Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that it has received Investigational New Drug (IND) approval from China’s Center for Drug Evaluation (CDE). The company will now commence a pivotal Phase III registration study in China for its TLX250-CDx (89Zr-girentuximab), an imaging agent used to support positron emission tomography (PET) for clear cell renal cell carcinoma (ccRCC). The study is a bridging to Telix’s global Phase III ZIRCON trial, with data from both studies intended to support a market approval filing.
Partnership and Deal Details
Telix is partnered with China-based Grand Pharmaceutical Group Limited (HKG: 0512) for the development of the imaging agent under a 2020 deal worth up to $225 million. The deal granted Grand Pharma development, manufacturing, and commercial rights in Greater China to three drugs (TLX591, TLX250, and TLX101) and exclusive promotion and manufacturing rights to radionuclide-drug conjugate (RDC) diagnostics TLX591-CDx, TLX250-CDx, and TLX599-CDx. Additionally, Grand Pharma acquired a 7.6% stake in Telix Pharma for $25 million as part of the agreement.
Product Overview and Regulatory Milestones
TLX250-CDx is an investigational imaging agent being developed by Telix for the non-invasive detection of ccRCC in patients with “indeterminate renal masses” (IDRMs) identified using MRI/PET scans. The imaging agent was granted Breakthrough Therapy Designation status by the US FDA in July 2020, highlighting the significant unmet clinical need to improve the diagnosis and staging of ccRCC, the most common and aggressive form of kidney cancer.
Future Outlook
The IND approval from CDE marks a significant milestone for Telix Pharmaceuticals in expanding its clinical development efforts in China. With the commencement of the Phase III study, Telix is well-positioned to address the critical need for improved diagnostic tools in the treatment of ccRCC.-Fineline Info & Tech
