Acalabrutinib (Calquence®) Included in China's 2023 National Reimbursement Drug List to Enhance Access for Mantle Cell Lymphoma Patients

Helping Patients with Mantle Cell Lymphoma Achieve High-Quality Long-Term Survival

ShanghaiDecember 13, 2023PR Newswire -- Today, the National Healthcare Security Administration officially announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2023 Edition)," featuring AstraZeneca's next-generation highly selective BTK inhibitor, Calquence.^®(Common name: Acalabrutinib Capsules, hereinafter referred to as "Acalabrutinib") has been successfully included in the National Reimbursement Drug List (NRDL). This product, as a monotherapy, is indicated for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, significantly improving the accessibility and affordability of this innovative drug and helping more Chinese MCL patients achieve high-quality long-term survival.

In recent years, with the continuous deepening of China's population aging, the number of elderly patients with malignant hematological diseases has also been increasing year by year. Mantle cell lymphoma (MCL) is a rare type of non-Hodgkin lymphoma (NHL), which is usually aggressive in clinical practice and currently incurable. The average age of patients is around 60 years old, and more than 80% are diagnosed at an advanced stage (stage III or IV).^[1], which not only seriously affects the silver years of patients' lives but also poses a severe threat to their health. In addition, since most patients with mantle cell lymphoma (MCL) are elderly, they may suffer from other underlying diseases, making it difficult for them to tolerate the toxicity of traditional chemotherapy. Moreover, although patients are sensitive to initial treatment, there is still a possibility of recurrence after first-line treatment, and the recurrence rate is relatively high.^[2]Data show that only 8% of MCL patients in China survive more than 10 years.^[3], the 5-year survival rate of conventional chemotherapy is < 30%^[4], still "struggling" on the road to achieving long-term survival.

With scientific advancements, an increasing number of innovative drugs are being introduced, providing patients with more treatment options for long-term survival. Among them, BTK inhibitors, as one of the targeted therapies for mantle cell lymphoma (MCL), primarily exert their anticancer effects by inhibiting the activity of Bruton's tyrosine kinase (BTK), which is essential for tumor cell replication and metastasis, and have become the preferred option for second-line and later treatments of MCL.^[5]Acalabrutinib, as the world's first new-generation highly selective BTK inhibitor, has shown a median overall survival (OS) of up to 59.2 months in the treatment of MCL patients who have previously received at least one therapy, according to long-term follow-up results from global studies. Additionally, through innovative optimization of its molecular structure, it has enhanced its selectivity for the BTK target.^[6], with a lower risk of adverse events related to off-target effects (such as diarrhea, hypertension, bleeding, arthralgia, etc.), which is beneficial for elderly patients with underlying health conditions and poor tolerance, helping to reduce their treatment burden and discontinuation rate, demonstrating overall good safety.^[7]The Lymphoma Diagnosis and Treatment Guidelines (2022) issued by the Chinese Society of Clinical Oncology (CSCO) listed acalabrutinib along with other BTK inhibitors as a Level Ⅰ recommendation for the treatment of MCL patients who have previously received at least one therapy; similarly, The Chinese Guidelines for Diagnosis and Treatment of Mantle Cell Lymphoma (2022 Edition), released by the Chinese Anti-Cancer Association (CACA), also included BTK inhibitors such as acalabrutinib in the recommended preferred salvage treatment options for MCL patients who have previously received at least one therapy.

Director of Harbin Hematology and Oncology Research Institute, Chinese Society of Clinical Oncology (Professor Ma Jun, Supervisor of the Board of Directors of CSCO"The primary treatment goal for patients with mantle cell lymphoma is to prolong survival and improve quality of life. However, before the advent of BTK inhibitors, there was a lack of satisfactory treatment options for such patients in clinical practice. As a next-generation BTK inhibitor, Acalabrutinib was approved for marketing in China this year and successfully included in the National Reimbursement Drug List (NRDL). It not only provides Chinese MCL patients with new internationally synchronized treatment options but also offers patients more confidence and hope in terms of long-term treatment safety and survival benefits."

Professor Zhu Jun, Party Secretary of Peking University Cancer Hospital and Chief Physician of the Department of Lymphoma Medical Oncology"It means that due to the fact that most patients with mantle cell lymphoma are elderly, the new generation BTK inhibitor acalabrutinib, compared with existing treatment options, has high selectivity for the target, fewer side effects, and a high remission rate. Patients are often more willing to accept and adhere to long-term treatment, meaning this option can bring better benefits to patients. This inclusion of acalabrutinib in the National Medical Insurance Catalogue can greatly reduce the financial burden on patients, thereby improving the accessibility and compliance of standardized treatment and extending the high-quality survival time of patients."

Mr. Kangwei Chen, General Manager of AstraZeneca China Oncology Business Unit"Acalabrutinib is a cornerstone in AstraZeneca's hemato-oncology portfolio, benefiting tens of thousands of patients worldwide with various types of hematological malignancies by providing an effective and tolerable new treatment option. Acalabrutinib was approved in China earlier this year and has now been successfully included in the National Reimbursement Drug List (NRDL) at the end of the year, marking a significant milestone. This further demonstrates AstraZeneca's commitment to bringing innovative medicines to Chinese patients. Moving forward, we will continue to introduce innovative treatment solutions to address unmet patient needs, improve the accessibility of innovative drugs, help patients achieve long-term, high-quality survival, and contribute to the realization of the ‘Healthy China 2030’ strategic goals."

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a science-led global biopharmaceutical business focused on the discovery, development, and commercialization of prescription medicines, primarily in the areas of oncology, biopharmaceuticals including cardiovascular, renal and metabolism, respiratory and immunology, vaccines and infectious diseases, as well as rare diseases. Headquartered in Cambridge, UK, AstraZeneca operates in over 100 countries worldwide, delivering innovative medicines to millions of patients globally. For more information, please visit www.astrazeneca.com.

About AstraZeneca China

Since entering China in 1993, AstraZeneca has adhered to the principle of science first, focusing on innovation to meet the growing health needs of China and achieve the grand vision of "pioneering innovation, benefiting patients, and becoming China's most trusted healthcare partner." AstraZeneca's China headquarters is located in Shanghai, with regional headquarters established in Beijing, Guangzhou, Wuxi, Hangzhou, and Chengdu. The company has production bases in Wuxi and Taizhou, Jiangsu Province, and has built a logistics center in Wuxi, China. In China, AstraZeneca's business focus mainly centers on treatment areas where Chinese patients have the most urgent needs, including oncology, cardiovascular, metabolism, renal, respiratory, gastroenterology, vaccines and antibodies, autoimmune diseases, and rare diseases. In 2017, the China Health Internet of Things Innovation Center was established in Wuxi, aiming to explore innovative integrated health IoT solutions for full disease management. In the same year, AstraZeneca formed Dizal (Jiangsu) Pharmaceutical Co., Ltd. as a joint venture with SDIC Innovation to accelerate local new drug development. In 2019, AstraZeneca announced its cooperation with Wuxi to jointly build the Wuxi International Life Science Innovation Park, gathering global wisdom to benefit Chinese patients. In 2020, AstraZeneca announced its support for the "Internet Hospital" project. In 2021, AstraZeneca officially upgraded its Global R&D China Center in Shanghai and jointly initiated the AstraZeneca CICC Healthcare Industry Fund with CICC Capital.

Disclaimer: This material is not intended for any promotional purposes, and the relevant information should not be used as advice for treatment or use. For any related questions, please consult a healthcare professional.

^[1] Chinese Anti-Cancer Association Hematological Oncology Professional Committee, Chinese Medical Association Hematology Branch, Chinese Society of Clinical Oncology Lymphoma Expert Committee. Chinese Guidelines for the Diagnosis and Treatment of Mantle Cell Lymphoma (2022 Edition)[J]. Chinese Journal of Hematology, 2022, 43(8):7.

^[2] Dreyling M, et al. Leuk Lymphoma. 2018 Aug;59(8):1814-1828.

^[3] AmJ Hematol. 2017 Aug;92(8):806-813.

^[4] McKay,P., Leach, M., et al. (2012). Br J Haematol. 159(4): 405-26.

^[5] Dreyling M, et al. Leuk Lymphoma. 2018 Aug;59(8):1814-1828

^[6] Pal Singh S, Dammeijer F, Hendriks RW. Role of Bruton's tyrosine kinase in B cells and malignancies. Mol Cancer. 2018 Feb 19;17(1):57.

^[7] Michael Wang, MD et al. Blood (2020) 136 (Supplement 1): 38–39.