Asieris, a China-based company, has agreed to pay up to $250 million to get the first-in-class, non-surgical treatment for HPV-associated cervical precancerous lesions in return for its own company’s license.
Global Rights and Commercial Strategy
So far, the drug-device combination, known as Cevira, is available only in China, but other regulators worldwide are reviewing it. As part of the deal, Theramex will assume commercial responsibilities in Europe (including in the U.K. offices), Australia, New Zealand and Turkey. Asieris will retain all other rights.
If the EU approval is granted, Asieris will utilize Theramex’s existing women’s health infrastructure in Europe, but will keep high-dollar markets such as the U.S. for itself.
Financial Structure and Conditions of the Deal
Theramex will initiate the deal with $15 million in upfront cash and up to $11 million based on regulatory milestones that are likely to be met in the near term. In total, further commercial milestones and tiered royalties could boost the potential deal value to over $250 million, Asieris said in a release.
Initial payment is dependent on several factors, such as the signing of a supply contract, successful audits at Cevira manufacturing facilities, and clarification from the European Commission regarding the clinical benefits of the device.
Regulatory Status and Phase 3 Data
The agreement was made while Cevira is awaiting approval from the European Medicines Agency. A photosensitizing drug and intravaginal light delivery device are used in the treatment, and it was first approved worldwide in March by the National Medical Products Administration (NMPA) of China. Both agencies based their decision on Asieris’ multicenter, international phase 3 trial, involving over 20% of European patients.
In the trial, patients with cervical intraepithelial neoplasia grade 2 (CIN2), a moderate-grade precancerous lesion at risk of becoming cervical cancer, showed a nearly 50% response rate to the treatment compared to 23% on placebo. By six months, 57.5% of patients treated with Cevira had a normal histology or low-grade squamous intraepithelial lesions (LSILs), easier to treat than CIN2.
According to Asieris’s March release, these results suggest that almost 60 percent of patients could be spared surgery after just one to two treatments. 60% of the HPV infections were also resolved in 6 months with the treatment.
Transforming the Cervical Care Model
Active surveillance has been the gold standard approach to date for younger patients with CIN2 and involves close monitoring every six months. If the condition worsens or doesn’t clear within two years, the abnormal tissue is surgically excised or ablated.
In contrast, Cevira should be taken in the clinic by a gynecological health provider. The device placement is quick and painless, taking less than 10 minutes, Asieris said. The patient can then resume his normal routine immediately after the treatment and can remove the device at the end of the treatment. The nonsurgical procedure could generate significant savings for European healthcare systems while providing female patients a new approach to the care and preservation of cervical tissue and changing the model of care, Theramex said.
Back in 2015, the Shanghai drugmaker revealed (along with partner Photocure) that the FDA had approved a study design for its phase 3 trial it was conducting in the U.S. on Cevira’s potential approval. But so far, no trial is underway
Asieris Signs Exclusive Licensing Deal With Theramex
Asieris Pharmaceuticals has entered into an exclusive licensing agreement with Theramex for CEVIRA (APL-1702), an innovative drug-device combination being developed to treat cervical precancerous lesions associated with human papillomavirus (HPV). Announced on October 7, 2026, the agreement has a potential total value of more than $250 million, marking an important step in Asieris’ international commercialization strategy.
Rather than an outright acquisition of the treatment or the company, the transaction grants Theramex exclusive rights to develop and commercialize CEVIRA across Europe, Australia, New Zealand and Turkey, subject to certain conditions. Asieris will retain rights in the rest of the world.
The agreement includes a $15 million upfront payment, subject to specified conditions, and up to $11 million in near-term regulatory milestone payments. Additional commercial milestone payments and tiered royalties could bring the total deal value to more than $250 million.
Asieris Expands Its Global Commercialization Strategy
The agreement gives Theramex an opportunity to expand its gynecology portfolio with a differentiated treatment candidate. The company focuses on women’s health, with existing business areas that include contraception, fertility, menopause, osteoporosis and uterine health.
For Asieris, partnering with an established women’s health company could support the product’s introduction into additional markets while allowing Asieris to retain international rights outside the licensed territories.
The agreement remains subject to conditions, including arrangements for product supply, manufacturing-site audits, alignment with existing licensing commitments and clarification with the European Commission concerning the device’s clinical value assessment. These requirements will be important to advancing the collaboration.
What the Deal Means for Women’s Health
The Asieris–Theramex agreement reflects continued pharmaceutical industry interest in treatments that could provide alternatives to conventional procedures. HPV-associated cervical precancerous lesions are an important area of women’s health because some lesions can progress toward cervical cancer if not appropriately managed.
CEVIRA Offers a Potential Non-Surgical Treatment Approach
Asieris developed CEVIRA as a photodynamic drug-device combination designed to treat cervical precancerous lesions associated with HPV. The treatment combines local drug delivery with controlled light activation through an integrated intravaginal device.
The approach is intended to provide a non-surgical option for appropriate patients, potentially helping preserve cervical tissue compared with procedures that remove abnormal tissue. Asieris believes this approach could address an unmet need in women’s health, particularly for patients who may be candidates for surgical intervention.
CEVIRA received approval from China’s National Medical Products Administration in March 2026 for the treatment of cervical intraepithelial neoplasia grade 2 (CIN2). However, its regulatory status differs by market, and the licensing agreement does not itself constitute European approval
