Uterine Cervical Incompetence

SHANGHAI, Jan. 8, 2024 /PRNewswire/ -- 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. Continue Reading Sophia Cao, Senior Vice President and Head of the Women’s Health Business Unit 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. SOURCE Asieris

SHANGHAI, Sept. 20, 2023 /PRNewswire/ -- Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, has announced that the multinational Phase III clinical trial of APL-1702 (Cevira®), a novel, non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has met its primary endpoint. Based on the results, APL-1702 holds the potential to become the world's first non-vaccine product with verified clinical efficacy against cervical HSIL. The company will be in communication with regulatory authorities on new drug application and market approval in the coming months. This study is a prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. It is led by Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and has enrolled 402 participants. The trial met its primary endpoint, together with a robust safety profile. Comprehensive data from this study will be presented at forthcoming academic conferences and published in scientific journals. According to the Global Cancer Statistics 2020, there were 604,127 new cases of cervical cancer in women, with 341,831 deaths worldwide, making it the fourth most prevalent malignancy among females. In China, cervical cancer stands as the second most common malignancy among women. The leading cause of cervical cancer is persistent HPV infection, which can result in precancerous cervical lesions. An alarming 20 percent of HSIL cases may progress to invasive cervical cancer within a decade. 1 According to Frost & Sullivan, the number of HSIL patients is projected to reach 16.6 million globally by 2030, with 2.2 million in China alone. With increasing adoption of cervical cytology screening, more individuals with precancerous cervical conditions are being identified at earlier stages, and this trend is expected to persist. Local operation as the traditional treatment of cervical HSIL often come 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. There has been no non-vaccine product approved for the treatment of precancerous cervical lesions with proven clinical efficacy in a Phase III trial. APL-1702 is a pioneering photodynamic drug-device combination product. As a novel and non-invasive therapy, APL-1702 offers a straightforward and patient-friendly procedure that doesn't disrupt daily life. The combination aims to spare HSIL patients the pain and side effects often associated with surgical procedures, with a particular focus on preserving the fertility of women of child-bearing age. Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said, "This milestone marks a significant leap forward in the management of HSIL, with the potential to transform care in this domain. Moreover, tackling precancerous cervical conditions is pivotal for early prevention of cervical cancer and is an integral part of the three-tier cancer prevention system. Asieris Pharmaceuticals is committed to playing an active role in advancing China's Action Plan to Eliminate Cervical Cancer (2023-2030) and contributing to Healthy China 2030, aligning our efforts with the WHO's global strategy to accelerate the elimination of cervical cancer." About APL-1702( Cevira®) APL-1702(Cevira ®) is a breakthrough photodynamic drug-device combination product that is being developed for non-surgical treatment of high-grade precancerous lesions of the cervix. Cevira ® holds the potential to serve the high unmet medical need for non-invasive treatment options for patients with HSIL in an outpatient setting, especially for young women of reproductive age. Asieris Pharmaceuticals entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to obtain the worldwide development and commercialization of Cevira ® in July 2019. Cevira ® is a registered trademark of Photocure ASA, based in Oslo, Norway. About Asieris Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. We strive to improve human health to preserve patient's dignity. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide. The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus. Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet clinical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally. SOURCE Asieris

A major clinical trial looking at surgery for women at risk of miscarriage and stillbirth have found that a type of wire commonly used reduces risk of infection. Women at risk of pregnancy loss who need a specialist surgical procedure could benefit from a single-stranded suture thread to reduce risk of infection, results from the C-STICH clinical trial found. The trial was the largest of its type and is published in The Lancet. It involved more than 2000 expectant mothers who needed a procedure called a cerclage, where a purse string suture is placed around the neck of the womb (the cervix) during their pregnancy. Women were randomly allocated to have the surgical procedure performed using either a single stranded thread or a braided thread. Researchers tested whether there would be any difference in miscarriage or stillbirth, due to an increased risk of infection, from using a braided suture thread. The research, which is funded by the National Institute For Health and Care Research, the research partner of the NHS, public health and social care, demonstrates that single stranded sutures could potentially improve outcomes for mothers at risk of preterm birth. The team led by researchers from the University of Birmingham and Birmingham Women's and Children's Hospital found that the mothers treated with single stranded threads had no differences in pregnancy loss or preterm birth but reported fewer instances of infection and sepsis. This could have important implications for the health outcomes of mothers and babies who are treated with a cervical cerclage in their pregnancy. Dr Vicky Hodgetts-Morton, NIHR Clinical Lecturer in Obstetrics at the University of Birmingham and Birmingham Women's Hospital explained the implications of the trial results. Dr Hodgetts-Morton said: "Preterm birth is a significant problem, complicating approximately one in ten pregnancies around the world. The consequences of preterm birth may be significant with some babies being born too early to survive, and those that survive are at increased risk of health complications. One cause for preterm birth is cervical insufficiency, occurring in 0.5% to 1% of pregnant women for which the placement of a vaginal cervical cerclage can be an effective treatment." "Suture thread choice has the potential to improve how well a cerclage works in preventing miscarriage, stillbirth and preterm birth. Both single stranded and braided threads are commonly used to perform cerclages and our findings show no differences in pregnancy loss and preterm birth. The C-STICH trial results did show an increased risk of infections in labour and around the time of delivery with braided threads and this supported our hypothesis that a single stranded thread could reduce the risk of infection developing during the pregnancy."