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9 new drugs approved clinically from Nuocheng Jianhua, Heyu Medicine, Tianjing Bio, etc.

 Last Update: 2021-11-04
 Source: Internet
 Author: User

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According to public information of various companies, a number of new drugs have recently been approved for clinical use
.

These drugs include targeted inhibitors such as SHP2 and FGFR4, as well as antibody-conjugated drugs, bispecific antibodies, etc.

1.
Nuocheng Jianhua: ICP-189

Mechanism of action: SHP2 allosteric inhibitor

On October 19, Nuocheng Jianhua announced that the company’s self-developed new protein tyrosine phosphatase SHP2 allosteric inhibitor ICP-189 has been approved by the China National Medical Products Administration (NMPA) to conduct clinical trials, becoming the company’s No.
9 innovative drugs entering the clinical stage
.

The clinical approval this time is a phase 1a/1b open, single-arm, multi-center study conducted in China, which aims to evaluate the safety and tolerability of ICP-189 single-drug and combination drugs in the treatment of patients with advanced solid tumors , Pharmacokinetic characteristics and effectiveness

ICP-189 was developed for the treatment of solid tumors.
It can be used as monotherapy and/or combination therapy with other anti-tumor drugs.
It aims to provide new clinical treatments for solid tumors such as lung cancer, head and neck cancer and gastrointestinal tumors
.

Pre-clinical studies have shown that ICP-189 is a highly selective oral SHP2 allosteric inhibitor with good selectivity to other phosphatases

2.
Heyu Medicine: ABSK011

Mechanism of action: FGFR4 inhibitor

On October 19th, Heyu Medicine announced that its innovative FGFR4 inhibitor ABSK011 and Roche's anti-PD-L1 antibody atezolizumab (atezolizumab) has been approved by the NMPA to carry out phase 2 clinical trials.
Carry out research on FGF19-positive advanced or unresectable hepatocellular carcinoma (HCC) patients
.

ABSK011 is an innovative oral FGFR4 small molecule inhibitor, independently developed by Heyu Pharmaceutical
.

About 30% of HCC patients have abnormal activation of the FGF19-FGFR4 signaling pathway, which promotes tumor growth and leads to liver cancer

3.
Biotech: BAT7104

Mechanism of action: PD-L1/CD47 bispecific antibody

On October 19, Biotech announced that it had recently received the "Clinical Trial Approval Notice" for the company's drug BAT7104 injection, which was approved and issued by the NMPA
.

BAT7104 is a bispecific antibody against PD-L1 and CD47 developed by Biotech, which is intended to be developed for tumor treatment

According to the announcement, BAT7104 activates macrophages to engulf tumor cells by blocking the CD47/SIRPα pathway; BAT7104 blocks the PD-L1/PD-1 pathway to relieve tumor cells from inhibiting T cells through the PD-L1/PD-1 pathway , To achieve the combined anti-tumor effect of T cells and macrophages
.

Through the differential design of affinity, the targeting CD47 arm of BAT7104 has moderate affinity, reducing the potential for toxic side effects; at the same time, its targeting PD-L1 arm has high affinity, which can improve the tumor cell selectivity of antibodies and enhance targeting Tumor cell toxicity

4.
Heavenly creatures: Efeinterleukin alpha

Mechanism of action: long-acting recombinant human interleukin 7 drug

On October 18th, Tianjing Bio-Bio announced that the Drug Evaluation Center of the National Medical Products Administration of China has officially approved the initiation of the combination therapy of efilinterleukin alpha (also known as T107/GX-17/NT-7) and anti-PD-1 antibody Phase 2 clinical trials for advanced solid tumors (including triple negative breast cancer and head and neck cancer)
.

According to the press release, Efilinterleukin a is a long-acting recombinant human interleukin 7 (rhIL7) drug
.

A number of pre-clinical and clinical studies have shown that eficilin-α can effectively increase the number and function of T lymphocytes by promoting lymphocyte proliferation.

5.
Hongri Pharmaceuticals: Picramine B mesylate for injection

Mechanism of action: dual-target bacterial pathogen-related molecular antagonists

On October 19th, Hongri Pharmaceuticals announced that its Phase 2 clinical study of injection-use picrocolamide B mesylate (CHS-201) for the treatment of sepsis has been approved by the US FDA
.

Previously, the product has been approved for clinical use in China, and phase 2b clinical studies are currently underway in China

According to the announcement, CHS-201 is a dual-target bacterial pathogen-related molecular antagonist, which treats sepsis by neutralizing bacterial endotoxin and bacterial genomic DNA, blocking or reducing the occurrence of inflammation
.
At present, no similar drugs have been approved for marketing in the world
.

6.
Hengrui Medicine: SHR-A2009

Mechanism of action: antibody conjugated drug

Recently, Shengdia Bio, a subsidiary of Hengrui Pharmaceuticals, received NMPA’s approval and issuance of the "Drug Clinical Trial Approval Notice" regarding SHR-A2009 for injection, and will start clinical trials for advanced or metastatic solid tumors in the near future
.

SHR-A2009 is an antibody-conjugated drug targeting tumor-specific antigens.
By binding to the target antigen on the surface of tumor cells, the drug is endocytosed into the cells and releases small molecular toxins to kill tumor cells
.
According to the announcement, no similar drugs have been approved for marketing in the world
.

7.
Sansheng Guojian: SSGJ-706

Mechanism of action: bispecific antibody

On October 19, Sansheng Guojian disclosed that its bispecific antibody SSGJ-706 was approved by the US FDA to enter Phase 1/2 clinical trials
.
This is an open, multi-center, phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SSGJ-706 in subjects with advanced solid tumors, relapsed or refractory lymphomas
.

According to the announcement, SSGJ-706 is a recombinant bispecific antibody developed by Sansheng Guojian using its bispecific antibody platform
.
The antibody simultaneously binds PD-1 and another target closely related to tumor immunosuppressive function, thereby more effectively promoting T cell activation and proliferation, and further enhancing its tumor killing activity
.

8.
Quanxin Bio: QX002N injection

Mechanism of action: recombinant humanized anti-IL-17A monoclonal antibody

On October 19th, Lupus Nephritis, a new indication for QX002N injection, was given the implied license for clinical trials in China
.
QX002N injection is a recombinant humanized anti-IL-17A monoclonal antibody injection.
It is the first class 1 innovative drug independently developed by Quanxin Biotechnology.
The proposed development indications include ankylosing spondylitis, lupus nephritis and psoriatic joints go far
.
The project is currently conducting Phase 2 clinical trials for adults with active ankylosing spondylitis
.

Studies have shown that IL-17 and IL-17-producing cells can infiltrate the kidneys and act synergistically with other cytokines to cause local inflammation in the kidneys
.
IL-17A inhibitors can specifically target and bind IL-17A derived from innate immune and acquired immune cells, block its binding to IL-17RA/C on the target cell membrane, thereby rapidly inhibiting downstream inflammatory cytokines and chemokines The network, in turn, may have a therapeutic effect on a variety of immune diseases mediated by IL-17A
.

9.
Kanghong Pharmaceutical: KH737 eye drops

Mechanism of action: Interaction with related receptors in the retina and sclera

On October 20, Kanghong Pharmaceutical announced that its KH737 eye drops had recently been approved by the NMPA for clinical trials, and it was intended to be used to delay the progression of myopia in children
.
According to the announcement, the active ingredients of KH737 mainly interact with the relevant receptors of the retina and sclera to inhibit the growth of the eye axis, thereby delaying the progression of myopia
.

references:

[1] The new SHP2 allosteric inhibitor ICP-189 independently developed by Nuocheng Jianhua was approved for clinical use.
Retrieved Oct 19, 2021, from https://mp.
weixin.
qq.
com/s/n3fj0jPFdOfdmzo84Zv7SQ

[2] The Phase II clinical trial of Heyu Medicine ABSK011 and Roche's combination drug was approved by NMPA.
Retrieved Oct 19, 2021, from

https://mp.
weixin.
qq.
com/s/fEavvmzpOqdwtvB5Q1VZjA

[3] Tianjing Biotech announced that the Phase 2 clinical trial of the combination of eficilin α and PD-1 antibody was approved by NMPA to start.
Retrieved Oct 18, 2021, from https://mp.
weixin.
qq.
com/s/pU2wt1uF6WlbLMX2VJDMJA

[4] Announcement of Hengrui Medicine on the approval of drug clinical trials by its subsidiaries.
Retrieved Oct 19, 2021, from http:// gssh0600276&announcementTime=2021-10-19

[5] Sansheng Guojian: Announcement on voluntary disclosure of the company's bispecific antibody SSGJ-706 to obtain FDA approval to enter clinical phase I-II.
Retrieved Oct 19, 2021, from http:// /disclosure/detail?stockCode=688336&announcementId=1211315258&orgId=9900041739&announcementTime=2021-10-19

[6]300026 Hongri Pharmaceuticals: Announcement on the KB project obtaining the US FDA clinical trial qualification.
Retrieved Oct 19, 2021, from http:// b706-4759-aedd-6b9d73a701e1

[7] Biotech Biopharmaceutical Co.
, Ltd.
Announcement on Voluntary Disclosure of Clinical Trial Approval Notice for BAT7104 Injection.
Retrieved Oct 19, 2021, from http://static.
sse.
com.
cn/disclosure/listedinfo/announcement /c/new/2021-10-20/688177_20211020_1_UdFdS1vN.
pdf

[8] Announcement on the company’s receipt of the drug clinical trial approval notice.
Retrieved Oct 20, 2021, from http:// -10-20

[9] New progress | Quanxin Biologics QX002N injection for new indications obtains the implied permission of clinical trials.
Retrieved Oct 20, 2021, from https://mp.
weixin.
qq.
com/s/CPf5PgimV3p5Gpj_3tV_lg

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