Nine Class 1 new drugs were approved clinically from Tengshengbo Pharmaceutical, Hengrui Pharmaceutical, Qilu Pharmaceutical and other companies

Text|Pharmaceutical Mission Hills

According to the latest announcement by the Center for Drug Evaluation (CDE) of the State Drug Administration of China, a number of Class 1 new drugs have recently obtained implied approval for clinical trials, including IL-17A antibody, PD-1/CTLA-4 bispecific antibody, and ERK kinase inhibitor agents of different mechanism of action, of C5a in development of drug targeting antibody, etc.

1.

Indications: Chronic hepatitis B virus (HBV) infection

BRII-179 (VBI-2601) is a new recombinant protein immunotherapeutic drug candidate developed by VBI Vaccines.

2.

Indications: Adult active psoriatic arthritis, advanced malignant tumors

SHR-1314 is a recombinant humanized monoclonal antibody targeting IL-17A

HRS2300 is a new chemical class 1 drug developed by Hengrui Pharmaceuticals.

3.

Indications: Nasopharyngeal carcinoma

Public information shows that QL1706 is a bispecific antibody developed by Qilu Pharmaceutical that can simultaneously target PD-1 and CTLA-4

4.

Indications: advanced solid tumor

JSI-1187 is an oral highly selective ERK1/2 small molecule kinase inhibitor, intended to be developed for the treatment of tumors with mutations in the MAPK kinase pathway

In preclinical studies, JSI-1187 has shown a high degree of inhibitory effect on tumors with mutations in the MAPK pathway

5.

Mechanism of action: C5a targeting antibody

Indications: Anti-neutrophil cytoplasmic antibody-related vasculitis

BDB-001 injection is a specific monoclonal antibody against the C5a target, which can efficiently and specifically inhibit the C5a signaling pathway
.
The product for the indications of moderate to severe hidradenitis suppurativa has entered the phase 2 clinical research phase.
This time it was approved for clinical use in China and is intended to be developed for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-related vasculitis (AAV).
) Patients
.

AAV is a group of diseases mediated by ANCA and characterized by necrotizing small vasculitis deposited by oligo-immune complexes
.
Studies have found that C5a, a downstream activation product formed by complement activation, is the core link in the pathogenesis of AAV
.
Inhibition of the C5a signaling pathway can effectively treat active AAV, and can replace hormones to induce disease remission, thereby avoiding the side effects caused by massive use of glucocorticoids and improving the quality of life of patients
.

6.
Ipsen: palovarotene capsules

Mechanism of action: selective RARγ inhibitor

Indications: Progressive ossifying fibrous dysplasia

Palovarotene is a selective RARγ inhibitor obtained by Ipsen’s acquisition of Clementia for more than US$1.
3 billion.
It is planned to be developed for use in progressive fibrodysplasia ossificans (FOP), multiple osteochondromas (MO), and dry eye disease.
And many other diseases
.
Prior to this, the product has submitted a new drug marketing application for FOP indications in the United States, and has been qualified for priority review by the FDA
.
The palovarotene capsule was approved for clinical use in China, and the proposed development indication is: it is suitable for preventing heterotopic ossification in adults and children with FOP
.

FOP is a very rare genetic disease, commonly known as "stone man disease", which means that with the development of the disease, people will be unable to move like a stone
.
Palovarotene has the potential to treat this disease
.
According to data from a clinical trial called MOVE, post-mortem analysis of the primary endpoint of the trial showed that compared with untreated patients in the natural history study, patients treated with palovarotene reduced the volume of new heterotopic ossification by an average of 62% each year.

.

7.
Laikai Medicine: afuresertib tablets

Mechanism of action: pan-AKT kinase inhibitor

Indications: HR-positive/HER2-negative breast cancer

Afuresertib is an oral small molecule pan-AKT kinase inhibitor that can strongly inhibit AKT1, AKT2 and AKT3 kinase
.
Excessive activation of the AKT signaling pathway is one of the key ways to drive cancer growth
.
By strongly inhibiting AKT kinase, it can inhibit the proliferation of tumor cell lines derived from a variety of tissues
.
Laikai Pharmaceutical signed an exclusive product licensing agreement with Novartis in 2018, and obtained the global development, production and sales rights of afresertib
.

Previously, afuresertib we have completed more than 20 clinical phase 1/2 study in a variety of cancer indications, including ovarian cancer, stomach cancer, multiple myeloma, melanoma
.
Among them, the global multi-center phase 2 clinical trial for the treatment of ovarian cancer has been fully launched in China and the United States
.
Existing data show that afuresertib has achieved clinical verification results in terms of clinical efficacy and tolerability safety in cancer patients
.
This time the product was approved for clinical use in China, and it is planned to be developed for the treatment of locally advanced or metastatic HR-positive/HER2-negative breast cancer
.

8.
Yasheng Pharmaceutical: APG-2575 tablets

Mechanism of action: Bcl-2 selective small molecule inhibitor

Indications: advanced solid tumor or ER-positive breast cancer

APG-2575 is a novel oral Bcl-2 selective small molecule inhibitor under research by Ascent Pharmaceuticals.
It can restore the programmed cell death mechanism (apoptosis) of tumor cells by selectively inhibiting Bcl-2 protein, thereby inducing tumor cell apoptosis
.
The product is currently undergoing clinical studies on various hematological tumors and solid tumors in the United States, China, Australia, Europe and other countries around the world, and five indications have successively obtained orphan drug qualifications granted by the FDA
.

This time, APG-2575 was approved for clinical use in China, and it is planned to be developed for advanced solid tumors or ER-positive breast cancer
.
It is worth mentioning that the clinical study of this product combined with CDK4/6 inhibitors in the treatment of patients with ER-positive/HER2-negative metastatic breast cancer has also been approved in the United States
.
Preclinical studies show, APG-2575 increased expression of pro-apoptotic protein BIM like, ER down-regulation levels, decreased phosphorylation of Rb, cyclin D1 protein levels and E
.
Therefore, its combination with CDK4/6 inhibitors can not only synergistically enhance the induction of cell cycle arrest, but also promote the apoptosis of ER-positive breast cancer cells
.

In addition to the above products, there are other new drugs that have recently been approved for clinical use in China.
Due to limited space, this article will not introduce them one by one
.
It is hoped that these products under development can progress smoothly in clinical research and bring new treatment options to patients as soon as possible
.

references:

[1] Center for Drug Evaluation (CDE) of China National Medical Products Administration.
Retrieved Aug 19, 2021, from http://#

[2] Official press releases and public information of each company
.