{"id":1614,"date":"2025-10-21T07:11:00","date_gmt":"2025-10-21T07:11:00","guid":{"rendered":"https:\/\/network.rvrising.com\/?p=1614"},"modified":"2025-10-21T07:11:00","modified_gmt":"2025-10-21T07:11:00","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:\/\/www.rvrising.com\/news\/health\/c-ray-therapeutics-chengdu-co-ltd-congratulates-partner-biokin-pharmaceutical-on-nmpa-ind-approval-of-first-proprietary-arc-drug-177lu-bl-arc001\/","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>, Oct. 11, 2025<\/span> \/PRNewswire\/ — C-Ray Therapeutics (Chengdu) 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

\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<\/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) 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<\/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) Co.,Ltd\u00a0has 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) Co.,Ltd will continue supporting Biokin with clinical supply and distribution through its automated production line<\/b> and China’s 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 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) 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\u00a0Biokin 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) Co.,Ltd<\/b>
C-Ray Therapeutics (Chengdu) Co.,Ltd is China’s 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

SOURCE C Ray Therapeutics\"\"<\/p>\n<\/div>\n

This release is auto-published via PR Newswire; our journal is not responsible for the content.<\/b><\/p>\n

Source link <\/a><\/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,<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,92],"tags":[476],"class_list":["post-1614","post","type-post","status-publish","format-standard","hentry","category-health","category-pr-newswire","tag-c-ray-therapeutics"],"_links":{"self":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts\/1614","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/comments?post=1614"}],"version-history":[{"count":1,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts\/1614\/revisions"}],"predecessor-version":[{"id":2204,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/posts\/1614\/revisions\/2204"}],"wp:attachment":[{"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/media?parent=1614"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/categories?post=1614"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rvrising.com\/news\/wp-json\/wp\/v2\/tags?post=1614"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}