Innovative drugs will not be defeated

2022-07-11 0 By

Source | Archimedes Biotech (the blue parker authorized reprint) | author Archimedes on February 10, the FDA held ODAC cancer drugs advisory committee meeting, the results can be seen, Chinese drug firms take clinical data of China to the United States declaration of new drugs this road has been largely won’t work.Combined with the factors of homogeneous competition and medical insurance cost control in the early stage, many people’s confidence in innovative drugs has fallen to a freezing point. However, the pace of scientific innovation will never be blocked by immediate fog. Based on expectations and the future, we can only forge ahead.Domestic innovative drugs have emerged less than ten years, but they have been able to spill over to the biotech base in the United States to apply for listing. No matter what the result is, it is a great step to take.Driven by policies and capital, domestic innovative drugs experienced an early period of prosperity, gaining confidence and strength, but also accumulating problems and perplexity.At this critical moment, we are all thinking about the change and invariance of the industry.Now there are two focus questions: how can the internationalization of innovative drugs break the situation, and where is the future of innovative drugs?Innovation medicine long-term prosperity has endorsed by national level nine departments before the Spring Festival jointly issued by the “difference” pharmaceutical industry development planning “(hereinafter referred to as the” planning “), the internationalization of paint magnificent picture: “cultivate a number of world famous personnel, formed a group of research and development production layout of globalization, the international sales proportion high big pharmaceutical companies.”The answer is clearer than ever.01 Long term prosperity unchanged PD-1 bears heavy inwinding blame.In the third quarter of 2018, Bristol-Myers Squibb (O drug) and Merck (K drug) PD-1 were successively launched in China. After charitable donations, the annual treatment cost of O drug was about 220,000 yuan, and the annual treatment cost of K drug was about 320,000 yuan.At the end of the same year, the domestic PD-1 came into the market, shouldering the responsibility of populizing noble medicine. So far, the annual treatment cost has been reduced to 30,000 to 50,000 yuan, and the self-payment after medical insurance only needs about 10,000 yuan.Patients should not forget the contribution of domestic innovative pharmaceutical companies while thanking medical insurance.The imported PD-1 was forced to withdraw and the annual treatment cost dropped to 100,000 to 150,000 won.The best way to reduce drug price is market competition, and the best way to market competition is the rise of domestic innovative drugs.In 2020, the sales volume of Sinda Bio Sinderizumab (2.29 billion yuan) and Hengrui Pharmaceutical Carrelizumab (4.89 billion yuan) in the Chinese market comprehensively surpassed that of K (2.41 billion yuan) and O (460 million yuan).The PD-1 illustrates the classic battle of domestic substitution of innovative drugs, and reveals an important rule: only with the rise of cost-effective domestic innovative drugs and the realization of independent control of the industrial chain and supply chain in the bottleneck field, can people afford advanced therapies.Innovation-driven, unremitting self-improvement.According to the plan, during the 14th Five-Year Plan period, the r&d investment of the whole industry will increase by more than 10% annually, and enterprises will be supported to integrate scientific and technological resources and carry out research on key technologies, core equipment and new materials in the production of drugs and medical devices.Sustainable high investment in RESEARCH and development needs reasonable profits to support, and the long-term prosperity of innovative drugs has been endorsed by the national level. In 2035, the strength of China’s pharmaceutical industry will realize an overall leap;Innovation-driven development has taken shape, with an increase in original new drugs and “leading” products, becoming an important source of global pharmaceutical innovation.In the future, A number of world-class pharmaceutical enterprises will be born in China.China has noticed the problem of homogeneity of innovative drugs, and the “Plan” proposes to “promote the rational layout of r&d pipeline of enterprises.”Support enterprises to focus on new targets and new mechanism drugs to carry out RESEARCH and development layout, focus on bottleneck technology to carry out key problems, the goal is to promote medicine to the source of innovation.Innovative Drugs 2021: So Love can go Away, Right?All the consequences of inrolling are foreseen.Most Biotech start out on the wrong track, with the dream of butterfly Biopharma, building a large and complete platform pipeline architecture that is too crowded on hot targets.CDE launched the new policy on the research and development of anti-tumor drugs and initiated the supply-side reform of innovative drugs.Not all Biotech companies need to become Biopharma, and commercialization is not the only path to self-built capacity and sales force.Biotech focuses money and manpower on early stage research and development, and later stage results can be monetized through a variety of external partnerships.Innovation pharmaceutical enterprises can completely appear benign exploration, from homogeneous competition to differentiation dislocation competition or complementary cooperation.The acquisition of Mingkang by Shiyao group and Jiashhi Medical by Jiecheng Medical, one of the “four dragons” of heart valve intervention, means the beginning of Biotech integration.Last year, Xinda Biological and Yasheng Pharmaceutical carried out a phenomenal cooperation. It was not a multinational pharmaceutical company or a traditional pharmaceutical company, but a chemical reaction between two complementary innovative pharmaceutical companies, in order to achieve the fastest development speed and maximize the commercial value, so as to grow by leaps and means.It can be seen that domestic innovative pharmaceutical enterprises have taken an important step in the exploration of business model.The previous wanchun Pharmaceutical, Kaituo Pharmaceutical, Xinda Biological as international pioneers, accumulated experience and lessons, enough to empower the entire innovative pharmaceutical industry.In particular, sinda Bio’s sindilizumab is different from previous cases in that its effectiveness and safety are not questioned. The main problem it faces is the change of attitude of FDA.The results of the meeting showed that the way for Chinese pharmaceutical companies to apply for new drugs in the United States with Chinese clinical data has become almost impossible.Previously, the market was optimistic, and 2021 or 2022 was seen as the first year of internationalization of Chinese innovative drug companies. Now this process may be delayed, and three important changes will take place.The first is the steep rise in the cost of going to sea.New drug filings in the US based on data from a single Chinese clinical study have been halted, but global multi-center phase III trials are costly, especially requiring “head-to-head studies”.Only have the ability of hematopoietic blood transfusion pharmaceutical enterprises can bear.Zebrutinib’s phase 3 global head-to-head clinical trial cost $100 million just to buy the control drug ibrutinib.The second change is higher barriers to innovation.The short ribs of the clinical trial plan are just the appearance. The fundamental reason for breaking the international situation is to get out of the ME-Better pattern, put innovation in the forefront, focus on new targets and new mechanism drugs to carry out research and development layout, and make leading innovation.Products with FIC or BIC advantages, with differentiated clinical value, FDA is not difficult to pass.Many FIC or BIC products of domestic innovative pharmaceutical companies have entered the critical POC (proof of concept) stage, with a high probability of international success, but it takes longer and more patience.The third change is in the selection and placement of clinical indications.Despite the proliferation of innovative drug targets, the layout of Chinese companies is much the same.As innovative drugs represented by PD-1 cover most areas of cancer diseases, the threshold of standard treatment is raised, which greatly limits the selection and layout of indications.If rare diseases (such as pharyngeal cancer and liver cancer) are selected for development, it may be easier to get regulatory flexibility from overseas regulatory agencies, but it is difficult to get corresponding returns after listing approval.Most small businesses can’t afford to spend too much money, take too long and keep up.In the early days of idealism, each Biotech built a big pipeline in hopes of becoming a Biopharma, but the market began to clear out the homogeneity.Now internationalization also began to bubble, improve the concentration degree, the external environment makes the head camp of Hengrui Pharmaceutical, Baiji Shenzhou, Xinda biological and other advantages more consolidated.Therefore, the market space of innovative drugs is still huge, especially the head of a few enterprises.After surviving the winter and correcting it, it will shine again.The plan describes a grand picture of internationalization: “Cultivate a group of world-renowned talents, and form a group of large pharmaceutical companies with a global layout of R&D and production and a high proportion of international sales.”The United States on February 2 announced the resumption of the “Cancer moonshot”, with the goal of reducing cancer rates by 50 percent over the next 25 years.Global resonance, the general trend, medicine is always the sunrise industry, innovative medicine is infinite prospects.In the future, we will also have our own multinational pharmaceutical enterprises.