NORROY BIOSCIENCE Granted FDA Breakthrough Therapy and Fast Track Designations for Kidney Cancer Imaging Product

WUXI, China, Aug. 19, 2026 /PRNewswire/ -- NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to NORROY's ⁶⁸Ga-NYM096, a potential radiopharmaceutical imaging agent targeting carbonic anhydrase Ⅸ (CAⅨ) for PET imaging of clear cell renal cell carcinoma (ccRCC).

⁶⁸Ga-NYM096 is the first China-originated innovative radiopharmaceutical to receive FDA Breakthrough Therapy Designation. It is being developed as a non-invasive PET imaging agent to enable the characterization of indeterminate renal masses identified by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and support the differentiation of ccRCC from non-ccRCC lesions.

The granting of this Breakthrough Therapy designation recognizes the potential of ⁶⁸Ga-NYM096 to provide meaningful clinical advantages over current diagnostic approaches based on preliminary clinical data, while addressing significant unmet clinical needs in the diagnosis and management of patients with ccRCC. The Fast Track designation is designed to facilitate the development and expedite the review of ⁶⁸Ga-NYM096 by enabling more frequent interactions with the FDA, enhanced regulatory guidance throughout the clinical development process, and potential eligibility for rolling review of a New Drug Application (NDA).

Clear cell renal cell carcinoma is the most common subtype of renal cell carcinoma (RCC), accounting for approximately 70%–80% of RCC cases. According to the American Cancer Society, in 2026, an estimated 80,450 new cases of kidney (renal) cancer will be diagnosed in the US, and 15,160 people will die from the disease.

NORROY Founder and CEO, Mr. Peng Fang, said: "We have seen promising clinical data from the ongoing development of ⁶⁸Ga-NYM096, supporting its potential to advance the diagnosis and management of patients with ccRCC. Additional clinical data of ⁶⁸Ga-NYM096 will be presented at the 2026 EANM Annual Congress. We plan to initiate Phase I clinical trials evaluating ⁶⁸Ga-NYM096 in both China and the United States, and will continue to work closely with the FDA to advance its clinical development. We believe this innovative imaging agent has the potential to reshape the diagnosis and management of ccRCC and ultimately benefit more patients worldwide."

About NORROY BIOSCIENCE

NORROY is a clinical-stage biotechnology company focused on the development and commercialization of innovative therapeutic and diagnostic radiopharmaceuticals, as well as automated synthesis systems and functional modules for radiopharmaceutical manufacturing in both R&D and GMP environments.

Founded in July 2021, NORROY has radiopharmaceutical candidates currently under clinical investigation in more than 10 disease targets across multiple therapeutic areas, including urological oncology, gastrointestinal oncology, and other oncology and non-oncology indications. Beyond innovative radiopharmaceuticals and automated manufacturing solutions, NORROY continues to establish a reliable global supply chain for multiple radioisotopes, build commercial GMP manufacturing facilities, and develop a global distribution network with international partners.

To date, NORROY has received six (6) IND clearances from the FDA and six (6) IND approvals from the National Medical Products Administration (NMPA). The Company is actively working with global regulatory agencies to advance its late-stage programs through internationally registered clinical trials.

To learn more about NORROY, visit https://www.norroybiopharm.com/

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NORROY Contacts

Media: BD@norroybioscience.com 

Important Information

⁶⁸Ga-NYM096 is an investigational product and has not been approved for marketing by the United States Food and Drug Administration (FDA) or any other regulatory authority. Its safety and efficacy have not been fully established.

FDA Breakthrough Therapy and Fast Track designations are intended to facilitate and expedite the development and review of certain investigational products to treat serious conditions and fill an unmet medical need. Such designations do not constitute marketing approval and do not guarantee that ⁶⁸Ga-NYM096 will receive regulatory approval.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the clinical development and regulatory progress of ⁶⁸Ga-NYM096; the presentation of additional clinical data; the planned initiation, timing, progress and results of clinical trials; interactions with regulatory authorities; potential regulatory submissions and approvals; manufacturing activities; and the potential commercialization of NORROY's product candidates in China and/or in the United States.

These forward-looking statements are based on NORROY's current expectations and assumptions and are subject to known and unknown risks, uncertainties and other factors that could cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. There can be no assurance that planned clinical trials will be initiated or completed as anticipated, that clinical results will support further development or regulatory submissions, or that any of NORROY's product candidates will receive regulatory approval or achieve commercial success.

Except as required by applicable law, NORROY undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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