Major Breakthrough: China's First CDK4/6 Inhibitor for Premenopausal/Perimenopausal Breast Cancer, Kisqali®, Launched

2023Year2Month18Recently, Novartis'重磅 breast cancer treatment drug -- CDK4/6Inhibitor Kaililong®(Novartis' Ribociclib Succinate Tablets) officially launched in China. As the first and currently the only approved drug for premenopausal women in China,/Initial Treatment for Perimenopausal Breast Cancer PatientsCDK4/6Inhibitor, Kaililong®In2023Year1Month19Approved by the National Medical Products Administration on [date], to be used in combination with aromatase inhibitors as hormone receptor (HR) Positive, Human Epidermal Growth Factor Receptor2（HER2) Negative locally advanced or metastatic breast cancer in premenopausal or perimenopausal female patients for initial endocrine therapy. When using endocrine therapy, it should be combined with luteinizing hormone-releasing hormone (LHRH) Agonist.

The launch event was simultaneously held in Shanghai, Beijing, Guangzhou, and Chongqing, where the attending guests jointly expressed their firm confidence in extending patients' survival time and enhancing their dignity of life. Under the witness of thousands of authoritative experts, scholars, and clinical doctors from home and abroad in the field of breast cancer diagnosis and treatment, Crylon®In China officially full“Li”Set off.

For patients with advanced breast cancer, every new treatment option brings a ray of hope, especially for younger premenopausal patients, for whom the emergence of targeted therapeutic drugs is particularly encouraging. For Novartis, which has long been dedicated to the field of breast cancer and consistently adheres to a patient-centered approach while continuously innovating in research and development, the needs and hopes of patients are especially well understood. Ms. Zhang Ying, President of Novartis Innovative Drugs China, stated,“In the process of listening to patients' voices, we have learned that many women suffering from breast cancer are the backbone of the workplace and the pillars of their families, and they are eager to return to normal work and life through treatment. Therefore, from Kaililong®Following approval in January, we have expedited the product's market launch, hoping to apply it clinically as soon as possible. As the first product in China indicated for late-stage frontline premenopausal breast cancer,CDK4/6Inhibitor, Kaililong®The official launch will bring more hope to patients.”

Safeguarding High-Quality Life, Building a Fence for the Dignity of Patients' Lives

According to the International Agency for Research on Cancer (IARC) of the World Health Organization2020 Global Latest Cancer Data in Recent Years: Breast Cancer Has Replaced Lung Cancer as the World's Top Cancer. In China, breast cancer is one of the most common malignant tumors in women, with an incidence rate ranking first among female malignant tumors. Among these cases, approximately...70%The patients areHR+/HER2-Breast Cancer. Particularly distressing is that the peak age of onset is in45-55Years old, earlier than in Europe and America10More than a year.

Breast cancer in China is not just a cold statistic of a large patient population. Currently, based on the treatment philosophy of prolonging patients' lives and helping them achieve a higher quality and more dignified life, endocrine therapy remains...HR+/HER2-Classic systemic treatment methods for advanced breast cancer still encounter treatment pain points such as primary or secondary drug resistance and significantly reduced efficacy.

Professor Zhi-Min Shao from the Fudan University-affiliated Cancer Hospital stated:“Very pleased to see Kaylilon.®Will soon be available for clinical use, which will undoubtedly benefit premenopausal women in China.HR+/HER2-A new treatment method has been provided for patients with advanced breast cancer, bringing more hope for a better life to countless patient families. Chinese breast cancer patients experience an earlier peak in incidence, approximately at45-55Between ages, for these premenopausal patients with aggressive disease and poor prognosis, appropriate treatment methods are needed. Kayron®Combined endocrine therapy achieved a median overall survival (OS）58.7months of ultra-long survival benefits, and at the European Society for Medical Oncology-Clinical Benefit Scale (ESMO-MCBS) and received a full score, which means forHR+/HER2-Dual Benefits in Efficacy and Quality of Life for Premenopausal Patients with Advanced Breast Cancer.”

Ms. Gao Rong, Head of Novartis Global Drug Development in China, stated:“Always patient-centered, clinical value-oriented, and ensuring innovative drugs benefit patients as early as possible is Novartis' unwavering approach to innovative R&D. In Kaililong®In China's R&D process, in order to introduce this new treatment option with excellent clinical benefits to China earlier and benefit Chinese patients, we continuously seek and seize opportunities, always committed to accelerating the progress of Kaililong while maintaining the generation of high-quality data.®The speed of market entry; and the results of the Chinese study once again confirmed the efficacy of Keytruda.®Excellent efficacy and good safety in the Chinese population.”

Unremittingly Setting New Heights, Novartis Promotes Chinese Patients to Benefit from Cutting-edge Achievements as Early as Possible

Kaililong®The innovative significance and value mark another major breakthrough by Novartis in its continued focus on the breast cancer field. Over the past century of endocrine drug treatment for breast cancer, Novartis has achieved several unique breakthroughs.

From letrozole, the aromatase inhibitor that has consistently led endocrine therapy for breast cancer, tomTORThe inhibitor everolimus,再到今年1Monthly Launch: The Only Treatment forHR+/HER2-First-line premenopausalCDK4/6Inhibitors, Novartis always“Patient-Centered”The philosophy runs through every aspect of innovative research and development, pursuing dreams and continuing the journey. In the field of breast cancer, Novartis will continue to develop and introduce breakthrough therapies at the forefront of the world, providing more new options for Chinese patients; at the same time, Novartis is also committed to accelerating and improving the accessibility of innovative drugs, aiming to benefit more patients and help them regain their strength of life.

It is reported that the drug has been manufactured and packaged in Singapore and Switzerland plants and has arrived in China, to be gradually available in major pharmacies across the country starting from the beginning of next week.

Currently, Kellylong®/Kisqali® (Ribociclib Succinate Tablets) have been approved in more than95countries have been approved. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have all approved the combination of this product with aromatase inhibitors for treatmentHR+/HER2-Initial endocrine therapy for female patients with locally advanced or metastatic breast cancer. As another重磅product from Novartis in the field of breast cancer treatment, 凯丽隆®Is the only drug worldwide that has been proven to be effective in combination with different endocrine therapies,HR+/HER2-Demonstrated statistically significant overall survival benefit in locally advanced or metastatic breast cancerCDK4/6Inhibitor. The data on overall survival benefits of this product combined with endocrine therapy have led to its inclusion in the "Guidelines for Standardized Treatment of Advanced Breast Cancer in China (2022Edition)》 was emphasized.

References

1，《2020Latest Global Cancer Data Report

2，"Guidelines for the Diagnosis and Treatment of Breast Cancer (2022Year Edition)》http://www.nhc.gov.cn/yzygj/s2911/202204/a0e67177df1f439898683e1333957c74/files/c001a73dfefc4ace889a1ea6e0230865.pdf

3，Haojie, Chen Wanqing, Li Ni, etc.. Guidelines for Breast Cancer Screening and Early Diagnosis and Treatment in Chinese Women (2021, Beijing)[J]. Chinese Journal of Oncology, 2021, 43(4):357-382. DOI:10.3760/cma.j.cn112152-20210119-00061.

4，Jia M, Liao N, et al. Breast Cancer. 2021 May;28(3):644-652.

5，Novartis Data on File. Novartis Pharmaceuticals Corp: 2021.