Chinese patent drugs are on the rise

In the field of medicine, innovation is an eternal theme. From imitation, imitation combination to innovation like a pyramid, at the bottom of the generic drug manufacturers will always face low profits, fierce competition; and at the top of the innovative drugs, you can get high profits. Facing the attractive market "cake", the world's major pharmaceutical powers are accelerating the pace of innovative drug development.

As the second largest pharmaceutical market in the world, more than 95% of the chemicals produced by thousands of pharmaceutical enterprises in China are generic drugs. As pharmaceutical companies pay more and more attention to the research and development of innovative drugs, and the proportion of R & D investment is increasing, China's innovative drugs have reached an important juncture facing breakthroughs.

Recently, two cross-border mergers and acquisitions in the domestic pharmaceutical industry have caused a stir in the industry: last year, Green Leaf Pharmaceutical Group announced a contract with Acino of Switzerland to purchase its transdermal drug delivery system and implant business for 0.245 billion euros. Shortly after this, Fosun Pharmaceuticals announced that it intends to acquire about 86.08 per cent of India's Gland Pharma Limited, which is by far the largest overseas merger and acquisition of a Chinese pharmaceutical company.

Increasing the intensity of mergers and acquisitions in the overseas pharmaceutical field has become an important focus for Chinese pharmaceutical companies to improve their research and development level and accelerate their access to the international market. The relevant person of Luye Pharmaceutical Group pointed out that the acquisition of such a European company with a leading professional level in the subdivision field will greatly enhance the international level of Luye Pharmaceutical's R & D and production, international registration, and market promotion in the field of new preparations., Helps to further develop the global market. Chen Qiyu, chairman of Fosun Pharmaceutical, said that the resource grafting of the two pharmaceutical companies will help promote the internationalization of Chinese pharmaceutical companies in R & D innovation and generic drug exports.

In fact, pharmaceutical companies represented by Luye Pharmaceuticals, Fosun Pharmaceuticals, Hengrui Pharmaceuticals, and Tasly have become the "first echelon" of innovative drug research and development in China ". At present, the products protected by patents account for more than 80% of the total revenue, and it has a rich research and development product line; during the 12th five-year Plan period, Fosun Pharmaceutical's R & D investment has exceeded 2 billion yuan; so far, Hengrui Pharmaceutical has undertaken four major national 863 science and technology projects, 22 projects have been listed in the national "major new drug creation" project, and has applied for more than 200 invention patents, among them, 100 global patents (PCT patents); Tasly is a representative of the modernization of Chinese medicine. Sun He, vice president of Tianshili Holding Group, introduced that after nearly 20 years of hard work, Tianshili Compound Danshen Dripping Pills has successfully completed the Phase III clinical trial of the US FDA and entered the stage of data statistics and preparation for new drug application. Once the registration is successful, it will become the world's first compound Chinese medicine product registered by the US FDA.

Ten years to sharpen a sword. With the rapid development of China's pharmaceutical industry, a group of local pharmaceutical companies represented by the "first echelon" of new drug research and development have emerged in the field of new drug research and development. From the perspective of R & D investment, although the total R & D investment of domestic enterprises is still far from that of multinational pharmaceutical enterprises, R & D investment has increased rapidly in recent years, and the momentum of catching up is strong. Statistics show that in 2015, the growth rate of R & D investment of 8 domestic enterprises with high R & D investment exceeded 20%, and the R & D investment of Hengrui Pharmaceutical, Fosun Pharmaceutical and Haizheng Pharmaceutical all exceeded 0.8 billion yuan, catching up with some of the world's top 50 pharmaceutical companies on the list of prescription drug sales. From the perspective of the proportion of R & D investment in sales revenue, Hengrui Pharmaceutical, Haizheng Pharmaceutical and other companies have reached or approached 10%, which has exceeded some of the world's top 50 generic drug companies.

Innovative drugs refer to drugs with independent intellectual property rights patents. It is a long, risky and expensive process for innovative drugs from the establishment of the project to the approval of the drug regulatory authorities, which generally requires a cycle of 10 to 20 years and about $1 billion. Among the 10000 new drugs under research, only 10 may eventually enter the clinic, and only one may be a "blockbuster" with real sales of more than $1 billion. On the other hand, because the patent protection period of innovative drugs can be as long as 20 years, once the new drug is successfully developed, the company's stock price will soar and make a lot of money.

As there is still a considerable gap with multinational pharmaceutical giants in terms of R & D strength, capital investment and new drug reserves, China's innovative drug research and development is still in its infancy.

In recent years, the 505 (B)(2) pathway of FDA new drug application has been paid more and more attention in the field of new drug research and development. This path can be applied to two types of declarations, one for new chemical molecules and the other for changes in approved drugs, including indications, formulations, dosage forms, routes of administration, regimens, etc. For Chinese pharmaceutical companies, the 505 (B)(2) path is a practical option. 505 (B)(2) is a high-success, low-risk R & D strategy that avoids the repetition of unnecessary proven trials and enables R & D companies to save money, speed up the process of drug marketing, and enjoy the market returns from new drugs.

Industry experts pointed out that for Chinese pharmaceutical companies that are currently dominated by generic drugs, in order to improve their competitiveness, there are two ways to try: one is to choose some products that are more difficult to imitate to overcome, so that competitors can retreat; The second is to challenge 505 (B)(2) products with lower technical barriers. Once successful, not only can they form professional advantages in certain products, at the same time, the exclusive right obtained also avoids the competition of peers.

On the other hand, as the registration and listing of new drugs in the United States is recognized as a "pass" for the international market, in recent years, Fosun Pharmaceutical, Hengrui Pharmaceutical, 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, and explore a set of international project model management of "combination of China and foreign countries, how fast, good and economical, it has created a new way for the registration and sales of Chinese pharmaceutical products in Europe and the United States.

Due to the particularity of innovative drug research and development, it is a long and complex 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 proposed that it is necessary to firmly grasp the new trend of international innovative drug development, build an alliance of government, industry, university, research and application, and do a good job of top-level design based on the reality of our country. China's patented drugs are on the rise. Under the active guidance of the government, we are willing to produce more conscience drugs and high-efficiency drugs to truly benefit the people.