(Yicai) March 4 -- Shares of Asieris Pharmaceuticals soared by their daily trading limit after China granted the drugmaker marketing approval for Cevira, the world’s first non-surgical, non-invasive treatment for cervical precancerous lesions caused by high-risk human papillomavirus.

Asieris [SHA: 688176] closed up 20 percent at CNY13.67 (USD1.97) per share in Shanghai today. The stock has gained almost 19 percent since the end of last year. 

Cevira has received its drug registration certificate from the National Medical Products Administration, opening the way for its commercial launch, Shanghai-based Asieris announced late yesterday. 

In the absence of other approved non-invasive treatments for cervical intraepithelial neoplasia grade 2, Cevira has the potential to reshape a therapy landscape long dominated by surgical and other invasive or minimally invasive interventions, the company said.

Cervical cancer is a major threat to women’s health and one of the most common malignant tumors in women. Its main cause is persistent infection with high-risk HPV.

“The approval represents a breakthrough in the diagnosis and treatment of cervical diseases in China,” said Wei Lihui, chair of the Chinese Society for Colposcopy and Cervical Pathology, honorary director of the department of obstetrics and gynecology at Peking University, and a professor at Peking University People’s Hospital.

Non-Invasive CIN2 Therapy

Cevira is an integrated therapeutic device loaded with a photosensitizing drug, according to the company’s website. It works by generating reactive oxygen species from the photosensitizer accumulated in targeted cells upon light irradiation, inducing apoptosis and necrosis of abnormal cells to achieve therapeutic effects.

In 2023, more than 700,000 patients in China were diagnosed with cervical high-grade squamous intraepithelial lesions, of whom about 60 percent were classified as CIN2, Asieris noted, citingresearch. The number of newly diagnosed CIN2 cases in China is projected to exceed three million per year by 2030. 

As a photodynamic drug-device combination product, Cevira can be administered by gynecologists in a routine outpatient visit without anesthesia, with the entire procedure taking less than 10 minutes, according to Asieris. Patients can return to normal daily life and work immediately after, and remove the device themselves once treatment is complete. 

This care model has the potential to materially improve healthcare efficiency and broaden access to treatment, Asieris pointed out. It also makes Cevira well-suited for use in primary care settings, helping bridge the ‘last mile’ between screening, diagnosis, and treatment, and supporting global efforts to eliminate cervical cancer.

The results of Cevira’s international multicenter Phase III clinical trial showed that after only one to two treatment courses, nearly 60 percent of patients can avoid surgery, the company said.

‘Global Forefront’

“The approval of Cevira positions China at the global forefront of non-invasive gynecological therapies,” said Di Wen, chair of the Chinese Obstetricians and Gynecologists Association, vice chair of the Chinese Society of Obstetrics and Gynecology, and a professor at Renji Hospital, Shanghai Jiao Tong University School of Medicine.

“This outpatient, short-course, non-invasive treatment not only helps preserve the reproductive potential of women of childbearing age, but also substantially reduces surgical trauma and psychological burden,” Di added.

“Cevira offers distinct clinical advantages, including targeted lesion elimination, HPV clearance, and preservation of reproductive function,” said Chen Fei, chief physician of obstetrics and gynecology at Peking Union Medical College Hospital and the China principal investigator of the international multicenter Phase III clinical study of Cevira.

“In particular, as a non-invasive therapy, it maximally preserves the anatomical structure and physiological integrity of the cervix, enabling nearly 60 percent of patients to delay or avoid surgery and providing patients with cervical precancerous lesions with a superior treatment option that effectively controls disease while maintaining fertility,” Chen noted.

Global Regulatory Pathways

On the international front, the European Medicines Agency accepted Cevira’s application for marketing authorization for review last month, marking a key regulatory milestone in the EU approval pathway. Asieris has also reached an agreement with the US Food and Drug Administration on the design of a separate Phase III trial to support Cevira’s potential US approval.

“We will accelerate the product’s global development and commercialization partnerships, while continuing to strengthen our photodynamic drug-device combination and other technology platforms, as well as the development of our pipeline assets,” said Kevin Pan, Asieris’ founder, chairman, and chief executive.

Asieris secured the exclusive global rights to develop and commercialize Cevira in 2019 under a licensing agreement with Norway’s Photocure.

Editor: Futura Costaglione