Asieris Announces Approval of its Phase III Trial of a Novel Single Oral Agent as First-line Treatment for Non-Muscle Invasive Bladder Cancer (NMIBC)

SHANGHAI,Nov. 5,2020 -- Asieris Pharmaceuticals (Asieris),a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases,recently announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved the clinical trial application (CTA) for its Phase III trial of APL-1202 as single oral agent for the first-line treatment of NMIBC.

"This Phase III clinical trial for the first-line treatment of NMIBC,a key step to verify the advantages and characteristics of APL-1202,is another milestone of Asieris," commented Dr. Kevin Pan,founder and CEO of Asieris. "The single oral drug therapy of APL-1202 has the potential to replace intravesical chemotherapy and thereby avoiding the pain and adverse reactions associated with catheterization. If proven,it should become a new choice to prevent cancer recurrence. Asieris will continue to adhere to the vision of 'we strive for healthy and dignified lives' and focus on genitourinary tumors and related diseases. We hope to bring better treatment choices to more patients soon."

Currently,another pivotal registration trial of APL-1202 is ongoing in China.The treatment regimen is a combination of oral APL-1202 and intravesical chemotherapy as second-line treatment of patients with intermediate and high-risk recurrences of intravesical chemotherapy. This finished enrollment in 2019.

The approved trial is a randomized,open-labeled,parallel controlled,multicenter study to compare the safety and efficacy of oral APL-1202 as single drug versus intravesical epirubicin hydrochloride for the treatment of naive NMIBC with recurrence-free survival as the primary endpoint. This study will expand the clinical utility of APL-1202 and if successful will demonstrate the characteristics and advantages of APL-1202.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

According to Globocan (2018),bladder cancer is the tenth most common type of cancer worldwide,with an estimated 549,000 new cases and 200,000 deaths every year. Among them,75% - 85% is non-muscle invasive bladder cancer (NMIBC). Currently,the common treatment of NMIBC is Trans-Urethral Resection of Bladder Tumors (TURBT). Because of high tumor recurrence rate after TURBT,intravesical chemo- or immuno-therapies are required after the procedure. Intravesical catheterizationrequires a hospital visit and is often associated with pain and other adverse reactions. No oral drugs have been approved for NMIBC to date.

About APL-1202

APL-1202 is a selective human methionine aminopeptidases II (MetAP2) inhibitor. In preclinical studies,APL-1202 has demonstrated both anti-angiogenic and anti-tumor activities as well as a potential synergistic effect with anti-BCG or epirubicin. APL-1202 is currently under clinical investigation for multiple indications. The treatment regimen with APL-1202 is convenient and well-tolerated,without causing pain or injury to the urethra,and may help some high-risk patients avoid radical cystectomy.

About Asieris Pharmaceuticals

Asieris Pharmaceuticals was founded inside the 'China Medical City' located in the city of Taizhou,Jiangsu Province,PRC,in March 2010. Asieris is determined to become a leading pharmaceutical company driven by innovative technologies and products that focus on genitourinary tumors and related diseases. The company and its professional teams are located in Shanghai,Beijing,Taizhou,and the US,with their research and development center in Jinqiao District,Shanghai. Asieris adheres to the growth model of proprietary R&D supplemented by in-licensing,to rapidly establish leadership in their focused fields with in-depth strategic plans. We create global values with our first-in-class innovative drugs with breakthrough potentials. Meanwhile,we have unique R&D platforms for anti-tumor and anti-microbial resistance drugs. In addition,we in-license late-development stage and marketed products for the Chinese market to enhance our pipeline and to quickly establish our leadership position in the domestic market.

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