- C-Ray Therapeutics (Chengdu) Co.,Ltd provided full CRDMO support for Biokin Pharmaceutical’s first radiopharmaceutical, [177Lu]-BL-ARC001, achieving implied NMPA clinical trial approval.
- The company leveraged its automated GMP radiopharmaceutical line and cold-chain logistics to complete process development, quality studies, and registration batch production in under a year.
C-Ray Therapeutics (Chengdu) Co.,Ltd has played a central role in advancing Biokin Pharmaceutical’s first radiopharmaceutical, [177Lu]-BL-ARC001 Injection, following implied approval from China’s National Medical Products Administration (NMPA) for clinical trials. The milestone represents Biokin’s entry into the Radiopharmaceutical Drug Conjugate (RDC) sector, complementing its work in large-molecule oncology therapies such as ADCs and bispecifics.
As the core CRDMO partner, C-Ray provided end-to-end services including radiolabeling process development, quality studies, and registration batch manufacturing. The company leveraged China’s first fully automated GMP-grade radiopharmaceutical production line to complete process development and quality studies in five months, followed by registration batch production in seven months. Its digitalised, automated approach ensures efficiency, consistency, and reduced manual risk.
C-Ray also addressed logistical challenges with a China-first international-standard radiopharmaceutical cold-chain system, enabling multi-centre clinical supply and distribution. These capabilities support Biokin’s ongoing clinical research and streamline the delivery of radiopharmaceuticals across long distances.
A Biokin executive commented: “C-Ray Therapeutics (Chengdu) Co.,Ltd has been an indispensable partner in the [177Lu]-BL-ARC001 program. Their expertise, execution speed, and customer-first mindset have accelerated our timeline while ensuring top-quality results.”
To date, C-Ray has delivered over 50 CRDMO projects, covering the full lifecycle of radiopharmaceuticals from early research and IND filing to clinical and commercial supply.
