Shanghai, China, November 29, 2023– Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases，announced that the new drug application (NDA) for APL-1706 (compound name: Hexaminolevulinate Hydrochloride for Intravesical Solution), a drug used for bladder cancer diagnosis and management has been accepted by the National Medical Products Administration (NMPA).
APL-1706 clinical trial results from China were first presented in the form of an oral presentation at the 43rd Congress of the Société Internationale d’Urologie (SIU) held in October 2023, as a Late-Breaking Abstract (LBA) at the conference. The study confirmed that, in Chinese patients, APL-1706 in combination with blue light cystoscopy (BLC) outperformed white light cystoscopy (WLC) in the detection of bladder cancer, particularly in cases of carcinoma in situ (CIS), and exhibited good tolerability.
APL-1706 is currently the only approved optical imaging agent indicated for the diagnosis and management of bladder cancer worldwide. The combined use of APL-1706 and BLC for the management of non-muscle invasive bladder cancer (NMIBC) has been included in the global expert consensus guidelines and Chinese Urological Association Guideline. The drug has not yet been approved for market launch in China.
According to the latest global cancer data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, bladder cancer is one of the top ten most common cancers worldwide. According to Frost Sullivan, the number of new bladder cancer cases globally increased from 573,000 in 2020 to 651,000 in 2025, with a compound annual growth rate of 2.6%. This trend is expected to continue, with an estimated 736,000 new cases of bladder cancer projected globally by 2030. In China, the number of new bladder cancer cases reached 86,000 in 2020, and it is estimated to increase to 101,000 by 2025, with a compound annual growth rate of 3.4%. Additionally, due to the high recurrence rate and long survival period of bladder cancer patients, who require regular follow-up and treatment, there is a significant unmet clinical need in this field.
Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, “Acceptance of the new drug application for APL-1706 by the NMPA is a milestone in our focused strategy in genitourinary tumors, and marks a significant move towards a comprehensive integration of bladder cancer diagnosis and treatment. We will continue to prioritize patient-centric care, deeply explore their pain points and unmet clinical needs, and actively advance the clinical development of the drug to provide innovative solutions for patients, while elevating the standards of bladder cancer diagnosis and treatment.”
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient’s dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
