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. This milestone marks Biokin's strategic entry into the rapidly expanding Radiopharmaceutical Drug Conjugate (RDC) field while reinforcing its leadership position in large-molecule oncology therapies.
The approval comes as Biokin continues to build on its innovation momentum, with its flagship asset BL-B01D1, a first-in-class EGFR×HER3 bispecific ADC currently in Phase III clinical trials, having secured a record-breaking global licensing deal worth USD 8.4 billion.
Manufacturing Partnership Delivers Rapid Development Timeline
C-Ray Therapeutics (Chengdu) Co., Ltd served as the core Contract Research, Development and Manufacturing Organization (CRDMO) partner for the [177Lu]-BL-ARC001 program, providing comprehensive end-to-end services including radiolabeling process development, quality studies, and registration batch manufacturing.
Leveraging China's first fully automated GMP-grade radiopharmaceutical production line, C-Ray completed process development and quality studies in just five months, followed by registration batch production in only seven months. This digitalized, automated manufacturing model eliminates traditional manual risks while ensuring efficiency, consistency, and product quality.
"C-Ray Therapeutics (Chengdu) Co.,Ltd has been an indispensable partner in the [177Lu]-BL-ARC001 program," said a Biokin executive. "Their expertise, execution speed, and customer-first mindset have accelerated our timeline while ensuring top-quality results. C-Ray's automated GMP production line and innovative logistics solutions overcame critical challenges in this field."
Addressing Cold-Chain Logistics Challenges
C-Ray also achieved significant breakthroughs in cold-chain logistics, addressing the complex challenges of long-distance, multi-center transport 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 to ensure smooth multi-center clinical research.
Industry Transformation Toward Integrated Theranostics
The approval positions Biokin alongside other leading Chinese pharmaceutical companies, including Kelun, Hengrui, Yunnan Baiyao, and Fosun, in expanding from ADCs and bispecifics into RDCs. This collective movement is pushing China's radiopharmaceutical industry toward a new era of integrated diagnosis and therapy.
C-Ray Therapeutics has established itself as a key integrator in this transformation, having delivered over 50 CRDMO projects comprising 35 CRO and 15 CDMO programs covering the full lifecycle of radiopharmaceuticals from early research and IND filing to clinical and commercial supply. The company maintains a strong isotope supply chain, including 14 projects involving Ac-225.
Company Profiles and Future Outlook
Biokin Pharmaceutical operates as a global biopharmaceutical company focused on oncology large-molecule therapies spanning ADC, GNC, and ARC platforms. The company has set a strategic goal to become a multinational oncology leader with global commercialization planned by 2028.
C-Ray Therapeutics (Chengdu) Co., Ltd operates as China's leading radiopharmaceutical CRDMO partner from its headquarters in Chengdu Medical City, featuring a 28,000 m² world-class GMP facility and GLP-like nonclinical research center. The company is building an open innovation platform to accelerate theranostic solutions and establish itself as a global benchmark in radiopharmaceutical development.
