The Clinical Data Of The 8 Chinese Medicine Injections In The New Crown Treatment Plan Are Still The Focus Of Attention.

The injection of Chinese medicine is another "fire" because of the new crown pneumonia epidemic.

Following the approval of the State Administration of drug administration, Jinhua qinggan granule, Lianhuaqingwen and Xuebijing injection were included in the treatment of the new crown pneumonia "three drugs and three parties".

According to the diagnosis and treatment plan of new coronavirus pneumonia (Trial Seventh Edition), Xi Yan Ping injection, Xuebijing injection, rehnning injection, Tanreqing injection, Xingnaojing injection, Shenfu injection, Shenmai injection and Shengmai injection have all been included in the recommended treatment plan.

In the past, as the largest market share in the field of Chinese medicine, it is also a pillar of the Chinese pharmaceutical industry. Chinese medicine injections have undergone several shuffling. The most notable concern is the safety issue. Whether the Chinese medicine injections can play a role in the new crown can be turned over again. The focus of attention is still focused on whether the clinical research data are detailed and scientific.

Clinical trials remain the focus of attention

The category of Chinese medicine injections was previously questioned because of the safety and quality problems, but this new process was "reemerging".

At present, many traditional Chinese medicine injections, which are included in the seventh edition, are part of the exclusive agent varieties of some enterprises. Some of the products have been "recalled" because of the control of medical insurance and the supervision of the auxiliary drug catalogue.

A number of people in the industry expressed a similar view to the twenty-first Century economic news reporter: "in the process of new crown, some Chinese medicine injections are coming out again, and the industry is most concerned about clinical trial data. Taking a case of Xuebijing injection as an example, one of the inclusion criteria is a high standard of pneumonia or oxygenation index, because patients are mostly in the state of first aid, so it is difficult to carry out randomized controlled clinical trials, so the experiment is a non randomized controlled clinical trial. For new drugs or drugs to increase indications, there must be a randomized controlled clinical trial to determine whether it is effective. Subsequently, a large sample of observational studies is needed to confirm the efficacy of the whole patient group.

Previously, the category of traditional Chinese medicine injections has also been controversial. According to the national adverse drug reaction monitoring report, from 2010 to 2016, Chinese medicine injections continued to occupy the first place in the list of adverse reactions / events, and the number of reports and the proportion of serious reports increased year by year. In 2012, all the serious adverse reactions reported by the national ADR monitoring network were the top 20 Chinese patent medicines.

Xuebijing injection is the exclusive product of Tianjin red sun pharmaceutical Limited by Share Ltd. In 2016, Xuebijing injection was included in the list of adjuvant drugs, and the performance of the red sun pharmaceutical industry also gradually declined.

But in this outbreak, Xuebijing injection played a huge role. Zhong Nanshan, senior member of the National Health Protection Committee and academician of the Chinese Academy of engineering, said that Xuebijing injection was effective in treating severe pneumonia, and it needed some evidence-based medicine evidence. We are now summarizing that it seems to be effective initially, reducing the fatality rate.

It is understood that before using the new crown, Xuebijing injection is suitable for sepsis, and it is mostly used for ICU first aid. The product is mainly used in high grade two and three hospitals. Its clinical value is widely recognized.

In April 2020, the drug supplement application approval issued by the State Administration of drug supervision showed that Xuebijing injection produced by Tianjin red sun pharmaceutical company was approved for use in severe, severe systemic inflammatory response syndrome or / or multiple organ failure in new coronavirus pneumonia, and the dosage and dosage were 2 times a day.

On April 22nd, Guangzhou's epidemic prevention and control ventilation conference, Yang Zi Feng, assistant dean of the Guangzhou Respiratory Research Institute, told reporters that the lack of clinical trials is a great constraint to clinical research of the next Chinese medicine. At present, the "three drugs and three parties" have been applied in clinical practice, and a large scale clinical trial has also been carried out in this outbreak. In addition, the issue of how to balance the safety and efficacy of drugs should be considered first in the special period of new crown pneumonia global pandemic and drug free use.

Chinese medicine injection turned over?

At present, the injection of traditional Chinese medicine into the diagnosis and treatment plan, besides Xuebijing, many other drugs have also been controversial before, and many drugs have been the exclusive drugs of the major pharmaceutical companies before the supervision and control of medical insurance and supplementary drugs have been strengthened.

Xi Yanping injection is the core product of Qingfeng Pharmaceutical Group. But the development of Xi Yanping injection has been criticized for many years. In the medical insurance directory of 2017, Xi Yan Ping injection was limited to only two or more critical patients in medical institutions. In September 2017, the State Administration of food and Drug Administration issued a notice saying that due to the severe adverse reactions such as chills and fever in the clinical application of Xi Yan Ping injection, the national recall was required.

Shenmai injection enterprises include Huarun Ya'an, Shenwei pharmaceutical, Zhengda Qingbao, Sichuan Sheng and Chuan Da Huaxi, Dali pharmaceutical, Yunnan plants and other 7 companies, with a market share of over 5 billion. In 2017, the Shenmai injection was at least 40 times in the national public hospital control fee storm. Subsequently, the State Food and Drug Administration announced in April 2018 that it was required to revise the instructions of Shenmai injection.

Re injection is the exclusive variety of Jiangsu Kang Yuan Pharmaceutical Co., Ltd., and entered the medical insurance directory in 2019. According to the company's earnings report, 52 million 620 thousand and 900 sales were sold in 2019. According to the price of 33.6 yuan / branch of Beijing medicine sunshine purchasing network, the annual sales volume is about 1 billion 768 million yuan, accounting for more than 10% of the total revenue of the company.

According to the data of the State Administration of drug control, Shengmai injection is produced by 8 pharmaceutical companies, including Huarun 39, Shanghai and Huang, Jiangsu, Changshu, Shanxi, Taihang pharmaceutical, Yibin, Sichuan, Huaxi and Ji'an.

Tanreqing injection is the exclusive product of Shanghai Kai Bao pharmaceutical industry, which was approved in 2003, accounting for more than 90% of the company's total revenue. According to the comprehensive drug database (PDB), the market of Tanreqing Injection in China is relatively stable, and the sales volume in 2018 is nearly 1 billion 300 million yuan.

The source material of traditional Chinese medicine injections is Chinese herbal medicines. Therefore, the research and quality standard research on screening, extraction, purification and concentration of Chinese herbal medicines directly determine the safety and effectiveness of Chinese medicine injections.

Li Lei, director of the re evaluation research group of the Chinese Medicine Association, attended and hosted several safety evaluation of traditional Chinese medicine injections. He believed that western medicine failed to follow the dialectical treatment of Chinese medicine, unscientific joint use, a large number of grass-roots use, and the elderly children could not be used cautiously, resulting in more than 70% of adverse reactions. These are the fundamental reasons for the frequent occurrence of adverse events of traditional Chinese medicine injections.

Lu Xianping, chairman of the Shenzhen micro core biological Polytron Technologies Inc, had said in an interview with the economic news reporters in twenty-first Century that "Chinese medicine injection is a product of history. If Chinese medicine injection is effective and controllable, it can still be used as a continuation of the drug by means of clinical data and methods. Previously, because of the changes in the drug policy, many related enterprises have begun to explore new ways to carry out small molecule antibody research and seek transformation through mergers and acquisitions, or new R & D and cooperation.