About Us
Company Introduction Strategic Development Social Responsibility
Scientific Research
Innovative Layout Innovative Field
International
Global Expansion Cooperative Partner Global R&D Centers International Cooperation
Investor Relations
Information Disclosure Corporate Governance Stock Information ESG Contact us
Products Services
Product center Product branding Quality & Safety
News
Company News Media Coverage Media Inquiries Multimedia zone
Career
Talent R&D Team Employee Life Job Opportunities
EN
CN
About Us
· Company Introduction · Strategic Development · Social Responsibility
Scientific Research
· Innovative Layout · Innovative Field
Products Services
· Product center · Product branding · Quality & Safety
News
· Company News · Media Coverage · Media Inquiries · Multimedia zone
Vocational
· Concept about Talent · R&D Team · Employee Life · Job Opportunities
> News > Company
Return
Grand Pharma’s Independently Developed, Blockbuster, Globally Innovative Radionuclide-Drug Conjugate, GPN01530, Has Been Approved for Clinical Trials in the United States
2025-12-18

GPN01530, a globally innovative radionuclide-drug conjugate (RDC) independently developed by the Group, 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. It marks another solid step forward in the Group’s global strategy for nuclear medicine anti-tumor diagnosis and treatment.

  • GPN01530 is a small molecule RDC drug that targets fibroblast activating protein (FAP). GPN01530 that independently developed by the Group optimizes the structure of the FAP ligand, improving its uptake in tumor tissues, while reducing its uptake in normal tissues.
  • Compared to other FAP-targeted ligands, exhibits rapid tumor targeting, higher tumor uptake, and superior pharmacokinetic properties.
  • The early research of the GPN01530 project was entirely independently developed by the Group based on its radiochemical labeling platform and animal molecular imaging platform at the Chengdu Radiopharmaceutical Base.

As the Group’s first self-developed RDC product that receives FDA approval for clinical trials, the successful approval of the GPN01530 clinical trial provides an important paradigm for the international development of the Group’s nuclear medicine product pipeline. It is a significant milestone in the Group’s global R&D and registration process for nuclear medicine anti-tumor diagnosis and treatment segment, fully demonstrating the Group’s comprehensive strength in the construction of cutting-edge nuclear medicine technology platforms, international clinical development, and registration applications, etc.

The Group will continue to advance the global R&D and registration of GPN01530 by relying on the international registration route of “dual filings in China and the United States”. Based on this, the Group will further deepen the globalization development strategy of this segment, actively promote the international clinical research and registration application of more independently developed innovative nuclear medicine products, and continuously enhance the Group’s core competitiveness and international influence in the field of nuclear medicine anti-tumor diagnosis and treatment.

Prev

Next

Related news

  • The NDA of Grand Pharma’s Global Innovative RDC TLX591-CDx Is Accepted by the NMPA
    The NDA of Grand Pharma’s Global Innovative RDC TLX591-CDx Is Accepted by the NMPA

    2026-01-19

  • Grand Pharma 2025 Annual Highlights Review
    Grand Pharma 2025 Annual Highlights Review

    2026-01-26

  • Grand Pharma’s Subsidiary Has Entered Into a Share Purchase Agreement to Acquire All Equity of Hebei Yuanda Jiufu Biotechnology Co., Ltd. and Baoding Jiahe Fine Chemical Co., Ltd.
    Grand Pharma’s Subsidiary Has Entered Into a Share Purchase Agreement to Acquire All Equity of Hebei Yuanda Jiufu Biotechnology Co., Ltd. and Baoding Jiahe Fine Chemical Co., Ltd.

    2026-01-04

Grand Pharma Group
About Us
Company Introduction Strategic Development Social Responsibility
Scientific Research
Innovative Layout Innovative Field
International
Global expansion Cooperative Partner Global R&D Centers International Cooperation
Investor Relations
Information Disclosure Corporate Governance Stock Information Contact us
Products Services
Product Center Product branding Quality & Safety
News
Company News Media Coverage Media Inquiries Multimedia zone
Vocational
Concept about Talent R&D Team Employee Life Job Opportunities
Copyright © Grand Pharma (China) Co., Ltd. All Rights Reserved E ICP B 10008288 EGWAB 42010402000597
Legal Provisions