China's Pharmaceutical Innovation Has Entered a Golden Age

China's pharmaceutical industry has ushered in its most significant policy development since the founding of the People's Republic of China. On October 8th, the General Office of the CPC Central Committee and the General Office of the State Council jointly issued the "Opinions on Deepening the Reform of the Drug and Medical Device Review and Approval System and Encouraging Innovation in Drugs and Medical Devices" (hereinafter referred to as the "Opinions"). This is another guiding document for deepening the reform of the drug and medical device review and approval system, following the "Opinions of the State Council on Reforming the Drug and Medical Device Review and Approval System" issued in August 2015, marking a milestone for the innovative development of my country's pharmaceutical industry.

"As an innovative pharmaceutical company, we are greatly encouraged and fortunate to have caught up with the best era for pharmaceutical innovation in China," said Ding Lieming, Chairman and CEO of Betta Pharmaceuticals Co., Ltd., in an interview with Science and Technology Daily.

Ding Lieming stated that the "Opinions" aim to vigorously promote the reform of the drug regulatory system. The advanced and scientific nature of its reform approach shows a momentum to catch up with developed countries, fully demonstrating the CPC Central Committee and the State Council's reform determination and resolve. This is a vivid example of the central government's comprehensive deepening of reforms. 

Encouraging Innovation: Clinical Trial Institution Qualification Shifts from Accreditation to Registration

"The core of the 'Opinions' is to encourage innovation, focusing on solving the public's medication problems, ensuring access to new and effective drugs, and providing doctors with more choices when treating patients," said Wu Zhen, Deputy Director of the State Food and Drug Administration, at a press conference on the 9th regarding the "Opinions."

For a long time, the slow and lengthy drug approval process has significantly hampered drug innovation, and the industry has been calling for reform.

In response, Wang Lifeng, Director of the Drug and Cosmetic Registration Department of the State Food and Drug Administration, stated that the relative scarcity of resources for clinical trial institutions is a deep-seated problem restricting the development of drug innovation.

"The first aspect of this reform is changing the qualification accreditation system for clinical trial institutions to a registration system, which is an important part of our clinical trial reform," said Wang Lifeng. "As everyone knows, clinical trials are the most crucial stage of drug development, taking a long time and incurring high costs." Currently, my country has over 10,000 secondary and tertiary medical institutions, and over 2,000 tertiary institutions. However, only about 600 institutions are certified to conduct drug clinical trials, and only about 100 are qualified to conduct Phase I clinical trials, which has become a bottleneck for pharmaceutical innovation.

Wang Lifeng believes that the current certification system for clinical trial institutions cannot meet the needs of innovation, especially since clinical institutions also undertake a large number of medical tasks. Therefore, it is crucial to allocate some resources within clinical institutions to conduct drug clinical trials. Changing the certification process for clinical trial institutions to a registration system can reduce procedures and improve efficiency.

"This reform also adjusts the regulatory model, shifting from certification of institutions to a comprehensive inspection of the entire process of experimental drugs, making clinical trial supervision more targeted and clear, focusing on capability rather than institution," said Wang Lifeng. He added that measures such as encouraging social investment in establishing clinical trial institutions will effectively expand the number of institutions, increase the enthusiasm of clinical trial researchers, and effectively alleviate the conflict between medical care and scientific research.

Accepting overseas clinical trial data will allow Chinese patients to access new drugs as soon as possible.

It is well known that the lack of medical care and medicine is a serious reality faced by the Chinese people. Data from 2004 to 2014 shows that the entry of innovative drugs from around the world into China faced a serious lag. During this period, only 79 of the 291 new molecular entities (NMEs) approved in the United States successfully entered China, a rate of less than 30%. Even after approval, these new drugs often required a lengthy approval process. For example, Chinese patients often had to wait more than five years to access new anti-cancer drugs.

Now, this situation is expected to be effectively reversed.

The "Opinions" specifically emphasize the need to "accelerate the review and approval of urgently needed clinical drugs and medical devices," and "encourage the research and development of new drugs and innovative medical devices, giving priority to the review and approval of new drugs and innovative medical devices supported by national major science and technology projects and national key research and development programs, as well as those clinically conducted by national clinical medical research centers and approved by the center's management department." Furthermore, in the review and approval process for new drugs, overseas clinical trial data can also be used for registration applications.

Wang Lifeng explained that clinical trial data obtained from multi-center clinical institutions overseas, if meeting my country's drug registration requirements, can be used for registration applications in my country. The aim is to reduce redundant trials, lower R&D costs, and improve market access efficiency, allowing Chinese people to use new drugs as soon as possible.

"Accepting overseas clinical data not only benefits foreign companies but also domestic innovative companies; it's a win-win situation," said Wang Lifeng. He noted that a number of innovative Chinese companies have already gone global, registering drugs abroad, particularly in the US, Japan, and the EU. Their overseas registrations and clinical trial data can then be used for drug registration in my country, reducing redundant clinical trials, improving efficiency, lowering R&D costs, and shortening the time it takes for some foreign drugs to enter the Chinese market.

Indeed, Ding Lieming believes the new policy accelerates the integration of pharmaceutical innovation with international standards, increasing the possibility for Chinese patients to access the latest global treatments sooner and paving the way for Chinese innovative drugs to go global. For example, Betta Pharmaceuticals entered into a strategic partnership with Xcovery in 2014 to jointly develop the next-generation targeted anticancer drug "Ensartinib." Currently, this drug is undergoing global multicenter Phase III clinical trials. The implementation of policies allowing access to overseas clinical trial data will significantly reduce new drug development costs and time to market, facilitating the simultaneous global launch of innovative drugs developed by Chinese companies and bringing benefits to patients worldwide.

Patent Linkage: A Comprehensive Approach to Innovative Drug Intellectual Property Protection

"What excites us even more is the protection of innovators' rights. In 2015 and 2016, I submitted proposals to the National People's Congress twice, calling for strengthened protection of intellectual property rights for innovative drugs and an appropriate extension of the effective patent period for innovative drugs. I am very pleased to see that the proposals have received high attention from the state and are beginning to be implemented," said Ding Lieming.

This "Opinion" explicitly proposes to explore the establishment of a drug patent linkage system, conduct pilot programs for drug patent term extension, and improve and implement data protection systems. "These three elements combined form a comprehensive approach to intellectual property protection, focusing on building a scientific and systematic protection mechanism, taking proactive measures to effectively protect the legitimate rights and interests of patent holders, and stimulating innovation," said Wu Zhen.

Wu Zhen explained that linking drug patents essentially connects drug approval with patents. Drug approval is handled by the State Food and Drug Administration, while patent disputes involve the State Intellectual Property Office and intellectual property courts. Linking them aims to resolve patent infringement disputes through court rulings during the drug approval process. This allows patent disputes and infringement risks to be resolved before the drug is launched on the market, protecting the legitimate rights and interests of patent holders, improving patent quality, and reducing the market risks for generic drug companies challenging patents.

Patent term extension refers to the time spent by patent holders during the administrative approval process. The longer the approval time from research and development to final market launch, the longer the patent protection period is consumed, diminishing the patent holder's rights. Therefore, regulatory authorities provide reasonable compensation for the patent time consumed.

"The series of measures for the protection of pharmaceutical intellectual property rights are fully in line with our country's needs for building an innovative nation and promoting the innovative development of the pharmaceutical industry. They will play a very positive role in protecting and stimulating the burgeoning innovation vitality of our national pharmaceutical industry, especially in the field of traditional Chinese medicine with independent intellectual property rights, and will comprehensively enhance the innovative development of my country's pharmaceutical industry," Wu Zhen emphasized.