Who will reshape the pattern of Chinese medicine in the second half?

"It used to be a big exhibition stand for foreign enterprises, but now it's really different," said a foreign enterprise official during the CSCO conference in Xiamen this year   As we have said, on this year's CSCO, the local exhibition stands represented by local innovative pharmaceutical companies have occupied most of the venues Apart from "appearance", the largest number of oral reports released by the conference is also local innovative pharmaceutical enterprises, Baiji Shenzhou Although the investment fever of innovative drugs has declined compared with the previous two years, the growth of China's local innovative pharmaceutical enterprises is a common goal See After several years of R & D, a number of domestic top innovative pharmaceutical companies began to realize the approval and listing of innovative drugs in the second half of 2018 At the same time, these enterprises have basically realized IPO listing, and their R & D capability and pipeline level have basically been recognized by the capital market 2019 will become a key year for local innovative pharmaceutical companies, and the commercialization capability of the innovative pharmaceutical companies will be tested This will be another challenge for innovative pharmaceutical companies If it was the "first half" of "story telling" with the R & D pipeline, then the more complex "second half" has quietly started Is the pattern set?   At present, among the listed companies in China, including Baiji Shenzhou, Junshi biology, zaiding medicine, Xinda biology, Fuhong Hanlin, etc., except for Baiji Shenzhou and zaiding medicine, which chose to list overseas earlier, most of them have completed listing in Hong Kong after the new listing rules of unprofitable biomedical enterprises were issued by the Hong Kong stock exchange After the launch of the science and Technology Innovation Board of the Shanghai stock exchange this year, Junshi biology and zaiding Medicine Co., Ltd Kangxinuo biology has announced that it will choose to go on the secondary listing of science and technology innovation board   Under the situation that Shanghai and Hong Kong exchanges are competing to "show favor" unprofitable biomedical enterprises, the relatively friendly open financing channels provide another choice for Chinese innovative pharmaceutical enterprises After all, the enthusiasm of investment institutions for innovative pharmaceutical investment has become rational Considering the general environment, although there is no need to shout "live", some innovative pharmaceutical enterprises with ordinary quality have been facing financing difficulties Hard From the product point of view, PD-1 inhibitors of Junshi biology and Xinda biology, rituximab biological analogues of Fuhong Hanlin have been approved for listing, two new drugs of zaiding medicine have been listed in Hong Kong and Macao, and tirelizumab of Baiji Shenzhou will also be listed in China this year, becoming the fourth PD-1 inhibitor in China This year coincides with nationwide volume procurement In the first year of the implementation of the policy and the adjustment of the national medical insurance catalogue, although the latter is obviously a more concerned trend for innovative pharmaceutical enterprises at present, it was considered possible to get the "admission ticket" of this year's medical insurance adjustment before the formal introduction of the policy of medical insurance catalogue adjustment, but in the final year of the adjustment of the medical insurance catalogue, the admission qualification of varieties was set to be approved before 2019 As a result, except for Junshi biology and Xinda biology, as well as futuximab of Fuhong Hanlin, who was directly listed in the national medical insurance according to the status of biological similar medicine, most of the others can only sigh with admiration In fact, the domestic innovative pharmaceutical enterprises will face these in the future, but most of their European and American enterprises of the same type do not need to consider Small biomedical enterprises driven by innovation in the United States It is usually called "biotech", which is a small company driven by scientific and technological innovation, with innovative drug research and development as its core business It often sells drugs to large pharmaceutical companies or companies when new drugs are developed to phase II or phase III, and usually does not undertake post marketing sales of drugs In recent years, more than half of the new drugs approved by FDA have come from biotech But when we interpret these Chinese biotechs, we can think that they are constrained by the environment and have to do so, and we can also think that they have more ambitious goals According to Dr Li Ning, chief executive officer of Junshi biology, this is first and foremost determined by China's pharmaceutical market environment and policies "The business environment, investment environment and policy environment of medicine in Europe and America are relatively mature For example, if I am the first to do PD-1, it is almost impossible to find someone else to help me do PD-1 Because you are the first one, you cannot find someone with experience " Li Ning told the author that if it is in the United States, Junshi biology "certainly does not make (produce) by itself, let cdmo do it, because I know that cdmo has experience, FDA can accept, and the production is very reliable" But in addition to technical problems in China, looking for cdmo will also face problems of production capacity and cost control The sales problem is similar to that of technology He believes that PD-1, a brand-new domestic product, must have a strong R & D team support from the perspective of market expansion From the perspective of production, the innovative pharmaceutical enterprises in the head are also making great strides in the direction of the whole industrial chain of production and commercialization   According to incomplete statistics, Baiji Shenzhou has already built Suzhou small molecule drug production base and Guangzhou biological drug production base phase I, Fuhong Hanlin has started Songjiang biological medicine production base this year based on the existing Xuhui production base in Shanghai, and Junshi has also started Shanghai port production base besides the original Wujiang pilot clinical drug and commercial production base in Suzhou It is expected that It was put into production in the second half of this year Zaiding Pharmaceutical Co., Ltd has also established a commercial small molecule production base and a large molecule pilot production base in Suzhou in 2017 and 2018 respectively Xinda biological Co., Ltd is also in the process of building a biological medicine production base in Suzhou with a production capacity of up to 80000 liters This is a glimpse of the ambitions of China's biotechnology companies They often have stronger R & D pipelines According to previous statistics, the average number of pipeline assets of Chinese biotechnology companies when they apply for listing on the Hong Kong Stock Exchange in 2018 is 10, while the average number of pipeline assets of biotechnology companies listed on NASDAQ in the United States is 4 "We are not positioning ourselves as a biotech company, but as a biopharmaceutical company." A person from an innovative pharmaceutical company said many people's opinions The latter requires full cycle operation from R & D, production to commercialization The second half of Red Sea's PD-1 campaign means that innovative pharmaceutical companies will face a more complex commercial market In addition to short-term sales performance, whether they can continue to innovate and have new drugs on the market will become an important factor to consider whether Chinese innovative pharmaceutical companies can continue to grow and grow   At present, several first-class innovative pharmaceutical enterprises have preliminarily proved their commercialization ability: in the first half of 2019, the sales revenue of Cinda bio's sindili MAb (dabeshu) reached 332 million yuan, that of Junshi bio's trepril MAb (tuoyi) reached 308 million yuan, and that of Fuhong Hanlin's rituximab (hanlikang) has recently exceeded the 100 million yuan mark, and that of zading pharmaceutical in Hong Kong The sales performance of products in Australia and Australia is also said to be "better than expected" PD-1 is still the most concerned main battlefield With the listing of tirelizumab in Baiji, China, in this year, PD-1 will form the pattern of "2 imports + 4 domestic products" in the domestic market for a period of time, and there are nearly 30 PD-1 in the clinical stage Overheating of PD-1 is not news, but Li Ning believes that at present, the domestic PD-1 market is far from saturated, and it is expected that the market will be saturated for another 3-5 years, while the market penetration is just beginning From the sales data of five PD-1 products in China, it can be seen that several products have no impact on each other "We are not in the same market to seize the share of others." Li Ning said he felt that new entrants to the market had no effect on what had already entered For example, the annual sales of K drug is about 2 billion yuan, and the sales of tuoyi in four months are 300 million yuan If we translate the time and price, "we can also have more patients with the same value of 2 billion yuan a year In fact, it has no impact on K drug What about domestic? In fact, after the sales of Cinda and Hengrui, there is no impact on our monthly sales volume, which means that the market is far from saturated, in fact, everyone occupies their own territory " As previously reported in the interface news, Li Ning also pointed out that at present, PD-1 is mainly used by end-line patients, while early-line patients are seldom used "The market moving from the end-line to the front line has not been opened, mainly because of the price, popularization and education level." The broad spectrum of PD-1 also makes it different from the past targeted anticancer drugs The final indications of PD-1 may reach dozens According to Li Ning, the domestic PD-1 market will probably be saturated in three to five years, because the first wave of indications should have been approved at that time, and the next thing to kill is combination therapy According to the forecast of Frost & Sullivan report, the market size of PD - (L) 1 in China will grow to 37.4 billion yuan in 2022, and to 98.4 billion yuan in 2030 From 2018 to 2022, the compound growth rate will reach 534.4% It is expected that by 2025, the sales of domestic brands will surpass that of transnational brands and continue to dominate Wu Qingyi, chief commercial officer of Baiji Shenzhou Greater China, called the PD-1 market competition "the most intense battle in the era of tumor treatment, with a large market, but a red sea" She thinks that the competition in PD-1 market can be divided into three stages The first stage is speed; the middle stage is business operation ability; and the last stage is product competition "I think this (product itself) is the most important, and the best product will surely get better market share." As we all know, tirelizumab in Baiji Shenzhou is behind in the first echelon in terms of time While Wu Qingyi admits the current situation, he also says that although the first indication will be slower, the overall layout of tirelizumab in terms of large indications is competitive, not only because of its wide layout, but also because it is not particularly backward in terms of time "In the whole market, apart from the self financed market, the most important is the health insurance market I think some layout on the big indications will help us to walk more steadily and better " Said Wu Qingyi However, it should also be noted that PD-1 or innovative drugs in a narrow sense are not all of the innovative pharmaceutical companies in China At present, the first domestic bio similar drugs have also been listed But Li Ning thinks that there is a difference between its sales logic and PD-1 The biological similar drugs rob the stock market, while the innovative drugs only do the incremental market There are essential differences between the two Therefore, the price, effectiveness and maturity of biological similar drugs will become the key to "rob the cake" Similar background and different playing methods According to the report on the transformation of local pharmaceutical enterprises previously released by ey, at present, PD-1 products of more than 10 local pharmaceutical enterprises are in the stage of clinical phase II to NDA After being listed, they may compete with the first tier enterprises in terms of price In the future, the professional sales ability, adaptive development, joint drug use layout and cost control ability of pharmaceutical enterprises are particularly important After the first half sales data of Junshi and Xinda PD-1 were released, although the sales amount and gross profit rate of the two sides were similar, there was a huge difference in sales expenses In the first half of the year, Xinda biological's sales and marketing expenses were 270-280 million yuan, accounting for about 80% of the total revenue in the first half compared with 346 million yuan in the first half of the year, while Junshi biological's sales expenses in the first half of the year were 111 million yuan, accounting for the sales expenses