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The application of semaglutide raw material drug was accepted, and Tianji biological peptide product

Time:2023-01-10 15:30:39     Views:346

New Media Department                   Yu Jie, Duan Yuqing                   January 10, 2023

Recently, Suzhou Tianma Pharmaceutical Group Tianji Bio-Pharmaceutical Co., Ltd. (hereinafter referred to as "Tianji Bio") applied for the marketing authorization of semaglutide raw material drug was accepted. Tianji Biologics became the first API manufacturer whose marketing application for this product was accepted in China.

The application of semaglutide raw material drug was accepted, and Tianji biological peptide product(图1)

The currently approved indications for semaglutide (two dosage forms/different strengths) include diabetes and obesity.

In December 2017, the FDA approved semaglutide for blood sugar control in adults with type 2 diabetes;

In June 2021, the FDA approved semaglutide for chronic weight management, suitable for obese (BMI≥30kg/m2) or overweight (BMI≥27kg/m2) adults with at least one weight-related comorbidity.

The phase 3 SUSTAIN series studies of semaglutide have confirmed the hypoglycemic efficacy and safety, and effectively improved hyperglycemia, hypoglycemia, and blood sugar fluctuations in diabetic patients.

With the dual effects of hypoglycemic and weight loss, semaglutide has become a phenomenon-level "new star".

In November 2022, Novo Nordisk, the original manufacturer of semaglutide, released its financial report for the third quarter. As the main product, semaglutide performed well. Among them, the sales of semaglutide injections for diabetes treatment in the first three quarters were approximately US$5.68 billion, with a growth rate of 69%; In addition, semaglutide Wegovy, which specializes in weight loss indications, had sales of US$497 million in the first three quarters of this year.

In the Chinese market, according to public information, after its listing in April 2021, semaglutide will achieve sales of approximately RMB 312 million in 2021. In the first three quarters of 2022, semaglutide will continue to grow strongly in the Chinese market, achieving sales of RMB 1.536 billion.


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