Shanghai, China, April 17, 2026 – Asieris Pharmaceuticals today released its 2025 Annual Report. Highlights include strong progress under its Commercialization 2.0 strategy, continued commercial momentum, the China approval of CEVIRA®, the world’s first non-invasive treatment for precancerous cervical lesions, and multiple key pipeline advances. With these milestones in place, 2026 is expected to mark an inflection point for Asieris and the beginning of a new chapter of growth. As of the end of the reporting period, the company maintained strong cash reserves of approximately RMB 1.692 billion, providing a solid foundation for continued development.
Strong Revenue Growth and Approval of a Flagship Product
In 2025, despite intensifying market competition, Asieris continued to advance its Commercialization 2.0 strategy, further strengthening its commercial platform and improving operating efficiency. During the reporting period, the company recorded operating revenue of RMB 277 million, up 37.49% 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. This performance underscores the company’s continuously strengthening commercialization capabilities and lays a solid foundation for the future launch of additional core products.
In March 2026, the company’s core women’s health product APL-1702 (trade name CEVIRA®), received a Drug Registration Certificate from China’s National Medical Products Administration and was formally approved for commercial launch in China. The product is the world’s first non-surgical, non-invasive treatment[1] for cervical intraepithelial neoplasia grade 2, or CIN2, filling a critical clinical gap and redefining a substantial, previously untapped market for non-invasive treatment.
CEVIRA® offers four core advantages: non-invasive and painless treatment, dual-target action—eliminating lesions while clearing HPV, simplicity and convenience, and fertility preservation. Its integrated drug-device design allows gynecologists to administer the treatment in an outpatient setting without anesthesia, with each procedure taking less than 10 minutes. Patients can resume normal daily activities immediately after placement and remove the device themselves once treatment is complete. Clinical data show that 97% of patients reported no pain in the treated cervical area, with no recorded cases of cervical structural damage. Mechanistically, CEVIRA® precisely targets and eliminates lesions while also enabling immune clearance of HPV. Importantly, its non-invasive profile preserves cervical anatomy and physiological function to the greatest extent possible, enabling nearly 60% of patients to delay or avoid surgery. This gives eligible patients a better option for controlling disease while preserving fertility. In the absence of any other approved non-invasive treatment, CEVIRA® has the potential to reshape a treatment landscape long dominated by invasive and destructive surgical approaches, shifting care from a one-size-fits-all model toward a preferred non-invasive pathway.
The company has launched a broad set of commercialization activities. On the clinical and scientific front, it is reinforcing CEVIRA®’s clinical evidence base, which has already been presented at major international congresses and published in top-tier journals, while expanding awareness through national academic platforms. It is also supporting updates to multiple clinical guidelines and expert consensuses, which are expected to be released on a rolling basis throughout 2026, and conducting disease burden and pharmacoeconomic studies to support the publication of a fertility-friendly cervical health blue book aimed at maximizing market accessibility. On the commercial and market access front, the company has proactively built out a professional team spanning medical affairs, marketing, sales, and support functions, with an omni-channel strategy centered on public hospitals. Together with the China Women’s Development Foundation, it has launched the “Fertility-Friendly Cervical Health Care” public benefit program to reduce unnecessary cervical excision procedures and raise public awareness of precancerous cervical lesions through dedicated cervical clinics and public education. The company has also optimized its supply chain and entered into a strategic partnership with SPH Keyuan Trade, collaborating closely across import, distribution, and related functions to accelerate the commercialization of CEVIRA® and benefit patients in China soon.
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 and is expected to work in synergy with Hexvix® to benefit patients. In parallel, Asieris is advancing the global development of a single-use flexible blue-light cystoscope. The product has been submitted for registration in the European Union and has been formally accepted for review.
Deepening Focus Areas and Rapidly Advancing 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. Multiple pipeline assets have first-in-class or best-in-class potential. During the reporting period, several pipeline programs made meaningful progress, further demonstrating the company’s R&D strength and clinical development capabilities in its areas of focus.
In women’s health, breast cancer, and gynecologic oncology, the globally first-of-its-kind photodynamic therapy product CEVIRA® has now been approved in China. The approval was based on its international multicenter Phase III clinical study, which enrolled more than 20% of patients in Europe. The study results were formally published in December 2025 in Med, a Cell Press journal, by Academicians Lang Jinghe and Zhu Lan together with Professor Peter Hillemanns of Hannover Medical School in Germany. The data were also presented in oral sessions at European Research Organization on Genital Infection and Neoplasia (EUROGIN) 2024 and EUROGIN 2026, the Society of Gynecologic Oncology (SGO) Annual Meeting 2024, and the Photodynamic Therapy & Photodiagnosis Update 2024. Further academic exchanges and scientific discussion with basic researchers and clinical specialists from China and abroad took place at the 27th National Clinical Oncology Conference & 2024 CSCO Annual Meeting, the International Papillomavirus Conference (IPVC) 2024, and the 37th Public Health Symposium 2025. Building on this body of high-quality clinical evidence, CEVIRA® was recommended, with Level 1A evidence, for the treatment of CIN2 in the 2026 updated photodynamic therapy consensus issued by the Chinese Society for Colposcopy and Cervical Pathology (CSCCP). This recommendation further reinforces its importance in the treatment of precancerous cervical lesions.
In international markets, the marketing authorization application for CEVIRA® has been accepted for review by the European Medicines Agency, and the company will also actively advance registrations in Belt and Road countries and regions.
The company is also in ongoing dialogue with the U.S. FDA regarding the design of a separate Phase III trial to support potential U.S. approval of CEVIRA®, while seeking overseas commercialization partners and planning to submit an application to initiate the U.S. Phase III study at an appropriate time. In addition, based on the strong HPV clearance potential of CEVIRA® demonstrated in the international multicenter Phase III study, as well as the significant unmet clinical need, the company has started exploring HPV-related indications and other therapeutic areas.
APL-2302, a USP1 inhibitor for the treatment of advanced solid tumors, has received clearance from both the U.S. FDA and China’s NMPA for its Phase I/IIa clinical trial. The first patient in Phase Ia was enrolled in March 2025, and enrollment is ongoing. APL-2501, a CLDN6/9 ADC, has completed in vitro and in vivo pharmacodynamic studies, GMP clinical drug manufacturing, and GLP toxicology studies in rats and cynomolgus monkeys. The company expects to submit an IND in mid-2026 and initiate a Phase I monotherapy dose-escalation study by year-end in patients with advanced solid tumors including ovarian cancer and non-small cell lung cancer. AT-018, a next-generation CDK inhibitor, is currently at the PCC stage.
In urologic oncology, the Phase I clinical trial application for APL-2401, an FGFR2/3 inhibitor, in patients with FGFR2/3-driven advanced solid tumors has been approved by regulatory authorities in both China and Australia. As a Class 1 innovative drug under global simultaneous development, APL-2401 was designed and filed in accordance with international clinical trial standards. It was successfully included in the 30-day review channel under the NMPA’s Announcement on Matters Relating to Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (No. 86 of 2025) published on September 12, 2025, and received approval in only 22 working days, making it one of the first projects in China approved under this new policy. The company’s first proprietary portable single-use blue-light flexible cystoscope, APLD-2304, completed its European registration testing in the fourth quarter of 2025, and the registration dossier has been submitted to and accepted by the EU notified body.
In other disease areas, APL-1401, a DBH inhibitor for moderate-to-severe active ulcerative colitis, delivered encouraging preliminary results in a Phase Ib trial. Dose escalation has been completed, the drug has demonstrated a favorable safety profile, and positive efficacy signals (including a histologic improvement rate of 41.9%) were observed after only four weeks of treatment. These results were presented at international conferences including ECCO 2026, and an extension study is currently ongoing. APL-1202 for the treatment of free-living amoebae (FLA) infections has received IND approval from China’s NMPA. The company has also entered into 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 for the treatment of FLA patients.
Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, said: “This past year was a defining one for Asieris. We delivered sustained sales growth, maintained a solid financial position, and achieved major pipeline progress. Most excitingly, earlier this year our core women’s health product, CEVIRA®, the world’s first non-invasive treatment for precancerous cervical lesions, received regulatory approval in China. CEVIRA® represents the cornerstone product for Asieris as we enter a new chapter of development, laying a strong foundation for our long-term competitive advantage. Looking ahead, as CEVIRA®and Hexvix® in combination with blue light cystoscopy move into commercialization, together with the steady clinical advancement of other programs in our focus areas, the year 2026 will mark an inflection point for Asieris and open a new chapter of growth. Today, Asieris has reached a significant new milestone, with the solid foundation, strong innovation capabilities, and the operational rigor needed to bring innovative medicines to patients as early as possible and create long-term value for shareholders.”
Disclaimer:
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[1] Insight Databas