Asieris Pharmaceuticals Announces 2021 Annual Report: Steady Progress in Core Product Pipeline and Progressive Implementation of the Integrated Diagnosis and Treatment Commercialization Strategy

SHANGHAI, April 14, 2022 /PRNewswire/ -- Asieris Pharmaceuticals (688176.SH), a global innovative pharmaceutical company specializing in the treatment of genitourinary cancers and related major diseases, announced its 2021 annual report today. The company is currently making steady progress in multiple global clinical trials for its core investigational drugs and is actively implementing its integrated diagnosis-treatment strategy for commercialization. In addition, the company has sufficient capital reserves for increased R&D investment. It will continue to focus on genitourinary cancers and related major diseases and to explore other highly unmet medical needs. Asieris Pharmaceuticals is becoming a leading global pharmaceutical company in its areas of focus with combined capabilities in R&D, manufacturing, and commercialization, especially by providing the best integrated diagnosis-treatment solutions for patients in China and around the world.

Indication Expansion and Pipeline Globalization

In the genitourinary (GU) disease area, our core product APL-1202 (trade name: Vesique^TM), independently developed by Asieris, is a first-in-class, orally available and reversible MetAP2 inhibitor for anti-tumor treatment, currently in pivotal/phase III clinical trials. It is also the world's first oral therapeutics for non-muscle invasive bladder cancer (NMIBC) in the pivotal/phase III clinical phase. Patient recruitment for the combination of APL-1202 and intravesically instilled chemotherapy in relapsed intermediate- and high-risk NMIBC was completed in September 2019, with follow-up currently ongoing. Patient recruitment for APL-1202 monotherapy as a first-line treatment in naive, intermediate-risk NMIBC started in September 2021.  In addition, an international multicenter phase I/II clinical trial for its oral APL-1202 in combination with BeiGene's tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) was approved by US FDA and China CDE in June and September 2021, respectively. Recruitment of the first patient has been completed. Previously, results from the phase II clinical trial of APL-1202 for the treatment of chemo-instillation relapsed high-risk NMIBC patients showed significant efficacy compared to chemo-instillation alone as a historical control, making APL-1202 potentially the first choice for second-line therapy in chemo-relapsed intermediate- and high-risk NMIBC patients.

APL-1706 (trade name: Hexvix®), another core product in the GU area from Asieris Pharmaceuticals, is the world's only approved imaging agent indicated for bladder cancer diagnosis or surgery. It has been marketed in more than 30 countries and received approval from China NMPA for a phase III bridging clinical trial in February 2022. APL-1706, combined with blue light cystoscopy, can effectively improve the detection rate of NMIBC (especially for carcinoma in situ), resulting in more complete resection and reduction of tumor recurrence rate.

APL-1501, independently developed by Asieris Pharmaceutical utilizing its proprietary Prodrug Accurate Drug Delivery (PADD) technology platform, is a second generation oral MetAP inhibitor for the treatment of GU tumors and drug-resistant urinary tract infections. A Phase I clinical trial is currently underway in Australia. Based on the results, Asieris Pharmaceuticals will continue the clinical development of APL-1501 for the treatment of GU tumors and drug-resistant urinary tract infections.

In the women's health area, Asieris' core product APL-1702 (trade name: Cevira®) is a drug-device combination photodynamic therapy product for non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL) caused by any HPV subtypes. It has received regulatory approvals for an international multi-center phase III clinical trial in China, Hungary, Ukraine, Germany, Slovakia, the Czech Republic, the Netherlands, and Poland. Patient recruitment is well under way. At present, non-surgical options do not exist on the market for HSIL patients. APL-1702 could provide patients with a new option that alleviates the pain and risky side effects commonly associated with surgical treatments. APL-1702 will be especially beneficial to women of childbearing age by eliminating the adverse impact of surgical treatment on reproductive functions.

Innovation in Integrated Diagnosis & Treatment Solutions with Accelerated Commercialization

Asieris Pharmaceuticals has strategically developed its business in the genitourinary field, via a highly differentiated product portfolio covering bladder cancer diagnosis, treatment, and follow-up. We effectively address the unmet clinical needs in this field with innovative and integrated diagnosis-treatment solutions for doctors and patients. These include APL-1706, the world's only approved imaging agent indicated for the diagnosis and surgical treatment of bladder cancer; APL-1202, the only first-in-class orally administered reversible MetAP2 inhibitor for bladder cancers (NMIBC and MIBC); and APLD-2101, a versatile integrated single-use flexible cystoscope for diagnosing bladder diseases.

Asieris Pharmaceuticals is also making solid progress in commercialization by building an end-to-end team: from marketing, sales, commercial operations, market access, integrated operation of diagnosis and treatment, to sales efficiency. We have also launched related products in Hainan Province's Bo'ao Lecheng National Pilot Zone of International Medical Tourism.

On 20 May 2021, Asieris Pharmaceutical and Sinopharm Group signed a strategic collaboration agreement for launching innovative pharmaceutical and device products in Bo'ao Lecheng. As a result, selected Chinese patients had early access to APL-1706, which also subsequently received approval in March 2022 by the CDE to be included in the real-world clinical data pilot program.

Asieris Pharmaceuticals will continue to develop and implement other comprehensive integrated solutions for diagnosis and treatment to serve patients around the world.

Maintenance of a Healthy Financial Position. Implementation of an ESG Management System

Asieris Pharmaceuticals maintained a healthy financial position while steadily advancing various new drug R&D projects. In 2021, the R&D expenditures amounted to RMB 190.74 million yuan, an increase of 10.88% from the previous year; the monetary funds and trading financial assets at the end of this reporting period amounted to RMB 2.98 billion yuan, with a sufficient capital reserve.

In terms of non-financial indicators, the company has incorporated environmental, social responsibility and governance (ESG) into its corporate development strategy, and continues to build and improve its ESG management system, including paying close attention to environmental protection and the goals of "carbon peaking and carbon neutrality", addressing climate change, optimizing environmental management practices, contributing to green environmental protection, and promoting sustainable development; adhering to the people-oriented principle and incorporating talents development into the company's strategic goals, protecting employees' rights, and creating a respectful, equal and collaborative working environment; establishing good corporate governance, strictly abiding by national and local laws and regulations, adhering to the code of integrity and ethics, and creating value for shareholders, customers, employees, partners, and communities.

 "In 2021, we have made steady progress across our R&D pipelines and have laid a solid foundation for commercialization and globalization", summarized Dr. Kevin Pan, Founder, Chairman, and CEO of Asieris Pharmaceuticals. "Going forward, we will continue to focus on our clinical specialties by delving deeply into the genitourinary oncology field, filling the gap in the diagnosis and treatment of bladder cancer and cervical precancerous lesions, and bringing more innovative solutions to patients worldwide. The road is long and arduous, and we must press on to achieve our goals. We will continue to adhere to our differentiated development and commercialization strategy and act in alignment with our corporate mission of improving human health and making life more dignified."

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