China's First Homegrown Radiopharmaceutical Receives Dual FDA Breakthrough Therapy and Fast Track Designations

On August 6, Nuoyu Medical announced that the U.S. Food and Drug Administration (FDA) has officially granted Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) to the company's independently developed 68Ga-NYM096. This marks the first product in China's original radiopharmaceutical field to receive FDA Breakthrough Therapy Designation, and the first to receive both FDA Breakthrough Therapy and Fast Track designations simultaneously, creating a milestone breakthrough in the radiopharmaceutical field.

68Ga-NYM096 is a small-molecule diagnostic radiopharmaceutical for renal cancer that specifically binds to CAIX, suitable for positron emission tomography (PET) imaging of suspected or confirmed metastatic clear cell renal cell carcinoma (ccRCC). It has received clinical trial approval (IND) from both China's NMPA and the U.S. FDA, and currently no similar products have been launched globally.

The two designations are based on the solid preliminary clinical trial data of 68Ga-NYM096, demonstrating the product's significant clinical advantages and potential in the precise diagnosis of ccRCC and subsequent patient treatment and management decisions, with the potential to redefine the diagnosis and treatment landscape of ccRCC in the future.

ccRCC is the most common pathological subtype of renal cell carcinoma, with significant variability in patient prognosis. The disease often presents no specific clinical symptoms in its early stages, with most cases detected incidentally through imaging. Some patients have already progressed to the metastatic stage at the time of diagnosis, representing a substantial unmet clinical need.

FDA Breakthrough Therapy Designation (BTD) encompasses all features of Fast Track Designation (FTD) and is a special designation mechanism established by the FDA to accelerate the development and review of innovative products for serious diseases. This designation typically indicates that the drug's efficacy will be significantly superior to existing therapies, and will provide important policy support and resource allocation for the subsequent clinical development and marketing of 68Ga-NYM096, including more intensive development guidance, eligibility for rolling review of New Drug Application (NDA) and priority review among other accelerated review mechanisms, thereby further expediting the product development process.

Nuoyu Medical will maintain close communication with the FDA, striving to bring the new-generation radiopharmaceutical to market as soon as possible, so that innovative therapies can benefit a wide range of patients.

Nuoyu Medical

Building a World-Class Leading Radiopharmaceutical Enterprise

Nuoyu Medical is an innovator and pioneer in the radiopharmaceutical field, committed to advancing the market launch of China's original radiopharmaceuticals and building an independent and controllable radiopharmaceutical industry chain and ecosystem. The company has developed multiple original theranostic radiopharmaceutical pipelines (including first-in-class and best-in-class drugs), has obtained multiple clinical trial approvals in China and the United States, and several pipelines have entered the late stages of clinical trials. Among them, the small-molecule theranostic radiopharmaceutical for renal cancer has achieved global leadership in research and development progress in this field. In addition, leveraging years of technical accumulation and ecosystem operations, the company has built a complete radiopharmaceutical industry chain and ecosystem, driving the global radiopharmaceutical ecosystem toward AI and unmanned development.