Huaota Biopharma Submits IND Application for First-in-Class CD73-Targeting ADC HB0052 in China

Feb 22, 2024 17:02 CST Updated 17:02

Huaota

Biological New Drug Developer

On February 22, the official CDE website showed,Huaota's Submission of Clinical Trial for Injectable HB0052 Accepted。

HB0052

HB0052 is the first antibody-drug conjugate developed on Huaota's antibody-drug conjugate platform, using a topoisomerase inhibitor as the payload and targeting the CD73 antigen.This ADC molecule can simultaneously exert the immune system regulatory function mediated by antibodies and the cytotoxic effects of small-molecule toxins on tumor cells, demonstrating a synergistic anti-tumor effect.

Preclinical animal model studies show that HB0052 has excellent anti-tumor effects.; Preclinical pharmacokinetic studies conducted in non-human primates showed that HB0052 exhibited linear pharmacokinetic characteristics, good plasma stability, low non-specific shedding levels, a long half-life, and satisfactory pharmacokinetic properties; toxicology studies indicated that HB0052 has good safety and tolerability.

November 6, 2023, Huahai Pharmaceutical announced that its subsidiaryShanghai Huaota Biopharmaceutical Co., Ltd.(hereinafter referred to as "Huaota") received FDA approval for injectableHB0052 for the New Drug Clinical Trial (IND) Application in Advanced Solid Tumors. This is Huaota BioThe First ProductAntibody-drug conjugate projects approved by the FDA for clinical entry.HB0052 is expected to become a new generation of cancer treatment drug.

Mechanism Diagram of ADC Drugs Against Tumors

Huaota Biopharmaceutical

Huaota Biopharmaceuticals is a biologics company focused on the independent development of novel drugs with a global perspective. Specializing in the research and development of biologics for oncology, autoimmune diseases, and fundus disorders, the company currently has 11 projects in clinical stages: including an IL-36R monoclonal antibody for generalized pustular psoriasis (a rare disease), which is about to enter pivotal Phase II trials as the first locally developed drug 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 dual-mechanism cytotoxic agent targeting difficult-to-treat cancers such as pancreatic cancer.

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