In the medical field, innovation is an eternal theme. From imitation, imitation, innovation to innovation, just like a pyramid, generic drug manufacturers at the bottom will always face low profits and fierce competition; And top-level innovative drugs can make high profits. Facing the attractive market "cake", the world's major pharmaceutical countries are accelerating the pace of innovative drug research and development.
As the second largest pharmaceutical market in the world, more than 95% of the chemicals produced by thousands of pharmaceutical companies in China are generic drugs. With pharmaceutical companies paying more and more attention to the research and development of innovative drugs, the proportion of R&D investment is increasing, and innovative drugs in China have reached an important juncture.
Increase investment in research and development
Recently, two cross-border mergers and acquisitions in the domestic pharmaceutical industry caused a sensation in the industry: On July 26th, Luye Pharmaceutical Group announced that it had signed a contract with Swiss company Acino to acquire its transdermal drug delivery system and implant business for 245 million euros; On July 28th, Fosun Pharma [2. 10% Capital Research Report] announced that it planned to acquire about 86.08% equity of Indian Gland Pharma Limited, which is the largest overseas M&A case of China Pharmaceutical [0.97%] enterprise so far.
Strengthening M&A in overseas pharmaceutical field has become an important focus for China Pharmaceutical [0. 15% Fund Research Report] enterprises to improve their R&D level and accelerate their entry into the international market. Relevant persons of Luye Pharmaceutical Group pointed out that the acquisition of such a European company with leading professional level in segmentation will greatly enhance the internationalization level of production, international registration and marketing of Luye Pharmaceutical in R&D and new preparations, and help to further explore the global market. Chen Qiyu, chairman of Fosun Pharma, said that the resource grafting between China and India will help promote the internationalization of Indian pharmaceutical companies in R&D innovation and generic drug export.
In fact, pharmaceutical companies represented by Luye Pharmaceutical, Fosun Pharma, Hengrui Pharma [- 1.32% funded research report] and Tasly [-0.96% funded research report] have become the "first echelon" of innovative drug research and development in China. At present, products with patent protection account for more than 80% of the total revenue of Luye Pharmaceutical, and have a rich product line under research. During the "Twelfth Five-Year Plan" period, Fosun Pharma's R&D investment has exceeded 2 billion yuan; Up to now, Hengrui Pharma has undertaken 4 national 863 major scientific and technological projects, 22 of which are listed in the national "major new drug creation" project, and applied for more than 200 invention patents, including global patents (PCT patents) 100; Tasly is the representative of modernization of traditional Chinese medicine. Sun He, vice president of Tasly Holding Group, said that after nearly 20 years of hard work, Tasly Compound Danshen Dripping Pills has successfully completed the third phase clinical trial of FDA in the United States, and entered the stage of data statistics and new drug application preparation. Once registered successfully, it will become the first compound Chinese medicine product registered by the US FDA in the world.
Sharpen a sword every ten years. With the rapid development of China's pharmaceutical industry, a number of local pharmaceutical companies represented by the "first echelon" of new drug research and development have made their mark in the field of new drug research and development. From the perspective of R&D investment, although the total investment of domestic enterprises in R&D is far from that of multinational pharmaceutical companies, R&D investment has grown rapidly in recent years, with a strong catch-up momentum. Statistics show that in 20 15 years, the growth rate of R&D investment of eight domestic companies with high R&D investment all exceeded 20%, and the R&D investment of Hengrui Pharma, Fosun Pharma and Haizheng Pharmaceutical [0.8 1% capital research report] all exceeded 800 million yuan, catching up with some of the top 50 pharmaceutical companies in the world in terms of prescription drug sales. Judging from the proportion of R&D investment in sales revenue, Hengrui Pharma, Haizheng Pharmaceutical and other enterprises have reached or approached 65,438+00%, surpassing some of the top 50 generic drug companies in the world.
"I wouldn't be surprised if China becomes an important source of medical innovation in 10 years." Luke Miels, executive vice president of global product portfolio and product strategy of AstraZeneca, said.
Looking for a breakthrough path
Innovative drugs refer to drugs with independent intellectual property rights patents. As everyone in the industry knows, it is a long, risky and expensive process from project approval to drug supervision department approval, which generally takes 10 to 20 years, with a capital of about 654.38 billion US dollars. Of the 10000 new drugs under research, only 10 may eventually enter the clinic, and only 10 may be the "blockbuster" whose real sales can exceed 10 billion dollars. On the other hand, because the patent protection period of innovative drugs can be as long as 20 years, once a new drug is successfully developed, it will often make the company's share price soar and make a lot of money.
Because there is still a considerable gap between China and multinational pharmaceutical giants in R&D strength, capital investment and new drug reserve, the research and development of innovative drugs is still in its infancy. In 20 15 years, all the 10 drugs with the highest sales volume in the world were developed and produced by multinational pharmaceutical companies. How to develop innovative drugs in China? Experts in the industry believe that it is necessary to find a breakthrough road suitable for the current situation of Chinese pharmaceutical companies based on national conditions. In this regard, the experience of some domestic enterprises may provide useful enlightenment.
Fosun Pharma has continuously improved the drug research and development system of "combination of imitation and creation", and built an efficient research and development platform in the fields of small-molecule chemical innovative drugs, macromolecular biological similar drugs, high-value generic drugs, and characteristic preparation technologies. Wu Yifang, president and chief operating officer of Fosun Pharma, said that the R&D, innovation and development of Fosun Pharma will be divided into three stages: in the near future, efforts will be made to build innovative capabilities, including talent structure, infrastructure support and clinical capacity building; Take the road of "imitation and creation at the same time" in the medium term; In the long run, it will become a completely innovative enterprise and strive to contribute most of Fosun Pharma's innovation-driven income after 10 to 15.
In recent years, the 505(b)(2) route of FDA's new drug application has attracted more and more attention in the field of new drug research and development. This path can be applied to two types of declarations, one is new chemical molecules, and the other is the change of approved drugs, including indications, dosage forms, routes of administration, drug schemes, etc. Dr. Xu Zhixin, former president of the American Association for the Development of Chinese Medicine and senior director of Roche Pharmaceuticals, believes that adopting route 505(b)(2) is a realistic choice for pharmaceutical companies in China. He said that 505(b)(2) can avoid repeating unnecessary proven experiments, so that R&D enterprises can not only save money, speed up the process of drug listing, but also enjoy the market returns brought by new drugs. This is an R&D strategy with high success rate and low risk.
Experts in the industry suggest that there are two ways to improve the competitiveness of China pharmaceutical companies, which are mainly generic drugs: first, choose some products that are difficult to imitate to overcome and let competitors retreat; The second is to challenge 505(b)(2) products with low technical barriers. Once successful, it can not only form professional advantages in some products, but also avoid peer competition.
On the other hand, because the registration and listing of new drugs in the United States is recognized by the industry as a "passport" to the international market, in recent years, Fosun Pharma, Hengrui Pharma, Luye Pharmaceutical, Tasly and other enterprises have set up R&D centers and related institutions in the United States to speed up international exchanges and cooperation, explore a set of international project management mode of "combining Chinese and foreign countries, faster and better", and create a new way for China's pharmaceutical products to register and sell in Europe and America.
Do a good job of top-level design
Due to the particularity of innovative drug research and development, it is a long and complicated chain from basic research, enterprise research and development, clinical trials, new drug registration to market promotion, involving scientific research institutes, enterprises, governments, hospitals and other links. In this regard, experts suggest that we should firmly grasp the new development trend of international innovative drugs, build the Industry-University-Research Alliance, and do a good job in top-level design from the reality of our country.
The most important thing for innovative drug research and development is to have a good policy environment. Wu Haidong, deputy director of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, proposed that the pharmaceutical industry should enhance its innovation ability during the 13th Five-Year Plan period, that is, increase investment and improve efficiency, and actively promote the strategic transformation of China from tracking imitation to independent innovation.
Wu Haidong introduced that the primary task proposed in the 13th Five-Year Plan of the pharmaceutical industry is to enhance the capability of independent innovation. First, promote product innovation, increase the research and development of original drugs, and upgrade drug research and development from imitation to creation to meet the needs of prevention and control of major clinical diseases in China; The second is to build a platform, build an innovation center for drugs and medical devices, focus on key technologies for industry development, break through the bottleneck of industrialization technology, and promote the transformation of innovation achievements; The third is to support the development of small and medium-sized innovative enterprises, build an innovation and entrepreneurship service platform, implement the venture capital plan of pharmaceutical industry, and support the development of a number of small enterprises engaged in new drug innovation, making them an important source of pharmaceutical innovation in China.