C-Ray Therapeutics (Chengdu) Co.,Ltd proudly congratulates its strategic partner, Biokin Pharmaceutical, on receiving implied approval from the 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 approval marks Biokin's entry into the fast-growing Radiopharmaceutical Drug Conjugate (RDC) field and reinforces its leadership in large-molecule oncology therapies (ADC/GNC/ARC). The company's flagship asset BL-B01D1 (a first-in-class EGFR×HER3 bispecific ADC) set a record-breaking global licensing deal of USD 8.4 billion, underscoring Biokin's innovation strength and global vision.

As the core CRDMO partner for the [¹⁷⁷Lu]-BL-ARC001 program, C-Ray Therapeutics (Chengdu) Co.,Ltd provided 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 model not only eliminates traditional manual risks but also ensures efficiency, consistency, and product quality.

C-Ray also made significant breakthroughs in cold-chain logistics, addressing long-distance, multi-center transport challenges for radiopharmaceuticals.

"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, and we look forward to continuing our partnership in advancing this important therapy."

Moving forward, C-Ray Therapeutics (Chengdu) Co.,Ltd 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-center clinical research.

Biokin joins other leading Chinese pharma companies, including Kelun, Hengrui, Yunnan Baiyao, and Fosun, in expanding from ADCs and bispecifics into RDCs, pushing China's radiopharmaceutical industry toward a new era of integrated diagnosis and therapy.

As a key integrator in this wave, C-Ray Therapeutics (Chengdu) Co.,Ltd has delivered over 50 CRDMO projects (35 CRO and 15 CDMO programs) covering the full lifecycle of radiopharmaceuticals—from early research and IND filing to clinical and commercial supply. With a strong isotope supply chain, including 14 projects involving Ac-225, C-Ray is committed to enabling partners to lead the global RDC race and bringing precision medicine to more patients.