The drug approval reform has led to the green light and another cancer drug approval has been completed!

On May 8th, the Insight database showed that the approval status of the application for the listing of the new drug, Erlotinib, was changed from “in the approval” to “approval-to-certification”. On May 9, the new drug was officially approved by the State Drug Administration.

As soon as this news came out, the industry cheered. Erlotinib is a novel small molecule multi-target tyrosine kinase inhibitor independently developed by the drug company. The drug has been reviewed and accelerated, which means that the third-line treatment of patients with advanced Chinese NSCLC has an effective New treatments.
It is understood that there are more than 4 million new cancer patients in China every year. On average, more than 10,000 people are diagnosed as new-onset people every day, and the incidence rate is increasing year by year.

Among them, lung cancer is one of the malignant tumors that can not be avoided in the world. Non-small cell lung cancer (NSCLC) restricts the improvement of various NSCLC treatments due to cell heterogeneity, drug resistance and individual differences. The survival time of lung cancer is also much lower than that of developed countries.

In recent years, with the development of traditional domestic chemotherapy, targeted therapy and immunotherapy have gradually entered the first-line and second-line treatment, and the efficacy of advanced non-small cell lung cancer (NSCLC) has been greatly improved. However, for Chinese patients with failed first-line and second-line treatments, the existing three-line treatments lack a recognized and effective treatment plan, and patients are often in a difficult situation with no medicine available. It is urgent to explore new treatment methods and prolong the life of patients.

According to clinical trials, the cocaine-resistant adverse reaction is mild and the patient is well tolerated. It is the only single-agent effective oral preparation for the anti-angiogenic targeted drugs of advanced non-small cell lung cancer. Industry experts predict that erlotinib is expected to be the standard of third-line treatment for patients with advanced non-small cell lung cancer.

It is understood that the 1.1 new drug, erlotinib hydrochloride hydrochloride, is a product developed on the sunny day after more than ten years of wind cream. It can effectively inhibit kinases such as VEGFR, PDGFR, FGFR and c-Kit, and has the dual effects of anti-tumor angiogenesis and tumor growth inhibition.

Wang Shanchun, president of the pharmaceutical company, said that the listing of erlotinib was mainly due to the ongoing drug review and approval reform measures of the State Food and Drug Administration.

In recent years, China's drug review and approval has entered the fast lane. In October 2017, China issued the "Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Pharmaceutical Medical Devices." Subsequently,

The State Food and Drug Administration issued the "Implementation Measures for the Protection of Drug Test Data (Provisional) (Draft for Comment)", which is intended to provide a 6-year data protection period for innovative drugs approved for listing in China, and 12 years of data protection for innovative therapeutic biological products. period. These initiatives have further promoted the development of pharmaceutical innovations and generic drugs.

“Because clinical studies have shown that erlotinib has obvious clinical advantages over existing treatments, it is included in the priority review sequence by the drug review center after the application. It is precisely because of the attention of the drug review department that the review experts work overtime. Adding points, so that rolotinib completed the market review and approval in a short period of time, so that the majority of patients can use safe and effective anti-tumor innovative drugs as soon as possible."

At the same time, he said that during the drug review period, it coincided with the reform period of the national drug review and approval policy, and the country's guidance for encouraging R&D innovation became more and more obvious. The approval of innovative drugs with outstanding clinical value such as erlotinib was obtained. Protection and incentives.

The continuous release of the current policy dividend has enabled pharmaceutical companies to continuously increase R&D investment, unlock innovation potential, and enhance innovation capabilities. What can be met is that in the future, the innovation of Chinese pharmaceutical enterprises will further meet the demand for clinical medication, reduce the cost of medication, and provide effective protection for public health.