Huahai Pharmaceutical Subsidiary Receives FDA IND Approval for Novel ADC HB0052 Targeting CD73 in Advanced Solid Tumors

Our Staff Reporter Wu Wenjing

On the evening of November 5, Huahai Pharmaceutical announced that its subsidiary, Shanghai Huaota Biopharmaceutical Co., Ltd. ("Huaota"), had received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of HB0052 Injection for advanced solid tumors.

It is reported that 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. Currently, no drugs targeting CD73 have been marketed globally, with the earliest ones in Phase III clinical trials. The indications under development include solid tumors, non-small cell lung cancer, breast cancer, pancreatic cancer, prostate cancer, etc.

Huahai Pharmaceutical stated that HB0052 has tremendous potential to become a new generation of cancer treatment drug. Preclinical animal model studies have shown excellent anti-tumor effects of HB0052; preclinical pharmacokinetic results conducted in non-human primates demonstrated that HB0052 exhibits linear pharmacokinetic characteristics, with 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.

Deng Zhidong, General Manager of Hainan Boao Medical Technology Co., Ltd., told the Securities Daily reporter that the approval of the drug's clinical trial application indicates that the drug has demonstrated safety and efficacy in the pre-clinical research phase and possesses promising application potential and clinical value. The drug is mainly used for the treatment of solid tumors and belongs to a class of innovative drugs. Currently, there are no CD73-targeted drugs on the market globally, and this drug has a large patient population and market prospects.

Yu Fenghui, a specially invited researcher of the China Financial Think Tank, told the Securities Daily that anti-tumor new drugs are currently one of the hotspots in the global pharmaceutical R&D field. The fact that Huaota has been approved to conduct clinical trials demonstrates the company's technical and R&D capabilities in this field. If this new drug is approved for marketing in the future, it will also bring economic benefits and competitive advantages in the market to Huahai Pharmaceutical.

To date, Huahai Pharmaceutical has invested approximately 38.75 million yuan in the HB0052 project. The company stated that it will strictly adhere to the requirements of the approval document to conduct clinical trials, and after the completion of the clinical trials, it will submit a clinical trial report and related documents to the U.S. FDA for the application of a production registration certificate.

Yu Fenghui stated that the biggest challenges faced by China's pharmaceutical companies in moving towards innovative drug development are technical barriers and financial pressure. The development of innovative drugs requires advanced technology and R&D capabilities, which demand substantial financial investment and long-term technical accumulation. During this process, they also need to face strict approvals and regulations, further increasing the R&D costs and risks.

Huahai Pharmaceutical also mentioned that the research and development of pharmaceutical products, including clinical trials as well as the cycle from registration application to industrial production, is relatively long with many stages. It is subject to various uncertain factors such as technology and review, and the competitive landscape of future products will also change. The company will closely monitor the actual progress of the drug registration application and make disclosures accordingly.

It is reported that in the field of drug research and development, Huahai Pharmaceutical focuses on a diversified R&D pipeline layout. Its subsidiary, Huaota, is deeply engaged in the independent R&D of large-molecule biologic innovative drugs in the fields of autoimmune diseases and oncology. In addition to the aforementioned projects, it has 11 R&D projects that have entered the clinical stage, including the self-developed HB0034 project, China's first domestically produced antibody targeting IL-36R; and the HB0025 project, a globally leading bispecific fusion protein targeting PD-L1/VEGF. At the same time, Huaota actively advances early-stage projects with differentiation and innovation, such as combination therapies and ADCs (antibody-drug conjugates), focusing on unmet clinical needs.

Huahai Pharmaceutical stated that the company has an innovative R&D system aligned with international standards, with capabilities in developing high-end generic drugs such as solid sustained-release and controlled-release formulations, complex injectables, solubility enhancement for poorly soluble drugs, first-to-market generics, and patent-challenging products, as well as biologics and innovative drugs. The company effectively achieves interaction and integration of information, talent, technology, and other R&D resources.

Since the beginning of this year, Huahai Pharmaceutical has made significant progress in drug development. In the fourth quarter alone, in addition to the aforementioned HB0052 being approved for clinical trials, on October 17, Huahai Pharmaceutical announced that Huaota's product HB0034 injection (anti-IL-36R monoclonal antibody) received orphan drug designation from the U.S. FDA for the treatment of generalized pustular psoriasis. Orphan drugs, also known as rare disease drugs, refer to pharmaceuticals used for the prevention, treatment, and diagnosis of rare diseases.