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Baiyang Investment incubated China's first innovative nuclear medicine approved, achieving a major breakthrough in the nuclear medicine sector
Ask AI · How will China’s nuclear medicine innovation change the SPECT diagnostic landscape?
Recently, Foshan Ruidio Medical Co., Ltd., an innovative nuclear medicine company incubated by Baiyang Pharmaceutical Group, and its controlling subsidiary Beijing Gilen Tai Pharmaceutical Co., Ltd., applied for approval of a Class 1 radioactive innovative drug—Technetium-4.5M Pexeritide Peptide Injection (, 99mTc-3PRGD2, trade name: Gilen Tai )—and the preparation of this drug, the Technetium-26B Pexeritide Peptide Injection Kit, officially received approval from the National Medical Products Administration ( NMPA ) for market launch. As China’s first independently developed Class 1 innovative nuclear drug and the world’s first broad-spectrum tumor imaging agent for SPECT imaging, the approval of 99mTc-3PRGD2 not only marks a major breakthrough in China’s自主研发 of nuclear medicine drugs from zero to one but also represents a significant leap from “following” to “leading in original innovation.”
** Filling the gap in SPECT tumor imaging and solving clinical diagnostic pain points**
Nuclear medicine, as an important component of precision medicine, has irreplaceable clinical value in the diagnosis and treatment of major diseases such as tumors and cardiovascular and cerebrovascular diseases. However, for a long time, China has had obvious shortcomings in the field of原创核医学药物, especially a lack of自主知识产权创新产品. Moreover, in the field of oncology, the number of new cancer cases exceeds 4.5 million annually, creating a huge demand for precise, dynamic, and cost-effective imaging diagnostic tools.
The newly approved specific tumor imaging agent—99mTc-3PRGD2—is an自主研发的核医学1类创新药 by Gilen Tai, and it is the world’s first broad-spectrum tumor imaging drug for SPECT diagnosis, as well as the first “First-in-class” drug targeting integrin αvβ3. It is mainly used as an auxiliary examination for patients with suspected lung cancer with regional lymph node metastasis. The approval of this product breaks through the bottleneck that SPECT imaging technology cannot be used for tumor diagnosis, staging, and efficacy monitoring, ending nearly 30 years of reliance on PET imaging technology for核医学肿瘤显像诊断.
As the world’s first radiopharmaceutical targeting integrin αvβ3 approved (RDC), 99mTc-3PRGD2 uses RGD peptide molecules to specifically bind to tumor neovascular endothelial cells and tumor cell surface integrin αvβ3 receptors, achieving precise imaging. Its accuracy in differentiating benign and malignant lung tumors is comparable to 18F-FDG PET/CT (, and it can significantly reduce misdiagnosis of lymph node metastases, greatly improving clinical diagnostic accuracy, especially in tumor staging and follow-up. Additionally, with a simpler drug preparation process, higher普及率 of SPECT devices, and lower patient examination costs, it greatly enhances the clinical accessibility of nuclear medicine diagnosis and treatment.
自主研发+产业赋能 竞逐核药蓝海
Currently, the nuclear medicine industry is entering a golden development period. According to Sullivan, China’s radiopharmaceutical market is expected to expand to 26 billion RMB by 2030 ). The approval of 99mTc-3PRGD2 will not only promote broader application of nuclear medicine in precision diagnosis and treatment but also help improve China’s自主创新 in nuclear medicine and clinical practice levels.
Relying on a mature peptide conjugation platform, Gilen Tai focuses on original innovation in nuclear medicine molecular imaging and treatment solutions. It is developing targeted therapeutic and diagnostic radiopharmaceuticals for the broad tumor field with strong targeting and effective treatment. Currently, the company’s自主研发的诊断核药99mTc-HP-Ark2 for HER2-positive breast cancer patients has received IND approval; a therapeutic nuclear drug targeting αvβ3, 177Lu-AB-3PRGD2, has initiated a Class 1 new drug application.
Efficient allocation of industry elements is the core driver of突破 in innovative enterprise development. In 2022, Baiyang Pharmaceutical Group made a strategic investment in Gilen Tai. Its listed subsidiary, Baiyang Pharmaceutical [1]SZ.301015[2], acquired commercial rights for several radiopharmaceuticals自主研发的, including 99mTc-3PRGD2 and 99mTc-HP-Ark2. As an industry investor in healthcare, Baiyang Pharmaceutical Group ensures efficient linkage between innovation incubation and industrialization through ecological resource allocation. It not only provides funding support but also empowers the entire chain—from R&D, clinical translation, registration, large-scale production, to commercialization—accelerating the clinical adoption and value realization of innovative成果.
Currently, Baiyang Pharmaceutical Group has invested in and incubated multiple high-growth innovative enterprises, including the full magnetic levitation artificial heart company Tongxin Medical, which is in IPO process; the AI radiotherapy robot company ZAP Surgical, approved in 26 countries and regions; and other innovative drug R&D companies focusing on anti-organ fibrosis and bone health. In the future, Baiyang will continue to leverage its创新生态系统 and brand-building capabilities to promote more original and clinically valuable research成果 into clinical practice, serving patients and optimizing healthcare scenarios through technological innovation.