49 new drugs have been approved for clinical use!

Yaozhi data shows that in this issue (October 15 to October 22), 49 new drugs have been approved for clinical trials (70 acceptance numbers); 35 domestic new drugs and 14 imported new drugs are involved.
More developments are as follows:

New Drug Clinical Application·Newly Approved

New Drug Clinical Application·Newly Approved

In this issue, 49 new drugs (70 acceptance numbers) have been approved for clinical trials, including 27 domestically produced Class 1 new drugs
.

Clinically approved innovative drugs include SHP2 allosteric inhibitors, kappa opioid receptor agonists, tyrosine kinase inhibitors, TGF-β activation inhibitors, Bcl-2 inhibitors, JAK inhibitors, CD47 monoclonal antibodies, PD- L1 monoclonal antibody, IL-17A monoclonal antibody, PCSK9 monoclonal antibody, ADC targeting Nectin-4, PD-L1/TGF-β double antibody, PD-L1/CD47 double antibody, EGFR/HER3 double specific antibody pair Co-drugs (ADC), etc.

Data source: Yaozhi data

1.
ICP-189 sheet

1.
ICP-189 sheet

ICP-189 is a novel protein tyrosine phosphatase (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor independently developed by Nuocheng Jianhua.
It is the company's ninth innovative drug that has entered the clinical stage
.

The approval this time is a phase Ia/Ib open, single-arm, multi-center study in China, which aims to evaluate the safety, tolerability, and tolerability of ICP-189 monotherapy and combination therapy in patients with advanced solid tumors.

2.
HS-10342 tablets

2.
HS-10342 tablets

HS-10342 was developed by Jiangsu Hausen Pharmaceutical Co.
, Ltd.
, and is intended to treat hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer
.

3.
SHR8554 injection/SHR0410 injection

3.
SHR8554 injection/SHR0410 injection

The clinical trial application of Hengrui Medicine SHR8554 combined with SHR0410 for the treatment of postoperative acute moderate to severe pain was granted the default permission of CDE
.

SHR8554 injection is a small molecule drug targeting the μ opioid receptor (MOR), which can activate the MOR receptor and is suitable for the treatment of pain

4.
Famitinib Malate Capsules

4.
Famitinib Malate Capsules

Famitinib Malate Capsules is a small molecule multi-target tyrosine kinase inhibitor independently developed by Hengrui.
It is effective against a variety of receptor tyrosine kinases such as c-Kit, KDR, PDGFR, VEGFR3, Flt1, Ret, and Flt3.
, C-Src, FGFR2, FGFR3 and PDGFRα have good inhibitory activity
.

This time, a number of clinical trial applications have been granted the default permission, and the indications include: Adaptation to recurrent or metastatic non-small cell lung cancer that is positive for PD-L1 expression (TPS≥1%) and is not accompanied by abnormal EGFR/ALK gene mutations , PD-L1 positive recurrent or metastatic non-small cell lung cancer, advanced non-small cell lung cancer that has failed treatment with platinum-based chemotherapy and immune checkpoint inhibitors

5.
HRS9531 injection

5.
HRS9531 injection

Hengrui Medicine's Class 1 new drug HRS9531 injection was approved for clinical use and is intended to be used for the treatment of type 2 diabetes
.

6.
HTPEP-001 for injection

6.
HTPEP-001 for injection

Chengdu Huitai Biotech's First-in class innovative drug was approved for clinical use.
The main indication is Progressive Fibrosing Interstitial Lung Diseases (PF-ILD): including Idiopathic pulmonary Fibrosis, IPF), connective tissue disease-related interstitial lung disease (CTD-ILD), pneumoconiosis, viral infection, and other causes of interstitial lung disease with progression of pulmonary fibrosis
.

It is reported that the drug is an inhibitor of TGF-β activation, and the results of preclinical studies suggest that HTPEP-001 is a promising anti-fibrosis product in the world

7.
FCN-338 pieces

7.
FCN-338 pieces

The FCN-338 tablets of Fosun Pharma's holding subsidiary Fosun Pharma have been approved for clinical trials of relapsed or refractory B-cell lymphoma
.

FCN-338 is a selective small molecule inhibitor of Bcl-2 independently developed by Fosun Pharma and its subsidiaries

8.
OB756 piece

8.
OB756 piece

Huadong Medicine/Hangzhou Bangshun Pharmaceutical has developed a class 1 new drug, OB756 tablets, for new indications and has been approved for clinical use.
It is intended to be used for the treatment of graft-versus-host disease
.

OB756 tablets are JAK inhibitors.

9.
MN-08 piece

9.
MN-08 piece

MN-08 is a multifunctional molecule obtained through the chemical modification of the molecular structure of memantine, which is independently and innovatively researched and developed by Magpie Pharmaceuticals.
It has a pioneering dual mechanism of action and is a Class 1 chemical new drug
.

Previously, the indication for idiopathic pulmonary arterial hypertension (IPAH) has been approved for clinical use, and the approved indication for this time is Alzheimer's disease

10.
Freeze-dried GT90008 antibody protein

10.
Freeze-dried GT90008 antibody protein

The PD-L1/TGF-β dual-target antibody (GT90008) introduced by Kaixing Pharmaceutical was approved by the NMPA to carry out clinical trials for the treatment of advanced solid tumors
.
GT90008 is a dual-target antibody against PD-L1 and TGF-βR2, which can simultaneously inhibit the high activity of PD-L1 and TGF-βR2, and has the potential to become a best-in-class drug
.
In August 2020, Kaifeng Pharmaceutical introduced the drug's Greater China rights and interests from Gensun of the United States
.
It is reported that this is the second new antibody drug in the clinical trial stage of the pioneering pharmaceutical industry
.

11.
Recombinant humanized anti-CD47 monoclonal antibody injection Shandong New Times Pharmaceutical Co.
, Ltd.

11.
Recombinant humanized anti-CD47 monoclonal antibody injection Shandong New Times Pharmaceutical Co.
, Ltd.

The clinical application of the recombinant humanized anti-CD47 monoclonal antibody injection of Shandong New Times Pharmaceutical of Lunan Pharmaceutical Group was approved by NMPA.
Indications: relapsed or refractory lymphoma
.
Yaozhi data shows that many domestic companies have deployed CD47 target new drugs, including Lunan Pharmaceutical, Biotech, YiminOnco, CSPC, Zhongshan Kangfang, Cinda Biological, Tianjing Biological, Hengrui Pharmaceuticals and so on
.

12.
TQB2450 injection Chia Tai Tianqing Pharmaceutical Group Co.
, Ltd.

12.
TQB2450 injection Chia Tai Tianqing Pharmaceutical Group Co.
, Ltd.

TQB2450 injection is an innovative anti-PD-L1 fully humanized monoclonal antibody developed by Chia Tai Tianqing.
At present, the highest research and development stage of the drug is clinical phase III, and its indications include head and neck cancer, cholangiocarcinoma, renal cell carcinoma, and triple negative.
Breast tumors, non-small cell lung cancer, small cell lung cancer and squamous cell carcinoma of the head and neck
.
This time, two new clinical trials have been approved for the consolidation treatment of locally advanced/unresectable stage III non-small cell lung cancer after simultaneous/sequential radiotherapy and chemotherapy, and PD-L1 positive locally advanced recurrent and/or metastatic non-small cell lung cancer Small cell lung cancer
.

13.
QX002N injection

13.
QX002N injection

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.
This time it has been approved for a new indication: lupus nephritis
.

14.
9MW2821

14.
9MW2821

The clinical trial application of the ADC drug product (R&D code: 9MW2821) of Maiwei Bio-targeting Nectin-4 was formally approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration, which can target urothelial cancer, breast cancer, Carry out clinical research on multiple solid tumors such as lung cancer
.
It is reported that this is the first type of Nectin-4 ADC approved for clinical research among domestic companies with the same target drug, and the second Nectin-4 ADC type approved for clinical research in the world
.

15.
BL-B01D1 for injection

15.
BL-B01D1 for injection

BL-B01D1 is a bispecific antibody conjugate (ADC) developed by Bailey Pharmaceuticals, which can target EGFR and HER3 at the same time.
It is planned to develop BL-B01D1 for the treatment of lung cancer, esophageal cancer, head and neck squamous cell carcinoma and other indications
.
The clinical indications approved this time are locally advanced or metastatic epithelial tumors
.

16.
BAT7104 injection

16.
BAT7104 injection

BAT7104 is a bispecific antibody against PD-L1 and CD47 developed by Biotech.
It is intended to be developed for tumor treatment.
BAT7104 blocks the CD47/SIRPα pathway to activate macrophages to phagocytose tumor cells; BAT7104 blocks PD-L1 /PD-1 pathway, relieves tumor cells from inhibiting T cells through PD-L1/PD-1 pathway, and realizes 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 and 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
.

17.
Recombinant humanized anti-PCSK9 monoclonal antibody injection

17.
Recombinant humanized anti-PCSK9 monoclonal antibody injection

Junshi Bio's PCSK9 monoclonal antibody ongorexisimab (R&D code: JS002) combined with PD-1 teriprizumab for the treatment of advanced tumors was approved by the NMPA.
This is the first clinically approved PCSK9+PD in China -1 Combination therapy
.
Angoreiximab (JS002) is the first domestic PCSK9 drug independently developed by Junshi Biologics and obtained NMPA clinical approval
.
PD-1 monoclonal antibody is a cornerstone drug of current tumor immunotherapy, and various related companies are committed to covering PD-1 and its combination therapy to more indications
.

18.
CAN103 for Injection

18.
CAN103 for Injection

CAN103 is an enzyme replacement therapy drug developed by Beihai Kangcheng and approved to carry out clinical trials for the long-term treatment of adults and children with Type I and Type III Gaucher disease
.
Gaucher disease is one of the most common lysosomal storage diseases.
In the past 30 years, clinical trials and real-world supporting data have shown that Gaucher’s disease is treated by glucocerebrosidase replacement therapy (ERT), which is mainly non-neural The quality of life of patients with systemic symptoms and health has been significantly improved
.

New Drug Clinical Application·New Acceptance

New Drug Clinical Application·New Acceptance

In this issue, CDE has newly accepted clinical applications for 46 new drugs (61 acceptance numbers)
.
Among them, 36 varieties (48 acceptance numbers) are domestic new drugs, and 10 varieties (13 acceptance numbers) are imported new drugs.
More developments are as follows:

Source: Yaozhi Data