The Price Of Drugs Will Be Greatly Reduced, And The Fourth Batch Of Centralized Purchase Will Be Superimposed In The National Medical Insurance Negotiation

"The life of pharmaceutical enterprises will be more difficult, and some enterprises may face a double blow." On December 14, Wang Ying, CEO of Bosia management consulting, said in an interview with 21st century economic reporter. The "double" mentioned by Wang Ying is the national medical insurance negotiation and the fourth batch of centralized purchasing. The relevant personnel of enterprises participating in the national health insurance negotiation (December 14-16) are waiting in the car, and the enterprises on the spot rarely disclose any information.

Many enterprises are "in a heavy mood" because they have to face the fourth batch of national drug centralized purchase, which starts from December 12 to the end of December, and publishes the results in January 2021. For the latter, it is estimated that there will be 44 "souls" involved in the price reduction of 375 products in the industry.

"All of them are price reduction, but the former is slow price reduction, and the latter is" soul bargaining ". Because the state still encourages innovation and R & D, it will be directly reflected in the price. " Wang Ying said.

In Wang Ying's view, if enterprises do not have their own innovation or exclusive varieties, but only generic drugs, the situation will be very passive; enterprises with exclusive varieties or innovative drugs can also strive to slow down the range and speed of price reduction. "Only by using existing generic drugs as the basis of income, supporting enterprises, using the money earned in the past to invest in R & D, or purchasing innovative varieties can solve the urgent problem. However, there are ideal enterprises that still need to make long-term planning and combine with their own R & D It is understood that Hengrui pharmaceutical, Zhengda Tianqing and Kelun pharmaceutical are all on the road of combining high imitation and innovation.

Zou Guowen, founder of Kaicheng capital, also told reporters of 21st century economic report that innovation and M & A have become the key for pharmaceutical enterprises, especially traditional generic pharmaceutical enterprises, to survive the winter. At present, many traditional enterprises ask for help in recommending innovative drugs (projects). Fu Gang, vice president of China Pharmaceutical Business Association, analyzed to the reporter of 21st century economic report that the national medical insurance negotiation and centralized purchase will make pharmaceutical enterprises return to their proper state, which is a manifestation of the industry's maturity. Efforts should be made to make truly innovative drugs, and the over treatment mode is unsustainable.

The competition of antineoplastic drugs is fierce

According to the list of drugs that have passed the formal examination in the 2020 national medical insurance drug list released by the medical insurance bureau in September this year, a total of 751 varieties have passed the formal examination, including 728 out of the catalog and 23 in the catalog.

According to industry estimates, nearly half of the 751 varieties are expected to be added to the list, that is, to enter the next price negotiation.

In this national health insurance negotiation, anti-tumor drugs are still one of the most concerned topics, and PD-1 / PD-L1 products are also the most competitive products in this year's national health insurance negotiation.

According to the statistics of 21st century economic report, there are 8 kinds of PD-1 products on the market in China, and at least 30 kinds are under research. In 2019, Xinda bio's sindilimab (trade name: dabashu) was included in the medical insurance catalogue with a price reduction of 64% through negotiation, and the unit price was reduced to 2843 yuan. According to the preliminary list released by the medical insurance bureau, all the 7 PD-1 / PD-L1 products approved for listing but not included in the medical insurance have passed the formal examination.

In the industry, these enterprises will not easily give up this big market, the competition will be very fierce. Especially in the indication of Hodgkin lymphoma, Xinda biology, Hengrui medicine and Baiji Shenzhou have been approved.

It is not easy to give up the medicine of "O" and "AstraZeneca" in the market.

In terms of global sales in 2019, the sales volume of drug K of Merck reached 11.1 billion US dollars, with 22 indications; the sales volume of drug o of Bristol Myers Squibb exceeded 8 billion US dollars, which also covered 10 cancer types. In 2019, more than 60% of the global sales of K drug exceeded 10 billion US dollars, more than 60% of which came from the field of lung cancer.

Shi lichen, director of Beijing Dingchen medical consulting and management center, said that as a drug with huge market space, PD-1 will be highly competitive, and several companies with the same indications will be approved at the same time, which brings great comparative advantages to the medical insurance negotiation.

In addition to the national health insurance negotiations, the fourth batch of national drug procurement with volume also started on December 12. There are 44 products and 90 product specifications involved in this centralized purchase. The specific categories are still mainly chemical drugs, but many anti sugar drugs and anti-tumor drugs are involved, and the injection is included in the national procurement for the first time.

According to the data of MI Nei net, in 2019, the market scale of terminal medicine injection in public medical institutions in China will exceed 630 billion yuan, and the total sales volume of top 20 products will exceed 100 billion yuan.

Although there are only 8 kinds of injections, they are clinical large varieties, which directly affect the sales revenue of dozens of pharmaceutical enterprises.

According to the data of micranet, the terminal sales of ambroxol injection in Chinese public medical institutions in 2019 will be 5.98 billion yuan. Pantoprazole, a proton pump inhibitor widely used in the treatment of gastritis and peptic ulcer, has annual sales of more than 5 billion yuan in 2019.

Among them, the original research enterprise of ambroxol injection was bringer Ingelheim, which accounted for 23.56% of the market share of public hospitals in China in 2019, according to the data from the Internet. The three enterprises that have been evaluated for consistency are Sichuan meidakang Huakang pharmaceutical, Huazhong pharmaceutical and Fuan pharmaceutical.

Shi lichen analyzed to the 21st century economic reporter that injection is different from oral medicine, most of which are only used in hospital clinic, which means that the competition of injection is more intense, and the hand of purchasing drugs with quantity has been extended to clinic, which will also drive a new round of price reduction of clinical drugs, and the whole industry pattern may change.

Pharmaceutical enterprises endure the winter

The influence of national medical insurance negotiation and national centralized purchase on the development of enterprises and their products should not be underestimated.

The fourth batch of state-owned centralized purchase began to report on December 12, but the results have not come out yet. On the evening of December 13, Zejing pharmaceutical issued a "warning" in advance.

On the evening of December 13, Zejing pharmaceutical announced that sorafenib oral regular release form (specification: 0.2g) was included in the fourth batch of centralized procurement varieties. Sorafenib is one of the competitive products of donafinil, which may reduce the market space of donafinil in the first-line targeted drugs for advanced liver cancer. Therefore, there is a risk of decline in market space and pricing after donafinil is listed.

Bayer sorafenib was included in category B of the national medical insurance catalogue after reducing the price by about 70% in 2017. In 2019, the sales volume of sorafenib in China was 1.35 billion yuan, and the retail price was 5700 yuan / box.

According to the price changes of the first three batches of drugs before and after entering the scope of centralized procurement, the price reduction range is usually about 53% - 59%.

According to Zejing pharmaceutical's calculation, sorafenib's entry into the scope of this centralized procurement may lead to a decrease of 6.10% - 15.24% in the stock market of first-line targeted drugs for advanced liver cancer.

However, Zejing pharmaceutical also said on the interactive platform that donafinil is a class 1 chemical new drug independently developed by the company. The compound patent of donafinil will be protected until September 2028 and the crystal form patent will be protected until May 2032. Under the current policy, donafinil will not enter the scope of centralized purchase during the patent protection period.

In the future, whether Zejing pharmaceutical donafinil will participate in the national health insurance negotiation is uncertain, but it can be predicted that the future competition will not be small.

The negotiation of national medical insurance and the centralized purchase of national drugs (devices) have become the norm. Wang Ying pointed out to the reporter of 21st century economic report that the price reduction of drugs in the future will also be normal, including drugs or exclusive drugs with patent period, mature generic drugs and medical device products.

In May this year, Wang Yibo, deputy director of the medical service management department of Sichuan Medical Security Bureau, said at a news conference that the main participants in the negotiations were pharmaceutical enterprises with patents or exclusive medicines, and many of them were imported pharmaceutical enterprises. For these pharmaceutical enterprises, it is crucial for them to gain exclusive access to the Chinese market with 1.4 billion people, and to increase the use of medical insurance by a large margin. Although the price has dropped, the dosage may increase greatly, and the total profit will be more, so these pharmaceutical enterprises still have the motivation to participate in the negotiation.

However, generic drugs are not completely out of the way. Yu Mingde, honorary president of the China Pharmaceutical Enterprise Management Association, pointed out that supporting innovation does not change the fact that generic drugs are still the main body of Chinese people's drug use for several years. At present, Hengrui pharmaceutical, Zhengda Tianqing, Kelun pharmaceutical and Yuandong biology are all on the road of high imitation and innovation.

In March this year, the China Securities Regulatory Commission further clarified the "3 + 5" index system of the science and technology innovation board. For the first time, China Securities Regulatory Commission raised the realization of import substitution to the level of registration and listing documents, and provided financial support for the transformation and innovation of generic pharmaceutical enterprises that realized import substitution with core technology, which greatly benefited the vast number of Chinese high-quality generic pharmaceutical enterprises landing on the science and technology innovation board.

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