{"id":40660,"date":"2025-10-11T12:45:00","date_gmt":"2025-10-11T12:45:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4795786_CN95786_0"},"modified":"2025-10-11T12:45:00","modified_gmt":"2025-10-11T12:45:00","slug":"c-ray-therapeutics-chengdu-co-ltd-congratulates-partner-biokin-pharmaceutical-on-nmpa-ind-approval-of-first-proprietary-arc-drug-177lu-bl-arc001","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=40660","title":{"rendered":"C-Ray Therapeutics (Chengdu) Co., Ltd Congratulates Partner Biokin Pharmaceutical on NMPA IND Approval of First Proprietary ARC Drug [177Lu]-BL-ARC001"},"content":{"rendered":"

CHENGDU, China<\/span><\/span>, Oct. 11, 2025<\/span><\/span> \/PRNewswire\/ — C-Ray Therapeutics (Chengdu<\/span>) Co.,Ltd proudly congratulates its strategic partner, Biokin Pharmaceutical<\/b>, on receiving implied approval from the National Medical Products Administration (NMPA)<\/b> for the clinical trial application of [177<\/sup>Lu]-BL-ARC001 Injection<\/b>, the company’s first radiopharmaceutical and a Class 1 innovative biologic.<\/p>\n

This milestone approval marks Biokin’s entry into the fast-growing Radiopharmaceutical Drug Conjugate (RDC)<\/b> field and reinforces its leadership in large-molecule oncology therapies (ADC\/GNC\/ARC). The company’s flagship asset BL-B01D1<\/b> (a first-in-class EGFR\u00d7HER3 bispecific ADC) set a record-breaking global licensing deal of USD 8.4 billion<\/span><\/b>, underscoring Biokin’s innovation strength and global vision.<\/p>\n

As the core CRDMO partner<\/b> for the [177<\/sup>Lu]-BL-ARC001 program, C-Ray Therapeutics (Chengdu<\/span>) Co.,Ltd provided end-to-end services including radiolabeling process development, quality studies, and registration batch manufacturing. Leveraging China’s<\/span> first fully automated GMP-grade radiopharmaceutical production line<\/b>, C-Ray completed process development and quality studies in just five months<\/b>, followed by registration batch production in only seven months<\/b>. This digitalized, automated model not only eliminates traditional manual risks but also ensures efficiency, consistency, and product quality<\/b>.<\/p>\n

C-Ray also made significant breakthroughs in cold-chain logistics<\/b>, addressing long-distance, multi-center transport challenges for radiopharmaceuticals.<\/p>\n

“C-Ray Therapeutics (Chengdu<\/span>) Co.,Ltd has been an indispensable partner in the [177<\/sup>Lu]-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.”<\/p>\n

Moving forward, C-Ray Therapeutics (Chengdu<\/span>) Co.,Ltd will continue supporting Biokin with clinical supply and distribution through its automated production line<\/b> and China’s<\/span> first international-standard radiopharmaceutical cold-chain system<\/b>, ensuring smooth multi-center clinical research.<\/p>\n

Biokin joins other leading Chinese pharma companies, including Kelun, Hengrui, Yunnan Baiyao, and Fosun<\/b>, in expanding from ADCs and bispecifics into RDCs, pushing China’s<\/span> radiopharmaceutical industry toward a new era of integrated diagnosis and therapy<\/b>.<\/p>\n

As a key integrator in this wave, C-Ray Therapeutics (Chengdu<\/span>) Co.,Ltd has delivered over 50 CRDMO projects<\/b> (35 CRO and 15 CDMO programs) covering the full lifecycle of radiopharmaceuticals<\/b>\u2014from early research and IND filing to clinical and commercial supply. With a strong isotope supply chain, including 14 projects involving Ac-225<\/b>, C-Ray is committed to enabling partners to lead the global RDC race and bringing precision medicine to more patients.<\/p>\n

About Biokin Pharmaceutical<\/b>
Biokin Pharmaceutical is a global biopharmaceutical company focused on oncology large-molecule therapies (ADC\/GNC\/ARC). Its lead asset BL-B01D1 is the first-in-class EGFR\u00d7HER3 bispecific ADC in Phase III clinical trials. The company’s strategic goal is to become a multinational oncology leader, with global commercialization planned by 2028.<\/p>\n

About C-Ray Therapeutics (Chengdu<\/span>) Co.,Ltd<\/b>
C-Ray Therapeutics (Chengdu<\/span>) Co.,Ltd is China’s<\/span> leading radiopharmaceutical CRDMO partner, providing one-stop solutions from process development and IND filing to clinical and commercial supply. Headquartered in Chengdu Medical City, C-Ray operates a 28,000 m\u00b2 world-class GMP facility<\/b> and GLP-like nonclinical research center. With more than 50 projects delivered and ongoing, C-Ray is building an open innovation platform to accelerate theranostic solutions and become a global benchmark in radiopharmaceutical development.<\/p>\n","protected":false},"excerpt":{"rendered":"

CHENGDU, China, Oct. 11, 2025 \/PRNewswire\/ — 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 […]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-40660","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"\nC-Ray Therapeutics (Chengdu) Co., Ltd Congratulates Partner Biokin Pharmaceutical on NMPA IND Approval of First Proprietary ARC Drug [177Lu]-BL-ARC001 - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=40660\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"C-Ray Therapeutics (Chengdu) Co., Ltd Congratulates Partner Biokin Pharmaceutical on NMPA IND Approval of First Proprietary ARC Drug [177Lu]-BL-ARC001 - My Blog\" \/>\n<meta property=\"og:description\" content=\"CHENGDU, China, Oct. 11, 2025 \/PRNewswire\/ — 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. 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