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42 new drugs have been approved for clinical use, and dual-antibody drugs have exploded!

 Last Update: 2021-09-19
 Source: Internet
 Author: User

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Yaozhi data shows that in this issue (September 1 to September 10), 42 new drugs have been clinically approved (67 acceptance numbers); 26 domestic new drugs and 16 imported new drugs are involved.
More developments are as follows:

New Drug Clinical Application·Newly Approved

In this issue, 42 new drugs (67 acceptance numbers) have been approved for clinical trials, including 23 domestically produced Class 1 new drugs
.

Clinically approved innovative drugs include a variety of combination bispecific antibodies, HER2 targeting ADCs, CTLA-4 monoclonal antibodies, targeting NGF monoclonal antibodies, interleukin 22-Fc fusion protein, FGFR4 small molecule inhibitors, and KRAS small molecule inhibitors Drugs, pneumonia vaccines, new Chinese medicines, etc.

Data source: Yaozhi data

1.
Two new bispecific antibody drugs from Pumis Biotech have been approved for clinical use

PM8001 injection is a PD-L1/TGF-β bispecific antibody developed by Pumis Biotechnology
.

Previously, the product has been approved for clinical use in China, and it is planned to carry out clinical research on advanced tumors such as lung cancer

PM1003 injection PD-L1/4-1BB bispecific antibody developed by Pumis Biotechnology
.

Such products can block the PD-1/PD-L1 immunosuppressive pathway by combining with PD-L1, and at the same time activate the downstream immune activation signal of 4-1BB, and promote the killing of tumor cells by immune cells

2.
Three PD-L1/4-1BB double antibodies were approved for clinical use

Three bispecific antibodies targeting PD-L1/4-1BB have been approved for clinical use, including PM1003 from Pumis Biologics, LBL-024 from Wei Lizhibo and QLF31907 from Qilu Pharmaceutical.

Up to now, a number of PD-L1/4-1BB double antibodies or PD-1/4-1BB double antibodies have entered the clinical stage in China.
In addition to the three approved this time, there is also Kewang's ES101.
Cornerstone Pharmaceutical’s NM21-1480.
And Baili Pharmaceutical’s four antibodies: GNC-039, GNC-038, GNC-035.
Xinda Bio-targeting PD-1/4-1BB double antibody IBI319.

3.
AK112 injection

AK112 is a PD-1/VEGF bispecific antibody independently developed by Kangfang Bio
.

Prior to this, AK112 has carried out a phase 1 clinical study of dose climbing and expansion in China, Australia and other countries

4.
BJ-005 for injection

BJ-005 is a recombinant bifunctional fusion protein developed by BoJi Biology, which can simultaneously target PD-L1 and TGF-β, and inhibit tumor growth by targeting immune checkpoints and cytokine pathways that regulate tumor cell growth.
To achieve the purpose of cancer treatment
.

In June 2021, BJ-005 was approved for clinical use in the United States, becoming the second independent research and development product approved by the FDA for clinical use by Boji Biotech

5.
HBM4003 injection

Two new indications of HBM4003 injection, a biological product for the treatment of the first class new drug of Hebo Pharma, have been approved for clinical use, namely advanced hepatocellular carcinoma and other solid tumors, and advanced malignant solid tumors
.

HBM4003 is a fully human anti-CTLA-4 heavy chain antibody.

6.
EP-9001A injection

EP-9001A injection is the first class 1 biological drug independently developed by Yuandong Biological.
It is a humanized monoclonal antibody drug with a new mechanism of action, targeting human nerve growth factor (NGF)
.

It selectively binds and inhibits NGF to prevent pain signals from muscles, skin and organs from entering the spinal cord and brain.

7.
Recombinant human interleukin 22-Fc fusion protein for injection

F-652 (recombinant human interleukin 22-Fc fusion protein for injection) is a class 1 innovative biological drug developed by Yifan, a subsidiary of Efan Pharmaceuticals.
It is a recombinant human interleukin 22-Fc expressed through CHO cells using genetic engineering technology.
(IgG2) Fusion protein
.

It is reported that the product completely mimics the activity mechanism of human interleukin 22, the Fc fragment greatly prolongs the half-life of interleukin 22, and has a significant improvement in drug efficacy

8.
ABSK-011 capsule

ABSK-011 capsule is an oral small molecule inhibitor of FGFR4 independently developed by Heyu Medicine
.
Studies have shown that the excessive activation of FGFR4 receptor is closely related to the growth, proliferation and survival of many cancers (especially hepatocellular carcinoma).
By inhibiting the activity of FGFR4 and blocking related signal transduction, it is expected to achieve the curative effect of inhibiting tumor growth
.
Previously, the drug has been approved for clinical trials for advanced malignant tumors.
This approved indication is advanced or unresectable hepatocellular carcinoma overexpressing FGF19
.

9.
HMPL-453 tartrate tablets

HMPL-453 is a potentially best-in-class, highly selective, high-efficiency small molecule inhibitor, and its inhibitory effect on FGFR1/2/3 is at a low nanomolar level
.
HMPL-453 exhibits potent anti-tumor activity in tumor models with abnormal FGFR activation
.
At present, the product has launched a phase 2 clinical trial for advanced malignant mesothelioma in China, and a phase 2 study for patients with advanced intrahepatic cholangiocarcinoma
.
This time, HMPL-453 was approved for clinical use in China, and the proposed development indications are: combined chemotherapy or anti-PD-1 monoclonal antibody for patients with advanced solid tumors
.

10.
TNP-2092 capsules

TNP-2092 is a multi-target coupling molecule that achieves bactericidal effects by inhibiting the three important targets of RNA polymerase, DNA helicase and topoisomerase IV, with stronger bactericidal activity and lower drug resistance Frequency
.
The compound was originally developed by Cumbre.
In April 2009, Cumbre declared bankruptcy and Dannuo Pharmaceuticals acquired the company
.
In November 2019, TNP-2092 was approved for clinical trials in China for the treatment of cirrhotic hyperammonemia and hepatic encephalopathy
.
This time, the new indication of the product has been approved for clinical use, and it is planned to be developed for the treatment of diarrheal irritable bowel syndrome (IBS-D)
.

11.
YL-15293 pieces

YL-15293 is a KRAS small molecule inhibitor developed by Shanghai Yingli Pharmaceutical Co.
, Ltd.
It acts by covalently binding to the cysteine in the KRAS G12C mutant protein to lock the KRAS G12C mutant in an inactive state
.
This time, it was approved to carry out clinical trials of YL-15293 tablets in the treatment of advanced malignant solid tumors
.
It is worth mentioning that the drug has previously been approved for clinical studies in the United States, and YL-15293 will be simultaneously undergoing clinical trials in China and the United States
.

12.
DN1508052-01 for injection

DN1508052-01 is a high-efficiency small molecule Toll-like receptor 8 (TLR8) agonist developed by Dino Pharmaceutical for cancer immunotherapy
.
Prior to this, DN1508052-01 has been clinically approved in the United States and China
.
Among them, the indications for which the product has been approved for clinical research in China are: for the treatment of advanced solid tumors that have progressed after standard treatment or have no standard treatment
.
This time, DN1508052-01 was once again approved for clinical use, and it is planned to be developed for advanced malignant solid tumors
.

13, JYP0061 piece

JYP0061 is a new class 1 small molecule drug developed by Jiayue Pharmaceutical.
This is the first time the product has been clinically approved in China.
It is intended to be used for autoimmune diseases such as moderate to severe rheumatoid arthritis (RA)
.

14.
AK3280 cream

AK3280 is a small molecule drug developed by Genentech
.
In July 2020, Shanghai Aike Biopharmaceutical Technology Co.
, Ltd.
carried out a phase II clinical trial in mainland China for the treatment of idiopathic pulmonary fibrosis
.
New indication approved this time: pathological scar
.

In addition, the first class of new drugs that have been implicitly approved by the clinical trial include: ST-1703 from Beijing Saite Mingqiang Pharmaceutical, which is intended to be used for the treatment of HER2-positive advanced solid tumors (including brain metastases); Lukang Pharmaceutical's CMS203 Tablets, intended for the treatment of male erectile dysfunction; Nanjing Aidecheng Medicine’s AL8326 tablets, intended for the treatment of advanced malignant solid tumors; Arnold Biology’s AN0025 tablets, intended for the treatment of locally advanced or locally recurring esophageal cancer; and Jilin Qinhuai Capsule, a new class 1 traditional Chinese medicine of Tianheng Pharmaceutical, is indicated for clearing away heat and eliminating accumulation, promoting dampness and turbidity.
It is used for the long-term treatment of patients with gout and hyperuricemia; Beijing Houcheng Medicine's new class 1 traditional Chinese medicine HC001 granules, Indications: Clearing heat and removing dampness, strengthening the spleen and stopping diarrhea, used for the treatment of acute watery diarrhea in children (damp-heat syndrome), symptom with watery stool or egg-like stool, or a small amount of mucus, or accompanied by abdominal pain, nausea, vomiting, mouth thirst, loss of appetite, irritability, crying, or accompanied by fever
.

New Drug Clinical Application·New Acceptance

In this issue, CDE has newly accepted clinical applications for 30 new drugs (38 acceptance numbers)
.
Among them, 26 varieties (34 acceptance numbers) are domestic new drugs, and 4 varieties (4 acceptance numbers) are imported new drugs.
More developments are as follows:

Data source: Yaozhi data

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