In recent years, policies such as “two-vote system†and “consistency evaluation†have been frequent. Enterprises such as Huada Gene, Zhaoyan New Drug, and Dingding Pharmaceutical have been listed in 2017, and the policy and market have been continuously improved and improved, indicating that China is in China. The development of the medical field has ushered in a new climax. According to EU statistics, in terms of annual growth in R&D investment, R&D investment in China's bio-pharmaceutical industry in the fiscal year 2015-2016 increased by 27.5% compared with the previous fiscal year, far exceeding the global annual growth rate of 9.8%. According to the IMS database, China's pharmaceutical market ranked third in the world in 2010, accounting for about 8%, second only to the US market's 40% and the Japanese market's 9%. According to statistics, in 2019, China's pharmaceutical market will account for 14% of the global market share, second only to the United States, accounting for 38% of the total, close to the five European countries. While the domestic pharmaceutical industry is welcoming a small climax, the CFDA is also in the process of issuing a series of documents. With the gradual rigor of the domestic pharmaceutical industry, the shortcomings of the domestic pharmaceutical industry are even more exposed. According to Insight data, China's current pharmaceutical market is mainly based on generic drugs, and the overall level is still at a low level and repeated imitation, resulting in overcapacity. In this regard, Yiou Great Health interviewed Liu Honggao, CEO of Fuhong Hanlin. Founded in 2010, Fuhong Hanlin is committed to the application of cutting-edge technologies for the research and development and industrialization of monoclonal antibody biosimilar drugs, bio-modified drugs and innovative monoclonal antibodies. The products cover tumors, autoimmune diseases and other fields. In the "2017 China Unicorn Enterprise Development Report", Fuhong Hanlin ranked 30, with a valuation of 3.18 billion US dollars. Up to now, Fuhong Hanlin has completed the IND declaration of 9 products and 16 indications, and 3 products have entered the clinical phase III research, leading the domestic monoclonal antibody biopharmaceutical industry. Among them, the first product HLX01 (rituximab injection) was submitted to CFDA in October 2017 for the application for new drug listing (NDA) and was accepted, and was subsequently included in the priority review process drug registration application list, which is also the first in China. A monoclonal antibody that is marketed on a biosimilar drug route. Thinking: Considering enterprise development from the ratio of input to output Liu Shigao believes that the field of pharmaceutical R&D is a field with high investment, high risk and long return on investment. However, some domestic pharmaceutical companies mainly focus on short-term interests, and “small-minded†by means of depletion of product quality and cost reduction. He believes that domestic pharmaceutical companies need to reverse the concept of enterprise development and focus on the development of core competence such as quality and production. According to the data of the Prospective Industry Research Institute, the success rate of Phase II clinical trials of new development projects has dropped from 25% to 12%, and the average success rate of new drug Phase III clinical trials and new drug declarations has also dropped below 60%. On average, only one of every 5,000-10,000 compounds is approved for marketing. In the face of such drug research and development background, Fuhong Hanlin still has not reduced the company's investment in drug research and development. According to the management report of Fuhong Hanlin, as of September 30, 2017, the company's total assets were 1.119 billion yuan and net assets were 359 million yuan. From January to September 2017, the company achieved operating income of 22 million yuan and the loss increased to 145 million yuan. Since all products are still in pre-clinical research or clinical trials and no products are on the market, Fuhong Hanlin has not been profitable yet. Liu Shigao told the health of Yiou, the founders of pharmaceutical companies need to change their roles. From the perspective of investors, they can reasonably plan the input-output ratio of enterprises. Only by improving the return on investment of enterprises from multiple dimensions can they promote the benignity of enterprises. development of. In response to the increase in corporate return on investment, Liu Shigao believes that this is mainly due to the company's return on capital and core capacity building. 1. Return on capital Judging from the return on capital, Liu Shigao told the billion-dollar health that some companies still adopt the method of making money or sacrificing product quality. However, he said that although companies can achieve profitability in the short term by adopting these methods, from the perspective of enterprise development, long-term return on capital should be used as a criterion. And believe that the core of the return on funds is the product itself. First of all, from the perspective of domestic policies, the current domestic market environment determines that companies need to constantly improve their products and improve quality. Liu Shigao believes that the emergence of policies such as "two-vote system" and "consistency evaluation" is actually a manifestation of the market from the policy level. In the future, regardless of market or policy, the quality requirements for generic drugs will continue to increase, and it will become increasingly rare to sacrifice product quality to benefit enterprises. In addition, Liu Shigao told Yiou Health that the majority of domestic monoclonal drugs were used in less than 10% in 2015. The main reason for the low rate of domestic monoclonal drugs is the high drug prices, not the quality of drugs. He said that based on the policy of “consistency evaluationâ€, the quality of generic drugs will be consistent with the original drug, but the price will be significantly lower than the original drug, so the market size will be very impressive in the future. From the perspective of enterprise development, the improvement of product quality is conducive to the return of capital of enterprises. According to the 2014 World Cancer Report, global cancer cases are expected to increase to 19 million new cases in 2025 and 24 million by 2035. According to IMS data, the average time for anti-cancer drugs from patent application to approval in 2013 was 10.25 years, and in 2015 it fell to 9.5 years. Liu Shigao said that according to the trend of the number of approved antibody drugs in the FDA over the years, the antibody drug market in 2016 has exceeded $90 billion, and last year exceeded $100 billion, of which about half were anticancer drugs. But the Chinese market is less than 1 billion US dollars. China has 20% of the world's population, and the drug sales volume is less than 1% of the world. The reason is not because of the quality of drugs, mainly because imported drugs are too expensive, and many drugs are in China. Approved very late. In this regard, Fuhong Hanlin has always adopted the attitude of product quality and international integration for its own product requirements, and the innovation package including the common name is consistent with the original research drug. Liu Shigao said that in October 2017, after the first product was declared for production, we submitted all the technical materials to the expert committee of the China Pharmaceutical Committee for review. In December of the same year, we passed the expert review of the drug inspection committee and got the same The generic name is rituximab. He said that the same generic name can enter the national medical insurance in the future as long as there is a supplementary application. This is a major measure of the national political reform. It is of great benefit to our domestically-oriented biosimilar drugs to our company that is brave enough to be in line with international standards. . Liu Shigao told Yiou Great Health that in terms of registration ability, Fuhong Hanlin has already applied for 15 INDs, and obtained 13 clinical approvals. Two more immediately entered clinical phase III; in addition, four innovative biological drugs have been declared. Three of the INDs received clinical approval from the FDA, CFDA, and TFDA. At present, the reporting speed of Fuhong Hanlin has reached 4~5 IND per year. Before the end of 2020, there are 5 products listed, of which 3 to 4 are the first imitation. 2. Core capacity building In addition, Liu Shigao believes that there is an interaction between the investment of products and the return of funds. According to the statistics disclosed by Fosun Pharma's financial report, as of June 30, 2017, the accumulated R&D investment of the five major monoclonal antibody projects under research has reached 648 million yuan. In addition to judging the input-output ratio of the enterprise from the level of capital return, the core capacity building level of the enterprise will directly affect the enterprise's products, which is mainly due to the team building. In this regard, Liu Shigao said that in addition to receiving direct revenue feedback, the establishment of core technology capabilities through investment, thereby promoting the continuous development of new products, is also the embodiment of value maximization. Fuhong Hanlin has always used the mechanism of “choosingâ€, “usingâ€, “cultivating†and “retaining†to build a sustainable development mechanism for talent cultivation. Referring to the balance between corporate vision and employee's personal career planning, Liu Shigao said that taking the product production process as an example, from pre-clinical to clinical stage to product declaration and production, Fuhong Hanlin team will take a complete process, employees In the process of professional knowledge, experience and so on. It is worth mentioning that Liu Shigao believes that enterprises should always put the interests of patients first, and only by establishing correct values ​​and corporate culture can attract talents. For example, in the production of good medicines that patients can afford, Fuhong Hanlin has all the technology platforms, and all R&D is rarely outsourced, mainly through high-tech to reduce costs and improve quality. In addition, it also generates economic scale benefits through rich research and development varieties. . So far, Fuhong Hanlin has nearly 500 full-time employees in Shanghai, and 50 to 60 full-time R&D personnel in the US and Taiwan. And established an innovative research and development center in Taiwan, the first IND was declared in 2010, and the valuation has achieved a 50-fold increase in the eight years since its establishment. Liu Shigao believes that the reason why the company progresses so fast is mainly relying on technology and talents. At present, the company's returnee team has more than 30 scientists, all of whom have 15 or 20 years of industry experience in the United States. Trend: Doing the right thing under an unprecedented opportunity In the face of the current domestic market for innovative pharmaceutical development, Liu Shigao believes that domestic companies in this field face unprecedented market opportunities. He believes that this is mainly reflected in four aspects. From the perspective of market demand, the domestic demand for innovative drugs is huge and unsatisfied. Especially in the case of cancer, the prevalence of cancer in China is increasing, but compared with the United States, the survival rate of domestic patients is half of that of the United States in five years. He believes that the main reason lies in the lack of good medicine in the market and the lack of good medicines that patients can generally afford. In addition, from the perspective of capital flow, he said that whether it is VC, PE or pharmaceutical companies, the government has begun to focus on the field of new drug research and development, and the industry has now opened a good window for enterprises within the track; From the perspective of policy standards, national quality and regulatory standards have begun to be in line with international standards, and China for global has become more feasible; From the perspective of medical technology development, in the field of tumor immunotherapy, new products represented by PD-1 and PD-L1 have begun to mature, providing strong support for the development of this medical field. In the field of new drug research and development, the future domestic competition will become more and more fierce, and for the survival and development of enterprises, Liu Shigao believes that the future will be an era of stronger and better survival. The "competition contestants" in the track can only improve their core competitiveness in terms of quality and technology platform, and can stand on the track and be in line with international standards. In addition, Liu Shigao also stressed that in the entire medical field, in the process of continuous growth and development of enterprises, we should always put the interests of patients first, and establish the social value of enterprises in the process of enhancing business value. Halal Empty Capsule Size 00,Empty Gelatin Halal Capsule,Halal Empty Gelatin Capsule,Halal Gelatin Capsule Empty Ningbo Jiangnan Capsule Co., Ltd. , https://www.ningbocapsule.com