Hengrui's 2 new drugs have been approved for clinical use!

Yaozhi data shows that in this issue (August 13 to August 20), 17 new drugs have been approved for clinical trials (28 acceptance numbers); 12 domestic new drugs and 5 imported new drugs are involved.

New drug clinical application approved

In this issue, 17 new drugs (28 acceptance numbers) have been approved for clinical trials, including 8 domestically produced Class 1 new drugs

Data source: Yaozhi data

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IMM01 for injection

IMM01 for injection is a new generation of immune checkpoint inhibitor with independent intellectual property rights developed based on ImmuneOnco’s “mAb-Trap” technology platform.
It targets the immune regulatory target CD47.
By activating the phagocytosis of macrophages on tumor cells, And present the phagocytosed tumor antigen to T cells, thus exerting a powerful tumor immunotherapy effect
.
This time, it has been approved to carry out 2 clinical trials, the indications are respectively HER2-positive solid tumors, combined with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
.

9.
Afuresertib tablets

Afuresertib is an oral small molecule pan-AKT kinase inhibitor that can strongly inhibit AKT1, AKT2 and AKT3 kinase
.
Prior to this, Afuresertib has completed more than 20 clinical phase 1/2 studies in a variety of cancer indications, including ovarian cancer, gastric cancer, multiple myeloma, and 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
.
This time, it 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
.
Laikai Pharmaceutical signed an exclusive product licensing agreement with Novartis in 2018, and obtained the global development, production and sales rights of afresertib
.

10.
Methotrexate injection (prefilled)

Methotrexate injection (prefilled) was approved to carry out clinical trials for adult rheumatoid arthritis (RA) indications
.
It is reported that the trial is a non-inferiority-designed clinical trial controlled by oral methotrexate, in order to evaluate the safety and effectiveness of the product in Chinese RA patients
.
Methotrexate injection (prefilled) products are low-dose and small-volume methotrexate injections of various specifications, which have been approved by the European Medicines Agency (HMA) for marketing
.
Currently, no methotrexate injection (including prefilled type) for the treatment of RA has been approved for marketing in China
.
CMS was authorized to introduce the drug from medac Gesellschaft für klinische Spezialpr paratem.
bH (medac) in September 2020
.

11.
Palovarotene capsules

Ipsen (Ipsen) Class 1 new drug palovarotene capsule has obtained the implied approval of clinical trials, and is intended to be developed for a very rare genetic disease: in patients with progressive fibrodysplasia ossificans (FOP) (myositis) Prevention of heterotopic ossification in adults and children (women 8 years and older, men 10 years and older)
.
Palovarotene is a new and selective retinoic acid receptor gamma (RAR gamma) agonist.
It is planned to be developed for use in progressive fibrodysplasia ossificans (FOP), multiple osteochondromas (MO), dry eye, etc.
Disease
.
The drug is derived from the acquisition of Clementia by Ipsen for more than US$1.
3 billion
.
The US FDA has accepted the new drug marketing application submitted by palovarotene and is expected to respond before November 30 this year
.
Previously, palovarotene has obtained the FDA and European Medicines Agency (EMA) orphan drug designation for the treatment of FOP and MO, as well as the fast track designation and breakthrough therapy designation granted by the FDA
.

New Drug Clinical Application Acceptance

In this issue, CDE has newly accepted clinical applications for 36 new drugs (46 acceptance numbers)
.
Among them, 26 varieties (35 acceptance numbers) are domestic new drugs, and 10 varieties (11 acceptance numbers) are imported new drugs.
More developments are as follows:

Data source: Yaozhi data