On November 24, 2024, Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (hereinafter referred to as " Hanx Biopharmaceuticals ") from Wuhan, Hubei, reported the company submitted a prospectus to the Hong Kong Stock Exchange, intending to list on the main board of Hong Kong through an IPO (Press release, HanX Biopharmaceuticals, NOV 25, 2024, View Source [SID1234655966]).
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Hans Biotech , an innovative biotechnology company with proprietary expertise and experience in structural biology, translational medicine, and clinical development, is dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class products for the precision treatment of cancer and autoimmune diseases, addressing global unmet medical needs. The company acquired an equity stake in Hangzhou Hans Biotech in 2017 and has since focused on proven therapeutic mechanisms.
As of November 18, 2024, Hans-Etienne has developed a pipeline of 10 drug candidates (eight in oncology and two in autoimmune disease in clinical or preclinical development) , including its core product HX009 (an independently developed PD-1/SIRPα bifunctional antibody fusion protein) , two key products HX044 and HX301, and seven preclinical-stage drug candidates, including antibody-drug conjugates, bsAbs, and mAbs, targeting the autoimmune and oncology markets. Hans-Etienne ‘s pipeline development strategy is based on validated targets and pathways, supported by molecules with unique target biology, translational evidence, clinical feasibility, and druggable structures. The company is positioned to provide next-generation immuno-oncology therapies, such as HX009, HX044, and HX016, to combat PD-1 resistance; first-in-class ADC molecule HX111, for the precision treatment of specific malignancies; and novel autoimmune therapies, such as the bsAb bifunctional antibodies HX035 and HX038.
Hansaitai ‘s core product, HX009, is an independently developed PD-1/SIRPα bifunctional antibody fusion protein. Phase I clinical trials for HX009 have been completed in Australia and China. The company is currently conducting two HX009 clinical programs in China: the HX009-I-01 China study (Phase Ib) for the treatment of advanced melanoma, and the HX009-II-02 China study (Phase I/II) for the treatment of R/R EBV+ non-Hodgkin’s lymphoma.
The two main products, HX301 and HX044, are in the clinical stage and focus on the treatment of cancer. HX301 is a multi-target kinase inhibitor targeting key pathways such as CSF1R, ARK5, FLT-3 and CDK4/6. Hans Aita has completed the Phase I clinical study of HX301 approved by the National Medical Products Administration, and plans to conduct a Phase II clinical study of HX301 in combination with temozolomide for the treatment of glioblastoma. HX044 is a novel dual-functional anti-CTLA-4 antibody SIRPα fusion protein designed to enhance the targeted efficacy of CTLA-4. Currently, the company is initiating a Phase I/IIa clinical study in Australia for the treatment of advanced solid tumor malignancies and has obtained the National Medical Products Administration’s acceptance notice for its clinical research in China.