SHANGHAI, China, Aug 28, 2026
Asieris Pharmaceuticals has released its 2026 Semi-Annual Report, highlighting progress in commercial operations, international expansion and clinical development as the company accelerates its transition from biotechnology to biopharmaceutical operations. During the first half of 2026, the company reported RMB 155 million in operating revenue, representing a 19.28% year-over-year increase, while its core product CEVIRA® was successfully launched in China following regulatory approval in March. The company also advanced multiple clinical and technology programs across women’s health, urologic oncology, breast cancer, gynecologic oncology and other disease areas. CEVIRA’s Marketing Authorization Application (MAA) has been accepted for review by the European Medicines Agency (EMA), marking an important step in Asieris’ international expansion strategy.
CEVIRA Launch Drives Commercial Expansion in China
Asieris reported significant commercial progress following the launch of CEVIRA®, described by the company as the world’s first non-invasive treatment for precancerous cervical lesions. The product received regulatory approval in China in March 2026 and achieved its first shipment in June, with the first prescription issued in Beijing on the same day. Within 10 days of its initial launch, CEVIRA prescriptions had expanded to 70 hospitals across 30 cities, with the product also introduced through an exclusive online launch on JD Health. By the reporting period, CEVIRA had been adopted by more than 150 hospitals nationwide, demonstrating rapid early commercial uptake. Asieris has established a specialized promotion organization of more than 100 professionals supporting physician education, clinical evidence dissemination, medical affairs, marketing and sales, alongside government affairs, market access, supply chain, commercial operations and compliance functions. The company is also conducting post-marketing studies and expanding academic activities to support broader clinical adoption of photodynamic therapy for cervical high-grade squamous intraepithelial lesions.
Innovation Pipeline Advances Across Oncology Programs
Alongside commercial development, Asieris reported progress across several clinical-stage pharmaceutical and medical technology programs. In urologic oncology, APL-2401, an FGFR2/3 inhibitor, enrolled its first patient in a Phase I clinical trial in January 2026, with dose escalation progressing and preliminary safety characteristics and efficacy signals observed. The company’s APLD-2304 portable single-use blue-light flexible cystoscope received EU CE certification in August 2026 and is being prepared for commercial production and potential Chinese market approval. In breast cancer and gynecologic oncology, APL-2501, a CLDN6/9-targeting antibody-drug conjugate (ADC), submitted IND applications in China and the United States during June and July, respectively, and received FDA and NMPA authorization to initiate clinical trials in August. The company plans to begin a Phase I monotherapy dose-escalation study by the end of 2026 in patients with advanced solid tumors, including ovarian cancer and non-small cell lung cancer. Meanwhile, APL-2302, a USP1 inhibitor, remains in a Phase I/IIa study for advanced solid tumors.
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Asieris Strengthens International Biopharma Strategy
The company is also expanding its global regulatory and commercialization strategy for its core products and pipeline. CEVIRA’s EMA review acceptance represents an important milestone toward potential European market entry, while Asieris is pursuing commercial partnerships in Europe, emerging markets and Belt and Road countries and regions. In urologic oncology, Hexvix®, described by Asieris as China’s first approved blue-light imaging agent for bladder cancer, is being prepared for broader market introduction alongside the SYSTEM BLUE blue-light cystoscopy system developed by its partner R.WOLF. The company also reported progress for APL-1401, an investigational therapy for moderate-to-severe active ulcerative colitis, with an extension study initiated following positive results from the first stage of its clinical program and data expected by the end of 2026. For APL-1202, which has shown initial efficacy against free-living amoeba infections, Asieris has secured an investigational drug supply agreement with the U.S. CDC under an Expanded Access Program and authorization under Health Canada’s Special Access Program. Together, these developments demonstrate Asieris’ strategy of combining commercial product launches, international regulatory expansion and innovation-driven clinical development as it builds a broader biopharma portfolio. Asieris said its commercialization and R&D progress during the first half of 2026 has strengthened the foundation for its transition from Biotech to Biopharma. The company plans to continue expanding CEVIRA’s commercial reach while advancing high-potential programs through clinical development and regulatory pathways. With multiple programs progressing across oncology, women’s health, urology and other therapeutic areas, the company is positioning its portfolio for additional clinical, regulatory and commercial milestones during the remainder of 2026 and beyond.
Source: Asieris Pharmaceuticals press release
