Multinational Pharmaceutical Companies Adjust Their R & D Strategy In China, Increase The Development Of New Drugs

Recently, Pfizer announced the plan to stop the Asian discovery Laboratory (ADL). Coincidentally, Novartis also announced a month ago to adjust China's R & D strategy and strengthen the development of new drugs in China. The focus of its R & D center in Shanghai will change from drug discovery to early clinical development and late clinical trials.

Regarding Pfizer's twenty-first Century economic report, this is based on the overall review and consideration of the company's product pipeline priorities, seeking research funding, biotechnology cooperation and equity investment through Pfizer's global emerging science and innovation team, thereby establishing a flexible partnership in the Asia Pacific region. Novartis said that the adjustment is due to the arrival of many mature products, and more from early drug development to drug development in the future, so that more new drugs will be listed as soon as possible.

In fact, the R & D center of multinational pharmaceutical companies in China has been adjusted in the past two years. For example, in early September 2017, Lilai closed down the early clinical research laboratory in Zhangjiang, Shanghai, and laid down 3500 people. In the second half of 2017, GSK abolished the research and Development Center for nervous system drugs in Zhangjiang, Shanghai, which has been established for 10 years.

In December 17th, Shi Lichen, head of Beijing Ding Chen medical management consulting center, analyzed the twenty-first Century economic report reporter. The adjustment of R & D strategy of multinational pharmaceutical companies is in line with its global strategy. "With China's accession to the ICH (International Association for the registration of drug registration technology), the results of R & D data between different pharmaceutical companies have been mutually recognized, resulting in the establishment of a number of R & D centers by multinational pharmaceutical companies to become a serious waste of resources in the world. The adjustment of R & D centers in China can effectively control costs, and with the introduction and listing of new drugs, the development efforts must be strengthened, including the development of generic drugs market that can not be ignored."

Adjustment of R & D strategy

It is understood that the original intention of ADL is to verify biological targets through the local community, so as to support Pfizer's external innovation in the Asia Pacific region.

To halt the launch of the discovery laboratory in Asia, Pfizer said it is based on the overall review and consideration of the company's product pipeline priorities. In the future, it will continue to explore opportunities to complement the emerging R & D resources and professional capabilities in China and the Asia Pacific region, and will continue to seek cooperation to promote emerging science, promising potential therapies and breakthroughs in technology.

In November 18th, Novartis announced that China's R & D strategy should be adjusted to strengthen the development of new drugs in China. The adjustment of the key R & D operations will affect the more than 100 positions of the research department, and the specific data will be determined early next year.

Over the past two years, multinational pharmaceutical companies have frequently heard the news of adjusting China's R & D department. In August 2017, GSK announced the abolition of the 10 year old research center for nervous system drugs in Zhangjiang, Shanghai. In early September 2017, Lilai closed down the early clinical research laboratory in Zhangjiang, Shanghai, and cut down 3500 people. In September 2018, Novo Nord announced the restructuring of the global R & D Center, accelerating the expansion of the pipeline for severe chronic diseases, and cutting about 400 employees in Denmark and China's R & D centers.

Shi Lichen pointed out that with China's accession to the ICH, the results of R & D data among different countries were mutually recognized, which resulted in the establishment of a number of R & D centers in the world by multinational pharmaceutical companies. It is a serious waste of resources and the trend of abolition of R & D centers in China is also a trend.

"For most multinational pharmaceutical companies, although there are R&D in China, it is also based on D (development development), not R (Research research and development). The downstream clinical development part of R & D is busy, with various clinical trials, but the upstream research part is basically following the headquarters research and development. It is difficult to have in-depth and pioneering research. Many Chinese R & D centers are not functioning well, so the early R & D department has become the focus of the abolition, and there are still many external cooperation channels to achieve. A multinational pharmaceutical research and development director told the twenty-first Century economic news reporter.

Wang Gang, chief scientist of Greater China, division of life sciences and pharmaceuticals, told the twenty-first Century economic analysis reporter that according to the analysis of Kerry Wei's annual global biopharmaceutical industry, more than 50% of the new molecular reality (NME) was approved to be listed from 2010 -2018. In other words, there are 100 new drugs listed on the world market, of which at least 50 drugs are involved in the transaction. Through such a way of transaction cooperation, it can effectively provide the fastest support for product listing and R & D pipeline expansion.

According to incomplete statistics, half of the new heavy drugs listed in the world in recent ten years are bought by small multinational R & D companies.

In China, multinational pharmaceutical companies are also strengthening cooperation with local companies or institutions in China. If Lilly closed its diabetes research and development center in Zhangjiang, Shanghai, in March 2018, it announced in March 2018 that it would set up an innovation cooperation center in Beijing to focus more on the early development of new drugs through local collaboration.

Bao Ruijie, President of Novartis biomedical research center, told the twenty-first Century economic news reporter that Novartis Shanghai R & D center will also strengthen cooperation with local R & D forces, speed up the pace of clinical development, and continue to strengthen personnel training. In the coming months, Novartis will inject $35 million into some venture capital institutions specializing in biotechnology start-ups in Shanghai, and Novartis has invested $10 million in the fortune of Shanghai based venture capital agency. In addition, Novartis will expand business expansion and introduce teams in Shanghai.

In an interview with the economic news reporters in twenty-first Century, Jin Yi, senior member of the industry, said that the trend of global drug research and development is changing from "introverted R & D" to "export-oriented and collaborative R & D". Pharmaceutical companies will collaborate more with external agencies in basic and early research fields, rather than completely inside.

Strategic cooperation with professional external R & D institutions can effectively reduce the high cost of personnel and venues for pharmaceutical companies, and streamline their own businesses, enabling enterprises to focus on other modules, and at the same time, achieve faster results and be more successful.

New drug development

Although multinational pharmaceutical companies are constantly adjusting China's R & D efforts, they are all planning to introduce new drug introduction and listing plans, and intensify their clinical development efforts.

If Bao Ruijie accepted an exclusive interview with the economic news reporters in twenty-first Century, he said that the operation of Shanghai R & D center will be changed from drug discovery to early clinical development and late clinical trials, so as to speed up the development of new drugs.

According to the twenty-first Century economic report and the media's public reports, many multinational pharmaceutical companies are speeding up the introduction and listing of innovative medicines in China.

If Lilly will be listed in China in the next 7 to 10 years, 40 new drugs and new indications will be concentrated in the fields of cancer, immunity, diabetes, pain and neurodegenerative diseases. Novo Norde plans to bring ten innovative medicines to China in the next 7-8 years. Novartis expects to submit 50 new drug applications in China between 2019 and 2023; in the next five years, AstraZeneca will have 55 new products and indications to be introduced into China; in the next few years, Takeda expects more than 10 innovative drugs to come to China; by 2026, there will be 40 new drugs / indications for listing in Roche, and Sanofi will introduce 30 new drugs and vaccines in 2025.

According to Shi Lichen analysis, the reason why China's new drug listing scheme is overweight is based on the acceleration of China's review system and its accession to the ICH in June 2017 as a member of the State Food and drug administration. "This means that the time lag of international innovative drugs in China will gradually disappear, and when it comes to European and American markets, China will use innovative drugs synchronously."

Bao Ruijie also pointed out to the economic report reporters in twenty-first Century that the reason for its adjustment of China's R & D strategy is to increase its development efforts: "a series of favorable new drug development policies such as the acceleration of drug review and approval in China are also an important reason for Novartis's adjustment of China's R & D strategy. "

At the same time, Shi Lichen also pointed out that multinational pharmaceutical companies to adjust R & D strategy is also closely related to the difficulty of new drug development.

The original research drug investment is large, takes a long time, has many resources, and faces great risks. At the same time, the speed of innovation will also be within a certain limit. After the development of new drugs, it will take time to open up the market and win the market.

There are about 15 thousand known diseases in humans, and at present, there are about 10% effective treatments. At the same time, the cost of research and development of new drugs is also rising, from the original 1 billion US dollars to 2 billion US dollars, and the failure rate in the early stage of new drug research and development is nearly 90%.

"The difficulty of new drug research and development is increasing. Multinational pharmaceutical companies will have fewer and fewer new drugs after the patent cliff. Multinational pharmaceutical companies will not only focus on patent drugs, they will not ignore China's huge patent medicine market, and they have the advantages of R & D, talent, equipment, management, etc., to develop high profit high-end generic drugs, do new indications research and development at the same time of development, and then apply for approval with new indications." Shi Lichen said.

In recent years, multinational pharmaceutical companies are also doing the layout of generic drugs in China. For example, Sanders, a generic drug company under Novartis, has declared products such as Levetiracetam Tablets, Voriconazole Tablets and Escitalopram Oxalate Tablets in China. Sanders also reported Clopidogrel Bisulfate Tablets, Ezetimibe Tablets and entecavir tablets.

Relying on the acquisition of domestic pharmaceutical companies, Wei Cai sells part of the profits through outsourcing sales, channels and promotion measures to improve conversion efficiency and seize the market of generic drugs. Japanese pharmaceutical company Eisai and Japanese medical workers announced in September 30th that they will cooperate in the field of generic drug business in China. For generic medicines licensed by Japanese medical workers in Japan, they will be sold through the Chinese subsidiary of Wei Cai after obtaining import sales license in China.

(Intern Liu Mengyu contributed to this article)