"An innovative drug can take 10 to 15 years to get a birth certificate. It can't enter the medical insurance list and can't enter the basic drug list normally. Who is there to innovate?"

In August 2011, "News Broadcasting" broadcasted the news of Xian Xian Pharmaceutical's research and development of the world's first small molecule treatment of rheumatoid arthritis drug "Edward" (Irammod). This news was only a few seconds old. However, it has attracted tens of thousands of people to use CCTV to call Xiansheng Pharmaceutical to ask when “Edison” can be purchased in the market.

At the beginning of this year, Edsys has officially launched in both domestic and foreign markets. However, Simson Pharmaceutical executives are not very optimistic about their market prospects. “Without the support of medical insurance, sales of innovative drugs are still very high. limit".

Right now, drug pricing, medical insurance and other policies have led pharmaceutical companies to high-risk, long-period R&D investments that do not necessarily result in high returns. This reality has caused pharmaceutical companies in China to fall victim to new drug development.

There is a big difference

In terms of the level of pharmaceutical innovation, China has not even caught up with India.

This gap can be seen first in the R&D investment. Wei Bach, chairman of the board of directors of the American Pharmaceutical Research and Manufacturers Association (PhRMA), revealed that the US spends more than 100 billion U.S. dollars annually for the development of new drugs.

Multinational pharmaceutical companies continue to be generous in R&D investment. The vast majority of multinational pharmaceutical companies invest 15 to 20% of annual sales revenue. Even with Indian-based pharmaceutical companies, which are mainly imitations, the proportion of R&D investment is close to 10% of annual sales revenue.

In China, the lack of corporate R&D investment and weak innovation capacity have always been a difficult problem for the development of China's pharmaceutical industry.

“There is a big difference between different companies. Now most R&D expenditures of pharmaceutical companies only account for 1% to 2% of sales, and few innovative companies such as Hengrui Pharmaceutical and Xiansheng Pharmaceutical can reach 7 % ~ 8%, individual can reach 10%, we Guangyao roughly accounted for 5% of the group's sales. "Guangzhou Pharmaceutical Group, deputy general manager, chief engineer Liu Jue told "First Financial Daily."

In terms of product structure, for many years, pharmaceutical companies in China have focused on imitation, and most of them are low-level and duplicative modified pharmaceuticals, with little innovation. The multinational pharmaceutical companies in China almost monopolized the high-end patent drug market.

The gap in talent is also obvious. Shi Wankui, deputy general manager of Strategic Investment Department of China Healthcare & Health Products Co., Ltd., once told a story:

In response to a medical new technology investment project, a returnee who returned from the world's leading drug research and development institution brought advanced monoclonal antibody early cancer screening technology, which is at the forefront of the world and is still a blank in the global market. A local government intends to invest in supporting entrepreneurs returning home, and invites well-known experts in the medical and pharmaceutical industries to participate in the review of investment decisions. However, these experts have invariably raised the issue of “Only foreigners are watching”—“Where has your technology been applied globally? Which authority is foreign? Experts acknowledge your results, and rashly negate them.

In addition, R&D personnel in multinational drug companies account for a high proportion, and the R&D personnel of 39 PhRMA member companies in the United States account for 72.8% of the total US R&D personnel. The domestic authoritative department found that among the 110 large-scale pharmaceutical companies in China, 13 were R&D personnel with more than 100 employees, only 10 were from 50 to 100 employees, and 49 had no patent full-time employees.

Jointly tangled

People can see the enormous value brought about by innovations in pharmaceutical companies, but they do not necessarily understand the heavy costs of innovation. Xian Sheng Pharmaceutical Chairman Ren Jinsheng named Elamedo's merchandise as “Ed Sinth”, meaning the hardships of 12 years of R&D.

Right now, both domestic and foreign pharmaceutical companies see huge market space released by factors such as population aging and new medical reforms. The development direction of local pharmaceutical companies is nothing more than three: Either focus on market segments and become the market leader. Either through mergers and acquisitions expansion, becoming a comprehensive giant; or relying on scientific and technological advantages, to achieve R & D-driven growth.

Regardless of which of the above development paths is chosen, independent innovation of the product is indispensable. The transformation and upgrading of the pharmaceutical industry in China, from pharmaceutical giants to pharmaceutical giants, must also rely on the strong innovative strength of pharmaceutical companies to achieve.

China's pharmaceutical market access process includes the three steps of marketing licensing, drug evaluation and pricing of medical insurance. People who have been in the pharmaceutical market for a long time are aware that under the current market environment, even if a new class of drugs has been successfully developed and marketed, the new drugs have become market-oriented and have achieved high levels under the influence of government pricing, medical insurance qualifications, and bidding and bidding policies. The return is easier said than done.

Current pharmaceutical pricing mechanisms and other policies have led pharmaceutical companies to high-risk, long-period R&D investments that do not necessarily lead to high returns. This has caused local pharmaceutical companies to fall victim to new drug development.

“Pharmaceutical companies are all technology-intensive companies in the world. Now, regardless of the requirements of the standards and the clinical requirements, they are gradually in line with the international community.” Xiao Wei, Chairman of the National People's Congress and chairman of Kang Yuan Pharmaceuticals, points out that innovation is needed. Pharmaceutical companies need to pay a huge amount, and domestic policies must support domestic innovative drugs to have a reasonable return.

In drug pricing and bidding, pricing according to quality has become the consensus voice of mainstream pharmaceutical companies. Different quality medicines cannot be "one size fits all" in price. Guo Guangchang, deputy to the National People's Congress and Chairman of Fosun Group, suggested that “at this stage, we must increase the price alone, give a certain number of really good medicines to be priced separately, and even take a certain percentage of products in all varieties to be priced separately. In the range of premium prices."

In addition, at present, it takes at least 2 years for an innovative drug in our country to enter the local medical insurance catalog after it is listed. It takes at least 5 years to enter the category A list of medical insurance. In response, Yan Xijun, the NPC deputy and chairman of Tianshi Li, said: “An innovative drug can take 10 to 15 years to get a birth certificate. It cannot enter the medical insurance list and cannot enter the basic drug list normally. Who is there to innovate?”