China: The Epidemic Situation Is Difficult To Hinder The Pace Of Innovation, And "Priority Review" Accounts For 65% Of The 48 Approved New Drugs

Review and approval of new drugs in China and the United States in 2020

The global pandemic of new epidemic in 2020 reshapes the pharmaceutical industry, while biopharmaceuticals with outstanding innovation ability try to play the role of terminator in the pandemic. For example, the search for antiviral drugs in the early stage of the epidemic is in full swing, and the vaccine research and development under various technical routes in the later stage are contending.

However, the national drug review and approval agencies, which are regarded as "gatekeepers", are very busy with the interweaving of political situation and epidemic situation this year. How many new drugs are approved to enter the market each year has become a guide for pharmaceutical enterprises and investors in various countries, and it also dominates the future development direction of the industry.

The year 2020 is even worse, because it is an unprecedented year of global epidemic. People deeply feel that innovative drugs are the important cornerstone of life safety in the public health crisis, and the global drug R & D enterprises and regulatory departments are highly concerned by all sectors of the world.

In the global drug market, China and the United States are the two most important "wind vane" for the pharmaceutical industry. The United States is the country with the most mature drug review and approval system, the strongest pharmaceutical innovation ability and the highest drug consumption capacity in the world, while China is the largest emerging drug market in the world, and also the country with the largest reform of drug review and approval system. It can be said that the market of these two countries is the world's multinational pharmaceutical enterprises must contend for.

So, in the year of the epidemic, let's look at the "report cards" of drug regulatory agencies of China and the United States on both sides of the ocean to see if they have stopped because of the outbreak, and what are the differences between 2020 and previous years? In addition, what impact and changes will it bring to the whole biopharmaceutical industry? (Lu Shan)

In 2020, with the outbreak of new crown pneumonia, an unprecedented war of prevention and control of the epidemic has been launched all over the country. However, in the face of the sudden epidemic situation, China's National Drug Administration (nmpa) has not lagged behind in reform and innovation. Since last year, the reform of the drug review and approval system has continued to deepen, At the same time, we will continue to promote the innovation and upgrading of China's pharmaceutical industry.

Under the pressure of the epidemic situation, the CFDA approved 48 new drugs in 2020, slightly lower than that in 2019. Since 2017, China's National Drug Administration (nmpa, former CFDA) has made a more active attempt to accelerate the review and approval, which also drives the development of domestic innovative pharmaceutical enterprises and the innovation investment and transformation of traditional pharmaceutical enterprises.

Under the epidemic situation, the reform of drug evaluation and approval system in China has been continuously deepened, which has helped the innovation and upgrading of China's pharmaceutical industry. IC photo

Unlike the FDA's preference for rare diseases, the new drug approved by China drug administration is still "cancer is king". In terms of disease field, tumor accounted for 34% (16 / 48) of new drugs approved by nmpa in 2020, and the other high proportion included infectious diseases (15%), nerve (13%), bone (6%) and endocrine metabolism (6%).

Eight drugs for rare diseases were approved, all of them were imported drugs, and 8 drugs were in urgent need of clinical use. The drugs for rare diseases include Takeda's lanaliyoumab, aganase α, Pfizer's meglumine chlorobenzoate, and Sanofi's laronidase. China food and drug administration also has rapid evaluation methods. In 2020, 31 of them have been "priority review", accounting for 65%.

During the epidemic period, in addition to the continuous approval of new crown anti epidemic materials, according to the data officially disclosed by nmpa, a number of key new drugs will be approved in 2020.

On February 12, 2020, the State Drug Administration approved the listing of clomivir hydrochloride capsules, a class 1 innovative drug of Beijing keyingling Biotechnology Co., Ltd. It can be used with or without compensatory cirrhosis in the treatment of chronic hepatitis C virus (HCV) infection in newly diagnosed or interferon treated adults with genotype 1, 2, 3 and 6.

This is also the second drug after danorevir sodium tablets, the first domestic drug for chronic hepatitis C treatment, has been approved for the market since then, and the three drugs are all HCV NS5A protein specific inhibitors can meet the needs of clinical treatment of chronic hepatitis C virus infection by combining with other antiviral drugs.

In March 2020, ametinib mesylate, a class 1 innovative drug of hausen pharmaceutical, was put on the market for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive EGFR T790M mutation. The drug is an innovative drug developed independently in China with independent intellectual property rights.

In March, benzocyquinium bromide nasal spray was approved for the market through the priority review procedure. The selective m-choline receptor antagonist developed by Yingu pharmaceutical can effectively treat allergic rhinitis with minor side effects, providing a new treatment option for patients with allergic rhinitis.

In May, Novartis innovative drug cinemod was approved for use in the treatment of adult relapsing multiple sclerosis, including clinical isolated syndrome, relapse remission disease and active secondary progressive disease. Cinimode is a sphingosine-1-phosphate (S1P) receptor regulator. It selectively binds to S1P receptor subtypes 1 (S1P1) and subtype 5 (S1P5) with high affinity, which prevents lymphocytes from escaping from lymph nodes and reduces the number of peripheral blood lymphocytes.

In June, in addition to Genzyme's laronidase for injection solution was launched for long-term enzyme replacement therapy in patients with mucopolysaccharidosis type I, and for the treatment of non neurological manifestations of the disease. Zabutinib, a Btk inhibitor in Baiji, was also launched in the same month. It is also the first Chinese innovative drug approved and approved by FDA as a breakthrough therapy for adult mantle cell lymphoma (MCL) patients who have received at least one treatment in the past and adult patients with chronic lymphoblastic leukemia (CLL) / small lymphocyte lymphoma (SLL) who have received at least one treatment.

In July 2020, remazolam besylate for injection of Renfu Pharmaceutical Co., Ltd. was approved for listing through priority review, and edaravone and d-camphor injection, a drug used in the treatment of stroke by Xiansheng Pharmaceutical Co., Ltd., were approved for marketing.

In November, ensatinib hydrochloride capsule, an innovative drug of Beida pharmaceutical, was put on the market for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with clazotinib or who are resistant to clazotinib. It also fills the blank of alk-tki targeted drugs in China.

In December, lanarizumab injection was approved to be used in the treatment of hereditary angioedema (HAE). It is an autosomal dominant hereditary disease, which is considered to be a rare disease in Europe, America and China. Nearly half of the patients may suffer from upper respiratory tract mucous membrane edema and cause asphyxia and life-threatening. Domestic treatment methods are limited and there are unsatisfied clinical manifestations Demand. Hengrui's fluzopari capsules were also approved for marketing in December. The drug is an innovative drug independently developed by China with independent intellectual property rights. It is used for the treatment of platinum sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer with embryo line BRCA mutation (gbrcam) after second-line chemotherapy. In addition, there is a new drug of Liaoning haisike cyclophenol injection on the market, which is used for sedation in gastrointestinal endoscopy.

At the end of 2020, China's first new coronavirus vaccine was officially put on the market with conditions. On December 30, 2020, the State Food and Drug Administration approved the registration application of new coronavirus inactivated vaccine of China biological Beijing Institute of biological products of State Pharmaceutical Group, which closed the whole year's new drug approval and opened a new stage for the fight against new coronavirus.