On December 26, Zhengda Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, approving the registration and listing of Everolimus Tablets (trade name: Chingvishi). Evervimox Tablet is not only the first generic in China, but also the first product that has been granted 12 months of market exclusivity due to "first generic approval + first successful patent challenge" since the implementation of the mechanism for early resolution of drug patent disputes (Drug Patent Linkage System) in China.

The approved indications of Zhengda Tianqing Everolimus Tablets are:
(1) Adult patients with advanced renal cell carcinoma who have failed prior treatment with sunitinib or sorafenib.
(2) Adult patients with unresectable, locally advanced or metastatic, well-differentiated (moderately differentiated or highly differentiated) progressive pancreatic neuroendocrine tumors.
(3) Adult patients with unresectable, locally advanced or metastatic, well-differentiated, progressive non-functional gastrointestinal or lung-derived neuroendocrine tumors (NET).
(4) Adult and pediatric patients with tuberous sclerosis (TSC)-associated subventricular giant cell astrocytoma (SEGA) requiring therapeutic intervention but not amenable to surgical resection. The efficacy of everolimus has been demonstrated primarily by sustainable objective remission (i.e., reduction in SEGA tumor volume). It has not been demonstrated whether patients with tuberous sclerosis-associated subventricular giant cell astrocytoma can achieve improvement in disease-related symptoms and prolonged overall survival.
(5) For the treatment of adult patients with tuberous sclerosis-associated renal vascular smooth muscle lipoma (TSC-AML) who do not require immediate surgical treatment.
(6) In combination with exemestane for the treatment of hormone receptor-positive, epidermal growth factor receptor-2-negative, postmenopausal, advanced female breast cancer patients after failure of treatment with letrozole or anastrozole.

Everolimus is a new targeted therapeutic agent, a selective inhibitor of mammalian target of rapamycin (mTOR), which inhibits mTOR kinase activity by binding to the intracellular protein FKBP12 to form an inhibitory complex, thereby decreasing the activity of mTOR's downstream effectors, S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4E-BP ) activity, thus interfering with the growth, differentiation and metabolism of cancer cells and exerting anti-tumor effects.

Everolimus is effective in the treatment of many malignant tumors, and its clinical value has been fully affirmed. Currently, there is no domestic production of everolimus tablets on the market, and the price of the original drug is high, and there are restrictions on reimbursement by medical insurance. The listing of Zhengda Tianqing everolimus tablets can provide patients with more choices of medication on the one hand, and greatly reduce the burden of patients' medication on the other hand, improve the accessibility of medication, and benefit more tumor patients.

It is particularly noteworthy that Zhengda Tianqing Everolimus Tablet is the first product that has been granted 12 months of market exclusivity with the status of "first generic approved + first successful patent challenge" since the implementation of the patent linkage system in China. China's drug patent linkage system, on the one hand, strengthens the protection of intellectual property rights at the drug review and approval stage, stimulates the enthusiasm of enterprises in R&D and innovation, and, on the other hand, encourages generic enterprises to initiate patent challenges and promote the early launch of drugs on the market. The acquisition of "market exclusivity period" rights and benefits of ChingWeiShi means that the implementation of China's drug patent linkage system has ushered in another milestone, which plays a good role as a model for domestic generic drug enterprises and promotes the positive development of the domestic generic drug ecology.

With rich experience accumulation, speed advantage and quality advantage in drug development, combining with the characteristics of innovative drug R&D in recent years, Zhengda Tianqing has formed a highly competitive innovative R&D ecology by focusing on advantageous resources and adjusting R&D strategy with the orientation of clinical drug demand. In the future, Zhengda Tianqing will continue to launch clinically needed, high-quality and economical drugs to bring benefits to the majority of patients.

https://mp.weixin.qq.com/s/wjRJF3oOCC-k0j6vvoYdBg