Recently, according to publicly available information from the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the technetium-99m ([99mTc]) hydrazinonicotinamide polyethylene glycol RGD peptide injection (referred to as "99mTc-3PRGD2") developed by Ruidiao Pharmaceuticals has been included in the priority review list. This also applies to the injection of toluenesulfonate hydrazone nicotinamide polyethylene glycol RGD peptide.

99mTc-3PRGD2 is a radiolabeled drug conjugate (RDC) independently developed by Ruidiao Pharmaceuticals. It is the first class I new drug for radiologic diagnosis in nuclear medicine in China and the world's first broad-spectrum tumor imaging agent for SPECT imaging. Notably, the success of this drug's development will change the current technical status and conventional understanding that SPECT/CT imaging technology in nuclear medicine cannot be used for tumor diagnosis, staging, and efficacy evaluation.

According to Ruidiao Pharmaceuticals, 99mTc-3PRGD2 targets integrin and specifically binds to the integrin αvβ3 receptor on tumor neovascularization, demonstrating high specificity and accuracy for diagnosing lymph node metastasis in lung cancer. In January 2022, 99mTc-3PRGD2 completed phase III clinical trials in China, achieving both primary and secondary endpoints and showing good safety and efficacy with significantly higher diagnostic specificity and accuracy compared to the control group.

Li Fang, chairman of the Nuclear Medicine Equipment and Technology Committee of the China Medical Equipment Association and a professor at Peking Union Medical College Hospital, has noted that the clinical diagnostic costs of using 99mTc-3PRGD2 for SPECT/CT imaging is likely to be cheaper than those of PET/CT (positron emission tomography/computed tomography).

In November 2023, Ruidiao Pharmaceuticals signed a strategic agreement with Baiyang Pharmaceuticals, obtaining exclusive commercialization rights for 99mTc-3PRGD2 and other radioactive drugs and SPECT imaging equipment in mainland China.

Radiopharmaceuticals, also known as radioactive drugs, are compounds and biological products marked with radioactive nuclides or nuclides used for diagnosing and treating diseases. They can be broadly classified into diagnostic radiopharmaceuticals and therapeutic radiopharmaceuticals based on their specific use. 99mTc-3PRGD2 falls into the former category, used for diagnosis.

Compared to other tumor treatment methods, radiopharmaceuticals have unique advantages. Diagnostic radiopharmaceuticals can quickly and accurately elucidate functional changes in diseased tissues, such as gene expression abnormalities, facilitating early disease diagnosis. Most importantly, they are currently the only medical diagnostic technology capable of imaging dynamic metabolic processes in a living body. Therapeutic radiopharmaceuticals can selectively and specifically treat diseased tissues through radionuclides.

Presently, the trend in radiopharmaceuticals is moving towards integrated diagnosis and treatment—first using diagnostic radiopharmaceuticals to determine tumor locations, followed by therapeutic radiopharmaceuticals for treatment.

However, the development of radiopharmaceuticals has high barriers due to the radioactive nature of their raw materials, facing challenges in production, transportation, and usage. For instance, radioactive elements have half-lives, meaning their radioactivity decreases over time, making long-term storage impossible; thus, their sales radius tends to be small, necessitating local production capacity. Additionally, improper control of radioactive elements could harm human health and the environment, leading regulatory authorities to impose stricter regulations and approvals for the development and production of radiopharmaceuticals.

Nonetheless, the unique advantages of radiopharmaceuticals in tumor treatment and the performance of early entrants in commercialization have attracted many pharmaceutical companies into the field. In 2018 and 2022, the U.S. FDA successively approved two drugs from Novartis, Lutathera and Pluvicto, with total sales surpassing $1.58 billion in 2023. Notably, Pluvicto achieved $270 million in revenue in its first year of launch (2022) and soared to $980 million in 2023, marking a staggering year-on-year growth of 263%, making it the highest-grossing radiotherapy drug globally.

This drug is also expected to be launched domestically. On September 24, according to announcements from the National Medical Products Administration, Novartis' Pluvicto is planned to be included in priority review. This drug is indicated for treating prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have undergone androgen receptor pathway inhibition and taxane chemotherapy.

According to a report published by Frost & Sullivan titled "Status and Future Development of China's Radiopharmaceutical Industry," there are currently 64 types of radiopharmaceuticals approved globally, with 339 innovative radiopharmaceuticals in development worldwide. These innovative drug candidates encompass both diagnostic and therapeutic fields, covering various diseases beyond oncology, including mental disorders and autoimmune diseases.

In contrast, China's radiopharmaceutical market started later than those in other countries. As of October 2023, 42 types of radiopharmaceuticals have been approved for sale in China, primarily generics. Since 2020, two innovative therapeutic radiopharmaceuticals have been approved: Bayer's Radium-223 [223Ra], for treating symptomatic bone metastasis without known visceral metastasis in castration-resistant prostate cancer patients, and Sirtex and Wand Pharmaceutical's Yttrium-90 resin microspheres for treating non-resectable liver metastases from colorectal cancer after standard treatment failure. Additionally, 32 radiopharmaceuticals are still in clinical trials or awaiting market approval, including 24 diagnostic and 8 therapeutic radiopharmaceuticals.

Currently, companies involved in the radiopharmaceutical sector in China include Jiangsu Hengrui Medicine, Wand Pharmaceutical, Xiantong Pharmaceutical, Ruidiao Pharmaceuticals, China Isotope & Radiation Corporation, and Dongcheng Pharmaceutical. Among them, the latter two are well-established radiopharmaceutical firms. According to incomplete statistics from Yaozhi Data, there are currently 152 radiopharmaceuticals available on the market in China (counting varieties), with the top 15 companies holding a market share of 91.4%. Seven of these companies are subsidiaries or holding companies of China Isotope & Radiation Corporation, and four are subsidiaries or holding companies of Dongcheng Pharmaceutical.

https://finance.eastmoney.com/a/202409293194257725.html