TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

HanX Biopharmaceuticals announces HX009 IND approval from FDA

Tuesday, May 23, 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."

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit