In July 2023, Norroy Bioscience Co., LTD. (hereinafter referred to as Norroy) announced that the new drug clinical trial (IND) application for 68Ga-NY104(NYM005), the global innovative kidney cancer nuclear drug independently developed by the company, was officially approved by FDA. 68Ga-NY104(NYM005) is the world's first  small molecule positron emission tomography (PET) diagnostic tracer for targeted renal cancer granted clinical trial approval. As a next step, Norroy will conduct a Phase I clinical trial for the diagnosis of clear cell renal cell carcinoma (ccRCC) using 68Ga-NY104(NYM005).

More than 400,000 new cases of renal cell carcinoma (RCC) and 175,000 deaths have been reported worldwide, with clear cell renal cell carcinoma (ccRCC) being the most common sub-type (approximately 75-80%). The onset of RCC is occult and the symptoms are not typical. Patients with advanced RCC are not sensitive to radiotherapy and chemotherapy and lack specific targeted drugs, so the treatment means are limited. In some patients, although the primary lesion was surgically removed in time, distant metastasis still occurred. Accurate identification and location of RCC metastatic lesion is of great importance for staging, prognosis assessment and subsequent treatment selection.

At present, 18F-FDG PET/CT is widely used in clinical practice, but it has limitations in the diagnosis of kidney cancer, in low-grade tumors, the lesion uptake of FDG is poor, and the tumor cannot be well detected. Therefore, a new type of small molecule nuclear medicine probe with high specificity and high affinity is urgently needed for functional imaging evaluation of renal cell carcinoma in order to improve the specificity and sensitivity of renal cell carcinoma diagnosis.

In the completed Ph0 clinical trials of nearly 100 subjects, 68Ga-NY104 has shown incomparable advantages in the diagnosis of recurrent and metastatic renal cancer, and has high clinical development potential. 68Ga-NY104 is expected to become a new breakthrough means for PET diagnosis of kidney cancer, and Norroy will continue to promote the development process of the next generation of therapeutic nuclear drug.

The approval of the IND application is an important milestone in the development process of Norroy, marking the company officially opened the prelude to the globalization of original research and innovation nuclear drugs. We will unswervingly strive to bring new hope to global patients with innovative new precision technologies and innovative drugs.