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Pharnex Cloud Data www.pharnexcloud.comMonitoring shows:Recently, Shanghai Huaota Biopharmaceutical Co., Ltd. and Huabio Biomedical Technology (Shanghai) Co., Ltd., subsidiaries of Huahai Pharmaceutical Co., Ltd., received the "Drug Clinical Trial Approval Notice" for HB0052 Injection issued by the National Medical Products Administration.

1. Basic Information of the Drug

Drug Name: HB0052 for Injection

Indications: Advanced Solid Tumors

Application No.: CXSL2400142

Dosage Form: Dry Powder Formulation

Application Item: Clinical Trial

Applicant: Shanghai Huaota Biopharmaceutical Co., Ltd., Huabo Biomedical Technology (Shanghai) Co., Ltd.

Conclusion: Approval for Clinical Trial

2. Other Relevant Information about the Drug

In November 2023, the U.S. Food and Drug Administration (FDA) approved the drug for clinical trials. Recently, the National Medical Products Administration (NMPA) has also approved the drug for clinical trials targeting advanced solid tumors.

As of April 29, the company has invested a total amount in the HB0052 project.R&D expenses approximately RMB 48.21 million。

Pharnex Cloud Data www.pharnexcloud.com; Timeline in China

HB0052 is the first antibody-drug conjugate developed on Huaota's ADC platform.Topoisomerase InhibitorsFor payload, targeting CD73 antigenThird-Generation Antibody-Drug ConjugatesThis ADC molecule can simultaneously exert antibody-mediated immune system regulation and the cytotoxic effects of small molecules on tumor cells, demonstrating a synergistic anti-tumor effect. Preclinical animal model studies have shown that HB0052 has excellent anti-tumor efficacy; preclinical pharmacokinetic studies conducted in non-human primates indicate that HB0052 exhibits linear pharmacokinetic characteristics, with good plasma stability, low non-specific release, a long half-life, and satisfactory pharmacokinetic properties; toxicology studies show that HB0052 has good safety and tolerability. HB0052 is expected to become a new generation of cancer treatment drug.

Currently, no drugs targeting CD73 have been marketed either in China or globally. Several monoclonal antibody projects are in clinical research stages, with indications under development including non-small cell lung cancer, breast cancer, pancreatic cancer, prostate cancer, and other solid tumors. Among them, Oleclumab (an anti-CD73 monoclonal antibody) developed by AstraZeneca is the most advanced, currently in Phase III trials for the treatment of unresectable NSCLC after concurrent chemoradiotherapy. HB0052, developed by Huaota, is the world’s second CD73-ADC drug to enter clinical trials.

Huaota Biopharmaceutical, a subsidiary of Huahai Pharmaceutical, is a biopharmaceutical R&D company that focuses on independent development and has a global perspective. Specializing in the R&D of biologics for oncology, autoimmune diseases, and fundus disorders, the company currently has 11 projects in clinical stages. These include an IL-36R monoclonal antibody, the first self-developed treatment in China targeting generalized pustular psoriasis (a rare disease), which has entered pivotal clinical trials; a PD-L1/VEGF bispecific antibody currently in Phase II clinical trials showing positive signals in multiple tumor types such as endometrial cancer, renal cell carcinoma, and advanced non-small cell lung cancer; and a CD73-ADC with dual cytotoxic mechanisms targeting difficult-to-treat cancers like pancreatic cancer.

Reference:

NMPA/CDE；

Pharnex Cloud Data www.pharnexcloud.com;

FDA/EMA/PMDA；

https://data.eastmoney.com/notices/detail/600521/AN202404291631597837.html;

Relevant companies public disclosure; etc.