Mablink Bioscience Congratulates Hua Medicine on FDA Clearance of HB0052, a First-in-Class CD73-Targeting ADC, for Clinical Trials
Huaota
Biological New Drug Developer
11On the 3rd of the month, Shanghai Huaota Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huaota") announced that it had received a notification from the U.S. FDA, approving its third-generation antibody-drug conjugate (ADC) project targeting the CD73 antigen, HB0052, to enter clinical trials. As the pharmaceutical research partner for Huaota's HB0052 project, Yantai Maibairui International Biomedical Co., Ltd. (hereinafter referred to as "Maibairui") congratulated HB0052 on its successful approval.
Public data shows that HB0052, as a First-in-Class innovative immunosuppressive target ADC with a topoisomerase inhibitor as its payload, can simultaneously exert antibody-mediated immune system regulation functions and the cytotoxic effects of small molecules on tumor cells. It demonstrates favorable CMC characteristics and significant anti-tumor activity, with the potential to bring clinical benefits to a wide range of cancer patients, especially those who are resistant or unresponsive to PD-1/PD-L1 inhibitor treatments.
Dr. Zhu Xiangyang, CEO of Huaota, pointed out: "Maibairui completed the CMC research work from process development to IND application for the HB0052 project. Maibairui’s one-stop service has left a deep impression on us. Meanwhile, their professional and efficient service provided strong support for the smooth FDA approval of this project to carry out clinical trials. Thanks to the Maibairui team for their contribution to the HB0052 project."
It is reported that the HB0052 project is the 17th ADC project for which the MabPion team has completed pharmaceutical research and obtained clinical trial approval. This project utilizes a Linker-Payload with independent intellectual property rights owned by MabPion. Dr. Li Xinfang, CEO of MabPion, stated: "We are very honored to provide CMC one-stop services for the HB0052 project, supporting Huaota's development of new oncology drugs. Over the years, MabPion has gained recognition from numerous clients due to its advanced technology R&D platform, leading international quality system, and integrated CDMO service model. In the future, MabPion will continue to leverage the advantages of various platform technologies to provide comprehensive solutions for clients, contributing to the vigorous development of China’s biopharmaceutical industry and making greater contributions to human health and well-being."
Shanghai Huaota Biopharmaceutical Co., Ltd. is a biopharmaceutical company focused on the independent development of novel drugs with a global perspective. Specializing in the research and development of biological drugs for cancer, autoimmune diseases, and fundus disorders, the company currently has 11 projects in clinical stages: including an IL-36R monoclonal antibody for pustular psoriasis (a rare disease), which is about to enter pivotal Phase II trials as the first domestically developed drug of its kind in China; a PD-L1/VEGF bispecific antibody already in Phase II clinical trials, showing promising signals in endometrial cancer and renal cell carcinoma; and a core project featuring CD73-ADC, the first drug with dual killing mechanisms targeting difficult-to-treat cancers such as pancreatic cancer.
Yantai Maibairui International Biomedical Co., Ltd. is a CDMO company focused on the biopharmaceutical field, specializing in providing professional, customized, and integrated CDMO services for biologics such as monoclonal antibodies, bispecific antibodies, multi-specific antibodies, fusion proteins, antibody-drug conjugates, recombinant vaccines, and recombinant proteins. It is one of the few companies globally capable of offering end-to-end CDMO services for antibody-drug conjugates. Currently, Maibairui has completed pharmaceutical research and received approval to conduct clinical trials for 48 projects, with several antibody and ADC projects expected to submit BLAs within this quarter.
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