New medical insurance era: PD-1 price has not yet bottomed out? How will the 4 + 3 competition pattern change? Can domestic innovative drugs make money?

"Chinese companies are very vulnerable when it comes to health care negotiations, because there is no other market to take on the cost, so they've saved their lives." On January 5, 2020, song Ruilin, President of China pharmaceutical innovation promotion association, said on the drug development in the era of new medical insurance at the 103rd forum of freehand brushwork co organized by e pharmaceutical managers and other units According to song Ruilin, China's pharmaceutical industry is on the way of climbing, "if there is no oil on the slope, it will not stop there but slide down", which may be the biggest risk of China's pharmaceutical industry at present At the forum, there were many discussions on this topic, with different views "I believe that opportunities outweigh challenges and advantages outweigh disadvantages." Wang Xuegong, vice president of China Pharmaceutical Enterprise Management Association, said Faster access, faster penetration and earlier peak sales are opportunities that medical insurance brings to domestic innovative drugs With more and more domestic innovative drugs approved, the examination questions of medical insurance negotiation lie on their way forward "Because twenty cents failed to talk about success, the head of an enterprise cried bitterly." Song Ruilin shared his experience of participating in the negotiation as a negotiation expert "As far as I know, in order to enter the healthcare negotiations in 2020, an innovative pharmaceutical company will try its best to approve its own medicine in 2019." Wang Xuegong said It seems that medical insurance has become the absolute target of most domestic innovative drugs 01 PD-1 price not bottomed yet? On November 28 last year, the state health insurance bureau held a press conference to introduce the list of drugs to be negotiated and admitted by the state health insurance in 2019 The concerned PD-1 entered and only entered one family, Cinda's sindili mAb Before the negotiation, the price of cindilimab was 7838 yuan (10ml: 100mg / bottle), the annual treatment cost was 266000 yuan before drug donation and 188000 yuan after drug donation After the successful negotiation, the price of cindilimab was 2843 yuan, and the annual treatment cost was reduced to 97000 yuan (calculated by 60kg patients), while the cost of self paying part of Hodgkin lymphoma patients after medical insurance was only 2400 yuan per month "Although the decline is more than 60%, the gross profit margin of products has not fallen so much." Yin Zhengzheng, a partner of Sany venture capital, said the manager of E medicine Yin Zheng pointed out that the sales volume and sales volume of domestic original new drugs, such as xidaban, conbercept and apatinib, have both increased after being included in the medical insurance In July 2017, the price of xidaban of microcellular organisms was reduced by about 30%, and it was successfully listed in the national medical insurance catalog, which also led to a large increase in sales It is shown that in 2017, the sales revenue of xidaban increased by 66.22% year on year From 2016 to 2018, the annual growth was achieved, with sales revenue of 55758800 yuan, 92683000 yuan and 137 million yuan, respectively The average sales price of xidaban tablets in the same period was 10253.56 yuan / box, 8557.99 yuan / box and 7349.93 yuan / box, respectively It is worth noting that the gross profit rate of the drug was 97.46%, 95.24% and 96.27% in the same period, without significant change For the current hot PD-1 price cut, the market is still expected to be positive Although Xinda bio's share price fluctuated after the results of health care negotiations were announced, it seems that the fluctuation range is not large at present "After the free medicine was removed, the decrease was not big The main reason for the price reduction of domestic drugs is the patent cliff " A medical policy research expert told e drug managers For the price reduction of Cinda, China Galaxy Securities directly pointed out that the negotiation base price of Cinda was based on the total price of the drug donation scheme of triprilimab of Junshi On the surface, the price reduction of cindilimab was very large, with an apparent decrease of 64% In fact, this was the victory of the pricing strategy and drug donation strategy of Cinda CSCI also believes that the price drop is within an acceptable range, especially for the brand promotion and cost saving of Xinda With the completion of the current new capacity construction, the entry of medical insurance will have a positive impact on the sales of xindili McAb "In the future, it will be the price of cabbage If you want to play this game, you have to accept this price There is no choice." Wang Lai, vice president of Baiji Shenzhou, told e pharmaceutical manager, "we will also participate in the negotiation after that, and the price of domestic PD-1 is expected to go down." The PD-1 of Baiji Shenzhou was approved by the end of 2019 If it goes well, it may be able to participate in the next round of health care negotiations For the market competition factors of PD-1 after being included in the medical insurance, Wang Lai thinks it still depends on the breadth and speed of indications, matching of production capacity, performance of data, etc., while in terms of price, due to the role of medical insurance, it will be similar in the future CSCI believes that at present, there is only second-line CHL for the approved indications of sindilimab, so entering the medical insurance will not have a great impact on the market competition of other PD-1 / PD-L1 products, and it is still optimistic about the PD-1 / PD-L1 market as a whole With the increase of indications covered by PD-1 mAb, the price competition for the same indications will be more intense At the same time, the whole body of PD-1 monoclonal antibody is still in a rapid volume stage In this case, the progress of coverage of large indications will become the core influencing factor of competition in the next two years 02 How to make domestic innovation? But how to treat the development of domestic innovative drugs after the medical insurance negotiation? Wang Xuegong expressed some concerns: can a single market support innovative drugs? Can "global low" support "global new"? In addition to the current profits of enterprises, can the circulation of new drugs be established in China in the long run? In addition to the drug price policy, another pressure of domestic innovative drugs comes from industry competition The proliferation of me too products further shortens the profitability of new drugs Different from PD-1, in the field of hepatitis C, which is more competitive, domestic innovative drugs have encountered an embarrassing exit Many multinational pharmaceutical companies, whether in the 4 + 7 or medical insurance negotiations, have shown a "survival desire" like price reduction, which pinches the lifeline of domestic new drugs into their own hands "Health insurance is a single buyer, and low price is a normal market behavior." Song Ruilin pointed out that, however, he believed that in order to improve the profits and value of innovative drugs under the trend of price reduction, we should not tie ourselves to health insurance Wang Xuegong believes that, first of all, whether the R & D cost and efficiency of domestic innovative drugs are good needs to be reflected In addition, from the perspective of the industry, improving the R & D output rate is a top priority Less money means that the fault tolerance rate is reduced, and money needs to be spent on the cutting edge M & A transactions between pharmaceutical companies will promote the reduction of repeated investment Song Ruilin said frankly that the internal pressure of price reduction will not change, and the external pressure caused by the rapid entry of foreign investment and strategic adjustment still exists Under this internal and external pressure, China's innovative drugs need to find a way to survive: integrate into the global pharmaceutical pattern "One belt, one road is a direction," Song Ruilin said CSCI believes that under the influence of medical insurance negotiation and volume purchase, in the process of continuous remodeling of the domestic drug price system, for innovative drug varieties, the internationalization ability will become an important source of premium in the future, and the varieties with global sales rights and capabilities will gain greater advantages in the competition in the future And this kind of attempt has been gradually popularized in China For example, Fuhong Hanlin, who has been acting continuously in the past two years This year, Fuhong Hanlin granted Colombian health care provider farmadecolombia hanlikang the exclusive license and commercialization rights in Colombia, Peru, Ecuador and Venezuela; granted the commercialization rights and patent rights of PD-1 in ten Southeast Asian countries to kalbegenexine company; granted the rights and interests of similar drugs of trastuzumab in Europe, East Africa and other overseas regions to accordhealthcare company Division, Fuhong Hanlin enjoy milestones and sales share With the approval of BTK inhibitor from Baiji Shenzhou in FDA, China's innovative drug has ushered in another milestone Lu Ming, chairman of Shangjian biology, also believes that in crowded areas such as PD-1, enterprises should consider changes in strategies in the future, such as entering overseas markets, because the data of some domestic new drugs are also good; secondly, Fuhong Hanlin's idea of trying PD-1 in the field of hepatitis B is also a reference; in addition, only 20% - 30% of the patients who really benefit from PD-1 can find joint use, etc To benefit more than 70% of patients As for project approval, "be sure to avoid homogenization" is emphasized by CSCI in recent research reports As an innovative pharmaceutical enterprise, there are two options in the future: first, for drugs with serious diseases, from project approval, research and development, clinical trials to post marketing academic promotion, there should be differentiated emphasis, including special patient benefits If it is only me too, there will be negotiations in the future Or "generic drugs" that may be used as foreign innovative drugs will be put in the same bidding group to fight; secondly, "niche" drugs for small diseases will be developed, including small treatment areas such as rare diseases, rare mutations of tumors, special dosage forms and drug delivery devices Even if such drugs are included in the medical insurance negotiations after being listed, due to their less pressure on medical insurance funds The price reduction may be relatively limited In addition, according to CSCI, the price should not be too low on the basis of differentiation It is necessary to consider the reduction of medical insurance negotiation, realize the reduction of price and theoretically save medical insurance funds to satisfy the medical insurance bureau In a word, he Ruyi, former chief scientist of CDE, said that the first in class should be encouraged in China, but it is not suitable for most enterprises in China at present, "the goal of Chinese innovative drugs is to be the best of its kind." Song Ruilin also added: "China's pharmaceutical innovation is not to do what can be done, but what the social needs do!"