Asieris Pharmaceuticals Releases 2026 Semi-Annual Report: Core Product Commercialization Delivers, Entering a Harvest Period as the Company Accelerates Its Transition to Biopharma

SHANGHAI, Aug. 28, 2026 /PRNewswire/ -- Asieris Pharmaceuticals today released its 2026 Semi-Annual Report, showing comprehensive progress across all business segments. With the gradual realization of commercial launch and international expansion for its core products, the company is accelerating its transition from Biotech to Biopharma: CEVIRA^®, the world's first non-invasive treatment for precancerous cervical lesions^[1], has been successfully launched in China, ushering in a new era of non-invasive therapy; its Marketing Authorization Application(MAA) in Europe has been accepted for review by the European Medicines Agency(EMA), marking the first step in internationalization. At the same time, the company's Commercialization 2.0 strategy is entering a harvest period, driving steady performance growth, while the innovation pipeline is advancing rapidly with multiple key milestones achieved.

Steady Growth in Commercial Performance with Core Drivers Further Strengthened

In the first half of 2026, amid a dynamic external market environment, Asieris successfully launched CEVIRA^®, the world's first non-invasive treatment for precancerous cervical lesions, and steadily advanced its Commercialization 2.0 upgrade, refining its commercial system and improving efficiency. During the reporting period, the company recorded operating revenue of RMB 155 million, up 19.28% year over year. Its breast cancer products Ouyoubi^® and Ounalin^®, together with kidney cancer product Dipaite^®, continued to drive growth through academic engagement and channel expansion, solidifying its commercialization capabilities and laying a foundation for the sales of its core product CEVIRA^®.

The company's core product CEVIRA^® received regulatory approval in China in March 2026, becoming the world's first non-surgical, non-invasive treatment for precancerous cervical lesions and filling a critical clinical gap in this therapeutic area. In just three months, in June 2026, the product achieved its first shipment, with the world's first prescription issued in Beijing on the same day—fully demonstrating cross-functional collaboration efficiency and commercial supply capabilities. Within 10 days of the initial launch, first prescriptions were rapidly rolled out across 70 hospitals in 30 cities nationwide, with an exclusive online launch on JD Health. To date, the product has been adopted in over 150 hospitals across the country.

Asieris will continue to accelerate the sales ramp-up of CEVIRA^®. The company has established a comprehensive omnichannel commercial presence centered on public hospitals, having successfully built a specialized promotion team of more than 100 professionals focused on physician education and clinical evidence dissemination for photodynamic therapy in cervical high-grade squamous intraepithelial lesions (HSIL), spanning medical affairs, marketing, and sales. This is complemented by a full commercial support structure encompassing government affairs and market access, sales excellence operations, commercial operations, supply chain, and compliance. Meanwhile, the company is also leveraging commercial partners to achieve full-territory business coverage in broader markets.

At the same time, the company continues to intensify market education efforts and drive the upgrade of therapeutic paradigms. On the academic front, it is prioritizing post-marketing studies to strengthen clinical data, continuously publishing multidimensional subgroup analysis results in domestic and international journals and at major congresses, and expanding dissemination through national academic platforms. In terms of guideline and consensus updates, two Chinese consensus documents have already been released in the first half of 2026. Notably, in the 2026 updated photodynamic therapy consensus issued by the Chinese Society for Colposcopy and Cervical Pathology (CSCCP), CEVIRA® is recommended, with Level 1A evidence, for the treatment of cervical intraepithelial neoplasia grade 2 (CIN2). During the 19th International Federation for Cervical Pathology and Colposcopy (IFCPC) Congress in June 2026, the company initiated an international expert consensus meeting on the standardized application of local photodynamic therapy (PDT) for precancerous cervical lesions, helping to shape global treatment guidelines.

To address accessibility and financial burden, the company has conducted and published disease burden and pharmacoeconomic studies, and released a Fertility-Friendly Blue Book in July 2026 to maximize market accessibility opportunities. Together with the China Women's Development Foundation, it has launched the "Fertility-Friendly Cervical Health Care" public benefit program, aimed at reducing unnecessary cervical excision procedures through the establishment of fertility-friendly cervical clinics. Following the successful kickoff meeting in Beijing at the end of 2025, the program has rolled out exchange activities and extensive public education campaigns across multiple provinces, building a fertility-friendly cervical care model while establishing public awareness of proper diagnosis and treatment for precancerous cervical lesions. In addition, the company continues to optimize its production and supply chain system to ensure sustained high-quality product supply.

In urologic oncology, Hexvix^®, China's first approved blue-light imaging agent for bladder cancer, has opened a new era of blue-light diagnosis and treatment for bladder cancer in the country. The SYSTEM BLUE blue-light cystoscopy system, developed by Asieris' partner R.WOLF, received market approval in April 2026, providing a realistic foundation for the clinical value of the blue-light diagnostic and treatment approach. The company will accelerate the market introduction of Hexvix^® in combination with the blue-light cystoscopy system to benefit patients as soon as possible. Meanwhile, to fully advance the integrated full-cycle diagnosis and treatment process for bladder cancer, the company has developed the world's first portable single-use blue-light flexible cystoscope for diagnostic and surveillance applications in bladder cancer^[2]. This product has received EU CE certification and will be further accelerated for market approval in China.

R&D Focused on Core Therapeutic Areas, Accelerating Advancement of High-Potential Programs

Guided by its strategic priorities, Asieris has continued to deepen its focus in core therapeutic areas, optimize resource allocation, and concentrate efforts on high-potential pipeline programs by leveraging its targeted and AI-driven drug discovery platform, drug-device combination platform, and innovative ADC technologies. During the reporting period, multiple pipeline programs achieved positive progress, demonstrating innovative advantages and competitive potential and fully reflecting the company's R&D strength and clinical development capabilities in its areas of focus.

In women's health, the core product CEVIRA^® has made positive progress in international market development, with its MAA successfully accepted for review by the EMA. The company is actively establishing commercial partnerships in Europe, emerging markets, and Belt and Road countries and regions.

In urologic oncology, the Phase I clinical trial of APL-2401 (FGFR2/3 inhibitor) completed enrollment of the first patient in January 2026, with dose escalation proceeding smoothly and efficiently, and preliminary safety characteristics and efficacy signals observed. APLD-2304 (the world's first portable single-use blue-light flexible cystoscope) passed review by the EU Notified Body and obtained EU CE certification in August 2026. The company is currently preparing for commercial production and actively exploring overseas commercialization partnership opportunities.

In breast cancer and gynecologic oncology, APL-2501 (CLDN6/9-ADC) submitted IND applications in both China and the U.S. in June and July 2026, respectively, and received FDA and NMPA approval to initiate clinical trials in August, with plans to start a Phase I monotherapy dose-escalation study by year-end enrolling patients with advanced solid tumors including ovarian cancer and non-small cell lung cancer. APL-2302 (USP1 inhibitor) is currently in an ongoing Phase I/IIa clinical trial for the treatment of advanced solid tumors.

In other disease areas, based on positive results from the first stage of the clinical study of APL-1401 for moderate-to-severe active ulcerative colitis (UC), the company has further initiated an extension study to evaluate the potential of this First-in-class therapy in a broader UC patient population over a 12-week treatment period. The clinical study is progressing smoothly, with data readout expected by the end of 2026. Given that APL-1202 has shown initial efficacy for the treatment of free-living amoebae (FLA) infections, the company has signed an investigational drug supply agreement with the U.S. CDC under its Expanded Access Program and obtained authorization under Health Canada's Special Access Program to ensure access for FLA patients.

Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, said: "In the first half of 2026, Asieris achieved multiple milestones in both commercialization and innovation pipelines. We delivered sustained sales growth and significant pipeline progress. Most excitingly, our core product CEVIRA^®—the world's first non-invasive treatment for precancerous cervical lesions—was successfully launched in China with a strong commercial start, marking the company's official entry into a phase of accelerated delivery of innovation outcomes and further solidifying the foundation for our transition from Biotech to Biopharma. Looking ahead, we are confident in continuing to achieve breakthroughs through steady growth, bringing more benefits to patients and creating greater value for shareholders and society."

Disclaimer:

This document is intended to disclose the company's latest developments and is not a product promotion advertisement. The relevant information is not intended for patients but is provided solely for the reference of healthcare professionals. If you would like to learn more about these diseases, please consult healthcare professionals. The aforementioned content includes forward-looking statements concerning the company's future plans and development strategies. These statements do not represent binding commitments by the company to investors. Investors are cautioned to consider investment risks.

SOURCE Asieris