China Approves World’s First Once-Weekly Ultra-Long-Acting Insulin for Type 2 Diabetes

The world's first and currently only once-weekly insulin has been approved in China.

On June 24, the National Medical Products Administration (NMPA) announced that the Class 1 new drug Icodec Insulin Injection (brand name: NovoCycle, icodec) developed by Danish pharmaceutical giant Novo Nordisk was officially approved for marketing in China. This product is a novel once-weekly basal insulin used for the treatment of adult patients with type 2 diabetes. It only requires one injection per week.

Regarding the commercial launch timing and pricing, Novo Nordisk told Era Finance, "We hope to bring this innovative drug to patients in China as soon as possible. The out-of-pocket price will be announced at the time of commercial launch."

Icodec insulin has a half-life of up to 196 hours (approximately 7 days), meaning that within a one-week dosing interval, this product provides a uniform distribution of blood sugar lowering effects. At clinically relevant doses, the hypoglycemic action can cover a full week.

Professor Mu Yiming from the First Medical Center of PLA General Hospital stated, "The results of the global Phase 3 clinical trial for Icodec insulin show that, compared with once-daily basal insulin, once-weekly Icodec insulin treatment offers superior efficacy, a higher safety attainment rate, and better compliance for patients with type 2 diabetes. It reduces the frequency of basal insulin injections from 7 times per week to just 1. Clinical research data indicates that Novo Nordisk’s Icodec helps more patients with type 2 diabetes achieve the treatment goal of HbA1c (glycated hemoglobin) <7% without hypoglycemia."

Icodec insulin has simultaneously initiated clinical trials in China, the EU, and the United States, with marketing applications for the drug also submitted concurrently. Apart from the Chinese market, this product has already been approved this year in the EU, Switzerland, Canada, and Australia, but not yet in the United States.

In May this year, a briefing document provided by scientists from the U.S. Food and Drug Administration (FDA) showed that "in a key trial, compared with Novo Nordisk's once-daily insulin degludec injection (brand name: Tresiba), the insulin icodec injection might cause hypoglycemia in patients." The U.S. FDA will also formally decide whether to approve insulin icodec for the treatment of type 1 and type 2 diabetes before the Prescription Drug User Fee Act (PDUFA) review deadline in the second half of 2024.

The 10th Edition of the IDF Diabetes Atlas shows that the total number of adult diabetes patients in China has reached 140 million, ranking first among all countries. Among them, type 2 diabetes patients account for the majority, but only 16.5% of Chinese adult diabetes patients have achieved blood glucose control targets. Insulin is the preferred choice for most diabetes patients, but when it comes to insulin use, patient compliance is often low. Many patients are reluctant to inject themselves with needles and are unwilling to inject medication multiple times a day. Therefore, the approval of long-acting insulin offers greater convenience for patients.

Data from Novo Nordisk shows that 93% of patients using insulin and 91% of doctors expressed hope that blood sugar can be well controlled without daily insulin injections. Therefore, both patients and doctors hope to improve treatment adherence and achieve good blood sugar control by reducing the number of injections.

Not only Novo Nordisk, but also Chinese insulin companies are laying out plans for long-acting insulin. Gan&Lee Pharmaceuticals (603087.SH), a leading company in the insulin sector, launched the Phase II clinical trial in China of its self-developed product GZR4 in September last year and completed the first dosing of subjects. This product is an ultra-long-acting insulin weekly formulation administered via subcutaneous injection once a week, indicated for diabetes.

At the end of June this year, Gan&Lee Pharmaceuticals announced the latest progress of this product at the 84th Scientific Sessions of the American Diabetes Association (ADA) in 2024. Gan&Lee Pharmaceuticals stated that, compared with Insulin Icodec injection, GZR4 showed a significantly increased affinity for human serum albumin (HSA) and a markedly reduced affinity for insulin receptors. After binding with albumin to form a complex, GZR4 can still maintain its ability to activate insulin receptors. In studies using diabetic animal models, the glucose-lowering effect of GZR4 was 2 to 3 times that of Insulin Icodec injection.

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