TOP 10 most anticipated new drugs on the market in 2021

Novavax is developing a COVID-19 vaccine for most of 2020
.
When Pfizer and Moderna made the headlines, Novavax received a $1.
6 billion Warp Speed ​​operating grant after it launched a phase 3 study with 30,000 participants
.

In late January this year, the company reported 89% of the efficacy in a phase 3 clinical trial in the United Kingdom, and 60% of the efficacy in a phase 2B trial in South Africa.
In the latter study, more than 90% of patients were infected with local infections.
The seemingly more virulent strain of B.
1.
351
.
Novavax is the first vaccine manufacturer to have important trial data on newly emerging mutant viruses, and its clinical data adds more and more evidence that the existing COVID-19 vaccine may not be as effective against B.
1.
351
.

Novavax has started research and development work for newly emerging strains in early January
.

Although Novavax's trial in the United States is not expected to release data in March or April, it is in discussions with the US FDA on the possibility of evaluating the vaccine based on its UK trial data, but there is no clear answer yet
.
The company expects its vaccine will be available in the UK for the first time
.

In the manufacturing industry, Novavax has established a global network and promised to produce 2 billion doses of vaccines each year, and plans to provide 110 million doses to the US government in the second quarter
.
Production delays have delayed its vaccine trials in the United States and Mexico, but it has doubled its speed in transactions and cooperation
.

Evaluate predicts that the sales of Novavax-COVID-19 vaccine in 2021 (first year) will be 2.
37 billion U.
S.
dollars, and the total sales in 2026 will remain at 2.
73 billion U.
S.
dollars
.

3.
efgartigimod

Company: Argenx

Indications: IgG-mediated autoimmune diseases

Estimated sales in 2026: $2.
5 billion

Argenx's efgartigimod is expected to be the first anti-FcRn drug approved.
According to analysts at SVB Leerink, the target market for this type of drug in the United States alone may reach US$20-25 billion by 2030
.

The company recently submitted an application for efgartigimod to the US FDA for the treatment of systemic myasthenia gravis (gMG) and expects to submit the same application to regulatory agencies in Japan and the European Union this year
.

In the Phase 3 trial Adapt, it was shown that efgartigimod can treat MG by improving symptoms in a larger proportion of patients than placebo
.
Among the trial patients who tested positive for the acetylcholine receptor (AChR) antibody, 67.
7% of the patients taking efgartigmod responded to the Myasthenia Gravis Activity of Daily Living (MG-ADL) score, compared with 29.
7% of the placebo group
.
As for the duration of treatment response, 56.
8% had a response to efgartigmod for at least 8 weeks, and 34.
1% of patients had a response for at least 12 weeks
.

This marks the first stage 3 victory of the FcRn category
.
Competitor, Utimer's anti-FcRn drug rozanolixizumab will announce the results of Phase 3 MG trial this year; Johnson & Johnson's Momenta announced the phase 2 midterm positive results of its leading product nipocalimab in June last year; Immuvent's IMVT-1401 received 2a in August last year After the victory of the phase trial, but recently discovered that the patient's cholesterol level was elevated, an extensive phase 2b trial was suspended; and Alexion's ALXN1830 (formerly SYNT001) is still in early development
.

According to a report by SVB Leerink, route and frequency of administration may be a key distinguishing feature
.
Both experts agree that most patients prefer subcutaneous injections rather than intravenous injections
.
Efgartigimod is currently injected intravenously (IV), but Argenx is exploring a subcutaneous injection formulation and is conducting a 50-person gMG bridging study on these two formulations
.
Utimes Bi and Immunovent drugs are injected subcutaneously, Momenta is in IV dosage form, and Alexion is available in both drug dosage forms
.

Argenx, like its FcRn competitor, is exploring a wide range of autoimmune indications, including primary immune thrombocytopenia, pemphigus vulgaris and pemphigus phyllodes, and chronic inflammatory demyelinating polyneuropathy , warm autoimmune hemolytic anemia, thyroid eye disease and the like
.

4.
bardoxolone methyl

Company: Reata Pharmaceuticals

Indications: Chronic kidney disease

Estimated sales in 2026: $2.
5 billion

Abbott initially promised Reata US$450 million in 2010 to obtain the right to sell bardoxolne methyl outside the United States
.
The following year, Abbott invested another $400 million as part of a global collaboration to develop and commercialize Reata’s autoimmune myopathy
.

However, the drug has problems in clinical trials of type 2 diabetes and stage 4 chronic kidney disease
.
The increased mortality from cardiovascular disease in people taking bardoxolne methyl has brought the study to an abrupt halt
.
Reata went back to square one, laid off half of the staff, and reconsidered the potential use of the drug
.

In 2014, Reata pushed bardoxolne methyl to a phase 2 trial of a new indication for pulmonary arterial hypertension (PAH)
.
It has also begun testing the drug in two types of hereditary kidney disease: Alport syndrome and autosomal dominant polycystic kidney disease
.
At the same time, AbbVie, which was spun off from Abbott, announced its withdrawal from the cooperation in 2019, using the then US$850 million investment in exchange for US$330 million in cash
.
Reata attributed this departure to AbbVie's development as a company and its stay away from kidney disease
.

At the end of 2019, Reata released positive data from the Phase 3 trial, showing that patients with chronic kidney disease who received bardoxolne methyl treatment due to Alport syndrome had improved renal function after 48 weeks, and continued to improve after 4 weeks of stopping the drug
.
Alport syndrome is the second most common cause of kidney failure, affecting as many as 60,000 people in the United States
.
There is currently no cure for this condition
.

Evaluate pointed out that early sales forecasts for bardoxolne methyl are few, and only a few million dollars in revenue is expected after approval this year
.
However, the drug will quickly reach a sensational status in 2024, with sales reaching 1.
12 billion U.
S.
dollars, and will further accelerate to 2.
5 billion U.
S.
dollars in 2026
.

5.
Deucravacitinib

Company: Bristol-Myers Squibb (BMS)

Indications: Inflammatory diseases such as psoriasis

Estimated sales in 2026: $2.
21 billion

In November 2020, BMS stated that in a phase 3 trial of patients with moderate to severe plaque psoriasis, the efficacy of the TYK2 inhibitor deucravacitinib surpassed that of Otezla
.
Compared with the latter, the skin condition of patients taking this new drug improved better
.
Earlier this month, in a second similar phase 3 study, deucravacitinib once again defeated Otezla in its efficacy
.

In the phase 2 trial of the drug, 69% of patients who took 3 mg of deucavacitinib twice a day had at least a 75% reduction in their psoriasis area and severity index (PASI) score at week 12
.

The results of the trial supported the US FDA's approval of the drug in 2014
.
The corresponding data verification in the phase 3 clinical trial of deucravacitinib means that the competition for the PDE4 inhibitor Otezla will be more intense
.

In the first nine months of 2020, Amgen Otezla’s sales reached US$1.
58 billion, an increase of 15% over the same period last year, but it has slowed down due to the emergence of COVID-19
.
In addition to psoriasis, BMS believes that the TYK2 pathway can also serve as a target for other inflammatory diseases, such as lupus, psoriatic arthritis and inflammatory bowel disease
.

6.
Inclisiran

Company: Novartis

Indications: Hypercholesterolemia

Estimated sales in 2026: US$2.
01 billion

Novartis’s newly acquired drug incisiran was originally planned to be approved by the U.
S.
FDA before the end of 2020, but in December last year, it unexpectedly received a reply letter expressing the FDA’s concerns about the PCSK9 drug for patients with high cholesterol
.

The fate of Inclisiran's approval this year is still unclear
.
Novartis CEO Vas Narasimhan (Vas Narasimhan) recently told reporters that although the Swiss drugmaker is expected to respond to US FDA requirements around the second or third quarter, it is not yet certain that the agency will eventually Will it inspect its production plants, so it is "difficult to comment on the timetable afterwards"
.
However, based on Novartis’s general expectation that the sales slowdown related to the flu epidemic will be lifted by the second half of 2021, it is still possible to approve inclisiran by the end of the year
.

As the regulatory fate of incisiran in the United States is pending, the company applied for approval and was approved in the European Union for the drug under the Leqvio brand name in December last year, six months earlier than the original plan
.
The aforementioned Italian plant is part of Novartis' plan for this approval
.

Better treatment compliance may be a big selling point of inclisiran
.
In the Orion clinical project of the drug, LDL-C levels of patients in different subgroups were reduced by 48%-52%
.
This effect is generally considered to be comparable to the two existing PCSK9 antibodies (Amgen Repatha and Sanofi/Regeneron’s Praluent)
.
However, these two drugs are self-administered by patients every two to four weeks, while inclisiran is injected every six months by professional medical staff after two initial doses
.

After entering the U.
S.
market in 2015, Praluent and Repatha faced pricing pressure from cost-effective regulators and payers, and their sales were still far below the blockbuster drug levels initially predicted by industry observers
.
In the third quarter of 2020, Repatha, which performed better of these two drugs, achieved sales of US$205 million, a year-on-year increase of 22%
.
In order to avoid the pricing review experienced by similar predecessors, Novartis stated from the beginning that it will price inclisiran within the cost-benefit range previously proposed
.
A new report from the Institute of Clinical and Economic Research sets the cost-effective price of incisiran at US$3,600-6,000 per year, which is consistent with the current list prices of US$5,400 and US$5,850 for these two antibody drugs
.

As of January this year, EvaluatePharma estimates that Repatha’s total sales in 2026 will be US$1.
97 billion, and that of Sanofi/Praluent will be only US$669 million
.
Both are lower than Inclisiran's estimate of $2.
01 billion at the time
.

7.
SRP-9001

Company: Sarepta Therapeutics

Indications: DMD

Estimated sales in 2026: $1.
88 billion

Sarepta already has two marketed DMD drugs: Exondys 51 and Vyondys 53, for specific patient subgroups
.
But the approval of these two drugs has previously attracted attention because they are based on surrogate endpoints in single-arm trials
.
Sarepta hopes to change this situation through gene therapy SRP-9001, but based on the data from the Phase 2 trial, the road ahead will be very difficult
.

Sarepta designed the Phase 2 trial of SRP-9001 in a placebo-controlled manner.
In addition to the improvement in the expression of microdystrophin compared to the baseline level, it will also be called the 17-point exercise capacity of the Polaris Dynamic Assessment (NSAA) The change of the table serves as its common primary end point
.
However, data released in January showed that the gene therapy failed
.

But in children treated with SRP-9001, the researchers recorded an average increase of 1.
7 points in NSAA from baseline at 48 weeks, compared with 0.
9 points in the placebo group
.
This difference is too small to cross the boundary of statistical significance
.
Sarepta pointed out that during the baseline examination, the patient's unbalanced health status was the cause of the failure
.

Sarepta hopes that the lessons learned from the Phase 2 study can guide the company to design a better Phase 3 trial, and that the company will not go alone in this regard
.
At the end of 2019, Roche prepaid US$1.
15 billion, including US$400 million in equity investment to purchase SRP-9001 rights outside the United States.
The potential milestone reached US$1.
7 billion
.

The huge amount of this transaction reflects the market potential of a successful DMD drug in the absence of treatment options
.
In the third quarter of 2020, Exondys 51 and Vyondys 53 brought a total of $121.
4 million in sales, and these sales only came from about 20% of the DMD patients they targeted
.

8.
Adagrasib

Company: Mirati Therapeutics

Indications: KRAS G12C mutation-positive cancer

Estimated sales in 2026: $1.
74 billion

KRAS was once considered an incurable cancer target, but it will soon be the first drug approved by the US FDA
.

Amgen sotorasib (AMG 510) is expected to be the first drug.
The company applied for its drug in mid-December 2020 for patients with KRAS G12C mutant non-small cell lung cancer who have received treatment
.
But Mirati Therapeutics' adagrasib is a close second, and EvaluatePharma analysts believe that, at least for now, it is a better choice than Amgen therapy
.

Sotorasib's US FDA approval application is based on data from a phase 2 trial
.
According to the latest results of the CodeBreak 100 trial recently published at the World Lung Cancer Conference, the drug triggered a response in 37% of NSCLC patients with KRAS G12C mutations, with a median duration of response of 10 months, and an overall effective rate of 37%.
But still lower than the 45% total effective rate obtained by adagrasib (MRTX849) in its ongoing Phase 1/2 Krystal-1 trial
.

Monotherapy is only an entry point
.
The SVB Leerink team pointed out that joint trials may bring more possibilities
.
Later this year, Mirati may report data on the first-line treatment of non-small cell lung cancer with adagrasib and Merck’s PD-1 blocker Keytruda, and the second-line treatment for colorectal cancer with Eli Lilly’s EGFR inhibitor Erbitux
.

As of January this year, EvaluatePharma expects sales of adagrasib in 2026 to be 1.
74 billion U.
S.
dollars, and by then, Amgen and its Chinese partner BeiGene's sotorasib sales are expected to be 1.
51 billion U.
S.
dollars
.

9.
Bempegaldesleukin

Company: Nektar Therapeutics

Indications: melanoma, renal cell carcinoma and other cancers

Estimated sales in 2026: $1.
72 billion

Its candidate drug bempegaldesleukin is a CD122-targeted IL-2 pathway agonist, referred to as bempeg, and is currently undergoing four phase 3 trials in conjunction with BMS’s Opdivo, including metastatic melanoma, kidney cancer, muscle invasive bladder cancer and Melanoma after surgery
.

So far, the company has seen promising data
.
In November, Nektar reported that 90% (18) of 20 patients with metastatic melanoma responded to the bempeg-Opdivo combination therapy
.
According to the commonly used RECIST indicators, the patient's target lesion size was reduced by 100%
.
77% of the patients in the study were still alive after 2 years
.

At the JPMorgan Chase Medical Conference in January, Nektar announced a trial plan for metastatic melanoma, set to go public in 2023
.
After that, it is expected that data on metastatic kidney cancer and muscle invasive bladder cancer will be released in 2022, and it is expected to be on the market in 2023
.

The company has been applying its advanced polymer conjugation technology platform to modify the chemical structure of pharmaceuticals since 1990
.
It has provided technology to Amgen, Merck, Pfizer and Utimes, and has developed its own drug candidates
.

Evaluate believes that bempeg will have annual sales of 1.
72 billion U.
S.
dollars in 2026 based on expected sales of 1.
27 billion U.
S.
dollars in 2025
.

10.
Bimekizumab

Company: UCB (UCB)

Apply to: Psoriasis

Estimated sales in 2026: $1.
63 billion

Anti-psoriatic monoclonal antibody therapies are increasing, but UCB hopes to use bimekizumab to enter the market this year
.
This anti-IL-17A and IL-17F injection was compared in the trial with Johnson & Johnson's Stelara and Novartis' best-selling drug Cosentyx
.

The Stelara head-to-head study published in the American Academy of Dermatology in June 2020 showed that 85% of bimekizumab patients reduced the area and severity of psoriasis symptoms by 90% or more at 16 weeks
.
Complete skin clearance (PASI100) occurred in 59% of patients
.
At the same time, Stelara only helped half of the patients to reach PASI90, and 21% of patients reached PASI100
.
In July, UCB announced that bimekizumab outperformed secukinumab in PASI100 in weeks 16 and 48
.

Evaluate wrote in June that the data from the Cosentyx trial may be of great reference value for UCB, and Evaluate expects sales of $1.
63 billion in 2026
.

One concern for UCB is whether smaller pharmaceutical companies can compete with pharmaceutical companies with large marketing budgets for psoriasis
.
AbbVie Skyrizi and Humira, Novartis Cosentyx, Eli Lilly Taltz, and Amgen Otezla are just a few psoriasis drugs that spend millions on mainstream TV advertising to build brands
.

But currently, the US FDA and European EMA have accepted bimekizumab biologics license application (BLA) for the treatment of patients with moderate to severe plaque psoriasis
.
The drug is being evaluated in ongoing Phase 3 clinical trials for other diseases, including psoriatic arthritis, ankylosing spondylitis, non-radiation axial spondylitis, and hidradenitis suppurativa
.

Reference: The 10 most-anticipated drug launches of 2021