Overview of the top ten blockbuster drugs in 2021

Every New Year is accompanied by the hope of new drug approval.

Recently, Fierce Pharma has forecasted global drug sales in 2026, and selected the ten most anticipated new drug approvals in 2021.

Top ten new drugs most anticipated to be launched in 2021

These drug candidates are accompanied by various controversies, people's expectations, ambitions to end the epidemic, and even the recurrence of the new coronavirus.

Leading the way is the industry's mixed Alzheimer's disease drug candidates-Biogen and Eisai's aducanumab.

Mentioned here is the second place on the list, Novavax's drug candidate new coronavirus (COVID-19) vaccine.

Among the top ten approved drugs, six drug candidates from previous years have reappeared on this year's list.

The FDA issued a surprisingly complete response letter.

Novartis is expected to respond to the FDA's request in the second or third quarter, but it is unclear whether the FDA will eventually inspect the plant.

Novartis is not the only 2020 drugmaker on the list last year that suffered an accident.

For example, Gilead Sciences abandoned its JAK inhibitor filgotinib for rheumatoid arthritis, while BioMarin's hemophilia A gene therapy valoctocogene roxaparvove remained stagnant after the FDA issued a full response letter.

AstraZeneca (AstraZeneca) and FibroGen's blockbuster anti-anemia drug roxadustat (roxadustat) are also still waiting for a new review date in March.

There is no doubt that the 2021 drug candidates are expected to avoid this fate of uselessness, but even if there is no pandemic, we will look back next year to something that has not been hyped.

1.

Drug: aducanumab

Company: Biogen, Eisai

Indications: Alzheimer's disease

Estimated sales in 2026: $4.

No drug candidate has been approved more than Biogen's anti-β-amyloid antibody aducanumab.

On the one hand, there are hopeful Alzheimer's patients, their families, promote therapists, pharmaceutical manufacturers, and some devotees within the FDA.

On the other hand are doctors, other drug makers with Alzheimer’s disease drug candidates, and most of the experts in the FDA’s advisory panel reviewing aducanumab-they say they understand that people urgently need a solution to Alzheimer’s disease However, these drugs are often not effective enough to bring changes to patients with Alzheimer’s disease.

Aducanumab strongly dispelled people's doubts about whether its phase III clinical trial provided "strong evidence to support the effectiveness of the drug in the treatment of Alzheimer's disease" on AdComm in November.
The two abstained.
The second round of voting on whether the small Phase Ib study showed "supportive evidence" of efficacy was almost equally frustrating, with 7-1 votes against and 4 members abstaining.

However, the drug entered the list with the FDA's approval briefing document.
In fact, this briefing was so positive that many members of the advisory committee accused FDA officials of apparently coaxing aducanumab into approval.

The committee’s veto and other vetoes were made after considering two Phase III studies (called EMERGE (aka Study 301) and ENGAGE), two of which were tested in patients with early and mild Alzheimer’s disease Aducanumab, and a phase Ib study with a difference-and still do not publish the results of the study.

For example, the patients who received the highest dose of aducanumab in the EMERGE trial had a statistically significant improvement on the clinical dementia scale, but the same patient group in the ENGAGE study was indeed worse than placebo patients on the same indicators and cognitive function tests.

Then, the Phase III project failed in the invalidation analysis in March 2019, which initially prompted Biogen to withdraw from the entire project.

But eight months later, the company’s surprise was that they insisted that the analysis was "incorrect.
" Biogen believes that this is based on a smaller data set, with fewer patients receiving high doses of aducanumab.
According to his estimates, other data did show that aducanumab reduced clinical decline, so it was decided to apply for approval.

This is why aducanumab is still on the list of the most anticipated drugs on the market.
Under the leadership of Biogen executives, many people still believe that the drug's approval path is clear and reasonable.

At the JPMorgan Chase Healthcare Conference last month, Biogen executives told aducanumab-focused investors that they were surprised by AdComm’s rejection and pointed out that the committee’s vote was not binding.

"The FDA has sufficient priority to disagree with the committee's vote.
" "We are still reviewing, and we will hope to know what their decision is before March 7.
" said Al Sandrock, head of Biogen's research and development.

This priority includes Sarepta Therapeutics' Duchenne muscular dystrophy drug.
Exondys 51 was approved in 2016, and despite the limited data, the advisory group’s recommendations were negative.
Recently, Vyondys 53, which was initially rejected by the FDA in August 2019, received a surprising green light in December of that year.
It is worth noting that the approval of aducanumab was approved by the same FDA neuroscience team as the Sarepta drug, which is led by director Billy Dunn.

However, now Biogen and the rest of the world will have to wait longer to get the FDA's decision.
The FDA was originally scheduled to give the final results in March, but last month decided to postpone it to early June.
News reports that Biogen’s stock price has jumped because some market observers believe the so-called delay is a signal that the FDA is considering approval, despite AdComm’s vote against it.

If approved, Evaluate expects moderate starting sales of 271 million U.
S.
dollars in 2021 and 765 million U.
S.
dollars in 2022, but then the drug will develop rapidly, reaching 4.
94 billion U.
S.
dollars by 2026.

2.
NVX-CoV2373

Drug: NVX-CoV2373

Company: Novavax

Indications: Novel coronavirus (COVID-19) vaccine

Estimated sales in 2026: $2.
73 billion

For most of 2020, Novavax's new coronavirus (COVID-19) vaccine was unknown.
Just as Pfizer and Moderna were grabbing the headlines, this small, Maryland-based biotechnology company received $1.
6 billion in "Warp-Speed" funding (which was obtained after the first batch of pharmaceutical companies injected capital), and established three A late-stage clinical development project including Phase III studies for 10,000 patients.

In late January, it reported 89% efficacy in its Phase III trial in the UK and 60% efficacy in the Phase 2b trial in South Africa.
More than 90% of the people in the study were infected with the B.
1.
351 strain that appeared to be more virulent, and Novavax was the first vaccine manufacturer to have important test data for the emerging variant-its clinical data increased There is increasing evidence that the existing COVID-19 vaccine may be less effective on B.
1.
351.

Novavax has started to study the structure against the new strain in early January.
The company believes that their method, including adjuvant fragments of spike proteins made in insect cells, is very suitable for evolving viruses.

"One of the main benefits of our adjuvant platform is that it uses a very small amount of antigens, enables rapid creation and large-scale production of combinatorial vaccine candidates, and can potentially address multiple epidemic strains of COVID-19," Novavax R&D President Gregory Glenn, MD said in a statement.
Analysts agreed with this.
Jeffries stated after the preliminary data results that Novavax is now “one of the premier COVID-19 vaccine companies”.

Another advantage of the Novavax adjuvant platform is that it is transported and stored at typical refrigerated temperatures, which is different from Pfizer and Moderna, but is roughly similar to Johnson & Johnson's drug candidates.

Although Novavax's ongoing US trial is not expected to announce results until March or April, CEO Stanley Erck said that it is discussing with the FDA the possibility of evaluating the vaccine based on its UK data, but there is no clear answer yet.
.
Novavax expects the first approval of the vaccine will be in the UK.

At the same time, this small biotechnology company is upgrading manufacturing and cultivating talents.

It appointed AstraZeneca veteran Filip Dubovsky as chief medical officer in June of this year, and appointed manufacturing supervisor Rick Crowley as executive FP and chief in December.
Operations officer.
He took over the position in the manufacturing department from Ben Machielse, who was hired in July and will continue to serve as a consultant to CEO Erck.

In terms of manufacturing, Novavax has built a global network and promises to produce 2 billion doses of vaccines every year.
Erck said at JPM that its plan includes providing 110 million doses to the US government in the second quarter.

Production delays have delayed vaccine trials in the United States and Mexico, and have doubled in terms of transactions and partnerships.

So far, its roster of production partners includes Fujifilm, which produces clinical supplies, and AGC Biologics and PolyPeptide, which help it produce Matrix-M adjuvants.
Generic drug manufacturer Endo is producing clinical trial drug candidates, and if the vaccine is approved, it will assume responsibility for commercialization.
Another deal with the Serum Institute of India involves the production of antigens used in the Novavax vaccine.
Its latest deal with Baxter BioPharma Solutions enables the German manufacturer to produce commercial vaccines for Europe and the United Kingdom.

Novavax has never brought a product to the market-along with the COVID-19 vaccine, it is also advancing its NanoFlu flu vaccine candidate in the United States.
It represents an effort under the leadership of the team that not only includes applying for FDA approval and commercialization, but also obtaining a global license, and exploring the potential of the combined influenza and COVID-19 vaccine to be used after the pandemic.

Evaluate evaluates Novavax's COVID-19 vaccine sales.
The estimated sales for the first year of 2021 are 2.
37 billion U.
S.
dollars.
Surprisingly, the sales level is expected to remain at 2.
73 billion U.
S.
dollars in 2026.

3.
efgartigimod

Drug: efgartigimod

Company: Argenx

Indications: IgG-mediated autoimmune diseases

Estimated sales in 2026: $2.
5 billion

Argenx's efgartigimod is expected to become the first approved anti-FcRn drug.
According to analysts at SVB Leerink, the drug may enter a US$20 billion to US$25 billion market in the United States by 2030.

The Belgian company recently submitted an application for systemic myasthenia gravis (gMG) to the FDA, and is expected to submit applications to regulatory agencies in Japan and the European Union this year.
Under this timeline, Argenx believes that it has an estimated starting advantage of three years compared to the candidate list of other clinical FcRn competitors.
This candidate list includes Johnson & Johnson’s newly acquired Momenta Pharmaceuticals, UCB and Alexion Pharmaceuticals (which will soon be included in Aspen Likang) and so on.

FcRn is known as the protective receptor for immunoglobulin G (IgG).
The principle behind drugs like efgartigimod is that blocking FcRn can reduce pathogenic IgG antibodies, which is related to several autoimmune diseases.

In the phase III adjusted trial, efgartigimod showed that it can be used to treat MG by improving the symptoms of a larger proportion of patients compared with placebo.
Among the test patients who tested positive for the acetylcholine receptor (AChR) antibody (an indicator of MG), 67.
7% of efgartigimod users were counted as responders in the myasthenia gravis activity of daily living (MG-ADL) score, while only 29.
7% Of placebo patients can achieve this effect.
As for the duration of treatment remission, 56.
8% of patients responded to efgartigimod for at least 8 weeks, and 34.
1% of patients responded for at least 12 weeks.

The trial also recruited AChR-negative patients, and a secondary endpoint analysis of all visitors also showed results.
However, just as Argenx pointed out the abnormally high placebo response, Thomas Smith of SVB Leerink suspected that the non-AChR subgroup was not statistically significant in a note in May, indicating that the final FDA label is still available for reference.
About 85% of MG patients have anti-AChR autoantibodies.

This marked the first phase III win for the FcRn category.
UCB's competitor anti-FcRn drug rozanolixizumab is scheduled to report Phase III MG results this year; Johnson & Johnson's Momenta released its lead product nipocalimab in June last year with optimistic results for Phase II mid-term; Immunovent's IMVT-1401 won Phase IIa last August Later, I focused on the possible phase III MG trial in the first half of this year, but recently in an extensive phase IIb trial, the trial was suspended after noticing that the patient’s cholesterol level was elevated; Alexion’s ALXN1830 (formerly known as SYNT001) was in Early development.

At the SVB Leerink event in July, two industry experts noticed some differences between the five clinical-stage anti-FcRn drugs, but more data are needed to determine whether they affect prescription behavior.
Specifically, UCB's rozanolixizumab was associated with a relatively high incidence of headaches in its phase II MG trial, while it was not a major problem in efgartigimod's phase III Adapt trial.

Experts point out that according to SVB Leerink's explanation, route and frequency of administration may be a key distinguishing feature.
Two experts predict that most patients prefer subcutaneous preparations to intravenous injections.
efgartigimod is currently available as an intravenous injection, but Argenx is exploring a subcutaneous dosing regimen and is comparing the two formulations in a 50-person gMG bridging study.
UCB and Immunovent are administered subcutaneously, Momenta is administered intravenously, and Alexion's two preparations are available.

Experts told SVB Leerink that patient coverage may also affect physicians' decision-making.
They pointed out that due to patient resistance, Alexion's C5 inhibitor Soliris has only limited use in refractory MG.
But Alexion's follow-up drug Ultomiris may be a better drug, and development of gMG and subcutaneous versions are underway.

Argenx, like its FcRn competitors, is exploring a wide range of autoimmune indications.
In the entire category, including primary immune thrombocytopenia, pemphigus vulgaris and deciduous pemphigus, chronic inflammatory demyelinating polyneuropathy, warm autoimmune hemolytic anemia, thyroid eye disease and other illnesses.

The SVB Leerink team stated in terms of the FcRn drug category: “We see that in a wider range of IgG-mediated diseases, we see greater potential.
We estimate that by 2030, the total target market in the United States will be approximately US$20 billion to US$20 billion.
$25 billion.
"

4.
bardoxolone methyl

Drug: Bardoxolone methyl

Company: Reata Pharmaceuticals

Indications: Chronic kidney disease

Estimated sales in 2026: $2.
5 billion

For Reata Pharmaceuticals' chronic kidney disease drug bardoxolne methyl, it has been an eventful time starting from the compelling Abbott partnership.
Abbott initially pledged $450 million to Reata in 2010 for the rights of bardoxolne methyl outside the United States.
Abbott invested another $400 million in the following year as part of a global collaboration to develop and commercialize Reata's autoimmune myopathy.

However, in 2012, there were problems with clinical trials of the drug in type 2 diabetes and phase 4 chronic kidney disease studies.
In people taking bardoxolne methyl, the death rate from cardiovascular causes increased, which caused the trial to stop suddenly.
Reata returned to the original plan, split the staff in two, and reconsidered the potential use of the drug.

In 2014, Reata pushed bardoxolone to a new indication, Phase II development of pulmonary arterial hypertension (PAH).
And began testing bardoxolone in two types of hereditary kidney diseases: Alport syndrome and autosomal dominant polycystic kidney disease, which is an inherited disease that causes a large number of cysts to grow in the kidney.

At the same time, Abbott, which has become a part of AbbVie, announced its withdrawal in 2019, when it traded its $850 million investment in cash for $330 million.
Reata attributed this departure to AbbVie's no longer research in the field of kidney disease.

Just one month later, one year after entering the Alport Cardinal study, Reata provided positive Phase III data at the end of 2019, showing that patients receiving the drug had better renal function after 48 weeks of treatment, and continued improvement after 4 weeks of stopping the drug.
The study compared the difference between bardoxolone and placebo in 157 patients with CKD due to Alport syndrome.
This syndrome gradually weakens the kidney's ability to filter blood, eventually leading to dialysis, end-stage renal disease, or kidney transplantation.

At the turn of two years, in November 2020, Reata announced that it had reached the primary and key secondary endpoints in the Cardinal study.
Reata also said that it has completed the pre-approval meeting with the FDA for new drugs and plans to submit the record in the first quarter of 2021.
At the same time, it has also started to submit for approval in Europe.

According to the Reata report, Alport syndrome is the second most common cause of renal failure, affecting up to 60,000 patients in the United States.
There is currently no treatment for this disease.

Evaluate，，。，bardoxolone methyl2024，11.
2，202625。

5.
deucravacitinib

：deucravacitinib

：（Bristol Myers Squibb）

：

2026：22.
1

（Bristol-Myers Squibb），TYK2deucravactinib（BMS-98615），CelgeneOtezla，。Ⅲ，。

11，，deucravacitinibⅢOtezla。Otezla。，ⅢOtezla。

Ⅱ，12，deucravacitinib3mg，，（PASI）75%69%。POETYK PSO-1 Ⅲ6mg。OtezlaⅢestem-1estem-2，30mg，31.
1%28.
8%1675%，2014FDA。deucravacitinibⅢ，PDE4Otezla。

Most psoriasis drugs are injected, with oral Otezla being a rare exception.
This is why the US Federal Trade Commission (US Federal Trade Commission) also raised anti-competitive concerns about another oral drug candidate, deucravactinib.
Although Otezla's oral dosage form may appeal to some patients, it is generally believed that it is not as effective as an injection dosage form, such as AbbVie's old dosage form Humira or the newer Skyrizi.
But for deucravacitinib, Bristol-Myers Squibb believes that it has the advantages of oral drugs and the same efficacy as injectable drugs.

Cantor Fitzgerald analyst Alethia Young said in a report last November that safety is also very important.
Bristol-Myers Squibb stated that the phase III safety of deucravacitinib is consistent with the previous phase II results, and Young believes that deucravacitinib is "quite benign.
" She added that since Otezla has relatively fewer side effects, one of its core strengths, safety comparison, will be the key.

If Otezla is a reference indicator, then deucravacitinib will have a huge market.
In the first nine months of 2020, Amgen’s sales of this drug were US$1.
58 billion, after COVID-19 slowed its year-on-year growth rate by 15%.

In addition to psoriasis, Bristol-Myers Squibb believes that the TYK2 pathway can be targeted to treat other inflammatory diseases, such as lupus, psoriatic arthritis and inflammatory bowel disease.
In terms of potential future competitors, Pfizer has a TYK2/JAK1 inhibitor called brepocitinib, which is currently in the phase II development stage for topical and oral preparations and has a wide range of indications.
However, SVB Leerink analysts have previously stated that Pfizer has difficulty beating deucavacitinib's Phase II performance, and that the company is about two years behind Bristol Myers.

6.
inclisiran

Drug: inclisiran

Company: Novartis

Indications: Hypercholesterolemia

Estimated sales in 2026: US$2.
01 billion

Novartis’s newly acquired inclisiran was originally planned to be approved by the United States before the end of 2020, but then COVID-19 broke out.
In December last year, the FDA unexpectedly issued a complete response letter concerning the PCSK9 drug application for patients with elevated levels of bad cholesterol.
Novartis described the FDA’s concerns as “conditions related to facility inspections” of its contractor Corden pharma’s Italian plant, but it has nothing to do with the efficacy, safety, or any other product-specific issues of inclisiran.
Previously, on-site inspections were scheduled for May 2020, but due to COVID-19, the FDA stopped foreign inspections.
In the documents submitted by Novartis, the FDA found some "problems related to process control," Novartis CEO Vas Narasimhan said.

The fate of inclisiran this year is still unclear.
Narasimhan recently told reporters that although the Swiss drugmaker is expected to respond to the FDA's request in the second or third quarter, it is not certain whether the FDA will eventually inspect the factory.
Therefore, "it is difficult to determine the specific time.
table".
However, Novartis predicts that the pandemic-related sales slowdown will improve in the second half of 2021, and it is still possible for inclisiran to be approved before the end of the year.

At the same time, Novartis’s management tried to actively mediate the delay, saying that it would enable the company to potentially avoid a more difficult listing during the pandemic and better prepare for approval when it arrives.

As inclisiran's regulatory fate in the United States is pending, it gave the green light to the European Union under the Leqvio brand in December last year, six months ahead of schedule.
The aforementioned Italian agency is part of Novartis's approval for packaging.
The company expects that the first batch of EU prescriptions will be issued from Germany in February this year.

In order to ensure the smooth promotion in the UK, Novartis signed the first similar group agreement with the UK government.
Novartis said the plan will address some of Leqvio's previous "nonclinical barriers", including patient compliance and access.
The plan is expected to be launched in the third quarter.

Potentially better treatment compliance is a big selling point of inclisiran.
In the Orion clinical project of inclisiran, the drug reduced LDL-C levels in different patient subgroups by approximately 48%-52%.
This effect is generally considered to be on par with the two existing PCSK9 antibodies-Amgen's Repatha and Sanofi, and Regeneron's Praluent.
However, these two drugs require patients to self-administer once every 2-4 weeks, while inclisiran is injected every 6 months by a healthcare professional after two initial loading doses.

After entering the U.
S.
market in 2015, Praluent and Repatha’s pricing faced setbacks from cost-effective regulators and payers, and their sales today are still far below what observers initially expected.
In the third quarter of 2020, Repatha, the better performer of the two, achieved sales of US$205 million, a year-on-year increase of 22%.

In order to avoid pricing review of similar products, Novartis stated from the beginning that it would price inclisiran within the cost-benefit range previously proposed.
A new report from the Institute for Clinical And Economic Review states that the cost-effective price of inclisiran ranges from US$3,600 to US$6,000 per year, which is consistent with the current list prices of the two antibody drugs of US$5,400 to US$5850.

As of January of this year, Evaluate estimates that by 2026, Amgen and its partner Astellas’ total sales of Repatha will reach US$1.
97 billion, and global sales of Sanofi and Regeneron’s praluant will be only US$669 million.
The valuations of these two companies at the time were both lower than Inclisiran's $2.
01 billion.

7.
SRP-9001

Drug: SRP-9001

Company: Sarepta Therapeutics

Indications: Duchenne muscular dystrophy

Estimated sales in 2026: $1.
88 billion

Sarepta Therapeutics has already launched two Duchenne muscular dystrophy (DMD) drugs Exondys 51 and Vyondyys 53 for specific populations.
But these approvals were surprising because they were based on surrogate endpoints in single-arm trials.
The company hopes to change this status quo through gene therapy SRP-9001.
But judging from the data of Phase II, the road ahead will be difficult.

DMD is caused by a genetic mutation that disrupts the expression of dystrophin, which is essential for muscle function.
Exondys 51 and Vyondys 53 partially restore dystrophin production by skipping specific exons near the mutation.
In their respective clinical trials, the drugs showed that they can indeed increase dystrophin, but there is no evidence that they can improve symptoms or slow the progression of the disease.
These two antisense drugs are also limited by their ability to target mutations that can cause specific exons to jump into SRP-9001.
It uses an adeno-associated virus to deliver a gene encoding microdystrophin to muscle tissue.

Sarepta designed the Phase II trial of SRP-9001 in a placebo-controlled manner.
In addition to the improvement in microdystrophin protein expression compared to baseline, it also called the change in the 17-point motor function scale as the North Star Dynamic Assessment (NSAA) as its common major end.

However, the data released in January showed that, in simple terms, the gene therapy failed.
But Sarepta management tried to paint a more complex picture, CEO Doug Ingram said, which made him "more confident than ever in the plan.
"

In children treated with SRP-9001, the investigators recorded an average improvement of 1.
7 points in NSAA from baseline at week 48, compared with an increase of 0.
9 points in the placebo group.
The difference is too small to cross the statistically significant bar.

But Sarepta pointed out that at the time of the baseline examination, the patient's unbalanced health status was the cause of the failure.
In this small study of 42 subjects, Sarepta divided the patients into two groups based on age.
According to Sarepta's research, there is not much difference in NSAA baseline scores among 6 to 7-year-old children.
Among children aged 4 and 5, SRP-9001 was associated with an average change of NSAA of 4.
3, which was significantly greater than 1.
9 in the placebo group.

Sarepta hopes that the experience gained from the Phase II study will guide it to achieve a better Phase III design, and the company will not fight alone on this goal.
At the end of 2019, Roche paid an upfront payment of US$1.
5 billion-including an equity investment of US$400 million-for SRP-9001 rights outside the United States, reaching a milestone of US$1.
7 billion.
This huge transaction reflects the market potential of a successful DMD drug in the absence of treatment options.
In the third quarter of 2020, the total sales of Exondys 51 and vyondyys 53 were US$121.
4 million, because their target patients accounted for only 20% of all DMD patients.

At present, Sarepta's closest competitor is Pfizer's PF-06939926, which was used in Phase I and III patients in January this year.
At least until the failure of Phase II of SRP-9001, Sarepta's drugs were considered superior to Pfizer's drug candidates based on their safety.
In Pfizer's phase II treatment, 3 out of 6 patients were hospitalized due to serious side effects (including 2 immune-related events), and the side effects of SRP-9001 appeared to be benign.

Before entering phase III, Sarepta is conducting a separate trial, but the company may provide the drug regulatory agency with phase II data and phase I results, including 4 patients with microdystrophin in muscle fibers.
The average expression rate was 95.
8%, and the average improvement rate of NSAA after two years was 7.
0%.

8.
adagrasib

Drug: adagrasib

Company: Mirati Therapeutics

Indications: KRAS G12C mutation-positive cancer

Estimated sales in 2026: $1.
74 billion

KRAS was once considered a target that cannot be treated with drugs, and it may soon be the first drug approved by the FDA.
Amgen's hyped sotorasib (AMG 510) is expected to be the first company to cross the finish line, as this large biotechnology company submitted a previously treated non-product containing the KRAS G12C mutation in mid-December last year.
Drug candidates for small cell lung cancer.
But Mirati Therapeutics' adagrasib is a close second, and Evaluate analysts believe that, at least for now, it is a better choice than Amgen therapy.

SotorasibFDAⅡ。CodeBreak 100，sortorasib37%KRAS G12CNSCLC，10。37%35%，MiratiⅠ/ⅡKrystal-145%adagrasib （MRTX849）。

10，SVB Leerink，adagasib。70%adagasib40%，sotorasibⅠ47%。，。，Mirati，。

，adagrasib，sotorasib。，。adagrasib。2，SVB LeerinkGeoffrey Porges，sotorasib，adagasib，sotorasibQT。

MiratiⅡ，Ⅲ。，，。

Mirati2021，。。SVB Leerink，。，MiratiadagasibPD-1KeytrudaNSCLCⅠ/Ⅰb，EGFRErbituxⅠ/Ⅰb。

As of January of this year, Evaluate predicts that the sales of adagasib will reach 1.
74 billion U.
S.
dollars in 2026, and by then, the sales of Amgen and its Chinese partner BeiGene's sotorasib will reach 1.
51 billion U.
S.
dollars.

9.
bempegaldesleukin

Drug: bempegaldesleukin

Company: Nektar Therapeutics

Indications: melanoma, renal cell carcinoma and other cancers

Estimated sales in 2026: $1.
72 billion

Combining a new cancer drug with an existing immuno-oncology highlight is a big ambition for Nektar Therapeutics.
The company's bempegaldesleukin, a CD122-directed IL-2 pathway agonist, referred to as bempeg, is currently in four phase III clinical trials with Bristol Myers Squibb's Opdivo.

These studies are testing the application of bempeg in cancer, including metastatic melanoma, kidney cancer, myometrial invasive bladder cancer, and postoperative melanoma.
Not to mention the Phase II trial of Nektar and Opdivo in bladder cancer, and the Phase I/II study of Merck's Keytruda in non-small cell lung cancer.

So far, the company has seen promising data.
In November, Nektar reported that among the 20 patients with metastatic melanoma, 90% or 18 patients who responded to the bempeg-Opdivo combination therapy had their target lesions reduced by 100% according to the commonly used RECIST indicator definition.
In this study, 77% of patients were still alive after two years.

At the JPMorgan Healthcare Conference in January this year, Nektar announced plans to release data on metastatic melanoma for the first time in the fourth quarter of 2021 or the first quarter of 2022, and plans to release it in 2023.
After that, data on metastatic kidney cancer is expected to be released in 2022, followed by data on muscle invasive bladder cancer, which is expected to be released in 2023.

These are indeed the ambitions of the San Francisco-based biopharmaceutical company, at least it seems.
But the company has been applying its advanced polymer conjugation technology platform to modify chemical structures since 1990.
It has provided technology to Amgen, Merck, Pfizer and UCB, and has developed its own drug candidates.

AstraZeneca's successful opioid constipation drug Movantik was developed using Nektar's technology.
There is also Takeda's Adynovate, a hemophilia drug that was developed with Baxalta.

In December of last year, Nektar sold royalties from future sales of Movantik and Adynovate for $150 million.
Nektar intends to use the money to fund early and late clinical trials of its immuno-oncology project.

Evaluate unanimously believes that bempeg’s annual sales in 2026 will be US$1.
72 billion, and on the basis of the expected sales of US$1.
27 billion in 2025, it has reached a sensational position the year before.

10.
bimekizumab

Drug: bimekizumab

Company: UCB

Indications: 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.
Anti-interleukin-17A and interleukin-17F injections appeared in both Johnson & Johnson's Stelara and Novartis's best-selling drug Cosentyx in the trial.

In June of this year, Be Vivid published a study in the American Academy of Dermatology, which was subsequently published in the journal Lancet.
The study found that 85% of bimekizumab patients had a 90% or higher reduction in the area and severity of psoriasis symptoms at 16 weeks, and 59% of patients had complete skin clearance with a PASI score of 100.
In the case of Stelara, only half of patients achieved PASI 90, and 21% of patients achieved complete skin clearance within the same period.

For a head-to-head comparative study called Be Radiant conducted by UCB and Novartis pharmaceutical giant Cosentyx (secukinumab), the interpretation of Be Vivid raised people's expectations of its potentially beneficial results.

In July of this year, UCB announced that in the Phase III study, its drug candidates "showed superiority over secukinumab in terms of complete skin clearance at 16 and 48 weeks.
" UCB promises that the complete research results will be announced "in due course.
"

The data from the Cosentyx trial may be of great value to UCB.
Analyst Jefferies predicts that bimekizumab's annual sales will reach around US$1.
5 billion.
If it beats Cosentyx, its sales are expected to rise to more than US$2 billion.

In the absence of specific Cosentyx-topping data from the Be Radiant study, Evaluate expects 2026 sales of $1.
63 billion.

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

In September of this year, the FDA and EMA accepted the UCB bimekizumab biologics license application (BLA) for the treatment of moderate to severe plaque psoriasis in adults.
The ongoing Phase III clinical trial is evaluating the efficacy of the drug in the treatment of a variety of other diseases, including psoriatic arthritis, ankylosing spondylitis, non-radiologically examined axial spondylitis, and hidradenitis suppurativa.

At the same time, more competition is coming.
DiCE Molecules, a biotechnology company in South San Francisco, received $80 million in new funding last month to invest its oral small molecule IL-17 project in clinical trials for psoriasis and establish a preclinical program.

In addition to IL-17 competitors, others are also looking for participation, especially some TYK2 inhibitors.
Bristol Myers Squibb's deucavacitinib recently defeated Otezla in a study, while Pfizer and Nimbus Therapeutics are both in phase II studies and have their own prospects.