Grand Pharma’s (0512.HK) innovative radionuclide-drug conjugate (“RDC”), GPN01530, has recently been approved by the United States Food and Drug Administration (“FDA”) to conduct a Phase I/II clinical study for the diagnosis of solid tumors.
GPN01530 is a small molecule RDC drug that targets fibroblast activating protein (“FAP”). FAP is one of the important markers of cancer-associated fibroblasts (“CAFs”), participating in processes such as extracellular matrix remodeling, regulation of tumor cell proliferation, and tumor immunosuppression, thus promoting tumor growth and invasion. It is a novel and specific target for tumor diagnosis and treatment. Studies have shown that FAP is not expressed or is expressed at low levels in normal tissues, but is highly expressed in 90% of epithelial tumor tissues and CAFs in various tumor microenvironments. Specifically targeting FAP, GPN01530 offers new possibilities for the diagnosis and treatment of various malignant tumors.
Serilink participated in the early research and development of GPN01530, providing solid scientific and technical support for discovery and the establishment of the Preclinical Candidate (PCC).
By integrating Grand Pharma’s its radiochemical labeling platform and animal molecular imaging platform at the Chengdu Radiopharmaceutical with Serilink expertise in medicinal chemistry and conjugated drug (XDC) development, both teams worked together to accelerate the clinical translation of radionuclide drug conjugates.
The IND approval of GPN01530 project by FDA into the clinical research stage demonstrates Serilink’s capabilities and advantages in the early research and development of conjugated drugs. Looking ahead, Serilink will continue to engage in the research, development, and translation of conjugated drugs, with the aim to speed up patients’ access to better treatments and achieve better therapeutic outcomes.
About Grand Pharma
Grand Pharmaceutical Group Limited ("Grand Pharma", HKEx: 0512) is an international pharmaceutical company of technological innovation. Its core businesses cover three major areas, namely nuclear medicine anti-tumor diagnosis and treatment and cerebrocardiovascular precision interventional diagnosis and treatment technology, pharmaceutical technology and biotechnology. Based on the pharmaceutical and biological industries, Grand Pharma focuses on the needs of patients, and takes technological innovation as the driving force. In response to the unmet clinical needs, Grand Pharma will increase its investment in global innovative products and advanced technologies, enrich and improve its product pipelines, consolidate and strengthen its industrial chain layout, and fully leverage the Grand Pharma’s industrial strengths and R&D capabilities to provide more advanced and diverse treatment solutions to patients worldwide.
About Serilink
Serilink Biotechnology Company Limited ("Serilink"), established in 2022, is located at the Hong Kong Science Park. The company was founded by Professor Xuechen Li, Associate Dean of the Faculty of Science and Chair Professor of the Department of Chemistry at the University of Hong Kong. Serilink was selected and accepted in for the Incu-Bio Programme by the Hong Kong Science and Technology Parks Corporation (HKSTP). The company has also received funding from the Technology Start-up Support Scheme for Universities (TSSSU) under the Innovation and Technology Commission for three consecutive years. Serilink is dedicated to building a leading conjugation technology platform to facilitate the development of various conjugated drugs (XDCs). The company aims to provide patients with better and more effective treatments while contributing to the growth of Hong Kong's biomedical industry.