New Drug Report 2020 -1

June 15, 2021

From the perspective of history and research, the new drug report 2020 introduced 148 kinds of chemical entities, biological agents and product development approved and marketed in various countries for the first time in the past year.

Field of treatment	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020
CNS	4	5	2	4	3	4	7	6	6	8	16
Respiratory System	1	1	2	1	5	3	1	1	2	1	0
The cardiovascular system	1	1	1	2	1	1	2	0	1	3	1
Kidney and urinary system	0	2	1	0	2	1	1	0	1	1	0
Hematological system	1	3	2	1	7	7	4	2	7	6	4
Alimentary system	1	0	1	4	1	4	1	4	2	1	0
Endocrine system	2	1	4	4	6	3	1	3	4	5	2
Dermatosis	0	1	2	1	1	2	4	3	3	5	3
Infectious disease	2	6	0	5	11	5	5	6	10	3	10
Musculoskeleta-l System	0	1	2	0	1	1	1	3	1	3	1
Immune system	5	4	5	11	2	5	10	8	5	4	7
Malignant tumor	7	7	10	12	10	14	5	18	18	13	21
Ophthalmic diseases	1	2	0	1	2	0	1	2	3	1	0
Metabolic diseases	4	2	2	7	3	5	4	4	5	2	4
Poisoning and drug abuse	0	0	1	1	0	0	1	0	0	0	0
Oral and dental	0	0	0	1	0	0	0	0	0	0	0
Diagnostic reagent	0	0	1	1	3	0	2	1	1	0	1
total	29	36	36	56	58	55	50	61	69	56	70

Table 1 Chemical drugs and biological agents marketed during 2010-2020

*Does not include product pipeline expansion drugs or EUA drugs.

Among the 148 products covered in this report, 70 new molecular entities and biological agents were approved for the first time in 2020. In addition, 42 important new product developments (the special term in this report refers to new combinations, new dosage forms and new indications of previously marketed drugs) have been launched worldwide. Another 27 new products, including new chemicals, biological agents and new product development, have been approved, but it is not possible to confirm whether these products would be available before December 31, 2020. The remaining nine products were approved for emergency use, as detailed below.

In terms of new molecular drugs, the most active therapeutic drugs are still anti-tumor drugs, with 21 new products first launched in 2020, followed by central nervous system drugs, with 16 types.

Nine first innovative drugs, including new drugs for migraine, HIV infection, hypercholesterolemia and a variety of malignant tumors, would be launched in 2020. In this report, the first new drug is defined as the first drug that is marketed in any country, targeted at any indication and has a new mechanism of action.

The United States has maintained its dominant position for many years and is still the most active new drug market in the world. The number of new drugs on the market in the United States accounts for 54% of the new products on the market in the world. The U.S. Food and Drug Administration (FDA) has always been committed to accelerating the process of new drug review. In 2017, researchers in the United States found that FDA’s drug review time during 2011-2015 was on average 60 days less than that of EMA; since then, the pace of review by US regulators has been further accelerated. FDA uses fast track and accelerated approval methods to make an ever increasing number of new drugs approved and less new drugs rejected, so that some people accuse FDA of becoming a partner of regulated enterprises. Japan is the second most active new drug market in 2020, with 14 new drugs on the market (accounting for 22% of the total new drugs on the market in the world). It is also worth noting that the number of new chemical and biological agents from local pharmaceutical companies in China continues to increase. Last year, eight of the world’s first products came from China, accounting for 12% of the global total.

Figure 1. Distribution map of new drugs on the market in 2020

Regulatory agencies (mainly FDA, although other countries have established corresponding procedures) can speed up the development and evaluation process of new drugs, and provide incentives for pharmaceutical companies by granting more special qualifications. The first such program authorized by the U.S. Congress was the orphan drug act of 1983, which was proposed and implemented to accelerate the development of drugs for rare diseases. Over the years, many countries have followed this orphan drug program initiated by the United States, and set up similar programs in their own countries. FDA’s “fast track” qualification was established in 1988 to promote the development of drugs to treat serious diseases and fill the gap in medical demand, and accelerate the evaluation of such drugs. Subsequently, the FDA passed the prescription drug user fee act (PDUFA) in 1992, which included “accelerated approval” and “priority review” procedures. At the same time, it formally required pharmaceutical companies to pay review fees to regulatory agencies for the first time. In 1997, PDUFA reduced the target review time from one year to 10 months. In 2012, the U.S. Congress increased the qualification of “breakthrough therapy”, so that the FDA has the right to exempt the normal approval procedures and requirements for new drugs whose curative effect is substantially improved compared with existing therapies. In 2012, FDA established a qualified infectious disease product (QIDP) qualification program after recognizing the market demand for anti-bacterial and anti-fungal drugs. About three-quarters of new drugs approved in the United States have obtained some kind of accelerated review qualification. In the European Union, Priority Medicine (PRIME) program is now in its fourth year, focusing on drugs that can significantly improve the efficacy of existing therapies or benefit patients who have no drugs available. European Medicines Agency (EMA) has also implemented the “accelerated assessment” program to speed up the review of drugs to fill the gap in medical demand (from 210 days to 150 days). In Japan, Sakigake (innovative drug) qualification system was established in 2015 to promote the development of innovative drugs, devices and regenerative medicine products. In 2020, only one year after the Orbis program was launched, a batch of new therapies would be approved. The Orbis project is an agreement reached by drug regulators in six countries (Australia, Brazil, Canada, Switzerland, the United Kingdom and the United States) to accelerate patient access to promising new anti-tumor drugs.

The two areas of treatment that benefit most from such accelerated reviews are anti-tumor drugs and rare disease treatments. A study conducted by the Wall Street Journal found that most of the anti-tumor drugs approved between 2015 and 2018 were qualified for fast track, and only 19% of them provided evidence that the drugs could significantly prolong the overall survival at the time of approval. However, the results of post market studies required by regulators to obtain full approval were not always consistent with the results of small sample studies provided in the accelerated review, because these small sample studies often used alternative endpoints.

Overall, in 2020, about half of all new chemical drugs, biological agents and product development on the market worldwide would be granted at least one special qualification in the listed countries.

In the report prepared for this special year, we also added a new chapter to summarize the repositioned marketed drugs for the prevention and treatment of covid-19, as well as the new chemical and biological agents with emergency use authorization (EUA). During the COVID-19 pandemic, almost all drugs and vaccines were approved in the corresponding countries through EUA or similar routes. In this annual report, a total of 9 chemicals and biological agents authorized for emergency use to prevent and treat covid-19 were introduced. The information of these drugs has been shown in Table 2 and Table 3, but it has not been listed in the new products listed in Table 1.

Drug name

Indication

Orphan Drug Designation (ODD)

Breakthrough Therapy Designation

Accelerated Approval

EU PRIME

Fast Track

Priority Review

US Real-Time Oncology Review

Orbis

QIDP

RPD

Japan Sakigake

EUA

Adalimumab

Gangrenous-s pyoderma

Anakinra

Deficiency IL-1 Receptor Antagonist ，DIRA

Afatinib

Gastrointestinal stromal tumor，GIST

Bamlanivimab

Covid-19

Baricitinib

Covid-19

BBIBP-CorV Covid-19inactivated vaccine

Prevention of Covid-19

Belantamab mafodotin

Multiple myeloma,MM

Belimumab

Lupus nephritis，LN

Berotralstat

Hereditary angioedema,HAE

Betibeglogene darolentivec

TDT

Borofalan(B10)

Head and neck cancer

Brexucabtagene autoleucel

Mantle Cell Lymphoma

Bulevirtide

Deltahepatitis

Calcium, magnesium, potassium, and sodium oxybates

Narcolepsy

Capmatinib

NSCLC

Casirivimab/imdevima-b

Covid-19

Cefiderocol

complicated urinary tract infection,cUTI; HABP

Detectnet (copper Cu 64dotatate) injection

Diagnosis of Neuroendocrin-e tumour

Covid-19 vaccine(ChAdOx1 S Recombinant adenovirus vector vaccine)

Prevention of Covid-19

Dapagliflozin

Heart failure

Decitabine/cedazuridin-e

myelodysplasti-c syndromes, MDS

Fenfluramine

Dravet syndrome, DS

Cefiderocol

HIV-1

Covid-19 vaccine(SPUTNIK V)

Prevention of Covid-19

Inebilizumab

NMOSD

Isatuximab

Itolizumab

Covid-19 cytokine storm

Lumasiran

PH1

Lumateperone tosylate

Schizophrenia

Lurbinectedin

SCLC

Luspatercept

Anemia of MDS

Mepolizumab

HES

Mitomycin

Covid-19 vaccine mRNA-1273

Prevention of Covid-19

Nintedanib

ILD

Oliceridine

Severe acute pain

Osilodrostat

Cushing’s syndrome

Peanut allergen

Peanut allergy

Pemigatinib

cholangiocarcino-ma

Pralsetinib

NSCLC

Thyroid carcinoma

Rilonacept

DIRA

Ripretinib

GIST

Risdiplam

SMA

Sacituzumab govitecan

Triple negative Breast cancer

Satralizumab

NMOSD

Selpercatinib

NSCLC; Thyroid carcinoma

Selumetinib

NF1

Tafasitamab

DLBCL

Tasimelteon

Smith-Magenis syndrome

Tazemetostat

Tepotinib

NSCLC

Teprotumumab

TAO

Tirabrutinib

PCNSL; WM; LPL

Tozinameran Covid-19 vaccine

Prevention of Covid-19

Trastuzumab deruxtecan

Breast cancer

Triheptanoin

LC-FAOD

Tucatinib

Breast cancer

Viltolaren

DMD

Table 2. Drug development under special review: special review status / qualification of new products in 2020

* Qualification is only applicable to relevant indications and listing countries. This table includes product pipeline development drugs and EUA drugs.

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