Why do Chinese medicine companies fight so?

The rumors of the relevant departments were brewing before the launch of a comprehensive launch of the drug market. The evaluation has recently been followed by new developments. Tianjin City has taken the lead in initiating research projects for large varieties of traditional Chinese medicines. The first batch of project municipal finances invested 22 million yuan to support the clinical re-evaluation of seven major varieties such as Xuebijing injection and Suxiao Jiuxin Pill.

It is reported that Tianjin Science and Technology Commission is conducting the screening of the second batch of projects and strives to restart the clinical re-evaluation study of 2 to 3 major Chinese medicine varieties. As an area where the strength of the Chinese medicine industry ranks among the top areas in the country, Tianjin has a good wind barometer.

During the interview, Song Minxian, a professor at Jiangxi University of Traditional Chinese Medicine, praised the research of large varieties of Chinese medicine. “The TCM companies should clarify the clinical efficacy and possible risks of the product, and pay attention to key diseases, in order to respond to the country’s limitations on the indications selected for the base medicine and medical insurance catalog products and changes in the health insurance payment model for the efficacy and safety of the drugs. Sex and economy provide scientific and authoritative data."

Medicare power

In the context of the trends of medical insurance payments such as disease-based payment, pricing based on medical insurance payment ability, third-party payment, etc., some researchers believe that such classic Chinese medicine varieties as "Liu Wei Di Huang Wan" may not find the disease corresponding to it completely in the future. Species. The adjustment of the medical insurance list is the highlight of this year.

The reporter learned that Xuebianjing injection, which has been included in the first batch of scientific research specialties, is a key product of Hongri Pharmaceutical. Its sales volume in the first three quarters of 2014 increased by approximately 30% year-on-year. Changjiang Securities Research reported that the product has entered more than 20 provinces' medical insurance catalogs, and there are more than a dozen provinces and cities have not entered the medical insurance. Analysts predict that once they enter the national health insurance directory in the future, they are expected to bring a new round of heavy volume. In the next few years, Xuebijing will also maintain an increase of more than 20%.

On the other hand, "at present, many Chinese medicines do not have the appellation title of Western medicine under the 'Indications of Function' in the description of the Chinese medicines, and they can't fit in according to the type of disease, or it will cause some Chinese patent medicines to be reimbursed for medical insurance." Kang Yuan Pharmaceutical Chairman Xiao Wei bluntly worried.

Song Minxian believes that “the key to deciding whether a product can enter the list of Medicare or drug-based medicines is whether the product is safe, effective, and quality-controllable, and can obtain certain evidence to support it.”

Industry insiders suggest that in addition to the top-level design of the post-marketing evaluation project, the competent authorities can also actively carry out re-evaluation research and provide evidence on the safety and effectiveness of evidence-based Chinese medicine varieties and their enterprises. Support when entering.

Experts from the Chinese Medicine Association of Traditional Chinese Medicine and Economics of the Chinese Medicine Association pointed out that for Chinese medicine companies, research on the functional convergence of products and the basic categories of medicines and medical insurance, and clarification of the combination of market re-evaluation and market value creation The methods and implementation paths for the re-study of large varieties after the listing are both the key to fostering strategic varieties and the driving force for the continued development of the industry.

Introduce third-party evaluation

In recent years, many re-evaluations of large varieties of traditional Chinese medicine have spread out one after another. For example, Guangdong Province's Adverse Drug Reaction Monitoring Center and some manufacturers of Chinese medicine injections such as Livzon Pharmaceutical, Yaan Sanjiu, and Baiyunshan Mingxing have commenced market evaluations. Tasly, Kangyuan Pharmaceutical, Buchang Pharmaceutical, Shenwei Pharmaceutical and other brand companies have also conducted post-marketing evaluation studies on their leading varieties; Dan Hong, Retonin and other clinical evaluations of a large batch of traditional Chinese medicine large variety injections It has also been included in the national science and technology plan and has already begun implementation.

However, according to the incomplete statistics of the Chinese Medicine Association, in 2012, there were nearly 200 varieties of single Chinese medicines that cost more than 100 million yuan. However, most of them failed to carry out systematic pharmacy research and safety studies according to the new drug standards and lacked high-level circulation. Medical evidence. The level of evidence in most Chinese patent medicine literature is concentrated in the “argument and comments, views” and “case report” levels. A considerable number of them are presented in the form of medical home-use medicine experience, prescriptions, and case sets, and there are problems such as rigorous design.

In addition, large enterprises have been making great efforts in recent years, of which the exclusive varieties or large varieties that have sold over 100 million yuan are still the main driving force for re-evaluation research. The universal model is the independent development of enterprises, the use of industry academic organizations, and the invitation of experts to participate in top-level design to achieve the goal of nurturing and developing large varieties. In contrast, breeds produced by small businesses, small breeds, especially many companies, tend to progress slowly or without progress.

"Re-evaluation after listing requires a lot of money, and requires companies to have strong scientific research strength." Zhang Chunbo, chairman of Baiyunshan Zhongyi Pharmaceutical, told reporters. Since 2007, the company has invested 10 million yuan in the postmarketing evaluation of Xiaoke pills, and has also invested 5 million yuan in the evaluation of pharmaceutical economics.

According to Song Minxian, active post-marketing research is a corporate social responsibility and a cost that pharmaceutical companies must invest. "For example, whether different dosage forms have the same clinical equivalence; whether there are differences in the medicines from different sources or not; whether the labeling of the 'not yet clear' label in the drug labeling should be further clarified."

The above experts suggest that a third-party appraisal agency for traditional Chinese medicines can be properly introduced to disclose research information and evaluation results by a third party and open it on a unified platform, placing everything under the supervision of sunlight and allowing the market to play a decisive role in resource allocation.