The New Coronavirus (NCV) is a “catch-all” virus that is highly transmissible, widespread, insidious, has a long incubation period, and is far more deadly than influenza. The New Coronavirus epidemic is the most serious public hazard of the last century, causing nearly 100 million infections and millions of deaths. It has had a tremendous impact on the world economy and politics, plunging the world into a situation where material supplies and medical resources are scarce.
Record number of new drug launches
A total of 125 drugs have been approved for marketing worldwide. Of these, 61, 18, 15 and 7 drugs were approved for marketing in the United States, China, Japan and India, respectively.While the new crown epidemic has had an impact on the biopharmaceutical development progress of companies around the world, there has been no slowdown in the rate of drug approvals to market in the United States.
The 125 new drugs include 83 small molecule therapeutics (67%) and 41 biologics (33%). Due to the difficulty of research and development of large molecule biologics, low drug resistance, high cost, small molecule drugs are still the “high ground” of drug development; if divided according to therapeutic areas, oncology drugs are still in the lead (33), followed by the treatment of rheumatoid arthritis (10) and the new crown pneumonia (8) drugs; in the dosage form including 50 drugs are injections, 25 drugs are tablets, 21 drugs are capsules and 29 other dosage forms.
From the review management point of view, 44 drugs were classified as special approval channel and qualified for “priority review”, 40 drugs were qualified as “orphan drugs”, and 24 drugs were qualified for “fast track”.
Accelerated pace of vaccine development
The speed of developing new vaccines has created a miracle in medical history. According to the statistics published by the World Health Organization (WHO), there are hundreds of new coronavirus vaccines under research worldwide, and several products have been conditionally approved for marketing, including inactivated vaccines, recombinant proteins, viral vectors, mRNA, etc. This reflects not only the close cooperation among government, enterprises, health care institutions and research institutions, but also the perfect value of solid platform technology in the process of meeting pharmaceutical needs.
At present, there are already several new crown vaccines conditionally approved for marketing. However, the supply of vaccine production is difficult and far from meeting the needs of the vaccinated population.
In addition to China, by the end of last year, the country with the highest percentage of new crown vaccination was Israel with 950,000 doses, accounting for 10.5% of the population; followed by the United Kingdom with 947,000 doses, accounting for 1.42% of the total population; the United States has received 3.48 million doses, accounting for 1.06% of the total population; and Russia with 440,000 doses, accounting for 0.3% of the population. Germany has received 165,000 doses, accounting for 0.2% of the population, and no other country has received more than 100,000 doses.
Through the available public information, it appears that the new coronavirus is mutating, with at least seven mutated strains spreading in more than 50 countries or regions of the world, and that these strains are more potent than the previous strains. This will not only increase the global health care burden, but will also challenge the effectiveness of existing drugs and vaccines.
On January 15, WHO noted that “the current spread of new coronaviruses and the fact that more variants are circulating suggest that this year’s outbreak will be more severe than last year’s.” As new variant viruses continue to increase, then cross-transmission is bound to see more variant viruses emerge. Although virus mutation is a normal biological evolutionary phenomenon, but its mutant virus transmission rate if indeed enhanced, will make it more difficult to prevent and control the epidemic, the original more effective epidemic prevention measures need to be adjusted or further strengthened.
New drugs approved in Europe and the U.S. to enjoy policy dividends
In 2020, the European Medicines Agency (EMA) approved a total of 42 new drug products containing 41 new active ingredients for marketing, including 17 orphan drugs. This number represents a significant increase compared to the 28 products with new active ingredients approved in 2019, but is slightly lower than the 45 approved in 2018.
Notable among these products are the first vaccine for COVID-19, Pfizer/BioNTech’s Comirnaty, and Gilead’s Veklury (raltegravir) for the treatment of adults with pneumonia requiring supplemental oxygen and adolescent patients infected with neocoronary pneumonia.
In addition, there are three gene therapy products and a series of new drugs approved for the treatment of various cancers, as well as some drugs approved under conditional marketing and “special circumstances” mechanisms.
In comparison to Europe, the U.S. Food and Drug Administration approved 53 new drugs in 2020, of which 40 (75%) were approved first in the United States. This is mainly due to the U.S. policies in new drug approval, such as fast-track approval, breakthrough therapies, priority review, and accelerated approval.
In addition, four new drugs were approved as “old drugs for new use” or “old drugs for new approval”. For example, China’s new antimalarial drug artesunate, approved in 1987, was listed in the second edition of the International Pharmacopoeia (Part V) by the WHO in 2003, while it was only approved for marketing in the United States last year.
However, it should be noted that most of the new drugs that enjoy the policy care often have “additional conditions”, which are conditional approval and need to improve their clinical effectiveness and safety or other studies after marketing.