Grand Pharma’s (0512.HK) innovative radionuclide-drug conjugate (“RDC”), GPN01530-2, has recently been granted Fast Track Designation (“FTD”) by the United States Food and Drug Administration (“FDA”) for diagnosis of solid tumors.
Earlier cleared by the FDA for a Phase I/II clinical study in solid tumor diagnosis, GPN01530-2 exploits the unique expression profile of fibroblast activation protein (“FAP”): while virtually absent in normal tissues, it is highly overexpressed in 90% of epithelial tumor tissues and cancer-associated fibroblasts (CAFs). Because FAP actively drives tumor proliferation, tissue remodeling, and immunosuppression, GPN01530-2’s ability to specifically target FAP opens promising new possibilities for the effective diagnosis and treatment of diverse malignant tumors. Preclinical studies results showed that GPN01530-2 achieves more rapid tumor targeting, higher uptake, and superior pharmacokinetic properties than competing FAP-targeted ligands. Additionally, ongoing investigator-initiated trials (IITs) confirmed its favorable safety profile, swift background clearance, and prolonged high-level tumor uptake. Crucially, GPN01530-2 provides sharper image contrast and a higher positive lesion detection rate than standard clinical PET/CT imaging agents.
Serilink supported the early R&D of GPN01530-2, providing robust scientific and technical support for lead discovery and preclinical candidate (PCC) establishment. By combining Grand Pharma’s radiochemical labeling and animal molecular imaging platforms at its Chengdu facility with Serilink’s expertise in medicinal chemistry and conjugated drug (XDC) development, the two teams worked together to accelerate the clinical translation of radionuclide drug conjugates (RDCs).
The FDA's decision to grant Fast Track Designation to the GPN01530-2 project not only showcases Grand Pharma’s comprehensive capabilities in cutting-edge radiopharmaceutical platform construction, international clinical development, and regulatory filings, but also serves as a recognition of Serilink’s technology platform for early drug discovery and its expertise in preclinical molecular design and optimization. Looking ahead, Serilink anticipates forging deeper collaborations within the industry, leveraging synergistic strengths to accelerate drug development timelines. Serilink will continue to advance the R&D and clinical translation of conjugated drugs, aiming at delivering more high-quality therapeutic options to patients worldwide sooner.
About FDA Fast Track Designation
FDA Fast Track designation is a regulatory process that accelerates the development and review of novel therapies aimed at serious or life-threatening conditions with substantial unmet medical needs. The designation enables closer collaboration and more frequent communication with the FDA, while offering potential eligibility for Rolling Review and Priority Review to significantly streamline the path to market approval.
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.