“Tirzepatide” is approved in China

On May 21st, according to the official website of NMPA, the Lilly GLP-1R/GIPR dual agonist dual excitement Injtie peptide injection (Mu Fengda®) was approved to be listed in the country. And/or sulfurbin drugs to treat patients with poor blood sugar (T2DM) patients with poor blood sugar.

Tirzepatide is the first GLP-1R dual-target hypoglycemic drug for Type 2 diabetes. It is administered once a week. Hot discussion.

In the United States, in May 2022, it was approved to be listed to treat type 2 diabetes, and at the end of last year, he was approved for weight loss indications. Today, this blockbuster drug has finally been approved in China. In addition, weight loss indications are currently in the domestic application stage and are under review.

Terpot peptide can selectively bind and excite the two natural intestinal insulin receptors of GIP receptors and GLP-1 receptors, reducing the empty stomach and blood glucose level of T2DM patients. There are currently 4 specifications of Mufengda®: 2.5 mg: 0.5 ml, 5 mg: 0.5 ml, 7.5 mg: 0.5 ml, 10 mg: 0.5 ml.

This approval is mainly based on the global key III registered test Surpass 1-5 and the Asia-Pacific phase registered test test Surpass-AP-COMBO (83.4% of the subjects 12). in:
The average diabetic disease of the T2DM patients incorporated by Surpass-2 is 8.6 years, the average HBA1C is 8.28%, the average weight is 93.7 kg, and the average physical index (BMI) is 34.2 kg/m2. Among them, Mu Fengda ® 5mg and 10mg treatment group subjects fell by HBA1C by 2.09%and 2.37%from the baseline at the 40th week.

In addition, the average changes in the weight self -based line are one of the key secondary end points. Mu Fengda ® 5mg and 10mg subjects weighed an average of 7.8 kg and 10.3 kg.

The average diabetic disease course included in the T2DM patients incorporated by Surpass-AP-COMBO is 7.7 years, the average HBA1C is 8.71%, the average weight is 76.6 kg, the average BMI is 27.9 kg/m2, and 47.5% is used. Essence Among them, Mu Fengda ® 5 mg and 10 mg treatment group subjects fell by HBA1C by 2.24%and 2.44%at the 40th week. The average drop in HBA1c, the glyphosate insulin group, was 0.95%.

In addition, the average changes of the weight -based self -based line are one of the key secondary end points. Mu Fengda ® 5 mg, 10 mg subjects decreased by 5.0 kg and 7.0 kg, and the average weight increase of glycry insulin group was 1.5 kg.

The overall safety of Mu Fengda® in the Asia -Pacific region, which is dominated by the Chinese population, is consistent with the global population and has not found new security signals. Gastrointestinal reactions are the most common adverse reactions. They usually occur in the dosage increasing period and reduce it with time. The severity is mostly mild or moderate.

The clinical trial of the Surpass series of doerpaptides began at the end of 2018, and 9 items have been completed, including 6 global III clinical trial 13-18, 1 Asia-Pacific regional regional III clinical trial 12 and 2 Japanese regional III Period clinical trial. At present, there are two other adult T2DM blood glucose control III tests in China are developing, which aims to study the effectiveness and safety of the Terpot peptide single -drug therapy (NCT05963022) and combined with basic insulin therapy (NCT05691712).

The main research end of the 9 Surpass series of clinical trials of the Surpass series is 40 weeks or 52 weeks, and the treatment period is up to 104 weeks. In T2DM patients, the Terpubon (5 mg, 10 mg, and 15 mg ) The effectiveness and safety of the treatment of hypoglycemic drug treatment as a single drug treatment and combined categories. Activated control drugs include Smeglin 1 mg, 0.75 mg of ductin peptide, and titer of insulin (deogin, glycry insulin, and preserved insulin). Overall, phase III clinical trial data shows that for T2DM patients who are in different doses of T2DM patients who are in different diabetic diseases (average diseases of about 5 to 14 years) HBA1C.

The Urpo peptide has been unstoppable since its listing. It was just launched in September 2022. The sales of hypoglycemic drugs MOUNJARO in 2023 reached US $ 5.163 billion, while the weight loss medicine Zepbound had a revenue of US $ 175.8 million in less than two months. In 2023, the total sales of Delpo peptides have reached US $ 5.339 billion.

At present, according to the Insight database, Terpubot peptides have started 26 phase III clinical trials. In addition to hypoglycemic and weight loss, they have begun to enter the new market. Reach the main end.