Drug registration verification storm struck

The threshold for drug registration will be higher and higher. Following the announcement by the State Food and Drug Administration that 90 companies withdrew 164 drug registration applications, on December 3, the State Food and Drug Administration received 62 companies to withdraw 87 drug registration applications. According to the “Securities Daily” statistics, as of December 8th, 19 listed pharmaceutical companies had issued announcements to withdraw their applications for drug registration. In addition, 10 listed companies, including Renhe Pharmaceutical, Jinling Pharmaceutical, Winbond Health, and Kelun Pharmaceutical, have not issued announcements to withdraw their applications for drug registration.

For this matter, Shi Lichen, head of the Beijing Dingchen Pharmaceutical Management and Consultation Center, told the Securities Daily reporter that in addition to listed companies, some SMEs withdrew more drug registrations. In the future, in the context of increasing the threshold for drug registration examination in the country, there will be more applications for withdrawal of drug registrations, and the peak period is far from coming.

Drug registration verification tightened

In July this year, the State Food and Drug Administration issued the “Announcement on Launching the Self-examination and Verification of Drug Clinical Trial Data”, striving to ensure the safety and effectiveness of drugs from the source. According to the information from the State Food and Drug Administration, self-examination and reporting of drug clinical trial data ended at 24:00 on August 25, 2015. The drug clinical trial involved 1,622 cultivars. Among them, applicants submitted 1094 registration applications for self-examination materials, accounting for 67%; active withdrawal of registration applications 317, accounting for 20%; applications for clinical trials such as exemption do not need to submit 193 registration applications, accounting for 12%.

After this, the State Food and Drug Administration issued announcements on October 15, November 6, November 26, and December 3 of this year that related companies had withdrawn their drug registration applications. As of December 5, 2015, a total of 166 companies had withdrawn their drug registration applications. In addition, the State Food and Drug Administration issued an announcement on November 11 that "The application for registration of 11 drugs in 8 companies will not be approved." The reason is that the clinical trial data is untrue and incomplete.

Shi Lichen believes that the self-examination and verification of the drug clinical trial data by the relevant departments is mainly due to three things: one is to solve the problem of backlog of drug registration applications; the other is that the current repeated application for drug registration, clinical trial data falsified more, making the existence of drug quality The third problem is that the State Food and Drug Administration conducts generic drug conformity assessment. Excessive low-quality drugs registered to the later generic drug conformity assessment will bring more workload.

For some companies currently withdrawing applications for drug registration, Shi Lichen believes that in actual practice, companies have withdrawn more privately. "There are still many companies watching the attitude of the government on the matter. If the government's attitude towards drug registration is still very strict, it is believed that more companies will actively withdraw drug registration next year."

The reason why the government raises the threshold for drug registration applications is that the pressure on medical insurance payment continues to increase. "At present, the market is full of many ineffective drugs, which allows doctors to open the original study drug (the price of the original research drug is generally higher than the price of generic drugs), and this to a certain extent also increases the cost of medical treatment for the people." Shi Lichen introduced to reporters. The purpose of the State Food and Drug Administration to do this is to control this unfavorable phenomenon from the source, thus reducing the pressure of payment for medical insurance.

Several listed companies withdrew their applications

From December 5th to December 7th, 9 listed drugs including Lianhua Pharmaceutical, Lukang Pharmaceutical, Renfu Pharmaceutical, China Resources Shuanghe, Health Yuan, Livzon Group, Baiyunshan, All Medicine, Asia Pacific Pharmaceuticals etc. The company issued an announcement to withdraw its application for drug registration.

Asia Pacific Pharmaceuticals withdrew Zaltoprofen Capsules and Zatoprofen Tablets from two drugs. Asia Pacific Pharmaceuticals stated that the company’s initiative to withdraw its application for registration of these drugs was a deliberate decision based on the State Administration of Food and Drug Administration’s latest review and approval policy for drugs. After further evaluation of the clinical value and market prospects of the above varieties, the company will determine whether to continue the in-depth research work. Zhongsheng Pharmaceutical announced that, based on the recommendations of clinical research institutions and contract research organizations, the company's wholly-owned subsidiary, South China Pharmaceuticals and Xianqiang Pharmaceutical, voluntarily withdrew the registration of five drugs. Livzon Group said that its wholly-owned subsidiary, Livzon Group Livzon Pharmaceutical Factory, withdrew its registration application for Bunan Selin.

In addition, it includes 10 companies including Hengrui Pharmaceutical, Kangyuan Pharmaceutical, Tianyao Pharmaceutical, Fosun Pharma, Lingkang Pharmaceutical, Shuangcheng Pharmaceutical, Connbay, Hisun Pharmaceutical, Huahai Pharmaceutical, and Kangzhi Pharmaceutical. The listed company issued an announcement to withdraw its application for drug registration.

According to the statistics of the "Securities Daily" reporters, 9 listed companies or their companies, including Fu Jen Pharmaceutical, Jinling Pharmaceutical, Winbond Health, Cologne Pharmaceuticals, China Resources Sanjiu, Xinli Tai, and Yuheng Pharmaceutical, have also withdrawn. Application for registration of related drugs, but related companies did not issue announcements.

The withdrawal of drug registration applications has also had an impact on the company's previous R&D investment. According to an announcement released by Renfu Pharmaceutical, the controlling subsidiary Yichang Renfu Pharmaceutical Co., Ltd. recently submitted an application for the withdrawal of registration of amlodipine besylate tablets to the Hubei Provincial Food and Drug Administration. As of the announcement date, Yichang Renfu has invested Rmb3 million in research and development projects for amlodipine besylate tablets. Baiyunshan Pharmaceutical Factory of Guangzhou Baiyunshan Branch withdrew the registration application for enafilium felodipine sustained-release tablets. The drug has invested about 6.5 million yuan in research and development. Asia Pacific Pharmaceuticals withdrew 2 applications for drug registration. The company’s accumulated investment in the above-mentioned drugs has not exceeded 5 million yuan. Hengrui Medicine withdrew its application for registration of ivabradine hydrochloride, and the company invested a total of 5.53 million yuan in research and development on this project.

"Compared to the original research drugs, the research and development costs of generic drugs are relatively low." An industry source told reporters that the country's vigorous application to rectify the registration of pharmaceutical companies also helps companies concerned to invest in R&D and produce high-quality generic drugs. .

However, improving the quality of medicines is a systematic project. While improving the threshold for drug registration applications, it should also be a market channel for high-quality generic drugs. “At present, tenders in some regions are held once every few years, which makes it more difficult for newly developed first generic medicines and high generic medicines to enter these markets. It is recommended that relevant departments have some problems, which will help improve the company’s R&D capabilities. , innovation power." Shi Lichen added.