{"id":28864,"date":"2025-03-07T00:37:05","date_gmt":"2025-03-06T16:37:05","guid":{"rendered":"https:\/\/flcube.com\/?p=28864"},"modified":"2025-03-07T00:37:07","modified_gmt":"2025-03-06T16:37:07","slug":"bioray-biopharmaceuticals-br111-receives-nmpa-clearance-for-clinical-trials-in-ror1-positive-malignancies","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=28864","title":{"rendered":"BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies"},"content":{"rendered":"\n

Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its Category 1 biologic product, BR111. The drug, an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, is being developed to treat ROR1-positive hematological malignancies and solid tumors, marking a significant milestone in the company’s oncology pipeline.<\/p>\n\n\n\n

BR111: A First-in-Class Anti-ROR1 Bi-paratopic ADC<\/strong>
BR111 utilizes BioRay’s next-generation CysX irreversible site-specific conjugation technology platform to conjugate an antibody targeting dual epitopes of ROR1 with the small-molecule toxin eribulin. As the world’s first anti-ROR1 Bi-paratopic ADC to enter clinical trials, BR111 demonstrates higher homogeneity and circulating stability. This innovative design significantly reduces toxin release in circulation, enhancing safety and optimizing the therapeutic window. No similar product has been approved anywhere in the world, positioning BR111 as a potential breakthrough in the treatment of ROR1-positive malignancies.<\/p>\n\n\n\n

Clinical Trial Outlook<\/strong>
The clinical trial clearance represents a crucial step forward in the development of BR111. BioRay Biopharmaceutical plans to evaluate the safety and efficacy of BR111 in patients with ROR1-positive hematological malignancies and solid tumors. The company anticipates that the trial will provide valuable data to support the further development of BR111 and potentially expand its therapeutic indications in the future.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to…<\/p>\n","protected":false},"author":1,"featured_media":28865,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,2575,16,62],"class_list":["post-28864","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-bioray-pharmaceutical","tag-cancer","tag-clinical-trial-approval-initiation"],"yoast_head":"\nBioRay Biopharmaceutical's BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its Category 1 biologic product, BR111. 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