25 new drugs under development lead the "innovative era" of biopharmaceuticals

New coronary pneumonia has greatly attracted people's attention to new coronary therapy, which may cause the neglect of breakthrough research in new drugs in other fields

dermatology

01 Deucvacitinib

Deucravacitinib is an oral selective tyrosine kinase 2 (TYK2) inhibitor

In April of this year, Bristol-Myers Squibb announced the positive data of two key Phase III studies (POETYKPSO-1 and POETYKPSO-2) of Deucravacitinib in the treatment of moderate to severe plaque psoriasis.

02 Roflumilast (Roflumilast)

Arcutis Biotherapy's topical phosphodiesterase-4 (PDE4) inhibitor Roflumilast cream for the treatment of plaque psoriasis may be approved in multiple markets in 2022

Diabetes and metabolic diseases

03 Tirzepatide

Eli Lilly’s Tirzepatide (LY3298176) is a glucose-dependent insulin nutritive polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor dual agonist administered once a week, which was demonstrated in the SURPASS clinical trial Better than Novo Nordisk's smeglutide: Compared with smeglutide, Tirzepatide achieves excellent glycosylated hemoglobin (A1C) and weight loss at three doses in adult patients with type 2 diabetes

04 Setmelanotide

Rhythm Pharmaceuticals is developing the oligopeptide melanocortin-4 receptor (MC4R) agonist Setmelanotide for the treatment of obesity

Gastroenterology

05 Mirikizumab

Eli Lilly announced in March that the monoclonal antibody Mirikizumab (LY3074828) has reached the primary and all key secondary endpoints of the Phase III LUCENT-1 study of ulcerative colitis

06 Larazotide

Larazotide Acetate (INN-202), developed by 9 Meters Biopharmaceuticals, has carried out a phase III trial for patients with celiac disease who must strictly follow a gluten-free diet

hematology

07 Roctavian

In January this year, BioMarin Pharmaceutical announced that its experimental gene therapy Roctavian (valoctocogene roxaparvovec) to achieve positive results for phase Ⅲ GENEr8-1 severe hemophilia A

Infectious Diseases

08 Cabotegravir

Cabotegravir, an HIV integrase inhibitor developed by ViiV Healthcare, is currently approved by the FDA as an oral (Vocabria) and intramuscular (Cabenuva) dosage form for the treatment of HIV infection

Cabotegravir can be used as a long-acting injection, making it ideal for patients who have difficulty swallowing or who tend to forget to take their daily medication

09 Lenacapavir

The HIV capsid inhibitor Lenacapavir developed by Gilead Sciences for the treatment of HIV has been awarded a breakthrough by the FDA

Gilead is also working with Merck, Lenacapavir and Merck’s Islatravir to treat HIV.

Global Data predicts that by 2029, sales of injectable anti-HIV therapies such as Cabotegravir and Lenacapavir will reach US$2 billion

10 Molnupiravir

Merck and Ridgeback Biotherapy are developing the antiviral ribonucleoside analog drug Molnupiravir for outpatient use in newly diagnosed patients with new coronary pneumonia

11 mRNA-1273.

The recent phase II trial of Moderna's second-generation mRNA-1273.
351 new coronary pneumonia vaccine showed a stronger effect than the company's currently approved mRNA-1273 vaccine: compared with mRNA-1273, a boosted dose of mRNA-1273.
351 It can make the neutralizing antibody response to B.
1.
351 variant patients appearing in South Africa for the first time higher
.
The adverse events of mRNA-1273.
351 are also less than that of mRNA-1273.

12 siRNA Nanoparticle Therapy for New Coronary Pneumonia

An experimental direct antiviral therapy uses a unique strategy to prevent virus replication, namely, gene silencing RNA technology for siRNA (small interfering RNA) targeting the SARS-CoV-2 genome
.
Lipid nanoparticles help deliver siRNA to the lungs
.
Nigel McMillan, a professor and director of the Infectious Diseases and Immunology Program at the Menzies Institute for Health Research (MHIQ) in Queensland, Australia, said that in a mouse model study, virus-specific siRNA can reduce viral load by 99.
9%
.
The new coronary pneumonia siRNA nanoparticle therapy was developed by researchers at MHIQ and the City of Hope Research Center (Duarte, California)
.

13 EXO-CD24

EXO-CD24, an overexpressing CD24 exosome drug developed by the Ichilov Medical Center in Tel Aviv, Israel, has shown potential in a phase I trial, and the drug has accelerated the recovery of patients with new coronary pneumonia
.
In this study, 30 patients with moderate to severe new coronary pneumonia received the inhaled drug
.
All recovered, 29 of them recovered within three to five days
.
Researchers at Ichilov Medical Center designed this drug to prevent the cytokine storm that may occur in some patients with new coronary pneumonia.
Phase II trials have been launched in Greece
.

Neurology

14 YTX-7739

Yumanity Therapeutics’ YTX-7739 may be a promising treatment for Parkinson’s disease
.
The drug candidate improved motor skills and reduced the accumulation of toxic proteins in a preclinical study in mice
.
YTX-7739 can combat α-synuclein pathology, which is a risk factor for Parkinson's disease
.
Yumanity said in a statement: “Our proprietary discovery platform has allowed the target stearoyl-CoA desaturase (SCD) to be found.
When it is inhibited, it reduces the association with pathogenic α-synuclein.
Toxicity
.
"

15 Donanemab

Eli Lilly’s Donanemab showed promise in a phase II trial of Alzheimer’s disease.
Compared with placebo, the rate of cognitive decline was reduced by about one-third
.
The TRAILBLAZER-ALZ study uses the Integrated Alzheimer's Disease Rating Scale (iADRS) to evaluate cognitive performance
.
Although Donanemab did not promote a complete improvement in cognitive ability, the drug is at least completely successful in the current study
.
The study also found that Donanemab slowed down the accumulation of tau protein in the brain regions of Alzheimer's patients
.
At present, more than 400 Alzheimer's disease drugs have failed clinical trials, and Donanemab is undoubtedly one of the few remaining promising projects in this field
.

Oncology

16 Pirtobrutinib

Eli Lilly’s third-generation Bruton's tyrosine kinase (BTK) inhibitor Pirtobrutinib (LOXO-305) Phase I/II study was published in The Lancet in March, showing its ability to treat relapse or refractory The potential of B cell malignancies
.
The study evaluated Pirtobrutinib in 139 patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, with an overall response rate of 63% at various doses
.

17 Asciminib

Novartis announced in February 2020 that its new research therapeutic drug Asciminib targeting ABL myristoyl pocket (STAMP) has received the FDA’s breakthrough therapy designation (BTD), which covers Philadelphia chromosome-positive chronic myeloid leukemia (Ph +CML) adult patients
.

18 Libtayo

Regeneron Pharmaceuticals' programmed cell death protein 1 (anti-PD-1) inhibitor Libtayo (Cemiplimab) and fianlimab (REGN3767) in combination have shown promising therapeutic applications in the treatment of melanoma patients in a phase I trial
.
Among the patients who had not previously received anti-PD-1 drug therapy, the efficacy was the highest; the objective response rate in this cohort was 64%, with 3 complete remissions and 18 partial remissions among 33 patients
.
Compared with Merck’s blockbuster Keytruda (pembrolizumab), Libtayo shows a higher progression-free survival and objective response rate
.

19 AGEN1777

Agenus' new bispecific antibody, AGEN1777, can block T cell immune receptors with Ig and ITIM domains (TIGIT).
The second target has not yet been disclosed
.
In preclinical development, AGEN1777 has shown great potential in tumor models in which anti-PD-1 or anti-TIGIT monospecific antibodies alone are not effective
.
On May 18, Bristol-Myers Squibb has signed a cooperation agreement with Agenus to obtain the exclusive global authorization of AGEN1777 for US$1.
56 billion
.

20 Relatlimab

Bristol-Myers Squibb's anti-LAG-3 antibody Relatlimab and Opdivo (nivolumab) used together with melanoma patients doubled the median progression-free survival
.
In the phase II/III RELATIVITY-047 study, Opdivo/relatlimab and Opdivo monotherapy were compared as first-line treatments
.
Promising research data may pave the way for an alternative to the combination of Opdivo and Yervoy (ipilimumab).
Opdivo/Yervoy is very effective but suffers from side effects, which leads to treatment interruption or doctors avoiding the combination therapy and turning to support Opdivo monotherapy, or Choose other anti-PD-1 and non-IO solutions
.

21 Teclistamab

Johnson & Johnson's B cell maturation antigen (BCMA) and T cell CD3 receptor bispecific antibody Teclistamab (JNJ-64007957), in an ongoing phase I study for the treatment of relapsed and refractory multiple myeloma Prove that it has good safety and effectiveness
.
At the recommended dose of Teclistamab administered subcutaneously, the objective response rate of the drug in a large number of pre-treated patients was 73%
.
Teclistamab's previous intravenous preparations also showed promise
.
Phase II trials of the drug have also begun
.

22 Ciltacabtagene autoleucel(cilta-cel)

Ciltacabtagene autoleucel (cilta-cel) is an investigative B cell maturation antigen (BCMA) directed chimeric antigen receptor T cell (CAR-T) therapy
.
In December 2020, Janssen announced the promising results of the phase Ib/II CARTITUDE-1 study of the drug for the treatment of severely preconditioned patients with multiple myeloma
.
The drug is jointly developed by China Legend Bio and Janssen, and currently has a rolling submission of Ciltacabtagene autoleucel biologics license application (BLA) to the FDA
.

23 Ziltivekimab

Novo Nordisk's research interleukin-6 (IL-6) inhibitor Ziltivekimab (COR-001) recently reached its primary endpoint in a phase II trial in patients with advanced chronic kidney disease and high cardiovascular risk
.
In a separate trial, Ziltivekimab reduced inflammation in the treatment of anemia in hemodialysis patients
.
The drug was developed by Corvidia Therapeutics, which Novo Nordisk acquired in 2020
.

24 NM21-1480

Numab Therapeutics has become a leading developer of trispecific antibodies that can simultaneously target cancer cells, receptor-activated T cells, and T cell proteins
.
Its main candidate, NM21-1480, is a trispecific antibody that can be used as a PD-L1 inhibitor and 4-1BB (CD137) agonist
.
In early in vivo studies, the drug has shown strong anti-tumor activity
.
CStone Pharmaceuticals has obtained the exclusive development and commercialization rights of the product in Greater China and some Asian countries by entering into a regional exclusive licensing agreement with Numab
.

ophthalmology

25 Sepofarsen

ProQr's research antisense oligonucleotide Sepofarsen can make the eyesight of patients with hereditary eye disease (Leber congenital amaurosis type 10) lasting improvement in clinical research
.
The company is conducting a phase II/III clinical trial involving 36 participants
.
In a 2018 study by the University of Pennsylvania, Sepofarsen injections every three months resulted in continuous improvement in the vision of 10 study participants
.