Asieris Pharmaceuticals (688176) is a prominent global biopharmaceutical firm specializing in the research, development, and commercialization of novel drugs targeting genitourinary tumors and related ailments. The company has recently declared the successful attainment of the primary objective in the Phase III bridging clinical trial of Hexvix® for diagnosing bladder cancer. This outcome is anticipated to be submitted to the Chinese National Medical Products Administration (NMPA) as part of a new drug application (NDA) in the ensuing months.

This prospective and self-controlled multicenter Phase Ⅲ study was designed to investigate the additional detection rate and safety of Hexvix® combined with blue light cystoscopy (BLC) in contrast to white light cystoscopy for patients suffering from non-muscle invasive bladder cancer (NMIBC), which includes tumors at stages of carcinoma in situ (CIS), Ta, and T1.

A total of 158 patients were enrolled in the study. Statistical analyses have been completed and confirm the successful achievement of the study's primary objective. Detailed results from the study are scheduled to be presented at forthcoming academic conferences.

Asieris Pharmaceuticals and Photocure ASA (Photocure, OSE:PHO), a Norwegian bladder cancer specialty company, entered a licensing agreement in January 2021. Asieris secured the exclusive registration and commercialization rights of Hexvix® in mainland China and Taiwan through this partnership.

Dr. Linda Wu, Chief Development Officer of Asieris, expressed her gratitude towards the researchers and participants, highlighting the significant progress marked by the clinical data of Hexvix®. She emphasized the company's commitment to further advancements, aiming for commercialization to benefit bladder cancer patients.

About Asieris Pharmaceuticals

Asieris Pharmaceuticals (688176.SH), established in March 2010, is a globally recognized biopharmaceutical company dedicated to innovating drugs for genitourinary tumor treatment and related conditions. Their mission is to enhance human health and uphold patient dignity. They strive to be a leading global pharmaceutical entity, integrating research and development, manufacturing, and commercialization to provide top-tier integrated diagnostic and treatment solutions worldwide, especially in China.

Leveraging proprietary R&D platforms and core technologies, Asieris actively pursues new mechanisms of action, efficiently evaluates drug candidates, and employs its in-house R&D expertise to advance first-in-class drugs and pioneering solutions for unmet medical needs. The company also strengthens its pipeline for genitourinary diseases through in-house R&D efforts and strategic collaborations, aligning with cutting-edge advancements in the field. Their comprehensive approach to product planning and lifecycle management seeks to establish a diverse portfolio covering diagnosis and treatment, ultimately benefiting patients in China and globally.

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