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On February 21, the official website of the State Food and Drug Administration showed that Sichuan Kelun Pharmaceutical's compound amino acid (15) dipeptide (2) injection was approved and reviewed as a supplementary application, and it was the first company to review the product
.
On February 22, Kelun Pharmaceutical issued an announcement saying that the first-class innovative drug SKB378/HBM9378 injection jointly developed by Sichuan Kelun Botai Biopharmaceuticals, a holding subsidiary of the company and Hebo Pharmaceutical, was approved for clinical use, and the drug was approved to carry out moderate-to-severe drugs.
Clinical trials in asthma indications
.
Prior to this, Sichuan Kelun Pharmaceutical's oral hypoglycemic drug Linagliptin was approved for production as a Class 4 imitation, which is regarded as over-evaluation
.
February 21, 2022 Drug approval certificate pending information release Compound amino acid (15) dipeptide (2) injection is suitable for patients who cannot be given oral or enteral nutrition, and those who cannot meet their needs through these ways, especially For patients with moderate to severe catabolic conditions
.
Sales of terminal compound amino acid (15) dipeptide (2) injection in Chinese public medical institutions in recent years (unit: 100 million yuan) Source: MINET The sales of terminal compound amino acid (15) dipeptide (2) injection in first-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) are nearly 500 million yuan, with a year-on-year increase of more than 10% in the first half of 2021.
Sichuan Branch Lun Pharmaceutical has the largest market share, exceeding 80%
.
Compound amino acid (15) dipeptide (2) injection has 4 companies with production approvals.
At present, only Sichuan Kelun Pharmaceutical Co.
, Ltd.
has reviewed it.
In the process of review and approval, it will be regarded as a review after approval
.
Basic information of the drug SKB378/HBM9378 injection is a class 1 innovative drug with global intellectual property rights, which is jointly developed by Sichuan Kelun Botai Biomedicine and Hebo Pharmaceuticals using the Hebo medical technology platform H2L2 fully human mouse, targeting TSLP (thymic stromal lymphopoietin, a fully human monoclonal antibody against thymic stromal lymphopoietin, and the two sides confirmed that Sichuan Kelun Botai Biomedicine and Hebo Pharmaceutical (Shanghai) will be the sponsors to advance clinical research
.
As of now, AstraZeneca/Amgen's Tezepelumab is the most advanced in the development of monoclonal antibodies with the same target in the world.
The monoclonal antibody was approved for marketing in the United States on December 17, 2021, and is undergoing Phase III clinical trials in China.
.
Domestic pharmaceutical companies such as Connoya and Hengrui all have a layout in this target, and no similar products have been approved for marketing in China
.
.
On February 22, Kelun Pharmaceutical issued an announcement saying that the first-class innovative drug SKB378/HBM9378 injection jointly developed by Sichuan Kelun Botai Biopharmaceuticals, a holding subsidiary of the company and Hebo Pharmaceutical, was approved for clinical use, and the drug was approved to carry out moderate-to-severe drugs.
Clinical trials in asthma indications
.
Prior to this, Sichuan Kelun Pharmaceutical's oral hypoglycemic drug Linagliptin was approved for production as a Class 4 imitation, which is regarded as over-evaluation
.
February 21, 2022 Drug approval certificate pending information release Compound amino acid (15) dipeptide (2) injection is suitable for patients who cannot be given oral or enteral nutrition, and those who cannot meet their needs through these ways, especially For patients with moderate to severe catabolic conditions
.
Sales of terminal compound amino acid (15) dipeptide (2) injection in Chinese public medical institutions in recent years (unit: 100 million yuan) Source: MINET The sales of terminal compound amino acid (15) dipeptide (2) injection in first-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) are nearly 500 million yuan, with a year-on-year increase of more than 10% in the first half of 2021.
Sichuan Branch Lun Pharmaceutical has the largest market share, exceeding 80%
.
Compound amino acid (15) dipeptide (2) injection has 4 companies with production approvals.
At present, only Sichuan Kelun Pharmaceutical Co.
, Ltd.
has reviewed it.
In the process of review and approval, it will be regarded as a review after approval
.
Basic information of the drug SKB378/HBM9378 injection is a class 1 innovative drug with global intellectual property rights, which is jointly developed by Sichuan Kelun Botai Biomedicine and Hebo Pharmaceuticals using the Hebo medical technology platform H2L2 fully human mouse, targeting TSLP (thymic stromal lymphopoietin, a fully human monoclonal antibody against thymic stromal lymphopoietin, and the two sides confirmed that Sichuan Kelun Botai Biomedicine and Hebo Pharmaceutical (Shanghai) will be the sponsors to advance clinical research
.
As of now, AstraZeneca/Amgen's Tezepelumab is the most advanced in the development of monoclonal antibodies with the same target in the world.
The monoclonal antibody was approved for marketing in the United States on December 17, 2021, and is undergoing Phase III clinical trials in China.
.
Domestic pharmaceutical companies such as Connoya and Hengrui all have a layout in this target, and no similar products have been approved for marketing in China
.
