Asieris Releases 2022 Annual Report: Makes Steady Progress in its Clinical Development, Global Expansion to Treat Genitourinary Tumors, and Implementing its Commercialization Strategy to Provide Integrated Diagnosis-to-Treatment Solutions

SHANGHAI, April 17, 2023 /PRNewswire/ -- Asieris Pharmaceuticals (688176.SH), a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary (GU) tumors and other related diseases, today released its 2022 annual report. While enhancing its product pipeline with steady progress in its global clinical trials, Asieris is building up its core marketing and sales team to implement its commercialization strategy that integrates solutions from diagnosis to treatment. Moreover, in 2022 the company increased its R&D investment, which includes expanding its Shanghai R&D Center, creating an innovation base and establishing a global clinical-development team in the US. Asieris is dedicated to becoming a global leader in diagnosis and treatment of GU tumors and other related diseases, by continuously focusing on the GU oncology field; strengthening its differentiated pipeline; developing a portfolio of competitive, integrated diagnosis-to-treatment solutions with potential blockbusters; and aggressively pursuing commercialization of these innovative products to soon deliver them to patients in need.

Accelerate Global Clinical Development and Deepen Strategic Implementation to Treat GU Tumors

Urological Disease Area

In the field of urological diseases, APL-1202 (trade name: Vesique®) is a core product that Asieris has independently developed. Through the ANTICIPATE study – an international, multi-center Phase I/II clinical study that examines the combination of oral APL-1202 with tislelizumab, an anti-PD-1 antibody, as a neoadjuvant therapy for Muscle-Invasive Bladder Cancer (MIBC) – APL-1202 has progressed smoothly into the Phase II stage of the trial and completed its first patient enrollment in December 2022. The protocol of ANTICIPATE study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022. One year later, at ASCO's 2023 Annual Meeting in June, Asieris will further present the safety and efficacy data from its Phase I clinical trial.

Meanwhile, APL-1202's ACCRUE trial – which examines oral APL-1202 in combination with intravesically-instilled chemotherapy for treating relapsed intermediate- and high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) – has been in close follow-up with patients. When the trial reaches its target event number, Asieris will immediately conduct the subsequent work, such as the database lock, unblinding, and statistical analysis. What's also steadily underway is the trial for APL-1202 monotherapy as a first-line treatment in naive, intermediate-risk NMIBC: it's in active patient recruitment in China.

As a first-in-class, orally available and reversible MetAP2 inhibitor for anti-tumor treatment – and currently in the pivotal Phase III clinical trials to treat NMIBC – APL-1202 holds great promise to fill the existing gap in the marketplace for treating bladder cancer.

Another core product that Asieris is developing for urological disease is APL-1706. Under the trade name Hexvix®, APL-1706's Phase III clinical trial in China completed its first patient procedure in November 2022; more patients are actively being enrolled. APL-1706 is actually the world's only approved imaging agent for bladder cancer diagnosis and surgical treatment. When combined with blue-light cystoscopy, APL-1706 has proven to effectively improve the detection rate of NMIBC – especially on carcinoma in situ. This results in more complete resection and reduced rates of tumor recurrence.

Women's Health Disease Area

In the field of women's health, Asieris' core product is APL-1702 (trade name: Cevira®), which is a drug-device combination photodynamic therapy product. In July 2022, its international, multi-center Phase III clinical trial completed enrollment. Asieris has been closely following up with patients in this trial. In June 2022, APL-1702's Phase III study protocol was also published in the peer-reviewed medical journal, BMJ Open. APL-1702 is mainly used for non-surgical treatment of cervical High-grade Squamous Intraepithelial Lesions (HSIL) caused by any HPV subtypes. APL-1702 could provide women with a new treatment option to alleviate the pain and risky side-effects commonly associated with surgical treatments. APL-1702 would be especially beneficial to women of childbearing age, because it aims to eliminate the adverse effects of surgical treatment on female reproductive functions.

Other Diseases & Pre-Clinical Projects

Asieris has also developed APL-1401, an oral drug to treat moderate to severe Ulcerative Colitis (UC) – for which there is currently no cure. In November 2022, the U.S. Food and Drug Administration (FDA) approved Asieris' Investigational New Drug (IND) application, for which Asieris is actively recruiting patients. As a dopamine β-hydroxylase (DBH) inhibitor, APL-1401 has a novel mode of action and is capable of raising dopamine (DA) and lowering norepinephrine (NE) concentrations – thereby normalizing intestinal immune homeostasis. Again, with no existing cure for UC, development of APL-1401 could provide UC patients a new treatment option.

Asieris has also entered a collaboration agreement with ReviR Therapeutics, which aims to discover and develop innovative treatments for genitourinary (GU) tumors and other related serious diseases. Except that this arrangement enables Asieris to leverage ReviR's proprietary AI drug-discovery platform and RNA-targeting technologies. With its deep understanding of the GU disease field, Asieris continues to elevate its R&D capabilities and expand its product pipeline – all of it intended to offer patients more treatment options.

Steady Implementation of Integrated Diagnosis-to-Treatment Commercialization Strategy, Centered Around Patients' Unmet Needs for Bladder Cancer Diagnosis & Treatment

With years of deep cultivation in the field of managing GU diseases, Asieris is creating an advantageous product portfolio: ranging from bladder-cancer diagnosis, treatment and follow-up surveillance, to the spectrum of unmet patient needs within the disease-management cycle. This initially includes oral-treatment drug APL-1202, imaging agent APL-1706, and single-use flexible cystoscope APLD-2101.

Administering the oral APL-1202 – combined with intravesically-instilled chemotherapy in relapsed intermediate- and high-risk NMIBC – could potentially lower the recurrence rate and help patients avoid or delay radical cystectomy, which would entirely remove their bladder. As a single-agent, first-line therapy for treating naive, intermediate-risk NMIBC, APL-1202 could possibly provide a new, safer option for patients and enable them to avoid painful intravesical treatment.

The imaging agent APL-1706 can effectively improve the detection rate of NMIBC, especially for carcinoma in situ. This will result in more complete resection and reduce the rate of tumor recurrence.

The single-use, flexible cystoscope APLD-2101 can provide multiple benefits: it significantly reduces a patient's discomfort and urethra damage caused by conventional rigid cystoscopes; avoids the risk of cross-contamination from repeat-use or incomplete sterilization; enhances operational convenience and simplicity; and even lowers the capital cost to hospitals and clinics. APLD-2101 now includes both an Uro-3500 (an electronic endoscope image processor) and an Uro-G (a disposable flexible cystoscope), after China's National Medical Products Administration (NMPA) accepted both of their registration applications – in July 2022 and February 2023, respectively.

Asieris has taken several other steps to execute the commercialization strategy of its integrated diagnosis-to-treatment solutions: in April 2023, an Asieris subsidiary, Hainan Yahong Pharmaceutical Trading Co., Ltd., received a GSP Certificate from the Hainan Medical Products Administration; in August 2022, Asieris launched its Integrated Bladder Cancer Center (IBCC) in Hainan Province, China; it independently developed the "Miyihui" online, a doctor-service platform to integrate online disease management with offline, in-person clinical diagnosis and treatment services; and completed the core structure of its marketing and sales department, by hiring numerous managers to handle sales, marketing, commercial, market access, governmental affairs, medical affairs, and specific aspects of the integrated diagnosis-to-treatment strategy. Moving forward, as the company achieves product registration and go-to-market progress, it will recruit and supplement its marketing and sales team with those who are experienced in innovative drug and device products.

Expanded the Company's R&D Capabilities, to Save Lives and Fulfill its Mission

As part of its expansion and commercialization plans, Asieris continues to grow its R&D team and enhance its innovative capabilities. In 2022, the company expanded its R&D team from 104 to 176 personnel, an increase of nearly 70% more than the previous year. To further increase the in-depth R&D coverage – as well as strengthen its global competitiveness – the company expanded its R&D Center in Shanghai and broaden the scope of R&D across multiple core pipelines. Meanwhile, it established an innovation base in the Bay Area of California, which focuses on new targets and mechanistic research. The company is also building a clinical development team on the East Coast of the US, to accelerate its global R&D progress.

Lastly, topping off all these achievements, in February 2023 the prestigious US magazine, Science, cited Asieris' role in saving a life. An American male patient was suffering from a rare "brain-eating" amoeba, when the University of California San Francisco (UCSF) reached out to Asieris for help. The amoeba, known as Balamuthia mandrillaris, is a very rare infectious pathogen of the central nervous system. Due to the lack of safe and effective treatments, the mortality rate of infected patients is reportedly as high as 90%. After screening thousands of compounds, a research team at UCSF and the Chan Zuckerberg Biohub discovered that nitroxoline was able to effectively fight Balamuthia. The UCSF team reached out to Asieris with an urgent request for assistance. Asieris immediately responded and shipped them APL-1202, its investigational drug for treating bladder cancer – which contains nitroxoline. APL-1202 went on to save this man's life. Such a meaningful contribution from Asieris also reflects the company's core values: to improve human health; bring greater dignity to the sick by developing impactful drugs; and fulfill its pledge to be a trusted partner in the healthcare industry.

As Dr. Kevin Pan, the Founder, Chairman and CEO of Asieris Pharmaceuticals, summarizes it: "Over the past year, as we focus our efforts on meeting the unmet needs in diagnosing and treating GU tumors and other related diseases, we continue our stellar progress across product pipelines. While trying to expedite our global clinical development globally, we've steadily implemented our commercialization strategies and plans. Moving forward, we will continue to focus on the fields of our expertise; further expand and enrich our product pipeline; create a competitive portfolio that includes diagnostic and therapeutic products with cutting-edge technologies; and accelerate our development of these products to the market. Our mission is to not only benefit patients in China, but around the world."

About Asieris

Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. 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 medical 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.

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SOURCE Asieris

Company Codes: Shanghai:688176

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