Shanghai, China, December 19, 2023– 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，announced the successful convening of the first domestic breast cancer care forum and national product launch conference for Ouyoubi (Neratinib Maleate Tablets) ,organized by the Qionghai Boao Cancer innovation Institute, in Shanghai.
According to the International Agency for Research on Cancer (IARC), a division of the World Health Organization, the global cancer data for the year 2020 revealed that breast cancer became one of the most common types of cancer worldwide. Approximately 2.26 million women were diagnosed with breast cancer, resulting in arou685,000 deaths, surpassing the number of lung cancer diagnoses for the first time. In response to this alarming trend, the World Health Organization launched the “Global Breast Cancer Initiative” with the goal of reducing the breast cancer mortality rate by 2.5% annually by the year 2040.
Neratinib is indicated for use in adult patients with HER2-positive early-stage breast cancer as part of an extended adjuvant treatment following adjuvant trastuzumab-based therapy. The two authoritative guidelines in China, the “Chinese Society of Clinical Oncology (CSCO) Breast Cancer Diagnosis and Treatment Guidelines 2023 edition” and the “China Anti-Cancer Association Committee of Breast Cancer Society (CACA-CBCS) Guidelines 2022 Essential Version,” both recommend neratinib as the only recommended option for extended adjuvant therapy after HER2-positive adjuvant treatment.
The results of the ExteNET trial, a multicenter, randomized, double-blind Phase III clinical trial, have confirmed that sequential neratinib as an extended adjuvant treatment for HER2-positive early-stage breast cancer patients, following one year of trastuzumab-based adjuvant therapy, significantly reduces the risk of disease recurrence by 33% compared to placebo at two years. This benefit is consistent across Asian and Chinese populations as well as the global population. Additionally, the hormone receptor-positive subgroup experiences even more significant benefits, with neratinib reducing the risk of disease recurrence by 51% in this subgroup at two years. Furthermore, the hormone receptor-positive subgroup shows even more significant benefits in patients who did not achieve pathological complete response after neoadjuvant therapy and in patients treated with neratinib for ≥11 months.
Professors Wang Haibo from The Affiliated Hospital of Qingdao University and Yuan Peng from Cancer Hospital Chinese Academy of Medical Sciences served as co-chairs, gathering authoritative experts, clinical doctors, and scholars from the field of breast cancer in China. They engaged in sharing and discussing strategies for strengthening adjuvant therapy and diagnostic patterns for HER2+ early-stage breast cancer, with the aim of promoting better treatment outcomes for domestic patients.
In his opening speech, Professor Wang Haibo stated that HER2+ breast cancer accounts for approximately 15% to 20% of all breast cancer cases. Despite significant improvements in the prognosis of early-stage patients with the introduction of large molecule drugs such as trastuzumab, some patients still face the risk of recurrence. In recent years, small molecule tyrosine kinase inhibitors (TKIs) such as neratinib have been introduced for the extended adjuvant treatment of HER2+ early-stage breast cancer. They play a crucial role in preventing and delaying the occurrence of brain metastasis and improving patient prognosis. The availability of neratinib in the domestic market in China will further alleviate the treatment burden for Chinese patients and strive for greater hope for breast cancer cure.
Professor Yuan Peng pointed out that Chinese doctors are not unfamiliar with the research on neratinib. The use of neratinib in extended adjuvant therapy for early-stage HER2+ breast cancer can further improve the cure rate and play a significant role in the comprehensive management of breast cancer. There is still a great clinical need for the treatment of breast cancer among Chinese patients, and it is believed that neratinib will provide Chinese doctors and patients with a more confident treatment solution.
Director Qin Bo of the medical documentary “Life Matters” attended the conference as a special guest and co-host, urging everyone to channel the power of attention and support to HER2+ early-stage breast cancer patients, injecting more hope and courage into their journey towards recovery.
Mr. Jiang Xinming, Vice President of Marketing Department of Asieris, stated, “Breast cancer, being one of the most prevalent cancer types worldwide, is witnessing a growing demand for treatment. Ouyoubi, as an enhanced adjuvant therapy drug targeting HER2-positive early-stage breast cancer, offers patients improved efficacy and enhanced quality of life. Additionally, the commercialization of Ouyoubi expands our product portfolio, solidifies Asieris’ competitive position in the market, and establishes a foundation for the company’s sustainable growth. We eagerly anticipate the broad application of Ouyoubi in the treatment field, bringing hope and good news to a larger number of breast cancer patients.”
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.