GRANDPHARMA (00512.HK): Innovative RDC Drug GPN01530-2 Granted FDA Fast Track Designation for Diagnosis of Solid Tumors

NewTimeSpace News: Grand Pharmaceutical Group Limited (stock code: 00512) announced on August 9 that GPN01530-2, the Group's self-developed global innovative radionuclide drug conjugate (RDC) for the diagnosis of solid tumors, has recently been granted Fast Track Designation (FTD) by the US Food and Drug Administration (FDA). Candidate drugs granted FTD may be eligible for more frequent communications with the FDA, priority review (if relevant criteria are met) and rolling review of new drug applications, accelerating the development and marketing process. GPN01530-2 had previously been approved by the FDA to initiate a Phase I/II clinical study for the diagnosis of solid tumors, and this FTD milestone marks another important step in the Group's global R&D and regulatory layout for its nuclear medicine oncology diagnostics and therapeutics segment.

GPN01530-2 is a small-molecule RDC drug targeting fibroblast activation protein (FAP), which is highly expressed in 90% of epithelial tumor tissues and cancer-associated fibroblasts (CAFs) in various tumor microenvironments, making it a novel specific target for tumor diagnosis and treatment. The commonly used PET/CT imaging agent 18F-FDG has relatively low sensitivity (40% to 68%) and limited value in early tumor diagnosis; GPN01530-2 optimizes the structure of the FAP ligand, and preclinical studies show it features rapid tumor targeting, higher tumor uptake and superior pharmacokinetic properties. Investigator-initiated trial (IIT) human studies conducted to date have shown good safety, rapid background clearance and strong and durable lesion uptake, with better clinical image contrast and accurate detection rate of positive lesions compared with 18F-FDG.

According to the announcement, the early-stage research of the project was fully independently completed based on the radiolabeling platform and animal molecular imaging platform of the Group's Chengdu nuclear medicine base, with the production and release of the registration batch achieved through a GMP-compliant production line, making it the first self-developed product from the Chengdu nuclear medicine base to enter the FDA clinical stage since the base commenced operation. In terms of market prospects, the global radiopharmaceutical market grew from USD 5.0 billion in 2018 to USD 9.7 billion in 2024 (CAGR of 11.7%), and is projected to reach USD 57.3 billion by 2035; the China market grew from RMB 3.6 billion in 2018 to RMB 7.4 billion in 2024 (CAGR of 13.0%), and is projected to reach RMB 75.8 billion by 2035.

The Group cautioned that the above products are still in the R&D stage, and whether they can be approved for marketing and production and sales is subject to various factors, with significant uncertainty as to whether they will ultimately be beneficial, and reminded shareholders and potential investors to exercise caution when dealing in the Company's securities.

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