SHANGHAI, April 18, 2025 /PRNewswire/ -- Asieris Pharmaceuticals has marked a significant milestone in its journey by releasing its 2024 Annual Report, showcasing a resolute commitment to advancing its pharma strategy and operational efficiency. The report highlights the company's successful efforts in surpassing commercialization targets while propelling its innovative products, APL-1702 and APL-1706 (Hexvix), closer to market launch. Furthermore, the research and development (R&D) arm is gaining substantial momentum, with a total of 12 products currently in the pipeline alongside 16 active research projects. As of the end of this reporting period, Asieris boasts cash reserves totaling approximately RMB 1.89 billion in cash, cash equivalents, and trading financial assets, which sets a firm foundation for sustained growth.

Revenue Surpasses RMB 200 Million in First Year of Successful Commercialization

The year 2024 is particularly noteworthy as it marks Asieris' first full year of commercialization. The company has made significant strides in refining its market strategies and ensuring high-quality execution in its operations while simultaneously managing costs effectively. As a result, Asieris reported an operating revenue of RMB 202 million, showcasing robust growth and successfully achieving break-even targets in its commercial operations.

During the reporting period, Asieris' two commercialized products, Ouyoubi and Dipaite, have experienced strong uptake in the market, reaching over 1,000 and 500 target hospitals respectively. Sales for these products have been impressive, with Ouyoubi capturing 27% of the neratinib tablet market and Dipaite securing 12% of the pazopanib tablet market.

In a bid to strengthen its foothold in key therapeutic areas, Asieris has introduced multiple products and established strategic sales partnerships, particularly within the domains of women's health and genitourinary (GU) tumors. Notably, in March 2025, the company licensed the eribulin mesylate injection, a cutting-edge microtubule inhibitor developed for the treatment of advanced breast cancer. This addition enhances Asieris' portfolio in breast cancer, which now encompasses effective treatments for both early and late-stage disease.

To boost commercialization efficiency, Asieris has initiated its Commercial Operation 2.0 strategy, building on its past successes. This new approach aims to create a more agile and streamlined operating model. Key initiatives include appointing a seasoned Chief Commercial Officer to oversee the function comprehensively, restructuring the organizational framework, enhancing commercial capabilities, and strategically expanding the team in line with priority areas and product launch timelines. In addition, the company has outlined five-year business goals, which include accelerating growth for existing products, gearing up for the commercial rollout of Hexvix and APL-1702, introducing new products in core therapeutic sectors, optimizing synergies across its pipeline, and enhancing sales efficiency to achieve even greater success.

Accelerating Product Launches to Build Sales Momentum

In the realm of women's health, APL-1702, which is a combination of a drug and a medical device specifically designed for the photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), is making steady progress toward market approval. In May 2024, the National Medical Products Administration (NMPA) officially accepted the marketing application for APL-1702. As of the report's release, the Center for Drug Evaluation (CDE) at the NMPA has completed the initial round of technical reviews, which encompassed a thorough evaluation of toxicology, clinical data, biostatistics, clinical pharmacology, and pharmaceutical quality. Notably, the Inspection Center also concluded its Good Clinical Practice (GCP) inspection during this period. Asieris has since received written feedback from the NMPA and is actively working to coordinate its responses to expedite the review process, bringing APL-1702 closer to approval.

As a first-in-class treatment poised to debut in China, APL-1702 is on track to become the worlds first non-invasive therapy for HSIL, underpinned by robust clinical evidence validated through an international Phase III trial. Experts have pointed out that, given China's demographic challenges and the increasing incidence of cervical intraepithelial neoplasia (CIN) among younger women, the surgical excision of the cervix presents growing difficultiesespecially concerning fertility preservation. APL-1702 is anticipated to fill this crucial treatment gap, contributing to a healthcare landscape that is more cognizant of fertility issues.

To further drive the commercialization of APL-1702, Asieris has conducted eight expert advisory meetings focused on the Phase III clinical data, the current landscape of HSIL diagnosis and treatment, and the pressing unmet clinical needs. These sessions have garnered considerable endorsement from leading gynecological and pharmaceutical experts, who recognize the innovation and clinical value that APL-1702 brings to the market. Additionally, the company has made meaningful strides in establishing strategic partnerships with government agencies and prominent academic associations. In a notable collaboration with the Cancer Foundation of China, Asieris unveiled the first real-world showcase of its innovative cervical cancer prevention and control system at the 7th China International Import Expo (CIIE). During this event, they also secured medium- to long-term strategic cooperation agreements with both the China Women's Development Foundation and the Cancer Foundation of China, set to roll out in 2025.

The Women's Health Division has undertaken extensive market and industry research, allowing for deep insights into the needs of doctors, patients, and the broader commercial landscape. Based on this comprehensive analysis, the team has finalized key launch strategies and developed a commercialization roadmap that will facilitate a swift market rollout once approval is obtained.

With innovation in the gynecological field remaining relatively scarce, APL-1702 stands out as a significant breakthrough, bolstered by strong clinical evidence and demonstrated efficacy. The company intends to prioritize APL-1702 and its photodynamic drug-device combination platform as part of a strategy to build a comprehensive and tiered gynecological portfolio. This approach will center on continuous product iteration and indication expansion while leveraging synergies across the pipeline to catalyze broader growth.

In terms of urological tumors, after the marketing application for Hexvix was accepted in November 2023, Asieris' dynamic and adept team sprang into action to support the review and approval process. Consequently, Hexvix achieved NMPA approval in November 2024, a remarkable seven months ahead of the anticipated timeline. This product has since made history as the first diagnostic imaging agent approved in China for photodynamic blue light cystoscopy in bladder cancer detection.

The Oncology Business Unit is meticulously refining the launch strategy for Hexvix, initially focusing on patients with commercial insurance or those prepared to pay out-of-pocket for the product. The early rollout is set to target the special and international medical departments of top-tier hospitals in major cities, alongside premium foreign-invested and private urology specialty hospitals. As clinical guidelines are published and endorsements from leading urology experts are secured, the launch will be synchronized with the introduction of disposable blue light cystoscopes. Together, these initiatives aim to accelerate the adoption of blue light cystoscopy across general hospitals and facilitate a cohesive approach to the diagnosis and treatment of bladder cancer.

Strategic Expansion and Fast-Tracking High-Impact R&D Initiatives

In alignment with its strategic vision, Asieris has made notable progress in clinical development throughout 2024, with global clinical initiatives advancing efficiently.

Within the fields of women's health, breast cancer, and gynecological tumors, Asieris has achieved remarkable milestones. Building upon the strong results of the international multicenter Phase III study of APL-1702, the company received productive feedback during its communication meeting with the U.S. FDA in December 2024. This culminated in an agreement on a new Phase III clinical design to support the U.S. launch of APL-1702. Asieris is currently on the lookout for international partners to facilitate the advancement of the U.S. Phase III clinical trial application. Furthermore, APL-1702 is being investigated for its potential in clearing HPV viruses. Concurrently, the U.S. FDA and China's NMPA approved Phase I/IIa clinical trial applications for APL-2302 (a USP1 small molecule inhibitor) targeting advanced solid tumors in October 2024 and January 2025, respectively, with the first patient enrolled in Phase Ia in March 2025. Progress on APL-2501 (CLDN6/9 ADC) is also on track, with its preclinical research and unique linker platform chosen for a poster presentation at the 2025 American Association for Cancer Research Annual Meeting (AACR 2025).

In the domain of urologic oncology, the Phase II clinical trial of oral APL-1202 in combination with tislelizumab as a neoadjuvant therapy for muscle-invasive bladder cancer (MIBC) was successfully completed in September 2024, yielding encouraging efficacy signals. Among those patients eligible under protocol, the pathological complete response (pCR) rates were 41% for the combination treatment versus 20% for monotherapy. Notably, the combination was particularly effective in patients with low PD-L1 expression, achieving a pCR rate of 42% compared to a mere 11% with monotherapy. Additionally, APL-2401 a dual FGFR2/3 small molecule inhibitor has entered IND-enabling studies, with its findings selected for a poster presentation at AACR 2025.

Moreover, the investigational new drug (IND) application for APL-1202 targeting free-living amoebae (FLA) infections received approval from the NMPA in June 2024. In January 2025, Asieris entered into an investigational drug supply agreement under the Expanded Access IND Program with the Centers for Disease Control and Prevention (CDC) in the United States for APL-1202. This agreement is subject to evaluation by CDC experts and is intended for treating FLA infections.

Dr. Kevin Pan, Founder, Chairman, and CEO of Asieris Pharmaceuticals, stated, "The year 2024 represents our first full year of commercialization. We have achieved strong growth across our marketed products and reached a critical milestone by breaking even in our commercial operations. Our pipeline is now entering an essential sprint toward market launch and is poised to drive the next wave of performance growth. While reinforcing our commercial capabilities, we are also accelerating clinical programs with a strategic emphasis on women's health and urological oncology. We are committed to building a robust pipeline of first-in-class and highly differentiated fast-follow therapies while actively expanding into global markets to unlock the full value of our assets. With relentless innovation and execution, we are confident that Asieris will continue to make a meaningful difference for patients, deliver solid returns to shareholders, and create lasting value for society."

Note: As of the publication date of this report, APL-1702 has not yet been approved for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL). This article is intended to inform about the latest developments regarding these products and should not be interpreted as a promotional advertisement. The information provided is not directed at patients but is intended solely for the reference of healthcare professionals. For further information about these diseases, please consult healthcare professionals.

SOURCE: Asieris