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8 Chinese medicine injections included in the anti-new crown diagnosis and treatment program, clinical data is still the focus of attention


The Chinese medicine injection was once again "fired" by the new coronary pneumonia epidemic.

Following the prior approval of the State Food and Drug Administration, Jinhua Qinggan Granules, Lianhua Qingwen Granules and Chinese Medicine Injection Xuebijing have been included in the "three medicines and three prescriptions" for the treatment of new coronary pneumonia.

According to the "New Coronavirus Pneumonia Diagnosis and Treatment Program (Trial Version 7)", Xiyanping Injection, Xuebijing Injection, Reduning Injection, Tanreqing Injection, Xingnaojing Injection, Shenfu Injection , Shenmai injection and Shengmai injection have been included in the recommended treatment plan.

Prior to this, as the dosage form with the largest market share in the field of Chinese medicine in China, it is also the mainstay of the Chinese pharmaceutical industry. Chinese medicine injection has undergone several reshuffles. The most high-profile is still the safety issue. This time it plays a role in the anti-new crown Whether the traditional Chinese medicine injection can turn over again, the focus is still on whether the clinical research data is detailed and scientific.

Clinical trials are still the focus of attention

The traditional Chinese medicine injection category has been questioned by the industry because of safety and quality issues, but in the process of anti-new crown, it has "reappeared".

Many of the traditional Chinese medicine injection products currently included in the seventh edition of the diagnosis and treatment program are exclusive products of some enterprises, and some products were once "recalled" because of the medical insurance control fee and the supervision of the auxiliary drug catalog.

Many industry insiders expressed similar views to 21st Century Business Herald reporters: "During the anti-new crown process, some Chinese medicine injection products have re-emerged again. The industry is most concerned about the clinical trial data. Take the currently disclosed case of Xuebijing injection As an example of a study, one of the inclusion criteria requires a high pneumonia severity index or oxygenation index standard. Because patients are mostly in emergency state, it is difficult to carry out randomized controlled clinical trials, so this trial is a non-randomized controlled clinical trial . For new drugs or increased drug indications, there must be randomized controlled clinical trials to determine whether they are effective, and subsequent large-scale observational studies are also required to confirm the efficacy of the entire patient population. "

The category of traditional Chinese medicine injections has been controversial. According to the National Drug Adverse Reaction Monitoring Report, from 2010 to 2016, Chinese medicine injections continued to occupy the top position of Chinese medicine adverse reactions / events, and the number of reports and the proportion of serious reports also increased year by year. In all serious adverse reaction reports received by the National Adverse Drug Reaction Monitoring Network in 2012, the top 20 proprietary Chinese medicines are all Chinese medicine injections.

Xuebijing injection is an exclusive product of Tianjin Hongri Pharmaceutical Co., Ltd. In 2016, Xuebijing injection was included in the list of auxiliary medicines in various places, and the performance of Hongri Pharmaceutical also gradually declined.

But in this epidemic, Xuebijing injection played a huge role. Zhong Nanshan, head of the high-level expert group of the National Health Commission and academician of the Chinese Academy of Engineering, said that Xuebijing injection has been found to be effective for severe pneumonia and whether it is effective for new coronary pneumonia through research. We are now summarizing, and initially it seems to be effective, reducing the case fatality rate.

It is understood that before being used against the new crown, Xuebijing injection is clinically applicable to sepsis and is mostly used for ICU first aid. The use of this product is mostly concentrated in high-level secondary and tertiary hospitals, and its clinical value has Wider recognition.

In April 2020, the "Pharmaceutical Supplement Application Document" issued by the State Food and Drug Administration showed that Xuebijing injection produced by Tianjin Hongri Pharmaceutical Co., Ltd. was approved for the use of new coronavirus pneumonia severe and critical systemic inflammatory response syndrome Or / and multiple organ failure, usage and dosage is 2 times a day.

At the press conference on prevention and control ventilation in Guangzhou on April 22, Yang Zifeng, assistant director of the Guangzhou Institute of Respiratory Research, told reporters that the lack of clinical trial participants will indeed cause great constraints to the subsequent clinical research of anti-epidemic medicine in traditional Chinese medicine. . The current "three medicines and three prescriptions" have been applied clinically. In this epidemic, more standardized large-scale clinical trials have also been conducted, and finally the efficacy has been proved. In addition, regarding the safety of drugs and how to balance the efficacy, in a special period such as the global pandemic of new coronary pneumonia and no drugs available, or life-saving should be considered.

Chinese medicine injection turned over?

In addition to the blood must be net, the traditional Chinese medicine injections currently included in the diagnosis and treatment program have also had some controversy before, and many drugs have been the exclusive drugs of major pharmaceutical companies before the medical insurance control fee and auxiliary drug supervision are strengthened. Sit on the throne of "Cash Cow".

Xiyanping injection is the core product of Qingfeng Pharmaceutical Group. However, the development of Xiyanping injection has been criticized in recent years. In the 2017 medical insurance catalogue, Xiyanping injection was limited to critically ill patients in secondary and higher medical institutions, and was later included in the supplementary and key monitoring drug catalogue. In September 2017, the State Food and Drug Administration issued an announcement saying that due to the clinical use of Xiyanping injection, there were many cases of severe adverse reactions such as chills and fever, which required a national recall.

Shenmai injection production enterprises include China Resources Ya'an, Shenwei Pharmaceutical, Zhengda Qingchunbao, Sichuan Shenghe Sichuan Huaxi, Dali Pharmaceutical, Yunnan Plant and other companies, with a market share of more than 5 billion. In 2017, in the storm of fee control in public hospitals across the country, Shenmai injection was included in the list of supplementary medicines used by health and planning committees or hospitals at all levels at least 40 times. Subsequently, the State Food and Drug Administration issued an announcement in April 2018 stating that it was required to revise the instructions for Shenmai Injection.

Reduning injection is an exclusive variety of Jiangsu Kangyuan Pharmaceutical Co., Ltd., which entered the 2019 medical insurance catalog. According to the company's financial report, sales of 52.609 million units in 2019. According to the price of 33.6 yuan / support of Beijing Pharmaceutical Sunshine Purchasing Network, the annual sales are about 1.768 billion yuan, accounting for more than 10% of the company's total operating income.

According to data from the State Food and Drug Administration, Shengmai Injection consists of 8 companies including China Resources Sanjiu, Shanghai Hehuang, Jiangsu Suzhong, Changshu Lei Yunshang, Shanxi Taihang Pharmaceutical, Sinopharm Yibin, Sichuan Dahuaxi, and Ji'an Yicheng. Pharmaceutical production.

Tanreqing injection is the exclusive product of Shanghai Kaibao Pharmaceutical Co., Ltd., which was approved for listing in 2003 and accounts for more than 90% of the company's total operating income. According to the Pharmaceutical Comprehensive Database (PDB), China's Tanreqing injection market is relatively stable, with sales of nearly 1.3 billion yuan in 2018.

The source material of traditional Chinese medicine injection is traditional Chinese medicine. Therefore, the screening, extraction, purification, concentration and other production process research and quality standard research of traditional Chinese medicine directly determine the safety and effectiveness of traditional Chinese medicine injection.

Li Lei, Director of the Office of the Re-evaluation Research Group of the Chinese Traditional Medicine Association, participated in and presided over several safety evaluations of traditional Chinese medicine injections. He believes that the adverse reactions caused by the failure of Western medicine to follow the syndrome differentiation treatment of traditional Chinese medicine, unscientific combined use, a large number of grassroots use, and the failure to use prudently by the elderly and children are more than 70%. These are the adverse events of traditional Chinese medicine injections. Root cause.

Lu Xianping, chairman of Shenzhen Microchip Biotechnology Co., Ltd., said in an interview with a 21st Century Business Herald reporter: "Chinese medicine injections are historical products. If the efficacy of Chinese medicine injections is accurate and the adverse reactions can be controlled, then pass the listing. Evaluation, using clinical data and methods to prove it, can still be used as a medicine. Since the change in the policy of medicines, many related companies have already begun through mergers and acquisitions, or started new research and development, cooperation, in some new differences Therapeutic field explores new ways to conduct small molecule antibody research and seek transformation. "