Farewell 2018: China's Pharmaceutical Industry Witnessed Historic 'Firsts' and Major Reforms

Editor’s Note: This article is republished from Medicine Observer, with authorization granted to VCBeat.

Do you still remember this year’s blockbuster film, “Dying to Survive”? This award-winning movie has once again focused public attention on the issue of patient access to medicines. In fact, ensuring that clinically urgent drugs reach patients more quickly, making them both accessible and affordable, has been a key focus of China’s pharmaceutical reforms in recent years. The year 2018, now drawing to a close, marked a year of critical breakthroughs in China’s drug regulatory reforms on this front.

Looking back at 2018, significant progress was made in drug review and approval. The priority review process was further accelerated, the implicit approval system for clinical trials was successfully implemented, a new policy of zero tariffs on imported anticancer drugs was introduced, and urgently needed imported drugs and rare disease medications received special priority review. Under these reforms, a series of achievements were gradually realized, particularly in the field of major diseases, where we witnessed numerous breakthroughs from scratch. A wave of domestically produced new drugs received approval, and urgently needed imported medicines reached patients with unprecedented speed.

In 2018, we witnessed many “firsts”: China’s first domestically developed novel anti-HIV drug was approved for market launch; the first PD-1 antibody drug, Opdivo, was approved in China; the first domestically produced PD-1 antibody, Tuoyi, received approval; the first domestically developed novel hepatitis C drug, Gluonvir, was launched; and globally debuted new drugs such as Aiyou Te and Airui Zhuo were introduced. Notably, as of December 24, there had been 157 records of drug research projects entering clinical trials via implicit approval.

In 2018, we also witnessed major policy changes in China’s pharmaceutical sector: institutional reforms involving the pharmaceutical industry, the release of the new National Essential Medicines List, the publication of the first national catalog of rare diseases, the “4+7” volume-based drug procurement pilot, and the issuance of the Draft Vaccine Administration Law.... These developments are ushering in a new era of drug regulation and hold profound historical significance.

Since the beginning of this year, the most impressive development has been that a cohort of innovative drugs, representing China’s innovation capabilities, has begun to bear fruit after more than a decade of arduous development, with some successfully approved for market launch. Meanwhile, the National Medical Products Administration (NMPA) has continuously optimized review procedures and simplified marketing authorization requirements to ensure that Chinese patients gain early access to new drugs already marketed abroad. As a result, a batch of imported drugs urgently needed for clinical use has entered the Chinese market at the fastest possible speed.

Below, we list only a selection of highly representative approved drugs (from the list of approved drugs published on the official website of the National Medical Products Administration):

On April 28, the National Medical Products Administration (NMPA) granted conditional approval for the market launch of the nine-valent human papillomavirus (HPV) vaccine for the prevention of cervical cancer (hereinafter referred to as the HPV vaccine). The nine-valent HPV vaccine is composed of virus-like particles formed from the major capsid proteins of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, which are highly purified and mixed. This vaccine is indicated for females aged 16 to 26 years for the prevention of cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, persistent infection, precancerous lesions, or atypical lesions caused by HPV. The import registration application for the nine-valent HPV vaccine was included in the priority review program. Its market launch signifies that all HPV vaccine varieties available globally are now accessible in China, providing a new and effective means for the prevention of cervical cancer.

On May 14, the National Medical Products Administration (NMPA) approved the marketing of Anlotinib Hydrochloride Capsules (Fukewei), a small-molecule multi-target receptor tyrosine kinase inhibitor, for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). Independently developed by Chia Tai Tianqing, Anlotinib Hydrochloride targets kinases including VEGFR1-3, FGFR1-4, c-KIT, and PDGFR-β. It significantly improves overall survival in patients with advanced NSCLC who have failed or are refractory to existing therapies, thereby providing a new therapeutic option. As a domestically developed targeted therapy for lung cancer, Anlotinib Hydrochloride Capsules were approved for market entry through the priority review and approval pathway.

On June 5, Frontier Biotechnologies announced that its albuvirtide for injection had been approved for marketing by the National Medical Products Administration (NMPA). Albuvirtide is a Class 1 new drug independently developed by Frontier Biotechnologies. It is the world’s first long-acting HIV-1 fusion inhibitor for the treatment of AIDS and China’s first original anti-HIV new drug, which was approved for marketing through the priority review program.

On June 15, the National Medical Products Administration (NMPA) announced the approval of the import registration application for nivolumab injection (Opdivo), indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are epidermal growth factor receptor (EGFR) mutation-negative and anaplastic lymphoma kinase (ALK)-negative, and whose disease has progressed during or after platinum-based chemotherapy or who are intolerant to such therapy. Developed by Bristol-Myers Squibb, this fully human monoclonal antibody targeting the PD-1 receptor was granted priority review status. As the first PD-1 inhibitor approved in China, its authorization marks the official entry of oncology treatment in the country into the era of immunotherapy.

On August 16, the National Medical Products Administration (NMPA) announced the conditional approval of pyrotinib maleate tablets (Airuini) for marketing, indicated for the treatment of recurrent or metastatic breast cancer. Developed by Hengrui Medicine, pyrotinib maleate is a dual-target tyrosine kinase inhibitor against HER2 and EGFR, representing an innovative drug independently developed in China. The drug received priority review and approval based on its Phase II clinical trial results, and is regarded as one of the paradigm cases for the priority approval pathway for domestically developed innovative drugs in China.

On September 5, the National Medical Products Administration (NMPA) announced the approval of fruquintinib capsules (brand name: Elunate) for the treatment of metastatic colorectal cancer. Fruquintinib is a quinazoline-based small-molecule angiogenesis inhibitor that primarily targets the vascular endothelial growth factor receptor (VEGFR) kinase family, including VEGFR-1, VEGFR-2, and VEGFR-3. Developed by Hutchison MediPharma, fruquintinib capsules are an innovative drug that had not been previously marketed either domestically or internationally. The drug was approved for market launch through the priority review and approval pathway, providing a new therapeutic option for patients with metastatic colorectal cancer.

On September 5, the National Medical Products Administration (NMPA) announced the approval of the import registration application for Eculizumab Injection, indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in adults and children. PNH and aHUS are classified as rare diseases globally. Developed by Alexion Pharmaceuticals of Switzerland, Eculizumab Injection is considered a clinically urgent medication and was included in the priority review program.

On December 4, the National Medical Products Administration (NMPA) announced the approval of the import registration application for emicizumab injection, a therapeutic agent for rare diseases, indicated for the treatment of patients with hemophilia A who have factor VIII inhibitors. Developed by Roche, emicizumab injection is a recombinant humanized bispecific monoclonal antibody that was included in the priority review program as a clinically urgent medical product.

On December 12, the National Medical Products Administration (NMPA) announced the approval of the import registration application for Selexipag Tablets for the treatment of pulmonary arterial hypertension. Selexipag is an orally active, highly selective, and long-acting non-prostanoid prostacyclin receptor agonist. It is the first oral formulation approved for the treatment of pulmonary arterial hypertension, thereby improving patient adherence. As a drug urgently needed in clinical practice, it was included in the priority review program.

On December 17, the National Medical Products Administration (NMPA) announced the conditional approval for the marketing of the first domestically produced PD-1 monoclonal antibody—Toripalimab Injection. This new drug was developed by Junshi Biosciences and its subsidiary Suzhou Zhonghe Biopharma. It is a fully human monoclonal antibody against the PD-1 receptor, independently developed in China with complete independent intellectual property rights. The drug was approved for marketing through the priority review pathway for the treatment of locally advanced or metastatic melanoma after failure of prior standard therapy.

On December 18, the National Medical Products Administration (NMPA) announced the approval of roxadustat capsules (brand name: Evrenzo), a novel therapeutic agent for renal anemia, for marketing in China. The drug is indicated for the treatment of anemia caused by chronic kidney disease (CKD) in patients undergoing dialysis. As the world’s first small-molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), this first-in-class novel drug was developed by FibroGen and has not yet been launched in any other country.

These newly approved drugs, whether landmark achievements in China’s pharmaceutical innovation or representative cases of expedited approval for clinically urgent imported medications, have all been published on the website of the National Medical Products Administration (NMPA). The greatest significance of these advancements lies in bringing advanced therapies, most needed by patients, directly to their bedside.

Looking back on the past year, several historically significant policy events have occurred:

In April, the State Council underwent institutional reform, with key adjustments in the pharmaceutical and healthcare sectors including: the establishment of the National Health Commission; the creation of the State Administration for Market Regulation, which replaced the former China Food and Drug Administration, while the National Medical Products Administration was established as a separate entity; and the formation of the National Healthcare Security Administration, which was officially inaugurated on May 31. This large-scale ministerial restructuring at the national level undoubtedly marks a new starting point for the next round of regulatory reforms and ushers in a new chapter for drug regulation.

On May 22, the national “First Batch of Rare Diseases Catalog” was released, including a total of 121 diseases. This signifies that rare diseases have gained attention at the policy level, which will promote the research and development of rare disease drugs as well as market access, marking a historic breakthrough.

On June 7, China’s National Medical Products Administration (NMPA) was elected as a member of the ICH Management Committee, thereby advancing the reform of China’s drug review and approval system, expanding the international influence of ICH guidelines, and accelerating the achievement of drug accessibility.

On October 25, the new edition of the National Essential Medicines List was released, increasing the total number of listed drugs from 520 to 685. While continuing to cover major clinical disease categories, the updated list places particular emphasis on cancers, pediatric conditions, and chronic diseases. The newly added medications include 12 antineoplastic agents, 22 urgently needed pediatric drugs, and a novel all-oral, pangenotypic medication for hepatitis C.

On November 11, the State Administration for Market Regulation released the Draft Vaccine Administration Law for public comment, signaling that standalone legislation on vaccine administration is imminent.

On November 15, the official documents for the first batch of the “4+7” volume-based procurement program, led by the National Healthcare Security Administration (NHSA), were formally released. Subsequently, a public notice announced the 25 drug varieties provisionally selected from the 31 pilot generic drugs. Among these, 22 were generic drugs that had passed the consistency evaluation, and 3 were originator drugs. The results of the winning bids demonstrated significant price reductions. As this volume-based procurement initiative was spearheaded by the NHSA and predominantly involved drugs that had passed the consistency evaluation, it attracted widespread attention within the pharmaceutical industry. Whether this model will become the mainstream approach for drug procurement in public medical institutions remains to be seen.

Looking back on the past year, China’s pharmaceutical industry has achieved remarkable progress in regulatory approval reforms and innovative development. Amidst this wave of innovation-driven reform, professionals across all sectors—centered on drug R&D, manufacturing, commercialization, and regulation—have dedicated their hard work and sweat in their respective roles. Notably, this year marks the 40th anniversary of China’s reform and opening-up policy. We have witnessed the growth of China’s pharmaceutical industry from weakness to strength, and from small scale to large scale. Although the journey has encountered twists and turns and offered lessons learned, the direction has always been forward. As winter gives way to spring, despite enduring hardships, we have pressed ahead with determination, striving for fruitful results.

As 2019 draws near, it is time to review the past and look ahead to the future. At this new historical starting point, Chinese pharmaceutical professionals must continue to strive for innovation and progress, uphold the noble mission of conquering diseases and benefiting patients, and bring greater hope to patients in China and around the world.