Asieris Pharmaceuticals released its 2023 Semi-Annual Report that highlights the accelerated progress in clinical trials, aiming to address the field's highly unmet diagnostic and therapeutic needs. Meanwhile, Asieris is establishing a specialized commercial team to enhance in-house capabilities to help achieve successful commercialization. With an ambition to become a global leader in GU cancer patient care, Asieris will continue to drive forward science in this field, strategically differentiate its product pipeline, and accelerate the time to market for its products to generate revenue.

In August 2023, Asieris achieved positive results from the Phase III clinical trial in China for one of its core products within the field of urological diseases: APL-1706 (Hexvix(R). APL-1706 is the only imaging agent approved in the United States and the European Union for the diagnosis and surgical treatment of bladder cancer. It leads to more comprehensive resections during surgery, thereby contributing to a reduction in the rate of tumor recurrence.

Also in August, the Department of Health under the Government of the Hong Kong Special Administrative Region granted its approval for the registration applications of the Uro-G and Uro-V disposable cystoscopic systems. Notably, the registration application of the Uro-G had been previously accepted by the National Medical Products Administration (NMPA) of China in February 2023. Furthermore, the registration application of theUro-3500, an electronic endoscope image processor used in tandem with the Uro-G, was accepted in July 2022. Upon reaching the predefined target number of events, subsequent phases, including database lock, unblinding, and statistical analysis, will be promptly initiated.

Concurrently, Asieris is recruiting patients in China for the Phase III clinical trial of APL-1202, which is designed to assess its efficacy as the first-line monotherapy for previously untreated patients with intermediate-risk NMIBC. The international multi-center Phase II clinical trial, which evaluates the combination of oral APL-1202 with tislelizumab, an anti-PD-1 antibody, as a neoadjuvant therapy for Muscle-Invasive Bladder Cancer (MIBC), is currently underway in both the United States and China. This trial completed its first-patient enrollment in December 2022.

The safety and efficacy data from the Phase I clinical trial were presented at the American Society for Clinical Oncology Annual Meeting in May 2023. In this trial, a total of 9 patients were enrolled, the clinical data showed oral APL-1202 in combination with tislelizumumab was well tolerated, and preliminary efficacy signals were observed in 8 evaluable patients. APL-1202, a first-in-class orally available and reversible MetAP2 inhibitor for anti-tumor treatment, is now in the pivotal Phase III clinical trials for the treatment of NMIBC.

It exhibits immense potential to bridge the existing gap for bladder cancer treatment. Asieris has built a robust portfolio, including oral therapeutic drug APL-1202 (Vesique(R), imaging agent APL-1706(Hexvix(R), and disposable bladder endoscope APLD-2101, to address the unmet needs in bladder cancer diagnosis, treatment, and post-treatment monitoring. These products offer integrated solutions to doctors and patients worldwide.

With consistent progress in portfolio development, Asieris is steadily delivering on its specialty pharma strategy. Through the successful commercialization of Dipeptid(R) and Ouyoubi(R), the company aims to cultivate a highly competent commercial team while enhancing customer engagement and brand impact, and driving down overall commercialization-related costs. The Hongyihui platform offers precise resource allocation, custom-tailored to individual products.