FDA approved 37 novel drugs IN 2022, lets find the potencial blockbusters.

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2022 FDA Approval & Potencial Blockbusters
Last year the FDA's Center for Drug Evaluation and Research
(CDER) approved 37 novel drugs, including 22 new molecular entities
(NMEs) and 15 biologics license applications (BLAs). This is a drop from the
highs of the past 5 years.
Note: you can find the approved drugs list on the FDA official website.
Figure 1. Novel FDA approvals since 1993. Source: reference [2]
Although the number of FDA-approved drugs in 2022 declined compared to
the previous five years, there were many highlights this year.
● Approval of several innovative therapies, including the world's first T-cell
receptor therapy, and a therapy for amyotrophic lateral sclerosis (ALS)；
● Approval of the first combination formulation targeting LAG-3, the third type
of immune checkpoint inhibitor for oncology treatment, after CTLA-4 and
PD-1/PDL1;

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● Approval of the first drug capable of intervening in the course of type 1
diabetes and four drugs targeting rare diseases.
The Mega-blockbusters of 2022 Approved Drugs
Kimmtrak: The First T-cell Receptor (TCR) Therapeutic
On January 25, 2022, the FDA approved tebentafusp-tebn (brand name
Kimmtrak) for HLA-A*02:01-positive adult patients with unresectable or
metastatic uveal melanoma. This is the first FDA-approved therapy for
unresectable or metastatic uveal melanoma, the first approved T-cell
receptor (TCR) therapy, and the first bispecific T-cell fusion protein for
solid tumors.
Tebentafusp is a novel form of immunotherapy based on the
immune-mobilising monoclonal T cell receptor against cancer (ImmTAC)
platform which fuses a gp100–HLA-targeted T cell receptor (TCR) domain to
bind cancer cells and an anti-CD3 single-chain variable fragment (scFv) to
recruit T cells .
The schematics below show how an ImmTAC molecule works. First, ImmTAC
molecules recognise and strongly bind to cancer cells displaying a defined
target (peptide-HLA) (1). Then, the free end of the ImmTAC molecule (an
anti-CD3 antibody fragment) recruits, or redirects’ circulating T cells to the
tumour site (2), so that there forms a bridge between the cancer cell and the T
cell, enabling the formation of a perfectly optimised immune synapse (3).
Finally, Lytic granules are released by the re-directed and activated T cell,
leading to destruction of the cancer cell (4).

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Figure 2. ImmTAC molecules in action, source:
http://www.immuno.myzen.co.uk/
The FDA approved the biologic on the basis of the phase
III IMCgp100-202 trial, in previously untreated patients with metastatic uveal
melanoma. This randomized pivotal trial evaluated the overall survival of
Tebentafusp in patients with previously untreated metastatic melanoma. A
total of 378 patients were randomly assigned in a 2:1 ratio to receive
tebentafusp or investigator's choice (pembrolizumab, ipilimumab, or
dacarbazine). Data from the trial showed that tebentafusp showed a
median overall survival benefit as first-line treatment.

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Figure 3. Overall Survival Benefit with Tebentafusp in Metastatic Uveal
Melanoma, Source: https://www.nejm.org/doi/full/10.1056/nejmoa2103485
Opdualag: First Drug Target LAG-3
On March 18, 2022, the FDA approved nivolumab and relatlimab-rmbw
(Opdualag, Bristol-Myers Squibb) for adult and pediatric patients 12 years of
age or older with unresectable or metastatic melanoma. Opdualag is a
fixed-dose combination of the LAG-3 blocking antibody relatlimab and the
PD-1 blocking antibody nivolumab. The launch of Opdualag makes LAG-3 the
third immune checkpoint in clinical use, after PD-1/PD-L1 and CTLA-4.
This approval is based on the results of clinical Phase 2/3 RELATIVITY-047.
The study compared the efficacy and safety of Opdualag (n=355) to that of
nabumetanib alone (n=359). The RELATIVITY-047 study met its primary
endpoint of progression-free survival (PFS). The median PFS was more
than doubled in the nabumab and relatlimab combination groups compared to
nabumab monotherapy, at 10.1 months (95% confidence interval [CI]:
6.4-15.7) and 4.6 months (95% CI: 3.4-5.6), respectively.
Peak sales of the relatlimab plus nivolumab combination could reach $2.3
billion (all forecasts are from BCG's analysis of EvaluatePharma data).
Mounjaro: The First New Class Of Diabetes Medicines Introduced
In Nearly A Decade

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On May 13, 2022, the FDA approved Lilly's new medication Mounjaro (also
known as tirzepatide), a GIP (glucose-dependent insulinotropic polypeptide)
and GLP-1 (glucagon-like peptide-1) receptor agonist for type 2 diabetes
management, in addition to diet and exercise. This first-in-class medication
has been shown to improve glucose levels and also dramatically improve
weight in clinical trials.
Three different doses of Mounjaro (5 milligrams, 10 milligrams and 15
milligrams) were evaluated in five clinical
trials — SURPASS-1, -2, -3, -4 and -5 — as either a stand-alone therapy or
as an add-on to other diabetes medicines. The efficacy of Mounjaro was
compared to placebo, a GLP-1 receptor agonist (semaglutide) and two
long-acting insulin analogs. Mounjaro outperformed active comparators on
blood sugar lowering activity. The newly approved drug also offered weight
loss benefits, of around 6.5–14% across dose levels.
Figure 4. Tirzepatide for diabetes, source: Moura, F.A., Scirica, B.M. & Ruff,
C.T. Tirzepatide for diabetes: on track to SURPASS current therapy. Nat
Med 28, 450–451 (2022). https://doi.org/10.1038/s41591-022-01733-2
Peak global sales of this drug could reach $10.8 billion.
Sotyktu: The First TYK2 Inhibitor
On Septemper 9, 2022, the FDA approved Sotyktu™ (deucravacitinib) a
first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for
the treatment of adults with moderate-to-severe plaque psoriasis who are
candidates for systemic therapy or phototherapy.
Deucravacitinib selectively targets TYK2, thereby inhibiting interleukin (IL)-23,
IL-12 and type 1 interferon (IFN) signaling, key cytokines involved in the
pathogenesis of multiple immune-mediated diseases. Deucravacitinib
achieves a high degree of high degree of selectivity by binding to the

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regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and its
downstream functions. At physiologically relevant concentrations,
deucravacitinib selectively inhibits TYK2. At therapeutic doses, deucravacitinib
does not inhibit JAK1, JAK2 or JAK3.
Figure 4. Deucravacitinib MOA
The approval was based on the results of the pivotal Phase 3 POETYK PSO-1
and POETYK PSO-2 clinical trials, which evaluated the safety and efficacy of
Sotyktu (6 mg once daily) versus placebo and Otezla (aprmilast) (30 mg twice
daily) in patients with moderate to severe in patients with plaque
psoriasis. Across both trials, deucravacitinib showed superior efficacy at
16 and 24 weeks, with responses continuing through 52 weeks vs
placebo and apremilast.
Peak sales could reach nearly $1.7 billion.
Relyvrio: Orphan Drug Designation For The Treatment Of ALS
On September 29, 2022, the FDA approved Relyvrio (sodium phenylbutyrate
and taurursodiol), developed by Amylyx Pharmaceuticals, for the treatment of
adults with amyotrophic lateral sclerosis (ALS). This is the first treatment to
significantly slow the loss of physical function and extend survival in
people living with ALS in a randomized, placebo-controlled clinical trial.
The mechanism by which Relyvrio exerts its therapeutic effect on ALS patients
is not clear. One explanation is that they improve the health of intracellular
mitochondria and endoplasmic reticulum, thereby delaying the death of nerve
cells. Preclinical trials have shown that the synergistic effect of the combination
of these two drugs can reduce nerve cell death due to oxidative stress by 90%.
Peak sales of Relyvrio could reach $1.3 billion.

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Tzield: First Therapy For Prevention Of Type 1 Diabetes
On November 17, 2022, the FDA approved Tzield (teplizumab) injection to
delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8
years and older who currently have stage 2 type 1 diabetes.
Teplizumab was first developed as a humanized anti-CD3 monoclonal
antibody (mAb) at the University of Chicago, and then further developed at
MacroGenics. Eli Lilly licensed the drug from MacroGenics back in 2007.
However, a Phase III clinical trial of teplizumab for type 1 diabetes (T1D) failed
to meet the primary endpoint. The drug was subsequently acquired by
Provention Biologics, which restarted development based on analysis of a
subset of the original trials.
Figure 5. Teplizumab MOA
A randomized, double-blind, event-driven, placebo-controlled trial (TN-10
study) of diabetes prevention with teplizumab showed that teplizumab delays
the progression of type I diabetes.
Peak sales of teplizumab could reach $1 billion.
Selected approvals to watch for in 2023
Several notable new drugs are potentially up for approval in 2023, including
two amyloid-targeting antibodies for Alzheimer disease, two RSV vaccines, a
haemophilia A gene therapy and a first-in-modality CRISPR-based therapeutic

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(Table 1).
Hunan Huateng Pharmaceutical Co., Ltd, founded in 2013, is a one-stop
contract development and manufacturing organization (CDMO) to
manufacture and supply researchers with PEG raw materials & PEG
derivatives and products used across the pharmaceutical value chain

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including intermediates, excipients, APIs, and reagents.
Refernces:
[1] Novel Drug Approvals for
2022, https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-
and-new-therapeutic-biological-products/novel-drug-approvals-2022
[2] 2022 FDA approvals: https://www.nature.com/articles/d41573-023-00001-3