Dr. Henry Li, CEO and CSO of Hanx Biopharmaceuticals, highlighted the attributes of HX044, which is a next-generation CTLA-4 bispecific antibody wholly developed by the company, from initial molecule design onward. The drug enhances Treg-depletion function within the tumor microenvironment using an effective cis-binding mechanism. This feature demonstrates strong efficacy against PD-1-resistant "cold" tumors in preclinical models, indicating the drug's superior therapeutic potential.

Hanx Biopharmaceuticals is renowned for its focus on structural biology, translational medicine, and clinical development. The company's mission is to develop next-generation immunotherapies that are safe, effective, and accessible, addressing the challenges posed by major diseases. With a commitment to innovation, Hanx Biopharmaceuticals seeks to discover and commercialize therapies that are First-in-Class and Best-in-Class, primarily targeting cancer and autoimmune diseases.

The company's ultimate goal is to meet unmet medical needs globally, contributing to the prevention, control, and elimination of diseases while enhancing global health outcomes. Through its pioneering efforts, Hanx Biopharmaceuticals aims to make significant contributions to global health initiatives, demonstrating its commitment to advancing medical science and offering new hope to patients worldwide.