Chinese healthcare company C-Ray Therapeutics (Chengdu) Co Ltd on Saturday welcomed the news that its strategic partner, Biokin Pharmaceutical, has received implied approval from China's National Medical Products Administration (NMPA) for the clinical trial application of [177Lu]-BL-ARC001 Injection, the company's first radiopharmaceutical and a Class 1 innovative biologic.

Biokin's flagship asset BL-B01D1 (a first-in-class EGFR HER3 bispecific ADC) set a record-breaking global licensing deal of USD8.4bn.

As the core CRDMO partner for the [177Lu]-BL-ARC001 programme, C-Ray provided end-to-end services including radiolabelling process development, quality studies, and registration batch manufacturing. Leveraging China's first fully automated GMP-grade radiopharmaceutical production line, C-Ray says that it completed process development and quality studies in five months, followed by registration batch production in only seven months. This digitalised, automated model is designed to not only eliminate traditional manual risks, but also ensure efficiency, consistency, and product quality.

C-Ray also says that it has made significant breakthroughs in cold-chain logistics, addressing long-distance, multi-centre transport challenges for radiopharmaceuticals.

The company will continue supporting Biokin with clinical supply and distribution through its automated production line and China's first international-standard radiopharmaceutical cold-chain system, ensuring smooth multi-centre clinical research.