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According to data on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, since 2022, 315 clinical trial applications have passed "implicit licenses"
315 Class 1 New Drugs
1.
1.
Mechanism of action: GnRH receptor antagonist
Indications: uterine fibroids
Indications: uterine fibroidsSHR7280 tablets declared by Hengrui Medicine were approved for clinical use, and the proposed indication is uterine fibroids with menorrhagia
Novel oral small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist for uterine fibroids with menorrhagia
2.
2.
Target: TSLP
Indications: severe asthma
Indications: severe asthmaThe HBM9378 (SKB378) injection declared by Hebo Pharmaceuticals was approved for clinical use, and the proposed indication is severe asthma
Thymic stromal lymphopoietin (TSLP), which is to be developed for the treatment of asthma, has a global interest in the drug
3.
Target: TGF-β/PD-L1
Indications: Advanced solid tumors
Indications: Advanced solid tumorsThe HB0028 injection declared by Huabo Bio and Hua Aotai Bio has been approved for clinical use, and the proposed indication is advanced solid tumors
According to public information, Huaaotai Bio was established in 2013 and is a subsidiary of Huahai Pharmaceutical
4.
4.
Target: c-MET
Indications: Advanced solid tumors
Indications: Advanced solid tumorsThe ASKC202 tablet declared by Osaikang Pharmaceuticals was approved for clinical use, and the proposed indication is advanced solid tumor
Oral small molecule c-MET inhibitors
Studies have found that c-MET is a well-characterized oncogene that is associated with poor prognosis in many types of solid tumors, including gastric cancer, hepatocellular carcinoma, and non-small cell lung cancer
ASKC202 has demonstrated its activity in a series of preclinical tumor models and is expected to provide a new treatment option for patients with tumors with abnormal c-MET pathway
5.
5.
Daewoong Pharmaceuticals: enavogliflozin tablets
Target: SGLT-2
Target: SGLT-2Indications: Type 2 diabetes
Indications: Type 2 diabetes The enavogliflozin tablet filed by Daewoong Pharmaceuticals was approved for clinical use in China
.
According to CDE announcement, this is a glucose sodium cotransporter 2 (SGLT-2) inhibitor.
The clinical research indication approved this time is as an adjunct to diet and exercise to improve blood sugar control in adult patients with type 2 diabetes
.
SGLT-2 inhibitors act on the SGLT-2 transporter in the body to prevent the reabsorption of filtered glucose in the kidneys, thereby effectively controlling blood sugar levels
.
It is worth noting that SGLT-2 inhibitors are a class of non-insulin-dependent hypoglycemic drugs, so there is basically no risk of hypoglycemia
.
According to Daewoong's official website, enavogliflozin is currently in Phase 3 clinical research overseas and is intended to be developed for the treatment of type 2 diabetes
.
6.
Saiao Bio: Human Amniotic Epithelial Stem Cell Injection
Saiao Bio: Human Amniotic Epithelial Stem Cell Injection
Mechanism of Action: Stem Cell Therapy
Mechanism of Action: Stem Cell TherapyIndication: acute graft-versus-host disease
Indication: acute graft-versus-host disease The Human Amniotic Epithelial Stem Cell Injection declared by Saiao Bio has been approved for clinical use, and the proposed indication is the treatment of hormone-resistant acute graft-versus-host disease after hematopoietic stem cell transplantation
.
Hematopoietic stem cell transplantation is an effective method for the treatment of hematological malignancies, but acute graft-versus-host disease (aGVHD) caused by hematopoietic stem cell transplantation is still a daunting clinical challenge
.
Studies have shown that human amniotic epithelial stem cells (hAESCs) are differentiated from the blastocyst stage epiblast on the 8th to 9th day of embryonic development and have strong immune regulation capabilities
.
According to literature reports and the in vitro and in vivo research results of Cyanobio, human amniotic epithelial stem cells have shown a good therapeutic effect on diseases caused by excessive immunity
.
7.
Lijiexun Pharmaceutical: Rupatifine Fumarate Capsules
Lijiexun Pharmaceutical: Rupatifine Fumarate Capsules
Indications: allergic rhinitis
Indications: allergic rhinitis Rupatifine Fumarate Capsules, declared by Fujian Mindong Lijiexun Pharmaceutical (referred to as "Lijiexun Pharmaceutical"), has been approved for clinical use and is intended to be developed for the treatment of allergic rhinitis
.
According to the press release of Lijiexun Pharmaceuticals, Rupatifene Fumarate Capsules is a new class 1 drug against allergic rhinitis.
The drug can antagonize histamine receptors, stabilize mast cells, and at the same time interact with platelet activating factor receptors Specific binding to achieve multi-target coverage of allergens
.
In addition, the drug has the characteristics of small central sedative side effects, large safety window, multiple anti-allergic effects, strong drug efficacy and fast onset of action
.
8.
Bojiyuan Pharmaceutical: BGT-002 Tablets
Bojiyuan Pharmaceutical: BGT-002 Tablets
Indications: Hypercholesterolemia
Indications: Hypercholesterolemia The BGT-002 tablet declared by Bojiyuan Pharmaceuticals was approved for clinical use, and the proposed indication is hypercholesterolemia
.
According to public information, Bojiyuan Medicine was established in September 2020 by three senior scientists from the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Nan Fajun, Xie Xin and Li Jingya
.
The company focuses on the field of oncology and chronic diseases, and is committed to the continuous research and development of original small molecule innovative drugs
.
In June 2021, the company announced the completion of the pre-A round of financing, and its R&D pipeline already includes a new drug candidate for multiple myeloma in Phase 1a clinical research
.
9.
Xinlitai Pharmaceutical: SAL0114 tablets
Xinlitai Pharmaceutical: SAL0114 tablets
Indications: major depressive disorder
Indications: major depressive disorder The SAL0114 tablet declared by Xinlitai Pharmaceutical has been approved for clinical use and is planned to be developed for patients with severe depression
.
According to the announcement of Xinlitai Pharmaceutical, SAL0114 tablet is a compound preparation independently developed by the company
.
Depression is a common mental illness, according to the announcement
.
The prevalence of depression in China is 2.
1%, and the lifetime prevalence of depression in adults is 6.
8%.
Patients with depression are rarely adequately treated, and there are unmet clinical needs
.
10.
Shandong Danhong Pharmaceutical: BC0305 Capsules
Shandong Danhong Pharmaceutical: BC0305 Capsules
Indications: Diabetes
Indications: Diabetes The BC0305 capsule declared by Shandong Danhong Pharmaceutical, a subsidiary of Buchang Pharmaceutical, was approved for clinical use, and the indication is diabetes
.
According to the announcement of Buchang Pharmaceutical, BC0305 is an investigational drug intended to improve blood sugar control in diabetic patients on the basis of diet and exercise
.
In addition to the above-mentioned products, there are a number of Class 1 new drugs that have obtained the implied license for clinical trials this week, and this article will not introduce them one by one
.
It is hoped that the follow-up studies of these new drugs under investigation will proceed smoothly and benefit patients as soon as possible
.
References:
References: [1] The official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China.
Retrieved Feb 18, 2022, From https:// The official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China.
Retrieved Feb 18, 2022, From https:// [2] Official websites and public information of each company
