SHANGHAI, January 29, 2024/PRNewswire/ -- Yahong Pharmaceutical (stock code: 688176.SH), a global innovative pharmaceutical company focusing on urogenital tumors, recently announced that the company announced phase III clinical trial data and real-world research data for the diagnosis and management of bladder cancer in the form of a poster (abstract number: 593) at the 2024 American Society of Clinical Oncology Symposium on Urogenital Oncology (ASCO GU).
A total of 158 patients were included in this trial (RCT, Randomized Controlled Trial). Of these, 37 were patients in the training group, 6 were randomly assigned without BLC, and 1 case was withdrawn. 114 patients comprised the full analysis set. Nineteen patients were included in the Real World Study (RWS). Among patients diagnosed with Ta, T1, or CIS, 42/97 (43.3%) in RCT and 4/12 (33.3%) in RWS patients had at least one confirmed lesion (p<0.0001) with BLC detected but not WLC. 11/114 (9.6%) CIS patients with RCT and 1/14 (7.1%) CIS patients with RWS detected 1 or more additional CIS lesions not detected by WLC under BLC. The BLC detection rates for PUNLMP, CIS, T1, and T2 to T4 tumors in RCT were NA, 94.7%, 100%, 98.2%, and 100%, and WLC detection rates were NA, 42.1%, 76.1%, 91.2%, and 100%. In RWS, BLC detection rates for PUNLMP, CIS, T1, and T2 to T4 tumors were NA, 100%, 100%; WLC detection rates were NA, 50%, 81%, 100%, and 100%, respectively; RCT and RWS confirmed that APL-1706 combined with BLC detected bladder cancer better than WLC in the Chinese population, especially in CIS, and was well tolerated.
The New Drug Marketing Application (NDA) for APL-1706 was accepted by the National Drug Administration (NMPA) in November 2023.
About Yahong Pharmaceutical
Established in March 2010, Yahong Pharmaceutical (stock code: 688176.SH) is a global innovative pharmaceutical company focusing on urogenital tumors and other major diseases. Adhering to the corporate mission of “improving human health and making life more dignified”, Yahong Pharmaceutical aims to become a leading international pharmaceutical company integrating R&D, production and commercialization in the field of treatment, providing the best integrated diagnosis and treatment solutions for patients in China and around the world.
The company insists on innovative technology and products as the core driving force. By building its own R&D platform and core technology, the company thoroughly explores the mechanism of action of drugs and efficiently screens and evaluates drug candidates. Through a complete internal R&D system and global drug development expertise, Yahong Pharmaceutical is committed to launching first-in-class (first-in-class) drugs and other innovative drugs with huge unmet treatment needs in therapeutic areas.
At the same time, through independent research and development and strategic cooperation, Yahong Pharmaceutical has carried out an in-depth layout of product pipelines around urogenital diseases, paid close attention to technological frontiers and treatment trends in this field, insight into and exploration of unmet clinical needs, carried out forward-looking product planning and life cycle management, and created an advantageous product portfolio covering disease diagnosis to treatment, thus benefiting more patients in China and around the world. For more information, please visit.