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Annual inventory: the world's top ten new blockbuster innovative drugs in 2022

 Last Update: 2022-12-30
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In 2022, the global drug discovery pipeline continued to maintain a rapid development momentum, and a variety of blockbuster innovative drugs were launched
.
During the year, the development of diabetes drugs was impressive, including the first drug that can delay the onset of type I diabetes (Tzield) and the first new class of type II hypoglycemic drugs (Mounjaro)
in 10 years.
In addition, a variety of diseases have also ushered in new drugs, including the first tyrosine kinase 2 (TYK2) inhibitor (Sotyktu), the first drug for the treatment of phosphatase deficiency (Xenpozyme), the first eye treatment bispecific antibody (Vabysmo), etc.
, the continuous development of innovative drugs has brought the possibility
of treatment of more diseases.

1 Mounjaro, the world's first GIP and GLP-1 receptor agonist

Common name: Tirzepatide

Common Name:

Trade name: Mounjaro

Trade name:

Company Name: Eli Lilly

Company Name:

Listing time: May 13, 2022

Time to market:

Indications: Can be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Indications:

On May 13, 2022, the US FDA approved the marketing of Eli Lilly Mounjaro for use in combination with diet control and exercise to improve blood sugar control in adults with type 2 diabetes, and the drug is the first and only one to obtain The FDA-approved GIP and GLP-1 receptor agonists also represent the first new class of hypoglycemic drugs
approved for marketing in nearly a decade.

Mounjaro integrates the effects of GIP and GLP-1 insulin into a single molecule to improve glycemic control
through a dual mechanism of action.
The drug is injected subcutaneously once a week, and the dose
can be adjusted according to tolerance.
At the same time, in addition to type 2 diabetes, Mounjaro has also shown potential in clinical trials to treat obese or overweight groups
.
According to discussions with the FDA, Eli Lilly will submit a marketing application
for tirzepatide for obese or overweight adults on a rolling basis this year.

2 The world's first EZH1/2 dual inhibitor - Ezharmia

Common name: Valemetostat tosilate

Common Name:

Trade name: Ezharmia

Trade name:

Company Name: Daiichi Sankyo

Company Name:

Listing time: September 26, 2022

Time to market:

Indications: For the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma (ATL).

Indications:

On September 26, 2022, Daiichi Mikyo (Daiichi Sankyo announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved Ezharmia for the treatment of relapsed/refractory adult T-cell leukemia/lymphoma (ATL).

The launch of Ezharmia marks the birth
of the first drug targeting EZH1 and EZH2.

ATL is a malignant clonal proliferative disease of the lymphatic system, which is highly prevalent in areas where the virus is endemic, and the prevalence is increasing year by year, and the median survival is only half a year
.
Ezharmia is a small molecule inhibitor that simultaneously targets EZH1/2, although EZH2 inhibitors have been marketed before, but the clinical results show that Ezharmia has obvious advantages in terms of safety, tolerability and therapeutic effect.
Ezharmia was granted orphan drug designation by MHLW and FDA in 2021
.
The listing of Ezharmia has also enhanced the confidence of latecomers in the study of EZH1/2 dual inhibitors, and three EZH1/2 dual inhibitors have entered clinical studies
.

3 The world's first bispecific antibody for eye therapy - Vabysmo

Common name: Faricimab -svoa

Common Name:

Trade name: Vabysmo

Trade name:

Company Name: Roche

Company Name:

Listing time: January 28, 2022

Time to market:

Indications: For the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Indications:

On January 28, 2022, the FDA approved the marketing of Roche's new drug Vabysmo, and in September of the same year, based on the good results of phase III clinical trials, the European Commission (EC) also approved the marketing of the drug for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), thereby improving vision
to some extent.

Vabysmo is a type that blocks both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) target bispecific antibody is also the only injectable eye drug
approved by the FDA and EC.
The EU's approval of Vabysmo is based on four items called TENAYA and LUCERNE; Phase III clinical results of YOSEMITE and RHINE, which showed that Vabysmo was superior to similar drugs and had a reduced injection frequency — every four months for the first year
.
Not only that, sticking to long-term injections can effectively improve vision
.
Vabysmo's good efficacy is also reflected in its sales, which have reached CHF 280 million (2,095.
8 million yuan) from its launch in January to November, contributing to Roche's performance
.

4 The world's first tyrosine kinase 2 (TYK2) inhibitor - Sotyktu

Common name: Deucravacitinib

Common Name:

Trade name: Sotyktu

Trade name:

Company name: Bristol-Myers Squibb

Company Name:

Listing time: May 2022, 9

Time to market:

Indications: For the treatment of adults receiving systemic therapy or phototherapy in patients with moderate to severe plaque psoriasis

Indications:

On September 9, 2022, the FDA approved the marketing of Sotyktu for the treatment of moderate to severe plaque psoriasis
in adults receiving systemic therapy or phototherapy.
At the same time, contraindications to the use of the drug are also proposed: it is not recommended to use
in combination with other effective immunosuppressants.

Sotyktu is the world's first and only inhibitor of TYK2, a member of the JAK family that does not contain SH2 and SH3 in its structure, but has two connected kinase regions located at the C terminus
.
Sotyktu exerts an inhibitory effect by inhibiting the regulatory domain of TYK2, and there are no serious side effects
while treating the disease.
The listing of Sotyktu is also an innovation in the treatment of severe plaque psoriasis, which also shows the great potential of TYK2 in the treatment of autoimmune diseases, based on this, many domestic companies have also deployed TYK2 inhibitors
.

5 The world's first drug for phosphatase deficiency - Xenpozyme

Common name: Olipudase alfa

Common Name:

Trade name: Xenpozyme

Trade name:

Company Name: Sanofi

Company Name:

Listing time: May 2022, 3

Time to market:

Indications: For the treatment of patients of the non-central nervous system with acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients

Indications:

On March 38, 2022, the Japanese Ministry of Health, Labour and Welfare approved the listing of Xenpozyme, In June and August of the same year, the European Union and the FDA approved the marketing application of the drug for the treatment of acid phosphatase deficiency in adult and pediatric patients, and the drug is the first and only drug
to treat ASMD.

Xenpozyme is a hydrolytic lysosomal sphingomyelin-specific enzyme, which can achieve the role of treating ASMD by decomposing sphingomyelins and reducing the accumulation of sphingomyelin, which is also a relatively new treatment method for the treatment of ASMD - enzyme replacement method
.
Normal human body has a sufficient amount of sphingomyeltase to hydrolyze sphingomyelin, but this balance is disrupted due to the lack of this enzyme, and the patient's lung function and spleen are abnormal
.
In order to accelerate the marketing of this drug, Xenpozyme was awarded breakthrough therapy, priority review, fast-track and other ways to accelerate market launch
.

6 The world's first IL-36R monoclonal antibody - Spevigo

Common name: Spesolimab

Common Name:

Trade name: Spevigo

Trade name:

Company name: Boehringer Ingelheim

Company Name:

Listing time: May 2022, 9

Time to market:

Indications: For the treatment of patients with generalized pustular psoriasis (GPP).

Indications:

On September 1, 2022, Boehringer Ingelheim Ingelheim) announced that the U.
S
.
Food and Drug Administration (FDA) has approved the marketing of Spevigo (spesolimab), a selective interleukin-36 receptor (IL-36R) antibody for the treatment of episodes of generalized pustular psoriasis (GPP).

Studies have found that IL-36 can promote the activation of T cells, promote antigen presentation and the expression of pro-inflammatory factors, and play an important role
in skin diseases such as psoriasis.
As a novel selective antibody, Spevigo (spesolimab) is the first FDA-approved therapy for generalized pustular psoriasis (GPP), which inhibits IL-36 signaling by specifically binding to IL36 receptors, thereby preventing downstream activation of pro-inflammatory and profibrotic pathways, and its clinical trials have confirmed that it has a significant effect
on the treatment of GPP attacks.

7 The world's first platinum-resistant folate receptor α-antibody conjugate (FRα-ADC) drug for ovarian cancer—ELAHERE

Common name: Mirvetuximab soravtansine-gynx

Common Name:

Trade name: ELAHERE

Trade name:

Company Name: ImmunoGen Inc.

Company Name:

Listing event: November 14, 2022

Listing Events:

Indications: For the treatment of adult patients with folate receptor α (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received one to three systemic regimens

Indications:

On November 14, 2022, the FDA accelerated approval of ELAHERE™ for the treatment of adult patients with folate receptor α (frα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had previously received 1 to 3 systemic regimens
.
Also approved is a companion diagnostic kit from Roche to diagnose patients
who are eligible for the treatment.

ELAHERE™ was approved to play a therapeutic role by targeting folate receptor α (FRα), a highly expressed receptor in cancer
.
As early as 2015, the drug was recognized as an orphan drug, and three years later, it was included in the fast-track approval channel by the FDA, but it was not until November 2022 that the drug was approved for marketing, and the twist was that the folic acid receptor FRα alone failed to obtain a good clinical treatment effect, but when the ADC was used as the carrier, the target gave new life, and the approval this time is also based on the name SORAYA Results of the III clinical trial
(Study 0417, NCT04296890).
At present, there are also a number of companies to layout the research and development
of FRα-ADC drugs.

8 The world's first gene therapy for hemophilia A – Roctavian

Common name: valoctocogene roxaparvovec

Common Name:

Trade name: Roctavian

Trade name:

Company Name: BioMarin

Company Name:

Listing time: May 2022, 8

Time to market:

Indications: For the treatment of adult patients with severe hemophilia A who have no history of factor FVIII inhibitors and are negative for AAV5 antibodies

Indications:

On August 24, 2022, BioMarin was conditionally listed
with approval by the European Union.
For the treatment of FVIII without FVIII Adult patients with severe hemophilia A with a history of factor inhibitors and negative AAV5 antibodies
.
It is also the world's first gene therapy
for hemophilia A.

Roctavian uses the AAV5 virus as a vector to deliver key coagulation factor VIII to cure hemophilia A at the gene level, thus achieving the goal
of lifelong cure in one injection.
Perhaps based on this concept, the drug was awarded breakthrough therapy, orphan drugs, etc
.
The approval is based on the results of a clinical trial called GENEr8-1, which is also the largest clinical trial of hemophilia gene therapy III
.
At present, the drug has submitted a marketing application
to the FDA.

9 Tzield, the world's first drug to delay the onset of type I diabetes

Common name: Teplizumab–mzwv

Common Name:

Trade name: Tzield

Trade name:

Company Name: Provention Bio, Inc.

Company Name:

Listing time: May 2022, 11

Time to market:

Indications: For delayed onset of stage 3 T1D in adult and pediatric patients aged 8 years and older with stage 2 type 1 diabetes mellitus (T1D) for intravenous injection only

Indications:

On November 17, 2022, the U.
S.
FDA approved the marketing of Tzield® for delaying the onset
of stage 3 T1D in adult and pediatric patients with stage 2 type 1 diabetes mellitus (T1D) aged 8 years and older.
The listing of Tzield has brought good news to T1D patients, and has also slowed down the frequency of
injecting drugs and testing to a certain extent.

Type I diabetes is a disease caused by insulin deficiency, and in the past, the effect of lowering blood sugar could only be achieved by real-time monitoring of blood glucose and exogenous insulin injection
.
As a monoclonal antibody targeting CD3, Tzield can promote the secretion of insulin at the source, thereby achieving hypoglycemic effects
.

As early as 2007, Tzield took advantage of the drug, but with the failure of the phase III clinical trial in 2011, the drug seems to have become a discard, fortunately in Provention Bio took over and eventually pushed it to the
top.

10 The world's first immunotherapy against LAG-3 - Opdualag

Common names: Nivolumab and Relatilimab-RMBW

Common Name:

Trade name: Opdualag

Trade name:

Company name: Bristol Myers Squibb (BMS)

Company Name:

Listing time: May 2022, 3

Time to market:

Indications: For the treatment of adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma

Indications:

On March 18, 2022, the FDA approved the marketing of Opdualag for the treatment of adult and pediatric patients
12 years of age or older with unresectable or metastatic melanoma.
This is the first drug to target LAG-3 and marks the arrival of a new member
of immune checkpoint inhibitors.

Opdualag is an immunotherapy composed of LAG-3 inhibitors and PD-1 inhibitors, both of which can help tumor cells achieve immune escape
.
Compared with PD-1 inhibitors alone (nivolumab), when both are shared, patients have doubled survival and a significantly reduced
risk of death.
The success of LAG-3 immunotherapy indicates that immune checkpoint inhibitors
have ushered in new targets.
At present, more than 20 drugs targeting LAG-3 have entered clinical trials
.

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