HanX Biopharmaceuticals announces HX009 IND approval from FDA

WUHAN,China,May 22,2023 --Hanx Biopharmaceuticals,Inc. (HanxBio),announced that the company has received Investigational New Drug (IND) approval to start clinical trial of the potentially first-in-class recombinant anti-CD47/PD-1 bispecific antibody (BsAb),HX009,in Patients with relapsed/refractory Lymphoma. This is a Phase IB/II clinical study to be conducted in the United States to evaluate HX009 in the treatment of lymphoma patients who have failed standard therapy.

This is another important milestone of HX009 development as well as in the company's drug development program. HX009 has been studied in Australia and China in both solid tumor and lymphoma indications. The approval by FDA to start clinical trial in US strengthens the development of HX009 globally,and enhances the company's position in the field of bispecific antibody research.

Dr. Lei Zhang,CMO of HanxBio,said: "We are very pleased that our HX009 program has received clinical trial research approval from the US FDA. Although immune checkpoint inhibitors (ICIs) have shown great promises in a wide range of oncology indications,there still remains many challenges including in lymphoma. Therefore,it is of great value to develop the next generation of ICIs,including BsAb,such as dual targeting CD47 and PD-1 BsAb like HX009. We look forward to rapidly advancing the clinical development of HX009,bringing new treatment options to patients to meet unmet medical needs."

About HANX BIOPHARMACEUTICALS,Co.,Ltd.

Hanx Biopharmaceutical Co.,Ltd. is a global biopharmaceutical company that develops innovative immune-oncology antibody drugs. It brings together well-known experts,from both China and United States,from early discovery,process development,business development,to clinical research. The company leverages expertise to develop proprietary and novel cancer therapies,including innovative treatments such as novel BsAb antibodies to address significant unmet medical needs,and to help patients around the world. The company aims to accomplish goal through in-house research development as well as external global collaborations.

ABOUT HX009

HX009 is the global first-in-class bispecific PD-1/CD47 antibody developed by HanxBio. Phase I clinical studies have been conducted in Australia and China. The company is expanding the next phase clinical development globally in various clinical indications.