On April 2, 2026, Foshan Radiopharmaceuticals Co., Ltd. (a subsidiary of Beijing Jiluntai Pharmaceutical Co., Ltd.), a nuclear medicine innovative enterprise incubated and invested by BAHEAL PHARMACEUTICAL GROUP, filed an application for its Class 1 innovative radiopharmaceutical, Technetium-99mTc Pexisiretide Injection (99mTc-3PRGD2 (trade name: Jiluntai) and Technetium for Injection used in the preparation of this drug99mTc-Peixiretide Injection Kit Officially Approved for Market Launch by the National Medical Products Administration (NMPA). As China’s first independently developed Class 1 innovative nuclear medicine product, it is also the world’s first broad-spectrum tumor imaging agent for SPECT imaging.99mThe approval of Tc-3PRGD2 not only marks a significant breakthrough from 0 to 1 in the independent research and development of nuclear medicine drugs in China, but also represents a major leap from “following” to “leading through original innovation.”
Filling the Gap in SPECT Tumor Imaging, Addressing Clinical Diagnostic Pain Points
Nuclear medicine, as a vital component of precision medicine, holds irreplaceable clinical value in the diagnosis and treatment of major diseases such as cancer and cardiovascular and cerebrovascular disorders. However, China has long faced significant shortcomings in the field of original nuclear medicine pharmaceuticals, particularly lacking innovative products with independent intellectual property rights. Furthermore, in the oncology sector, with over 4.5 million new cancer cases diagnosed annually, there is substantial clinical demand for precise, dynamic, and cost-effective imaging diagnostic tools.
The tumor-specific imaging agent approved this time——99mTc-3PRGD2 is not only a Class 1 innovative nuclear medicine drug independently developed by Jiluntai, but also the world’s first broad-spectrum tumor imaging agent for SPECT diagnostic imaging. Furthermore, it is the global first-in-class drug targeting integrin αvβ3, primarily used as an adjunctive examination for regional lymph node metastasis in patients with suspected lung cancer. The approval of this product has overcome the bottleneck that previously prevented SPECT imaging technology from being used for tumor diagnosis, staging, and treatment response monitoring, thereby breaking the nearly 30-year monopoly of PET imaging technology in nuclear medicine tumor diagnostics.
99mAs the world’s first approved radionuclide-drug conjugate (RDC) targeting integrin αvβ3, Tc-3PRGD2 utilizes an RGD peptide molecular probe to specifically bind to integrin αvβ3 receptors on the surface of tumor cells and endothelial cells of tumor neovasculature, thereby enabling precise imaging. Phase III clinical trial results demonstrated no statistically significant difference between Tc-3PRGD2 and 18F-FDG PET/CT in differentiating benign from malignant pulmonary lesions.[1], more importantly, in the evaluation of lymph node metastasis in lung cancer,99mTc-3PRGD2 SPECT/CT demonstrates significantly higher specificity and accuracy than 18F-FDG PET/CT, correcting 59% of false-positive results for lymph node metastasis on 18F-FDG PET/CT imaging and effectively improving the accuracy of tumor diagnosis and staging. Meanwhile, its simpler radiopharmaceutical preparation process, the wider availability of SPECT equipment, and lower patient examination costs substantially enhance the clinical accessibility of nuclear medicine diagnostics and therapy.
Independent R&D + Industrial Empowerment: Competing in the Blue Ocean of Radiopharmaceuticals
Currently, the radiopharmaceutical industry is entering a golden period of development. According to Frost & Sullivan’s forecasts, the market size of radioactive drugs in China is expected to expand to RMB 26 billion by 2030.[2]。99mThe approval of Tc-3PRGD2 will not only promote the broader application of radiopharmaceuticals in precision diagnosis and therapy, but also help enhance China’s level of independent innovation and clinical practice in nuclear medicine.
Leveraging Gilentech’s “flexible spacer modification” strategy, along with its high efficiency and stability99mTc Labeling Method: The company focuses on original innovation in integrated solutions for molecular imaging diagnosis and therapy in nuclear medicine. It has established a robust R&D pipeline by strategically deploying targeted therapeutic and diagnostic radiopharmaceuticals with proven efficacy in the pan-oncology field. Currently, Gilentai’s independently developed diagnostic radiopharmaceutical for HER2-positive breast cancer patients99mTc-HP-Ark2 has received IND approval; the targeted αvβ3 therapeutic radiopharmaceutical 177Lu-AB-3PRGD2 has initiated a Class 1 new drug application.
Efficient allocation of industrial factors is the core driving force for the breakthrough development of innovative enterprises. In 2022, BAHEAL PHARMACEUTICAL GROUP made a strategic investment in Gilentai Company, and its listed subsidiary, BAHEAL Pharmaceutical (SZ.301015), obtained including99mTc-3PRGD2、99mCommercialization rights for multiple radiopharmaceuticals independently developed by Gylent, including Tc-HP-Ark2. As an industrial investor in the healthcare sector, BAHEAL PHARMACEUTICAL GROUP ensures efficient synergy between innovation incubation and industrialization through ecosystem-based resource allocation. In addition to providing financial support to portfolio companies, it empowers them across the entire value chain—including R&D advancement, clinical translation, regulatory filing, scaled manufacturing, and commercial launch—thereby accelerating the clinical adoption of innovative achievements and realizing their value.
Currently, BAHEAL PHARMACEUTICAL GROUP has invested in and incubated multiple high-growth innovative enterprises, including Tongxin Medical, a developer of fully magnetically levitated artificial hearts that has entered the IPO process; ZAP Surgical, an AI-driven radiosurgery robotics company whose products have received approval in 26 countries and regions; and innovative drug R&D companies focused on anti-organ fibrosis and bone health. In the future, BAHEAL will continue to leverage its collaborative innovation ecosystem and brand-building capabilities to facilitate the clinical translation of more original and clinically valuable research outcomes, thereby serving patients and genuinely optimizing healthcare scenarios through technological innovation.
[1] Chinese Society of Nuclear Medicine Physicians. Innovative Achievements in Chinese Nuclear Medicine Unveiled at ASCO: Clinical Phase III Trial Results of the World’s First Tumor SPECT Imaging Agent Targeting Integrins Announced Internationally [EB/OL]. (2025-06-12)[2026-03-04]. https://mp.weixin.qq.com/s/7GHzqzgqyYaW-hDNZE2QQw.
[2] Frost & Sullivan. Blue Book on the Current Status and Future Development of China’s Radiopharmaceutical Industry [R]. Shanghai: Frost & Sullivan Consulting, 2023.