Kunming Pharmaceuticals high growth deposit hidden worry

Xuesaitong injection and Xuesaitong for injection (lyophilized) entered the national basic drug adverse event report and ranked top five in Chinese medicine injections.

Shuanghuanglian injection, Houttuynia injections and other traditional Chinese medicine injections all have serious adverse events. Traditional Chinese medicine injections have once again become the focus of social attention.

In the national adverse drug reactions/events report just released by the State Food and Drug Administration (2013), Xuesaitong injection and Xuesaitong for injection (freeze-dried) have entered the national essential drug adverse event report. The top five.

This time, bear the brunt of the impact of Kunming Pharmaceutical Group Co., Ltd. (hereinafter referred to as "Kunming Pharmaceutical", 600422.SH) of the fist product. The company’s financial report showed that sales of Xuesaitong (lyophilized) for injection increased by 76% in 2012; in 2013, Xuesaitong (lyophilized) for injection increased by 31.49% over the same period of last year. At present, only two companies in the country produce Xuesaitong for injection (lyophilization), and in 2012, the market share of Xuesaitong (lyophilization) for injection of Kunming Pharmaceuticals accounted for 31.0%.

Guo Fanli, research director of China Investment Consulting, told the “China Business” reporter that the above report of the State Food and Drug Administration will affect the rapid growth of the Xuesaitong (lyophilized) products for injection in the market for basic drugs.

According to the above report of the State Food and Drug Administration, some basic medical and health institutions involved in Chinese medicine injections have a relatively large number of reports, suggesting that the use of such medicines at the grassroots level may present higher risks. According to industry sources, 70% of the revenue of Kunming Pharmaceutical Xuesaitong comes from the primary hospital market. Therefore, after the gorgeous financial statements of Kunming Pharmaceutical Injection Xuesaitong (freeze-dried), there are hidden concerns.

Single component mystery Chinese medicine injection relapse.

The analysis report of monitoring data of adverse drug reactions in Xishuangbanna, Yunnan, from July to August 2013 showed that from July to August, the state reported one case of death in the adverse drug reaction report, which was caused by suspected injection drug Xuesaitong. Adverse reactions Symptoms are chest tightness and difficulty breathing.

Xuesaitong for injection (lyophilized) is a prescription drug made from Panax notoginseng saponins, and Kunming Pharmaceuticals is the original manufacturer of this product. The Kunming brand Xuesaitong injection (formerly known as Panax notoginseng saponin injection) is an important achievement jointly researched by the company and Kunming Institute of Botany, Chinese Academy of Sciences and other scientific research institutes. It was put on the market for the first time in 1985, and it was formally named blood seizure in June 1985. Tong injection. In 1996, the company applied freeze-drying technology to the production of natural medicine injections for the first time, and developed a total freeze-dried powder of panax notoginsenoside-luotai (blood plug blood for injection).

According to industry sources, in December 2007, the State Food and Drug Administration issued the “Basic Technical Requirements for Injectables for Traditional Chinese Medicines and Natural Medicines”, and the ingredients contained in injections should be basically clear. The chemical composition of the components contained in the total solids of the injection should be systematically studied. The content of the single component of the injection made of the active ingredient should be not less than 90%, and the content of the specific component of the total solid in the injection made of multiple components should be not less than 60%.

The main component of Xuesaitong (lyophilized) for injection is Panax notoginseng saponins. Kunming Pharmaceutical Co., Ltd.'s invention patent for this product, a "Sanqi soap powder" claim shows that "Panax saponin content is 50%~99.5%".

According to industry insiders, if the single component of the drug does not reach the scope of the national regulations, it will bring about two problems. First, it will reduce the efficacy, and second, there will be more impurities and the safety of medication. influential.

What is the content of a single component of Kunming Pharmaceutical Xuesaitong Injection and Xuesaitong (freeze-dried) for injection? In response to the reporter, Kunming Pharmaceuticals stated that the contents of Xuesaitong injection and Xuesaitong (freeze-dried) for injection produced by Kunming Pharmaceutical Co., Ltd. are in line with the “Basic Technical Requirements for Traditional Chinese Medicines and Natural Drug Injections” issued by the State Food and Drug Administration. The requirements of relevant regulations.” The content of the single component of Xuesaitong (lyophilized) is still unknown, and the reporter’s question was not clearly answered.

The hidden dangers of safety The above report from the State Food and Drug Administration shows that the phenomenon of combined use of TCM injections is outstanding and should be alert to the interaction of drugs. However, according to the data analysis of TCM adverse reactions reported in 2013, the phenomenon of combined drugs has not been effectively alleviated. In 2013, the number of TCM adverse drug reactions/incidents reported in the top 20 drug combinations was 41.0% for combined drugs, and 54.1% for serious drugs.

The State Food and Drug Administration reported that clinicians should use Chinese medicine injection alone, contraindications and other drugs in accordance with the "Basic Principles for Clinical Use of Traditional Chinese Medicine Injections," and prudent combination of drugs. If it is really necessary to use other drugs in combination, it should be considered with Chinese medicine injections. Intervals and interactions.

The existing medical literature shows that injection of Xuesaitong (lyophilized) combined with conventional therapy can improve the clinical efficacy, but the combined use of drugs has brought great challenges to the safety of drug use. The journalists searched the Chinese Academic Journal Full-text Database (CNKI), Wanfang Database, etc., but it was difficult to find medical literature on the separate application of Xuesaitong (lyophilized) for injection.

Then, has Kuntai Pharmaceutical used Xuesaitong (lyophilized) for injection in randomized, controlled, multi-center clinical trials for single use?

The reply of Kunming Pharmaceutical to this reporter only stated: “Kunming Pharmaceuticals has always attached great importance to the issue of drug safety. Since the 1990s, Kunming Pharmaceutical has selected several domestic authorities in accordance with the “Guidelines for Drug Clinical Trials (GCP)”. The clinical trial base conducts clinical trials.” There is also no positive response to reporters.

The use of Xuesaitong (lyophilized) for injection combined with conventional therapy has a contradiction between efficacy and safety, or a seemingly unsolvable problem.

Zhou Chaofan, a researcher at the Academy of Chinese Medical Sciences and an executive committee member of the editorial committee of the Pharmacopoeia of the People's Republic of China, pointed out in an interview with the media: "Reliable treatment is the basic condition for the market. We have found that many traditional Chinese medicine injections are effective in the study of the effectiveness of traditional Chinese medicine injections. In fact, taking Shuanghuanglian Injection as an example for the treatment of infectious diseases, only 45 (1.03%) of them did not use Western medicine antibiotics in their 4382 study records. It's still an unknown number to increase."