In July, these 110 new drugs were approved clinically. Hengrui, Baiji, and Cinda lead the way!

◆A total of 179 new drugs were approved for clinical use in July, involving 110 varieties (list attached)

Data sources for this report: Insight database, CDE drug clinical trial registration and information disclosure

New clinical drug varieties approved this month

The Insight database (https://db.

Among domestic companies, Hengrui has received clinical approval for 7 new drugs, Baiji has received clinical approval for 4 new drugs, and Cinda has also received clinical approval for 3 new drugs, continuing to lead the development of innovative drugs

The following is an introduction to some of the key products of clinical varieties approved this month.

Introduction of New Drugs Approved for Clinical Use In July, there were 179 clinical acceptance numbers for new drugs approved for clinical use, involving 110 varieties.

Drug name: 6MW3211 injection company name: Maiwei Bio

6MW3211 injection is a CD47/PD-L1 bispecific antibody developed by Maiwei Biotechnology, which is intended to be used for the treatment of advanced malignant tumors

Drug Name: ABL001 Tablet Company Name: Novartis Pharmaceuticals This month, Novartis's Class 1 new drug, ABL001 Tablet, obtained two clinical trials implied approval, and it is planned to be developed for the treatment of adult patients with chronic myelogenous leukemia in the chronic phase

Drug name: BAT6005 injection company name: Biotech

Biotech's innovative drug BAT6005 injection was approved for clinical use and is intended to be used for the treatment of advanced solid tumors

Drug name: CAN106 injection company name: Nuoai Pharmaceutical

Nuoai Pharmaceutical's CAN106 injection has obtained clinical tacit approval and is intended to be used for the treatment of paroxysmal nocturnal hemoglobinuria

Drug Name: ET0038 Tablets Company Name: Yituo Pharmaceutical

ET0038 is an allosteric inhibitor of SHP2 independently developed by Etoppharma and with global intellectual property rights.

Drug name: EX103 injection company name: Aismin Biotech

The drug was developed by using ExMab, a four-chain bispecific antibody platform from Esmin Biotech.

Drug Name: GB5005 Chimeric Antigen Receptor T Cell Injection Company Name: Jibei Bio

The drug is a CAR-T cell therapy targeting CD19.

Drug Name: GFH925 Tablets Company Name: Jinfang Pharmaceutical

GFH925 tablet is a Class 1 innovative drug applied by Jinfang Pharmaceutical for clinical trials.

Drug Name: HR17031 Injection Enterprise Name: Hengrui Medicine

HR17031 injection is a fixed ratio compound injection of basic long-acting insulin and GLP-1 analogs independently developed by Hengrui.

Drug Name: IMP5471-CA Capsule Company Name: Yingpai Pharmaceutical

Yingpai Pharmaceutical's IMP5471-CA capsule was approved for clinical use, and its indication is hematological malignancy

Drug Name: MK-1026 Tablet Company Name: Merck & Co.

Merck's Class 1 new drug, MK-1026 tablets, has obtained implied approval from two clinical trials and plans to be developed for the treatment of hematological malignancies

Drug Name: Ociperlimab Injection Company Name: BeiGene

Ociperlimab (BGB-A1217) is an investigational TIGIT monoclonal antibody.
This target inhibits T cell/NK cell-mediated tumor immune activation and is an immune checkpoint
.
Indications are advanced solid tumors, esophageal tumors, metastatic non-small cell lung cancer, nasopharyngeal carcinoma, squamous cell carcinoma, and cervical cancer
.

Drug name: Relatlimab/Nivolumab fixed-dose compound injection Company name: Bristol-Myers Squibb

Bristol-Myers Squibb relatlimab/nivolumab fixed-dose compound injection obtained the implied approval of clinical trials, and it is planned to be developed for advanced solid tumors
.
Relatlimab is an anti-LAG-3 antibody.
Previously, its combination therapy with the anti-PD-1 antibody nivolumab (Opdivo, nivolumab) has been used to treat 2/3 of newly-treated patients with metastatic or unresectable melanoma In phase 3 clinical trials, the primary endpoint of progression-free survival (PFS) was reached.
This is also the world's first phase 3 clinical trial to report the efficacy of anti-LAG-3 antibodies
.
The relatlimab/nivolumab fixed-dose compound injection was approved for clinical use in China, which means that the combination therapy is about to start clinical trials in China
.

Drug Name: RG001 Tablet Company Name: Lingji Biological

The clinical trial application of the new anti-tumor drug SHP2 allosteric inhibitor RG001, a new anti-tumor drug independently developed by Lingda Biologicals, has obtained implied permission for phase I clinical trials of advanced malignant tumors (including solid tumors and hematomas)
.

Drug Name: RRx-001 Injection Enterprise Name: Saisheng Pharmaceutical

The drug is a next-generation small molecule immunotherapy with good safety, targeting the CD47-SIRPα axis
.
As a potential immunotherapy that transforms tumors "tolerant to treatment" into tumors that are "sensitive to treatment", RRx-001 can be used as a monotherapy or in combination with chemotherapy, other immunotherapies, radiotherapy and targeted drugs
.
Saisheng Pharmaceutical was authorized to introduce from the US EpicentRx, and obtained 10-year patent commercialization licenses in Mainland China, Hong Kong, Macau, and Taiwan
.
The approved indication is extensive-stage small cell lung cancer
.

Drug name: SBK001 injection company name: Shibeikang Biological

The drug is the second chemical Class 1 new drug independently developed by Chengdu Shibeikang and approved for clinical use
.
SBK001 injection is a brand-new mechanism of action, a brand-new compound, and has global patents; its indications are: used for the preventive treatment of acute lung injury, such as acute lung injury caused by surgery, viruses or bacteria
.

Drug Name: SHR-1906 Injection Enterprise Name: Hengrui Medicine

The drug is a new class 1 drug developed by Hengrui Medicine, and its indication is idiopathic pulmonary fibrosis (IPF)
.
According to public information, SHR-1906 may be CTGF antibody, and it is also the first domestically produced CTGF antibody
.
CTGF is a multifunctional heparin-binding glycoprotein, which is usually expressed at low levels, but is significantly enriched in almost all fibrotic conditions
.

Drug name: SHR6508 injection company name: Hengrui Medicine

SHR6508 is a new class of molecules independently developed by Shanghai Hengrui Medicine.
It is intended to be used for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on maintenance hemodialysis
.
At present, there is no similar intravenous drug product on the market in China
.
Up to now, SHR6508 injection related research and development projects have invested about 13.
33 million yuan in research and development expenses
.

Drug name: SKB336 injection company name: Kelunbotai

The drug is a humanized and innovative monoclonal antibody targeting FXIa/FXI factors developed by Kelun Botai, a subsidiary of Kelun Pharmaceutical, and is intended to be developed for the prevention and treatment of thromboembolic diseases
.
Non-clinical research data confirmed that SKB336 injection has high affinity and high selectivity for the endogenous coagulation factors FXI and FXIa, but has no effect on other exogenous coagulation factors and the downstream coagulation factors of the common pathway
.
No antibody drug with the same target as SKB336 has been approved for marketing in the world
.

Drug name: CEND-1 for injection Company name: Qilu Pharmaceutical

The CEND-1 for injection introduced by Qilu Pharmaceutical was approved by a clinical trial, and it is planned to be developed for the first-line treatment of advanced metastatic pancreatic cancer
.
Public information shows that CEND-1 is a potential "first-in-class" anti-cancer therapy developed by Cend Therapeutics.
In February 2021, Qilu received a $10 million down payment + a milestone payment of up to $225 million from Cend Therapeutics This product has exclusive rights in Greater China (including China, Hong Kong, Macau and Taiwan)
.

Drug name: LBL-015 for injection company name: Wei Li Zhibo Biological

The drug is a dual-function fusion protein independently developed by Nanjing Weilizhibo Biotechnology and has intellectual property rights.
It is formed by the fusion of a high-affinity anti-PD-1 monoclonal antibody and TGFβRⅡ protein, which can simultaneously block PD-1/ PD-L1 and TGFβ immunosuppressive pathway
.
The clinical research indication approved in China this time is advanced malignant tumor
.

Drug name: MT1013 for injection company name: Maicoot

The drug is an innovative bifunctional peptide independently developed by Mecoot.
This time it has been approved for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease undergoing maintenance hemodialysis
.
The MT1013 developed by Mecoot is a dual-target functional peptide.
Preclinical studies have shown that this molecule has extremely high safety and effectiveness.
Compared with the marketed drugs, it not only achieves the same PTH-lowering effect, but also can significantly reduce low blood pressure.
Risk of Calcemia
.

▲The above data comes from the Insight report progress database