Domestic nuclear medicine "from 0 to 1": The world's first broad-spectrum tumor imaging agent for SPECT imaging developed by Baiyang Pharmaceutical | Quick Read Announcement

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（Source: Caixin Global）

Caixin Global, April 2 (Reporter He Fan) Beijing Baiyang Pharmaceutical (301015.SZ) has officially announced that its commercialized product—its radiopharmaceutical innovation drug Jilante—has been approved for market launch, becoming the first self-developed nuclear medicine Class 1 innovative drug in China and the first broad-spectrum tumor imaging agent globally used for SPECT imaging. The company stated that the RDC (radioisotope conjugated drug) approved in this round is expected to fully leverage SPECT’s clinical value.

Tonight, Baiyang Pharmaceutical said in an announcement that recently, the National Medical Products Administration (NMPA) approved Jilante through the priority review and approval process. It approved the filing submitted by its holding subsidiary Ruidiao (a holding subsidiary of Beijing Jilante Pharmaceutical Co., Ltd.) for the Class 1 radiopharmaceutical innovation drug technetium [99mTc] peixiruite peptide injection (brand name: Jilante) for market launch. With the drug’s marketing license application approved, it can be manufactured and sold.

It is understood that technetium [99mTc] peixiruite peptide injection is a radiopharmaceutical targeting integrin. It is mainly used for auxiliary examinations of suspected lung cancer patients’ regional lymph node metastasis.

According to an introduction to Caixin Global reporters by Baiyang Pharmaceutical, as an RDC, Jilante is structurally similar to antibody-drug conjugates (ADCs) and consists of three parts. The drug uses a linker to conjugate an RGD peptide molecular imaging probe targeting integrin αvβ3 with the radioisotope technetium [99mTc]. The probe can specifically recognize and bind to the integrin αvβ3 receptors overexpressed on tumor neovasculature and tumor cell surfaces, thereby completing targeted delivery of the radionuclide to tumor tissues and achieving precise imaging. Overall, compared with PET imaging technology, nuclear medicine SPECT imaging has higher equipment penetration, simpler drug preparation, and lower clinical examination costs. In the past, due to a lack of effective imaging drugs in clinical practice, it limited SPECT technology’s ability to play a role in tumor diagnosis and efficacy evaluation. Jilante is expected to fully realize SPECT’s clinical value.

In November 2023, Baiyang Pharmaceutical announced that it signed commercialization cooperation agreements with Ruidiao and Maithees Medical, respectively. Baiyang Pharmaceutical obtained exclusive commercialization operating rights in mainland China for a series of radiopharmaceutical products, including the Class 1 innovative nuclear medicine tumor imaging diagnostic drug 99mTc-3PRGD2, as well as imaging equipment products such as SPECT, from Ruidiao. It also obtained exclusive commercialization operating rights in mainland China for Maithees Medical’s “electromagnetic localization puncture guidance equipment for ultrasound” and related products.

Subsequently, in April 2025, Baiyang Pharmaceutical’s wholly owned subsidiary Baiyang Zhihé entered into a 《Commercialization Cooperation Agreement》 with Jilante. Under the agreement, Baiyang Zhihé and its affiliated companies are to obtain exclusive commercialization rights for the cooperative drug technetium [99mTc] peixiruite peptide injection.

At present, Jilante’s independently developed diagnostic radiopharmaceutical for HER2-positive breast cancer patients, 99mTc-HP-Ark2, has obtained IND approval; the targeted therapeutic radiopharmaceutical 177Lu-AB-3PRGD2 targeting αvβ3 has initiated a Class 1 new drug application.

Currently, the radiopharmaceutical industry is entering a golden period of development. According to Sullivan’s forecast, China’s radiopharmaceutical market size is expected to expand to RMB 26 billion by 2030. Data from Molme (Mol is it) Medical shows that currently there are 20 RDC clinical trials in China, covering indications such as oral and maxillofacial tumors, recurrent/refractory hematologic malignancies, and advanced solid tumors, as well as thyroid micro papillary tumors.

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