Asieris Pharmaceuticals (Stock code ：688176.SH) has announced its set-up of the Women’s Health Business Unit for commercialization. This strategic move is designed to enhance the company’s focus on genitourinary diseases and strengthen its position in women’s health. The new business unit will center around core asset APL-1702, a potentially first-in-class non-surgical treatment of cervical high-grade squamous intraepithelial lesions. Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women’s health.
Prioritizing women’s health and bolstering efforts in the prevention and treatment of cervical cancer hold significant social importance. The China National Program for Women’s Development (2021-2030), issued by the State Council, identifies “women and health” as the top priority. In November 2020, the World Health Organization (WHO) released a Global Strategy to Accelerate the Elimination of Cervical Cancer. In response, ten Chinese ministries, including the National Health Commission, jointly formulated the Action Plan to Accelerate the Elimination of Cervical Cancer (2023-2030) as part of the Healthy China 2030 initiative. The objective is to achieve a 70% screening rate for cervical cancer among women of appropriate age and a 90% treatment rate for patients with precancerous cervical lesions by 2030.
APL-1702, a photodynamic drug-device combination developed for the treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has demonstrated positive results in the global international multi-center phase III clinical trial, and the complete data will be released at EUROGIN in March 2024. APL-1702 is on track to become the world’s first product with proven efficacy in the non-surgical treatment of HSIL. The company is proactively preparing for New Drug Application (NDA) procedures.
Every year, approximately 528,000 individuals worldwide are diagnosed with cervical cancer, leading to about 266,000 deaths. According to the National Cancer Center’s “2022 National Cancer Report,” approximately 119,000 people are diagnosed with cervical cancer in China each year, and approximately 37,000 people die from cervical cancer annually. The primary cause of cervical cancer lies in precancerous lesions stemming from persistent HPV infections, with about 20%~30% of HSIL cases progressing to invasive cervical cancer within a decade. According to Frost & Sullivan, the global and Chinese populations of HSIL patients are projected to reach 16.6 million and 2.2 million, respectively, by 2030. As cancer screening and cervical cytology examinations become more prevalent, an increasing number of patients with precancerous cervical lesions are being identified at early stages, and this trend is expected to persist, leading to a steady increase in the number of patients.
Local operation as the traditional treatment of cervical HSIL often comes with potential adverse reactions such as cervical bleeding, infections, and cervical insufficiency. Cervical insufficiency can lead to a range of reproductive issues, including premature delivery, miscarriage, and higher rates of cesarean sections. To date, there has been no non-surgical product approved for the treatment of precancerous cervical lesions with proven clinical efficacy in a phase III trial. Given the psychological challenges faced by cancer patients and the inherent risks associated with surgical interventions, there is a significant and unmet clinical need for non-surgical treatments for precancerous cervical lesions.
To further deliver its strategic vision and commitment in the realm of women’s health, Asieris Pharmaceuticals has announced the establishment of the Women’s Health Business Unit. The company has appointed Ms. Sophia Cao, who brings over 20 years of expertise in pharmaceutical commercialization, as the Senior Vice President and Head of the Women’s Health Business Unit.
Sophia’s previous roles include serving as the head of women’s health at Organon China, where she led long-term business strategy, implemented multi-channel business models, and spearheaded transformative initiatives to propel business growth. She also held the position of Chief Marketing Officer at Sanofi Pasteur China. Prior to that, she dedicated 16 years to Eli Lilly China, serving as Marketing Director, Specialty and Retail, and Commercialization Head, Osteoporosis, Emerging Market. In these roles, she developed domestic and international commercialization strategies for various products.
Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, stated, “The establishment of Women’s Health Business Unit is a testament to our steadfast confidence and commitment to our gynecological pipeline, with APL-1702 as the cornerstone. This move solidifies our leadership in women’s health in China. We are confident that Sophia’s invaluable industry experience, unique business insights, and strategic thinking will expedite our strategic goal of becoming a leader in women’s health. Moving forward, we will continue to increase our investment in this field, making a positive contribution to women’s health in China and worldwide, particularly in the realm of cervical cancer prevention and treatment.”
In addition to making strides in women’s health, the Oncology Business Unit, led by Mr. Xinming Jiang, Senior Vice President, has embarked on its commercialization journey. Notably, the kidney cancer treatment, Dipaite, and the breast cancer product, Ouyoubi, have been successfully launched.
During the clinical development phase, Asieris Pharmaceuticals has built a strong portfolio in the field of urological tumors, unveiling a series of positive results. A notable development is the positive interim analysis results from the phase II clinical trial for its oral drug APL-1202 in combination with PD-1 inhibitor tislelizumab, as a neoadjuvant therapy in muscle-invasive bladder cancer (MIBC). These results will be released in the Rapid Oral Abstract session at the American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium 2024. Furthermore, the phase III clinical trial of APL-1706, another drug for bladder cancer diagnosis and management, has met its primary endpoint. The new drug application has been accepted by the National Medical Products Administration (NMPA).
APL-1202 is currently involved in two concurrent phase III/pivotal clinical trials. The first, a pivotal clinical trial, is studying the use of APL-1202 in combination with infusion chemotherapy for the treatment of relapses in intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) patients who have undergone chemotherapy. The second phase III clinical trial is investigating the use of APL-1202 as a monotherapy in previously untreated patients with intermediate-risk NMIBC.