National Drug Control catalog impact! The performance of traditional Chinese medicine injection sector declined seriously

On July 1, the website of the national health and Health Commission issued the notice on printing and distributing the first batch of national key monitoring and rational drug use catalogue (chemical and biological products), which is also the first batch of drug catalogue issued after the notice issued by the state at the end of last year will formulate the national auxiliary drug catalogue Now, the power of the catalogue seems to be beginning to show Many listed companies affected by the new policy of auxiliary drugs, such as Lizhu group, kunyao group, saisheng pharmaceutical, and Bubu pharmaceutical, etc The half year report of 2019 is not very good-looking In the first half of the year, the performance of the injection sector has declined to varying degrees In fact, with the dim prospect of traditional Chinese medicine injections, some enterprises have begun to lay out new profit-making ways, seek diversified development models, put eggs in multiple baskets, and enhance the anti risk ability of enterprises themselves It is obvious that the introduction of the national auxiliary drug catalogue has an important impact on the future development direction of enterprises In the first half of the year, the performance of Lizhu group in the field of traditional Chinese medicine injection is hard to be optimistic According to the annual report, compared with the rapid progress in the field of chemical medicine, the operating revenue of traditional Chinese medicine preparation sector in the first half of 2019 was RMB 709 million, a year-on-year decrease of 17.68%, and the proportion in the total revenue is constantly shrinking Shenqi Fuzheng injection is the largest single product of Lizhu group In the first half of 2019, Shenqifuzheng injection achieved sales revenue of 455 million yuan, down 16.58% year on year Moreover, in the context of medical insurance and cost control, the expenditure of auxiliary drugs will be greatly reduced Shenqifuzheng injection may be kicked out of the list of 1 billion single products in 2019 Kunming Pharmaceutical Group also said in the semi annual report that although the catalogue of national key monitored drugs does not contain traditional Chinese medicine, it has made new regulations on the prescription right of traditional Chinese medicine If strictly implemented, most Western doctors will no longer have the prescription right of traditional Chinese medicine, and the clinical promotion and sales of traditional Chinese medicine, especially traditional Chinese medicine injection, will be affected Based on this, kunyao group has made great efforts to adjust the product structure and promote the increase of potential varieties under the condition of limited use of the leading product base In the first half of the year, the sales of key varieties such as Xuesaitong (freeze-dried), Xuesaitong Soft Capsule and gastrodin injection increased by 27%, 27% and 18% respectively In addition, gastrodin injection is also included in the 2019 version of the national medical insurance catalogue published a few days ago The sales volume of Danhong injection, the main product of step pharmaceutical, also declined under the influence of the tightening of auxiliary drug policy The market share of Danhong injection in 2017 was 5.49% However, according to the performance report of the first half of 2019 released by step pharmaceutical, the market share of the product in the first half of 2019 dropped to 4.39% As a product listed in the key drug monitoring catalogue of 31 provinces and cities, Dan The market space of red injection has been greatly reduced In addition to the above three enterprises, Beijing saisheng pharmaceutical industry has also been greatly affected Saisheng pharmaceutical said in the half year report just released that its main business is the research and development, production and sales of injection, and its leading products are biochemical drugs, involving three drug fields of cardiovascular and cerebrovascular diseases, immune diseases (anti-tumor) and nervous system diseases In the first half of 2019, saisheng pharmaceutical achieved a total operating revenue of 540 million, down 6.6% year-on-year, and a net profit attributable to the parent of 93.355 million, down 29.2% year-on-year At present, the main products of nervous system drugs in the three main fields of saisheng pharmaceutical are "Saidian" monosialotetrahexosylganglioside sodium injection (hereinafter referred to as "GM1") However, 20 kinds of drugs, including ganglioside and cerebrosine, are listed in the list of national key monitoring drugs In fact, drugs containing gangliosides have been listed in the provincial key monitoring drug list In March this year, Jiangxi Provincial Health and Health Commission issued the notice on adjusting the first batch of provincial key drug monitoring catalogue in 2019, saying that the provincial key drug monitoring catalogue will be dynamically adjusted according to the purchase amount and standardized use of non essential drug drugs by medical institutions in the province from July to December 2018 In "the first batch of provincial key drug control catalogue in 2019" of Jiangxi Province, four specifications of GM1 are prominently listed "GM1 market sales have declined," saisheng pharmaceutical said in its 2018 annual report At the same time, GM1 withdrew from Tibet's medical insurance catalog in the 2018 provincial medical insurance catalog supplement It can be said that the decline of the pharmaceutical industry's performance is closely related to the monitoring and use of the above main varieties In fact, saisheng Pharmaceutical Co., Ltd has also announced that due to the impact of pharmaceutical industry policies, the company's operating costs have increased, and its product sales have declined slightly compared with the same period last year Where is the next stop? The limited use of traditional Chinese medicine injection has had an impact on their own performance, and it is impossible for related enterprises to wait for the dead How about the future? Major enterprises have also given their own answers At present, the R & D direction of Lizhu group is to change the track Since the development of traditional Chinese medicine is limited, it should extend its tentacles to chemical agents and biological drugs The half year report shows that in terms of chemical agents, 2 chemical projects have been applied for production, 1 in the summary of be research, and 6 be research projects have been started; in terms of biological drugs, the recombinant humanized anti-il-6r monoclonal antibody injection is in clinical phase I, the recombinant anti HER2 domain II humanized monoclonal antibody and the group humanized anti-PD-1 monoclonal antibody are in preparation for phase IB clinical trials, and the recombinant all humanized anti OX40 is in preparation Clinical approval was obtained for mAb However, the above-mentioned chemical and biological medicine projects are in the early stage of R & D, and there is also a period of time before commercialization In the future, Lizhu group may be affected by the limited performance growth of traditional Chinese medicine injection Like Lizhu group, Kunming Pharmaceutical Group has also increased its research and development efforts in the field of chemical drugs, including ky43031, an antihypertensive chemical, and ky43045, a chemical for postoperative analgesia, which have been applied for listing; and ky70091, a class 2 new drug for the treatment of bone related diseases, has also been applied for clinical application It is worth mentioning that in the semi annual report, China Kunming Pharmaceutical Group also said that the application of "phase II clinical trial of indications of dihydroartemisinin tablets for the treatment of systemic lupus erythematosus and discoid systemic lupus erythematosus" submitted by the Institute of traditional Chinese medicine of the Chinese Academy of Chinese medicine where Tu youyou's team is located has been approved, and Kunming Pharmaceutical, as the responsible unit, has carried out clinical trials and is now in the group stage Step pharmaceutical began to seek transformation, from sales company to technology company; from Chinese patent medicine to biological medicine, chemical medicine, medical equipment, Internet medicine; gradually from China's localization to globalization In fact, there are various signs that the industrial transformation of step pharmaceutical from sales type to scientific research type has achieved preliminary results For example, in the field of biopharmaceutical, there are currently 10 biological products under development, some of which have entered the clinical phase II to phase III, covering the scope of tumor, osteoporosis, anemia, arthritis, cardio cerebral vascular, etc., and are expected to become a step in the future The starting point of long-term achievements in pharmaceutical industry However, the above transformation also needs some time The external impression of step pharmaceutical is still that it is a large traditional Chinese medicine enterprise Moreover, in the field of chemical medicine and biological medicine, the competition is also fierce For step pharmaceutical, which started halfway, the transformation has a long way to go In view of the bleak prospect of traditional Chinese medicine injection in the future, the major enterprises adjust their course in time, which is beneficial to the enterprises themselves After all, compared with the more controversial traditional Chinese medicine injection, turning to chemical medicine and biological medicine can more reflect the R & D strength of an enterprise, which is also the most important value of the enterprise's future development.