#China #Chengdu #C-Ray Therapeutics #Biokin Pharmaceutical #[177Lu]-BL-ARC001

C-Ray Therapeutics Congratulates Biokin Pharmaceutical

C-Ray Therapeutics (Chengdu) Co., Ltd. is thrilled to announce its heartfelt congratulations to strategic partner Biokin Pharmaceutical for securing approval from the National Medical Products Administration (NMPA) for the clinical trial application of [177Lu]-BL-ARC001 Injection. This marks a significant milestone as Biokin embarks on its journey in the rapidly developing arena of Radiopharmaceutical Drug Conjugates (RDC).

The approval of [177Lu]-BL-ARC001 signifies not just a regulatory victory but also Biokin's assertion as a front-runner in the innovative field of large-molecule oncology therapies. This class of drugs is characterized by their advanced targeting capabilities, aiming to deliver treatment directly to cancerous cells while minimizing collateral damage to healthy tissues. Biokin’s renowned asset, BL-B01D1, a pioneering EGFR×HER3 bispecific antibody-drug conjugate (ADC), had previously set the standard in this domain by clinching a record global licensing deal valued at a staggering USD 8.4 billion, a clear testament to the company’s innovative prowess and expansive vision.

In its vital role as the core Contract Research and Development Manufacturing Organization (CRDMO) partner for the BL-ARC001 project, C-Ray Therapeutics provided comprehensive support throughout the development process. This included crucial aspects such as radiolabeling process development, rigorous quality studies, and the manufacturing of the registration batch. Leveraging China's first fully automated GMP-grade production line for radiopharmaceuticals, C-Ray achieved significant process development milestones within a mere five months followed by a swift registration batch production in just seven months. This cutting-edge digital and automated approach not only mitigates the risks associated with traditional manual methodologies but also enhances the efficiency, consistency, and overall quality of the produced drugs.

Furthermore, C-Ray has made notable advancements in cold-chain logistics, addressing the challenges associated with the long-distance transportation of radiopharmaceuticals that require stringent temperature controls. A representative from Biokin remarked, "C-Ray Therapeutics has been an indispensable partner throughout the BL-ARC001 initiative. Their expertise, swift execution, and commitment to high standards have enabled us to adhere to our timelines more effectively," emphasizing the critical role C-Ray played in overcoming the complex challenges present in this field.

As Biokin Pharmaceutical gears up to expand its production capacities with the support of C-Ray’s automated facilities and the pioneering cold-chain system compliant with international standards, both companies are optimistic about the future of clinical research and supply chain effectiveness.

Biokin joins notable Chinese pharmaceutical titans such as Kelun, Hengrui, Yunnan Baiyao, and Fosun, who are also transitioning from ADCs and bispecifics into the RDC domain. This trend signals a new chapter for the radiopharmaceutical industry in China, promising enhanced integrative approaches to diagnostic and therapeutic interventions.

C-Ray Therapeutics has happily noted its involvement in over 50 CRDMO projects, including a notable 14 projects related to Ac-225, showcasing its commitment to facilitating partners in the global race in radiopharmaceutical development. C-Ray is dedicated to furthering the reach of precision medicine, making cutting-edge therapies accessible to a broader patient population.

About Biokin Pharmaceutical

Biokin Pharmaceutical is a pioneering global biopharmaceutical company dedicated to large-molecule oncology therapies. Its flagship asset, BL-B01D1, is the first-in-class EGFR×HER3 bispecific ADC and is currently in Phase III clinical trials. Biokin aims to establish itself as a key player in the multinational oncology sector with planned global commercial launches by 2028.

About C-Ray Therapeutics (Chengdu) Co., Ltd.

Headquartered in Chengdu Medical City, C-Ray Therapeutics is recognized as China's foremost radiopharmaceutical CRDMO partner, offering comprehensive solutions from initial research to clinical and commercial supplies. C-Ray operates a state-of-the-art 28,000 m² GMP facility alongside a GLP-like nonclinical research center, significantly propelling innovation within radiopharmaceutical development.