Academician of Science and Technology Innovation - Zhang Dan: Only by going out can we cultivate Huawei in the field of biomedicine in China

The centralized bidding and procurement of drugs, which began in April 2019, has set off a round of waves in the domestic pharmaceutical industry and investment market. Especially in the field of new drug research and development, practitioners are urgently thinking and discussing: where is the road?

On this topic, Zhang Dan, a foreign academician of the Russian Academy of Engineering and chief scientist of Xingwan Biology, proposed in a speech in Shenzhen on September 9 that only by "looking at the world with the motherland in mind" and going out in the first step of research and development activities can we cultivate Huawei in China's biomedical field.

The speech event was named "Science and Technology Innovation Academician Lecture Hall" and co-sponsored by Shenzhen Innovation and Development Research Institute, BoYan Education, Shenzhen Enterprise Federation, Tongxin Club, etc. It is for the sixth issue.

Joined the "WTO in the field of biomedicine"

Under the influence of the global biomedical innovation development trend, since 2015, a series of national pharmaceutical-related policy reforms and improvements, as well as the government's vigorous promotion, have continuously improved the innovation strength of the biomedical industry. Zhang Dan pointed out that Document No. 44 of the State Council in 2015 (Opinions on Reforming the Review and Approval System for Pharmaceutical Medical Devices) and Document No. 42 issued by the CPC Central Committee and the State Council in 2017 (Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Pharmaceutical Medical Devices) laid the foundation for all major changes in China's biomedical field. In 2016, the country changed the definition of new drugs, from a national one - China did not approve the new drug, to a global - the world has not approved the new drug. This change has a huge impact, greatly raising the threshold for new drug approval.

China's accession to the ICH (International Technical Coordination Committee for the Registration of Medicinal Substances for Human Use) in 2017 is even more landmark. Zhang Dan said that joining the ICH is equivalent to joining the WTO in the field of biomedicine. Under the framework of the ICH, the technical standards for drug review between members are harmonized, and the test data is mutually recognized, and "data mutual recognition is used to accelerate the review and avoid duplication of experiments and duplicate data products".

The direct impact of joining the ICH is that foreign original drugs can quickly enter the Chinese market. The most typical example is the bivalent and nine-valent HPV (cervical cancer) vaccines. Before China joined the ICH, it took 11 years for GlaxoSmithKline's bivalent HPV to be approved by China because, according to the policy at the time, China did not recognize its overseas trial data. It's going to do a new phase I, II, and III trial in China. As a result, it was withdrawn within half a year of listing in China, because Merck's nine-valent HPV vaccine was quickly approved under the ICH framework.

Although the entry of foreign original research drugs into China inevitably puts some pressure on domestic pharmaceutical companies, the latter also enjoyed the dividends of joining the ICH in the early stage. Before that, No innovative proprietary medicine in China had entered the mainstream market in the West. After joining the ICH, there are two drugs that are really researched by Chinese companies and whose main clinical data comes from China. One is Zebutinib in BeiGene, which was first approved by the United States and not approved domestically until more than half a year later. Its Phase II trial data came from China, with Phase I being done in the United States and Australia. This is the historic entry of China's innovative drugs into the U.S. market. The other is Fruquintinib from Hutchison Whampoa, which was approved domestically and then in the United States. Recently, a number of Chinese pharmaceutical companies' PD-L1 drugs (an immune drug) are queuing up to apply for approval in the United States, which clearly reflects the significance of joining the ICH.

Bear in mind the motherland and look at the world

Zhang Dan introduced that the patent application for biomedicine is a long road and costs a lot, and the latest estimates show that the average total investment in the development of a drug is about 2.6 billion US dollars. With such a huge cost, pharmaceutical companies have to pursue the fastest possible research and development, speed to market and the largest possible market. The ICH framework offers exactly that possibility.

Take the matter of drug collection, although its impact on pharmaceutical companies is obvious, China has its own national conditions, and drug collection has its rationality and necessity. In the United States, the law does not allow the government to engage in collective procurement, and its commercial insurance market is huge, and the drug reimbursement is generally reported the next day after approval, including some extremely expensive drugs. This is very attractive to pharmaceutical companies.

In addition, Zhang Dan said that the efficiency differences caused by the new drug review system and process in various countries are worth considering by pharmaceutical companies. For example, the United States may have the most experienced and efficient innovative drug review body in the world, "80% of the world's new drugs have been first launched in the United States in the past two years." The waiting time for approval of a clinical trial in Australia can be as short as 6 weeks. In order to speed up the approval of anti-tumor drugs, the United States has led a "seven-nation alliance", "one batch, one piece", including the United States, Canada, Australia, Switzerland, Singapore, the United Kingdom and New Zealand. Zhang Dan named it "Super ICH": "This is very good for pharmaceutical companies, they don't need one country to apply, as long as one of them is approved, it suddenly opens up a huge market in 7 countries." ”

Zhang Dan believes that following the principle of ICH, Chinese pharmaceutical companies can only gain space for survival and development if they adopt the strategy of two-wheel drive and the combination of internal and external markets. In the short term, "it is best that our products can be sold in various countries to make up for the temporary market reduction caused by collection and procurement"; in the long run, only by going out can We produce Huawei in the biomedical field.

"Now to do innovative drugs, in Shenzhen, in Shanghai, Beijing, you have to bear in mind the motherland, look at the world." The risk of fighting alone in only one market is very large," Zhang Dan warned many pharmaceutical companies and investment institutions at the scene of the speech.

In order to go global, it is necessary to take the right direction at the first step. Zhang Dan pointed out that pharmaceutical companies should consider whether it is possible to achieve multinational and multi-center from the first phase of clinical trials, rather than only doing clinical trials in one country and one institution. In this way, the products developed can be recognized by many countries as soon as possible. However, "most of our companies have not done it, we have a new drug, but from the moment we started to fall behind, this is a very important thing." Zhang Dan said.

It is proposed to establish a "Belt and Road" version of ICH

By coincidence, the COVID-19 pandemic has given Chinese pharmaceutical companies the opportunity to prove their strength. With the popularity of China's COVID-19 vaccine in many countries around the world, a new market for Chinese biomedical products has unexpectedly emerged - the market of the "Belt and Road" countries (regions). Zhang Dan believes that China's biomedical industry should go to Western rich countries with international standards, and even more to the "Belt and Road" countries and regions, which "will add up to a very large amount."

Drawing on the aforementioned "Seven-Nation Alliance" for anti-tumor drug review, Zhang Dan suggested that China can also initiate the establishment of a drug review coordination organization between "Belt and Road" countries (regions) to achieve mutual recognition of data and products. "If these countries can accept China's vaccine products, why can't they accept China's PD-L1 drugs?" If there are good research data and products that can objectively prove the efficacy, including Traditional Chinese medicine products, I think the difficulty of acceptance will be greatly reduced. Zhang Dan said.