Китайская биотехнология NORROY получила разрешение на проведение третьей фазы клинических испытаний радиопрепарата для лечения рака простаты

WUXI, China, Sept. 2, 2026 /PRNewswire/ -- NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that it has received regulatory clearance from China's National Medical Products Administration (NMPA) to initiate a pivotal Phase III clinical study of 177Lu-NYM032 in China. 177Lu-NYM032 is a novel investigational PSMA-targeted, small-molecule therapeutic radiopharmaceutical for radioligand therapy (RLT) independently developed in China. Led by the Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, a randomized, open-label, multicenter Phase III study is being conducted at multiple sites across China to evaluate the efficacy and safety of 177Lu-NYM032 in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). 177Lu-NYM032 has demonstrated promising anti-tumor activities and a favorable safety profile in its Phase I/II clinical study, with the data to be disclosed in a Top-Rated Oral Presentation (TROP) at the 2026 Annual Congress of the European Association of Nuclear Medicine (EANM 26). Previously, the corresponding diagnostic radiopharmaceutical pair, 68Ga-NYM032, was dosed in the first patient in a Phase III clinical trial, marking a key milestone in the advancement of the company's integrated prostate cancer theranostic pipeline. The 68Ga/177Lu-NYM032 theranostic pair has also received U.S. FDA Investigational New Drug (IND) clearance. The pair of diagnostic and therapeutic agents of NYM032 are derived from the same precursor structure, enabling a fully integrated theranostic approach and offering the potential to provide patients with prostate cancer in China with a more precise and coordinated diagnosis and treatment option. Prostate cancer is the fifth leading cause of cancer death among men worldwide. In 2022, more than 134,000 patients in China were newly diagnosed with prostate cancer, and approximately 47,500 deaths were reported. A substantial proportion of the patients will eventually progress to have metastatic castration-resistant prostate cancer (mCRPC), an aggressive late-stage form of the disease. At that stage, many patients face limited treatment options after exhausting standard-of-care therapies, thus underscoring the substantial unmet medical need for novel targeted radiopharmaceuticals in China. About NORROY BIOSCIENCE NORROY is a clinical-stage biotechnology company focused on the development and commercialization of innovative therapeutic and diagnostic radiopharmaceuticals, as well as automated synthesis systems and functional modules for radiopharmaceutical manufacturing in both R&D and GMP environments. Founded in July 2021, NORROY has radiopharmaceutical candidates currently under clinical investigation in more than 10 disease targets across multiple therapeutic areas, including urological oncology, gastrointestinal oncology, and other oncology and non-oncology indications. The U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to NORROY's diagnostic imaging agent for kidney cancer, 68Ga-NYM096. Beyond innovative radiopharmaceuticals and automated manufacturing solutions, NORROY continues to establish a reliable global supply chain for multiple radioisotopes, build commercial GMP manufacturing facilities, and develop a global distribution network with international partners. To date, NORROY has received six (6) IND clearances from the FDA and six (6) IND approvals from the National Medical Products Administration (NMPA). The Company is actively working with global regulatory agencies to advance its late-stage programs through internationally registered clinical trials. To learn more about NORROY, visit https://www.norroybiopharm.com/ and follow us on LinkedIn: https://www.linkedin.com/company/norroybiopharm/ NORROY Contacts Media: [email protected] Important Information 177Lu-NYM032 is an investigational radiopharmaceutical product and has not been approved for marketing by the U.S. Food and Drug Administration (FDA), China's National Medical Products Administration (NMPA), or any other regulatory authority. Its safety and efficacy have not been fully established. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding the clinical development and regulatory progress of 177Lu-NYM032; the timing, progress and results of ongoing and planned clinical trials; the presentation of additional clinical data; interactions with regulatory authorities; potential regulatory submissions and approvals; and the potential commercialization of Norroy's product candidates in China, the United States and other markets. These forward-looking statements are based on Norroy's current expectations and assumptions and are subject to known and unknown risks, uncertainties, and other factors that could cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. There can be no assurance that planned clinical trials will be initiated or completed as anticipated, that clinical results will support further development or regulatory submissions, or that any of Norroy's product candidates will receive regulatory approval or achieve commercial success. Except as required by applicable law, Norroy undertakes no obligation to publicly update or revise any forward-looking statements contained in this press release as a result of new information, future events, or otherwise. SOURCE Norroy Bioscience Co., Ltd.