Breast cancer is the most common cancer among women worldwide. According to statistics from the International Agency Research on Cancer, there were about 41 new cases of breast cancer in China in 202060,000 and about 11 deaths70,000, accounting for about 17 of the world's breast cancer deaths1%1。Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer is the most common type, accounting for approximately 70% of all breast cancer patients2.
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On December 13, 2023, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security released the National Catalogue of Drugs for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2023) (the "New Catalogue"). Eli Lilly & Company's anti-tumor CDK4&6 inhibitor Weixue (Abeciclib tablets) combined with endocrine** for the adjuvant indications of HR+, HER2- node-positive, high-risk and KI-67 20% of patients with early-stage breast cancer** were included in the medical insurance for the first time, and the two major indications of HR+, HER2- advanced endocrine sensitivity and advanced endocrine resistance were successfully renewed. The newly adjusted National Medical Insurance Catalogue is expected to be implemented from January 1, 2024, and the reimbursement process and time in various regions are subject to the local ** announcement.
Abeciclib Tablets is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6, and is the only CDK4&6 inhibitor approved in the world and China for the three major indications of HR+, HER2- breast cancer high-risk early adjuvant**, advanced endocrine sensitivity and advanced endocrine resistance3. Studies have shown that Justex (Abeciclib tablets) can reduce the 5-year long-term** risk of high-risk early-stage breast cancer patients by 32%4 while prolonging the overall survival of patients with HR+, HER2- advanced breast cancer5,6, and all its indications have been unanimously recommended by authoritative guidelines at home and abroad (including CSCO7, CACA8, NCCN9, etc.). Since its launch, WiseBenz has benefited more than 60,000 breast cancer patients in China.
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In December 2020, Benziclib Tablets was approved in China for dual indications for advanced breast cancer for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: (1) in combination with aromatase inhibitors as initial endocrine in postmenopausal female patients**;2) In combination with fulvestrant in patients with disease progression after receiving endocrine** in the past, and entered the National Medical Insurance Catalogue in 2021, becoming the first CDK4 & 6 inhibitor to enter the National Medical Insurance Catalogue. In December 2023, the dual indication for advanced breast cancer was successfully renewed, enabling patients with advanced breast cancer to continue to use the innovative CDK4 & 6 inhibitor with preferential medical insurance**, realizing multiple dividends of clinical value and patient benefits.
In December 2021, the adjuvant indication of Abeciclib tablets was approved in China for the adjuvant ** indication of early-stage breast cancer, that is, the combination of endocrine** (tamoxifen or aromatase inhibitors) is suitable for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high-risk and K-67 20% of patients with early-stage breast cancer**, and is the first and only CDK4&6 inhibitor approved for patients with early-stage breast cancer in China. Previous studies have shown that approximately 30% of high-risk patients will develop metastatic disease after endocrine alone10 and develop metastatic disease that cannot be developed, with a 5-year** risk of being 3 times higher than that of other non-high-risk patients11. The indication for abeciclib was successfully expanded in August 2023 for high-risk populations included in the Monarche study, i.e., clinicopathologic features 4 positive lymph nodes, or 1-3 positive lymph nodes with at least one of the following: tumor size 5cm, histologic grade 3, or Ki-67 20%. Abeciclib is the first breakthrough in the field of postoperative adjuvant ** for HR+, HER2- high-risk early breast cancer in the world in 16 years12. The inclusion of the adjuvant ** indication of early breast cancer in the national medical insurance catalogue for the first time will fill the gap of no targeted drugs in this field in the current medical insurance catalogue, further promote the early stage of breast cancer, reduce the cost and economic burden of patients, maximize the accessibility and affordability of patients, and further promote the development of breast cancer in China.
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So far, Weize (abeciclib tablets) has not only become the first CDK4 & 6 inhibitor to be included in the national medical insurance list, but also the only CDK4 & 6 inhibitor that is currently covered by the national medical insurance for people with early and advanced breast cancer.
References: 1] Global Cancer iarc.2020.
2] howlader n, altekruse s, li c. us incidence of breast cancer subtypes defined by joint hormone receptor and her2 status. j natl cancer inst. 2014;106(5).
3] Instructions for abeciclib tablets.
4] n. harbeck, et al. adjuvant abemaciclib plus endocrine therapy for hr+, her2-, high-risk early breast cancer: results from a preplanned monarche overall survival interim analysis, including 5-year efficacy outcomes. lba17. presented on esmo 2023.
5] sledge jr gw, et al.2022 sabcs abstract pd13-11
6] matthew p. goetz, et al.2022 esmo abstract lba15
7] Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Breast Cancer 2023 Edition
8] Guidelines and Norms for the Diagnosis and Treatment of Breast Cancer of the Chinese Anti-Cancer Association (2021 Edition).
9] j natl compr canc netw. 2023 jun;21(6):594-608.
10] stephen r d johnston et al. lancet oncol. 2023 jan;24(1):77-90.
11] sheffield km, et al. future oncol 2022; 18(21):2667-2682.
12] sainsbury r. cancer treat rev. 2013 aug;39(5);507-17