Asieris Pharmaceuticals Reports Strong First‑Half 2026 Results, Launches World’s First Non‑Invasive Cervical Lesion Treatment CEVIRA® in China
The biotech‑to‑biopharma firm posted a 19% rise in revenue and rolled out CEVIRA®, the first non‑surgical therapy for precancerous cervical lesions, while advancing several pipeline candidates toward global markets.
By SamacharDaily Editorial Team••2 min read
Asieris Pharmaceuticals released its 2026 semi‑annual report showing a robust commercial performance despite a volatile market environment. Operating revenue climbed to RMB 155 million, a 19.28% increase year‑on‑year, driven primarily by the launch of CEVIRA® – the world’s first non‑invasive, non‑surgical treatment for high‑grade cervical intraepithelial neoplasia (CIN). After receiving Chinese regulatory approval in March 2026, the product entered the market in June, with the first prescription issued in Beijing on the same day. Within ten days, CEVIRA® was prescribed in 70 hospitals across 30 cities and is now available in more than 150 hospitals nationwide, supported by an exclusive online channel on JD Health. The company has built an omnichannel commercial network centred on public hospitals, deploying over 100 specialists for physician education, medical affairs, and market access, and is leveraging partners to achieve full‑territory coverage.
In addition to CEVIRA®, Asieris highlighted progress in its broader oncology portfolio. Hexvix®, China’s first blue‑light imaging agent for bladder cancer, is paired with the newly approved SYSTEM BLUE cystoscopy system, and a portable single‑use blue‑light flexible cystoscope (APLD‑2304) secured EU CE certification. The pipeline saw several key milestones: the Phase I trial of FGFR2/3 inhibitor APL‑2401 enrolled its first patient; ADC candidates APL‑2501 (CLDN6/9‑ADC) received IND clearance in both China and the United States, with FDA and NMPA approval to start Phase I trials; and APL‑1401 for ulcerative colitis entered an extension study with data expected by year‑end. The company also reported that its Marketing Authorization Application for CEVIRA® has been accepted for review by the European Medicines Agency, marking the start of its international expansion.
CEVIRA® addresses a critical gap in women’s health by offering a fertility‑preserving, non‑surgical option for precancerous cervical lesions, which traditionally require excisional procedures that can compromise reproductive outcomes. Its rapid adoption across Chinese hospitals, coupled with inclusion in national consensus guidelines at Level 1A evidence, signals strong clinical acceptance and could reshape treatment standards in a market of over 100 million women at risk. Internationally, the EMA review opens pathways to European markets, potentially setting a new global benchmark for photodynamic therapy in cervical disease.
Beyond the flagship product, Asieris’s advancing pipeline in bladder and solid‑tumour oncology, together with its AI‑driven drug discovery platform, positions the company to transition from a biotech focused on single products to a full‑scale biopharma with diversified revenue streams. Successful commercialization of CEVIRA® and upcoming launches of Hexvix® and the portable cystoscope will provide cash flow to fund late‑stage trials, while partnerships in Europe and Belt‑and‑Road regions aim to broaden market reach. Investors and healthcare stakeholders will watch the EMA decision and upcoming Phase I data as indicators of the firm’s ability to sustain growth and deliver innovative therapies worldwide.
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•1 min read
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