Drug development enters the "golden age"

2020 In the year, China's drug review and approval system reform entered its fifth year.

　　This year, the benefits of drug review reform were fully released: the "Drug Administration Law" and "Vaccine Administration Law" were officially implemented, a series of detailed and practical supporting regulations such as the "Drug Registration Management Measures" were successively introduced, the drug review mechanism and technical review system were continuously improved, further stimulating pharmaceutical innovation vitality, promoting China's pharmaceutical R&D to shift from generic to innovative drugs, from local to global, continuously meeting the public's new demands for life and health.

　　 Implementation of New Registration Regulations Guiding the Industry Towards Innovation Concentration

　　Since 2015 the drug review and approval system reform has advanced to a higher level this year. 7 Month 1 Day, the newly revised "Drug Registration Management Measures" (hereinafter referred to as the "Measures") officially came into effect. The "Measures" implement the "Drug Administration Law" and the framework blueprint of the drug review and approval system reform, introducing new concepts and institutional designs, further optimizing processes, improving measures, and encouraging drug R&D and innovation. For example, the "Measures" specially added a chapter on accelerated drug market registration, establishing four accelerated channels: breakthrough therapy drugs, conditional approval, priority review and approval, and special approval, supporting drug innovation guided by clinical value. In addition, the risk-based review, inspection, and testing model implemented by the "Measures" changed the previous review, verification, and testing from " serial connection ” to " parallel connection and the implied clinical trial approval system, communication system, and other contents have created conditions for accelerating product market entry, receiving widespread praise in the industry.

　　Before and after the implementation of the "Measures," a series of supporting regulations were also issued. On the 6th Month 30 Day, the National Medical Products Administration issued the "Classification and Application Materials for Biological Product Registration" and "Classification and Application Materials Requirements for Chemical Drug Registration." Both documents clearly define new drugs as innovative drugs and improved new drugs, which are drugs not yet marketed domestically or abroad and have clinical value. Meanwhile, the "Classification and Application Materials Requirements for Traditional Chinese Medicine Registration" issued on the 28th clearly classify traditional Chinese medicine registration into innovative TCM drugs, improved new TCM drugs, ancient classic prescription compound preparations, and same-name same-form drugs, with the first three categories considered TCM new drugs. According to Song Ruilin, president of the China Pharmaceutical Innovation Promotion Association, the new registration classification method has a very positive significance for promoting drug innovation and pharmaceutical industry development in China: it clarifies the classification of innovative and improved new drugs for chemical drugs and biological products, helping research institutions and development units to clarify R&D directions and establish goals to fill clinical gaps and achieve effective substitution; it expands traditional Chinese medicine beyond the previous scope of classical prescriptions and TCM theory, building an important channel connecting China's traditional medical treasure with modern medicine, opening broader prospects for the orthodox innovation of TCM. 9 Month Review Resources Tilted

　　 Accelerating Innovative Drug Market Entry On the day, the National Medical Products Administration issued three major documents: "Breakthrough Therapy Drug Review Work Procedures (Trial)," "Conditional Approval for Drug Marketing Application Review and Approval Work Procedures (Trial)," and "Priority Review and Approval Work Procedures for Drug Marketing Authorization (Trial)," officially opening the four fast lanes for new drug market entry.

　　7 Month 8 The documents clearly define the applicable scope and policy support measures for the three work procedures mentioned above—such as breakthrough therapy drugs can submit data on a rolling basis during clinical trials, receive communication and guidance from the drug review center, and be prioritized for review; priority review drugs can submit data on a rolling basis during the marketing application stage, shortening review time and prioritizing verification and testing. " Within a week after the documents were issued, four companies submitted applications for their innovative products to be included as breakthrough therapy drugs. The industry's attention to "breakthrough therapy drugs" is self-evident. ” Along with the implementation of new regulations, the National Medical Products Administration's Drug Review Center (hereinafter referred to as the Drug Review Center) further prioritized review work, legally adjusting the scope of priority review to include more drugs with significant clinical value, clinically urgent shortage drugs, and innovative drugs in the priority review process. At the recently concluded 2020 Smart Regulation Innovation Conference, Drug Review Center Director Kong Fanpu introduced that as of the end of

　　month this year, a total of Within a week after the documents were issued, four companies submitted applications for their innovative products to be included as breakthrough therapy drugs. The industry's attention to "breakthrough therapy drugs" is self-evident. cases have been included in the priority review and approval process, with

　　cases completed. Among them, are new drugs with significant clinical value, 11 are products with simultaneous applications. The completion rate of priority review tasks by deadline has increased month by month, reaching 212 97.22% by 241 month, effectively promoting the early market entry of innovative drugs and clinically short-supply drugs. 35% The review speed for clinically urgently needed overseas new drugs has also accelerated. On the 10th 20% day, the Drug Review Center announced the third batch of clinically urgently needed overseas new drugs, involving 11 drugs for hematological diseases, genetic metabolic diseases, neurological diseases, and others. So far, among the three batches, there have been companies

　　varieties that have submitted registration applications, Month 29 varieties approved for marketing or completed review, 7 with 100% of review tasks completed within the time limit. 36 Close International Cooperation 45 Obvious Trend of Synchronized New Drug R&D 39 Currently, China's pharmaceutical innovation capability has entered the global second tier. On the 10th day, the newly revised "Patent Law" was promulgated, adding an early resolution mechanism for drug patent disputes and, for the first time at the legislative level, proposing a new drug patent term compensation system, giving innovative pharmaceutical companies a

　　 reassurance, greatly enhancing China's attractiveness as the preferred location for new drug launches and promoting the early global launch of new drugs in China.

　　According to statistics, since the beginning of this year, as of November Month 17日，新修订《专利法》颁布，法条中新增了关于药品专利纠纷的早期解决机制，并首次在立法层面提出了新药专利权期限补偿制度，给创新药企吃下了一颗 " 定心丸”，也大大提高我国作为新药上市首选地点的吸引力，促进全球范围的新药尽早在我国上市。

　　据统计，今年以来，截至11 By the end of the month, hydrochloride clopidogrel, benzalkonium bromide nasal spray, and others 9 units 1 types of innovative drugs have been approved for marketing, among which 7 were submitted by domestic companies. In addition, BeiGene's zanubrutinib capsules and Novartis's siponimod tablets are also products submitted simultaneously.

　　In fact, when the third batch of urgently needed overseas new drugs for clinical use was announced, the Center for Drug Evaluation clearly stated in the announcement that " the historical problem of slow approval of urgently needed overseas new drugs for clinical use in China has basically been resolved. Moreover, with the deepening of the reform of the review and approval system, ICH guidelines have been implemented, and China has gradually established a regulatory system for simultaneous research and development and application of overseas new drugs domestically, encouraging overseas new drugs to carry out simultaneous R&D and application in China."

　　With the rapid development of innovative R&D in China, multinational pharmaceutical companies are also updating their R&D models in China, and further strengthening innovative cooperation is a clear trend. At the recently concluded 3rd China International Import Expo, RDPAC (China Association of Enterprises with Foreign Investment Pharmaceutical Research and Development Committee) Executive Committee Chairman and President of Xi'an Janssen Pharmaceutical Ltd., An Sijia, stated that many RDPAC member companies have conducted extensive cooperation with local Chinese pharmaceutical companies in scientific research, medicine, business, and other areas. The partners include both large-scale pharmaceutical companies and startups, " and if we can achieve win-win results in a fair, transparent, and sound pharmaceutical ecosystem and business environment, we believe this will be very beneficial for both pharmaceutical companies and the development of China's pharmaceutical industry."

　　Many foreign companies such as Novo Nordisk, Roche, and Takeda are including China in their global R&D systems. Novo Nordisk's Global President and CEO Fude Zhou stated that in the coming 7、8 years, Novo Nordisk will bring 10 innovative drugs in multiple disease areas, " and the improvement of laws and regulations in the field of intellectual property in China means that more new drug R&D will be conducted in research centers in China in the future, including not only early-stage scientific research but also clinical trials and product manufacturing."

　　In addition, the cooperation between foreign pharmaceutical companies and the Boao Lecheng International Medical Tourism Pilot Zone in Hainan in introducing innovative drugs is one of the best examples of international cooperation supporting Healthy China. The use of real-world clinical data in the Lecheng Pilot Zone has received joint policy support from the National Medical Products Administration, Customs, Health Commission, Development and Reform Commission, and Ministry of Finance, opening a special green channel ” .