Domestically Developed Innovative ARC Enters Clinical Stage, Ushering in the Era of China's Self-Developed Radiopharmaceuticals
News Summary
On November 4, the official website of China's Drug Clinical Trial Registration and Information Publicity Platform showed that BIOKIK Pharmaceutical has registered a Phase I clinical study for its Lutetium[177Lu]-BL-ARC001 injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
This marks the company's first Class 1 innovative drug candidate in the field of Antibody–Radionuclide Conjugates (ARCs) developed based on its proprietary HIRE-ARC platform. It is also a potential global first-in-class (FIC) ARC drug for which Baili Tianheng holds full independent intellectual property rights.
The Phase I clinical study registered by Baili Tianheng focuses on patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors. This represents a rare attempt within China's radiopharmaceutical field to expand into new therapeutic indications.
This direction not only breaks through the previous target limitations of radiopharmaceuticals, which were largely concentrated on prostate or neuroendocrine tumors, but also opens new possibilities for the application of radiopharmaceuticals in the treatment of a broader range of solid tumors.
More strategically significant, BL-ARC001 is China's first Class 1 innovative Antibody–Radionuclide Conjugate (ARC) to enter the clinical stage.
If Novartis's Pluvicto® represents the global leading force in the commercialization of Radioligand Therapies (RLT), then Baili's BL-ARC001 marks the starting point of China's independent innovation in radiopharmaceuticals—from target mechanisms to conjugation processes, Chinese companies are establishing their own independent technological systems and innovation pathways.
As the CRDMO partner for Baili's BL-ARC001 project, C Ray will continue to leverage its systematic R&D and production capabilities to accelerate the efficient transition of Baili Tianheng's program from registration batches to commercialization. Together, we aim to advance China's radiopharmaceutical industry into a new era of global innovation.
We believe the initiation of this milestone project not only demonstrates a technological breakthrough for Chinese radiopharmaceuticals but also signals the comprehensive maturation of the domestic radiopharmaceutical industry chain—from innovative R&D to clinical implementation.
Introduction to C Ray Therapeutics
C Ray Therapeutics is dedicated to delivering end-to-end solutions for innovative radiopharmaceuticals to clients around the world. Our services span process development, quality research, preclinical evaluation, IND Enabling, clinical supply, and commercial scale cGMP production, all backed by a reliable, robust logistics network. As of 2024, we have raised over USD 187 million in total funding.
As a dedicated CRDMO partner in radiopharmaceuticals, one of our core strengths is a stable, diversified supply of radionuclides. We are actively developing high-quality domestic sources while playing a leading role in integrating and fortifying the global supply chain—most notably securing access to challenging isotopes such as Ac-225. To date, we have supported the development of 16 Ac-225–labeled projects.
Committed to empowering the industry, C Ray Therapeutics is building an open, integrated “production–academia–research–application” platform. By pooling resources across the value chain and pioneering critical radiopharmaceutical technologies, we accelerate the clinical translation of integrated diagnostic & therapeutic solutions. Our goal is to drive innovation and industrial upgrading in the radiopharmaceutical sector, establishing ourselves as a global benchmark in the field.
