China's first independently developed innovative nuclear medicine approved for market launch, Baiyang Pharmaceutical positions itself in a new blue ocean

Source: Shanghai Securities News · China Securities Network

China Securities Network from Shanghai Securities News reports (Reporter Zhao Binbin) On April 2, the Type 1 innovative radiopharmaceutical—99mTc-佩昔瑞特加肽 injection (99mTc-3PRGD2, brand name: 吉伦泰) for nuclear medicine—declared by Foshan Ruidiao Pharmaceutical Co., Ltd., a nuclear medicine innovation company incubated with investment by Baiyang Pharmaceutical Group (a controlling subsidiary of Beijing Jilentai Pharmaceutical Co., Ltd.), and the accompanying technetium-99m 佩昔瑞特加肽 injection kit used to prepare the drug, have officially been approved for marketing by the National Medical Products Administration (NMPA).

A relevant person from Baiyang Pharmaceutical said that 99mTc-3PRGD2 is the first Type 1 innovative radiopharmaceutical independently developed in China, and also the world’s first broad-spectrum tumor imaging agent used for SPECT imaging.

Nuclear medicine, as an important component of precision medicine, has irreplaceable clinical value in the diagnosis and treatment of major diseases such as cancer and cardiovascular and cerebrovascular diseases. However, for a long time, China has had a shortcoming in the field of original nuclear medicine drugs, especially in terms of innovative products with independent intellectual property rights. In addition, there is huge demand in the cancer field for precise, dynamic, and economical imaging diagnostic tools.

According to the report, the specific tumor imaging agent 99mTc-3PRGD2 approved this time is the world’s first “First-in-Class” drug that integrates integrin αvβ3 as the target, mainly used as an adjunctive examination for regional lymph node metastasis in patients with suspected lung cancer. “With the approval of this product, it breaks through the bottleneck that SPECT imaging technology cannot be used for tumor diagnosis, staging, and efficacy monitoring, and overturns the situation over the past nearly 30 years in which nuclear medicine tumor imaging diagnosis relied only on PET imaging technology.” the aforementioned person from Baiyang Pharmaceutical said.

In 2022, Baiyang Pharmaceutical Group made a strategic investment in Jilentai. Among its listed companies, Baiyang Pharmaceutical obtained commercialization rights for multiple radiopharmaceutical products, including 99mTc-3PRGD2 and 99mTc-HP-Ark2. According to Baiyang Pharmaceutical, the diagnostic radiopharmaceutical 99mTc-HP-Ark2 independently developed by Jilentai for patients with HER2-positive breast cancer has already obtained IND (new drug clinical research application) approval; the targeted therapeutic radiopharmaceutical 177Lu-AB-3PRGD2 for integrin αvβ3 targeting has initiated a Type 1 new drug application.

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