Embracing a Golden Age of Pharmaceutical Innovation

Following the release of the “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” by the State Council in August 2015, the call to accelerate the development of new drugs has grown ever louder. In 2016, the inaugural year of the 13th Five-Year Plan, a flurry of newly introduced incentive policies and an increasing number of groundbreaking basic research findings have ushered in what can be described as the golden age for drug development—particularly for the creation of major new drugs.

The policy environment is becoming increasingly comprehensive.

Currently, innovation has risen to the level of a national strategy, and a series of policies introduced by the pharmaceutical industry have created a favorable environment for innovation. In 2016, the State Council, the National Medical Products Administration, and relevant ministries and commissions successively issued numerous policy and regulatory documents to support and encourage drug innovation.

In October 2016, the CPC Central Committee and the State Council issued the “Healthy China 2030” Planning Outline, which calls for promoting the development of the pharmaceutical industry, strengthening pharmaceutical technology innovation, improving the collaborative innovation system involving government, industry, academia, research, and application, and driving pharmaceutical innovation and industrial upgrading. The plan emphasizes vigorous development of new biological drugs, innovative chemical drugs, high-quality traditional Chinese medicines, high-performance medical devices, novel excipients and packaging materials, and pharmaceutical manufacturing equipment, thereby boosting the industrialization of major pharmaceutical products.

In November 2016, six ministries and commissions, including the Ministry of Industry and Information Technology, jointly issued the “Guidelines for the Development Plan of the Pharmaceutical Industry,” proposing to promote development in key areas. By grasping the direction of industrial and technological advancement and targeting major market demands, we will vigorously develop new varieties of biopharmaceuticals and chemical drugs, high-quality traditional Chinese medicines, high-performance medical devices, novel excipients and packaging materials, and pharmaceutical equipment. We will accelerate the development and application of new technologies across various fields, thereby promoting upgrades in products, technologies, and quality.

In November 2016, the State Council issued the “13th Five-Year Plan for the Development of National Strategic Emerging Industries,” which called for accelerating the pace of innovative development in the bio-industry and building a new biomedical system. The plan emphasized speeding up the development of innovative drugs and biological products that address significant clinical needs, accelerating the adoption of green and intelligent pharmaceutical manufacturing technologies, strengthening scientific and efficient regulatory oversight and policy support, promoting the internationalization of the industry, and expediting the country’s journey toward becoming a global powerhouse in biomedicine.

Meanwhile, in 2016, the National Medical Products Administration focused on improving drug quality and encouraging pharmaceutical innovation, introducing and implementing a series of policy measures that yielded significant results. The administration reformed the classification system for chemical drugs and raised the standards for registration applications by issuing the "Work Plan for the Reform of Chemical Drug Registration Classification" and the "Trial Requirements for Submission of New Registration Applications for Chemical Drugs." It also launched a pilot program for the Marketing Authorization Holder (MAH) system: the Administration promptly provided policy interpretations of the MAH pilot program and issued the "Notice on Doing a Good Job Regarding the Pilot Work of the Drug Marketing Authorization Holder System." Furthermore, the administration optimized and streamlined approval processes to enhance the efficiency of review and approval procedures. In 2016, it released the "Opinions on Addressing the Backlog of Drug Registration Applications through Priority Review and Approval." To strengthen clinical trial oversight and rebuild the R&D ecosystem, the Administration issued more than 20 notices over the past year, including the "Notice on Issuing the Procedures for the Verification of Clinical Trial Data for Drugs (Provisional)." Additionally, it initiated an evaluation of the consistency between generic drugs' quality and efficacy. To date, more than 10 working documents and guiding principles have been released. “These successive ‘combination punches’ aimed at encouraging innovation are conducive to promoting standardization and progress within the pharmaceutical industry,” said Yao Zhong, Director of Registration Affairs at the Beijing Branch of Quintiles Management Services (Shanghai) Co., Ltd.

The pace of new drug development is accelerating.

Under an increasingly comprehensive policy environment, from January to November 2016, the National Medical Products Administration approved a total of 189 drug marketing applications. Notably, in May 2016, a new Class 1.1 drug—the nemonoxacin malate capsules, a next-generation fluoroquinolone-free agent—was approved for market launch. Unlike traditional fluoroquinolone antibiotics, nemonoxacin is a new-generation selective inhibitor of bacterial topoisomerases. In vitro antibacterial studies have demonstrated that nemonoxacin exhibits broad-spectrum antimicrobial activity, effective against both Gram-positive and Gram-negative bacteria, anaerobes, and atypical pathogens. It is particularly effective against Streptococcus and Staphylococcus species, including multidrug-resistant Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus (MRSA).

In September 2016, with long-term support from the national key science and technology project for “Major New Drug Development,” China’s independently developed Class I biological product—polyethylene glycol interferon alpha-2b injection—was approved for marketing as a treatment for viral hepatitis. This drug has broken the long-term monopoly held by imported counterparts, significantly reducing medication costs for hepatitis patients and yielding substantial economic and social benefits.

The world’s first effective prescription specifically designed for the treatment of influenza A (H1N1)—“Jinhua Qinggan Formula”—was officially launched in September 2016. This also marked the first new traditional Chinese medicine approved for market launch in China in 2016. The Jinhua Qinggan Formula has demonstrated remarkable efficacy in treating patients with influenza A.

In addition, in 2016, a batch of important innovative products entered the clinical research stage: BGB-A317, a PD-1 monoclonal antibody developed by BeiGene, received clinical trial approval from the Administration for use in the treatment of advanced solid tumors; SHR-1210, a PD-1 monoclonal antibody product developed by Hengrui Medicine, became the first drug approved by the Administration to proceed to Phase II and Phase III clinical trials...

These achievements demonstrate that China’s capability in new drug development has made significant progress. Sang Guowei, chief technical advisor of the “Major New Drug Creation” national key science and technology project, stated that since the 12th Five-Year Plan, this project has focused on major diseases and aligned its R&D efforts with the industrial chain, resulting in the approval of a total of 24 Class 1 new drugs—nearly five times the number approved since the founding of the People’s Republic of China. Nearly 300 platforms of various types have been established, and more than 50 core and critical technologies have been breakthroughs. Over 60 industrial innovation incubation bases have also been supported. China’s biologic vaccine R&D ranks among the world’s top, innovative research in chemical drugs has reached international standards, and the traditional Chinese medicine industry is showing a trend toward global expansion, all of which are propelling China’s pharmaceutical science and technology from imitation to innovation and its pharmaceutical industry from a large country to a strong one.

Basic research continues to provide strong support.

In 2016, in fields such as anti-tumor, antiviral, and anti-infective therapies, Chinese scientists, through their relentless efforts, published numerous significant and far-reaching studies one after another in internationally renowned journals, further accelerating the pace of new drug development in China.

In the field of antiviral drug development, the international academic journal *Cell* has published online an article by the research team led by Gao Fu from the Institute of Microbiology, Chinese Academy of Sciences, and the China Center for Disease Control and Prevention. This study elucidates, at the molecular level, a novel mechanism that triggers viral membrane fusion, providing new targets for antiviral drug design and laying an important theoretical foundation for responding to and controlling the Ebola virus disease epidemic.

“Science” has published groundbreaking research findings from the team led by Professor De-min Zhou and Academician Li-he Zhang at the School of Pharmaceutical Sciences, Peking University. Using influenza virus as a model, they have developed a technology that artificially controls viral replication, thereby directly converting the virus into a vaccine—a breakthrough that fundamentally transforms the approach to virus vaccine development.

In the field of antitumor drugs, the international academic journal Nature has published online the collaborative research feedback of the research groups led by Xu Chenqi and Li Boliang at the Institute of Biochemistry and Cell Biology, Shanghai Institute of Life Sciences, Chinese Academy of Sciences. This research has revealed that modulating cholesterol metabolism can regulate the antitumor activity of T cells, and has identified a new target for tumor immunotherapy—the cholesterol esterification enzyme ACAT1—as well as corresponding small-molecule drug precursors, laying a foundation for the development of novel tumor immunotherapy approaches.

An important research advance resulting from the collaborative efforts of the research groups led by Jiang Hualiang and Yang Caiguang at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and the research group led by Liu Jiang at the Beijing Genomics Institute has been published online in Cancer Cell. This study provides pharmacological validation of SPOP as a potential drug target for clear-cell renal cell carcinoma, while also pointing to a novel therapeutic approach—different from kinase inhibitors—for the discovery and clinical application of SPOP inhibitors in the treatment of renal cancer.

In the field of anti-infective drugs, researchers from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, together with colleagues from East China University of Science and Technology and other institutions, have collaboratively identified a novel drug target—CrtN protein—for combating (drug-resistant) Staphylococcus aureus infections. The related study has been published online in the international journal Nature Chemical Biology, providing a fresh avenue for the development of antibiotic alternatives, particularly antimicrobial agents that target pathogenicity.

In the field of metabolic syndrome treatment drugs, the journal *Cell* has published the latest research findings by Professor Li Pingping’s team from the Institute of Materia Medica, Peking Union Medical College, Chinese Academy of Medical Sciences: Galectin-3, a galactoside lectin, serves as a key molecule linking obesity, inflammation, and insulin resistance, playing an important role in the pathogenesis of diabetes and thus providing a new drug target for diabetes treatment.

Researcher Jin Yiguang from the Institute of Radiation and Radiation Medicine at the Academy of Military Medical Sciences stated: “The rapid advancement of basic sciences and the discovery of a series of new mechanisms and novel targets have laid a solid foundation for the development of new drugs and injected even greater momentum into this field.”