Novartis Oncology Drug Afinitor® (Everolimus) Expands Reimbursement Coverage in China's 2019 National Reimbursement Drug List with Unique mTOR Inhibitor Mechanism

Beijing, November 28, 2019 /PRNewswire/ -- Today, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security issued a notice on including the drugs negotiated in 2019 into Category B of the "National Drug List for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance." Through the latest round of negotiations, a total of 97 drugs were included in the National Medical Insurance Drug List. In this round of negotiations, Afinitor, an innovative oncology therapeutic drug from Novartis Oncology,^®(Everolimus) Successfully Renewed Its Inclusion in the National Reimbursement Drug List and Added New Reimbursable Indications, Benefiting More Patients in China.

Malignant tumors are a common disease threatening human health, with consistently high incidence rates, high mortality and disability rates, and expensive treatment costs. To alleviate the societal burden of disease, in ChinaUniqueApproved Antitumor Drug mTOR Inhibitor Finito^®(Everolimus) was included in the National Reimbursement Drug List in 2017 for the treatment of advanced renal cell carcinoma, pancreatic neuroendocrine tumors, and renal angiomyolipoma associated with tuberous sclerosis complex. Today, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security announced the updated "National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug List," which now additionally includes Afinitor.^®(Everolimus) indications for non-functional gastrointestinal or lung-origin neuroendocrine tumors and subependymal giant cell astrocytoma associated with tuberous sclerosis complex are included in the reimbursement scope. After this negotiation, Afinitor^®(Everolimus) All indications have been included in the national medical insurance coverage, further benefiting more patients with advanced solid tumors, including some patients with major rare diseases and children who urgently need societal attention and care. This helps reduce the medication burden on patients, improve drug accessibility, and is of great significance for extending survival periods and improving the quality of life for cancer patients.

Aberrant Regulation of the mTOR Signaling Pathway Is Closely Associated with Tumorigenesis

With the continuous advancement of medical research, the treatment of malignant tumors has evolved from traditional surgery, radiotherapy, and chemotherapy to an era of precision medicine dominated by targeted therapy. Targeted therapy primarily focuses on specific "targets" that are clearly identified as essential for carcinogenesis and tumor growth. By using corresponding targeted drugs to inhibit or block these targets, it aims to improve the quality of life for cancer patients and plays a significant role in oncology treatment. Feinituo^®(Everolimus) is a targeted drug that precisely inhibits the mammalian target of rapamycin (mTOR), and it is currently the only mTOR inhibitor approved in China for the treatment of tumors.

The so-called mTOR is a serine/threonine protein kinase that primarily regulates cell growth by integrating signals from growth factors and nutrients. The mTOR signaling pathway is one of the essential pathways required for human cell growth. Located at a multifunctional hub, it acts as a central sensor, receiving upstream receptor signals while simultaneously influencing downstream effectors, thereby playing a pivotal role in cellular signal transduction. These signaling pathways function like messengers, transmitting various extracellular signals into the cell to activate a series of processes involved in cell maintenance, survival, proliferation, and nutrient utilization. Through these mechanisms, the human body can respond to external stimuli. When the mTOR signaling pathway becomes dysregulated or impaired, the homeostasis of cells within the body is disrupted, leading to disordered cellular tissue management and an increased susceptibility to various diseases, particularly tumorigenesis.

mTOR Inhibitors Offer New Options for Cancer Treatment

Given the close association between dysregulated mTOR signaling and tumorigenesis, which extensively participates in processes such as growth, proliferation, differentiation, apoptosis, and invasion of tumor cells, mTOR is involved in various biological functions including gene transcription, protein translation, ribosome biogenesis, and apoptosis under the activation of multiple factors. It plays roles in inhibiting the synthesis of proteins essential for tumor cells, regulating cell growth and proliferation, and suppressing the formation of new tumor blood vessels. Therefore, mTOR has become an important target for cancer therapy.

In recent years, mTOR inhibitors have been widely used in targeted cancer therapy. By using mTOR inhibitors, tumor patients can effectively intervene and control the mTOR signaling pathway to inhibit the growth and proliferation of tumor cells.

Fenitoin^®(Everolimus) Novartis commits to improving the accessibility and affordability of innovative medicines in China

As a domesticUniqueApproved anti-tumor drug mTOR inhibitor, Afinitor^®(Everolimus) oral tablets, as a mode of administration, help to some extent improve patient adherence and facilitate health management for cancer patients. Currently, Afinitor^®(Everolimus) has been approved for marketing in 122 countries and regions worldwide, with evidence from over 70,000 cases globally, providing a solid clinical basis for exploring the mTOR treatment model, helping patients extend overall survival and improve quality of life.

As of November 2019, all 11 Novartis Oncology products marketed in China had been included in the National Reimbursement Drug List. As a company with robust R&D capabilities and a portfolio of medicines that transform treatment paradigms and address unmet clinical needs, Novartis remains committed to its patient-centric philosophy, aiming to alleviate patient suffering and improve quality of life. Meanwhile, the company has actively supported and responded to national initiatives to reduce the disease burden on patients, ensuring that Chinese patients have affordable access to high-quality innovative medicines launched simultaneously in global markets.