One injection per week! Novo Nordisk's new compound preparation Kyinsu has been approved by the European Union
On November 26, 2025, Novo Nordisk announced that the European Commission (EC) had approved the marketing authorization for its Kyinsu8 (a weekly IcoSema, a combination of basal insulin weekly preparation Ecoinsulin and GLP-1RA weekly preparation Smeaglutide). This drug is suitable for adult patients with type 2 semiuria who receive basal insulin or GLP-1 receptor agonist therapy but have poor blood glucose control. It is used as an adjunct to diet and exercise, in combination with oral hypoglycemic drugs.
The approval of the European Commission is based on the positive results of the Combine Phase 3a clinical trial project. All three trials in this project achieved the primary endpoint, demonstrating that once a week IcoSema is superior to its single component in reducing blood glucose (measured by HbA1C changes), and has non inferiority in reducing blood glucose compared to the daily basal meal insulin regimen. In addition, lCoSema showed more significant weight loss and lower incidence of hypoglycemia (clinically significant or severe hypoglycemia). Throughout the Phase 3a clinical trial project, once a week, lcoSema demonstrated safe and well tolerated characteristics.
This marketing authorization applies to all 27 member states of the European Union, as well as Iceland, Norway, and Liechtenstein. This approval was obtained after the European Medicines Agency's Committee for Medicinal Products for Human Use gave a positive opinion in September 2025.
Kyinsu @ has completed registration applications in multiple other countries and is expected to receive more regulatory decisions by 2026
Kyinsu8 (once a week lcoSema) is a combination of basal insulin weekly preparation icoinsulin and GLP-1RA weekly preparation semaglutide. The maximum weekly dose for a single injection is 350 doses per unit (350U icoinsulin/1.0mg semaglutide). In the EU, it is approved to be used for adult type 2 diabetes patients who receive basic insulin or GLP-1 receptor agonist treatment but have poor blood glucose control. As an auxiliary means of diet and exercise, it is combined with oral hypoglycemic drugs.
Ganli Pharmaceutical launches China's first monthly GLP-1RA weight loss phase III clinical study GRADUAL-3
On November 26, 2025, Ganli Pharmaceutical Co., Ltd. (hereinafter referred to as Ganli Pharmaceutical, stock code: 603087. SH) announced that the company's independently developed glucagon like peptide-1 receptor agonist (GLP-1 RA) and Bofang advertising peptide (R&D code: GZR18) injection has officially launched a phase II clinical trial (GRADUAL-3) for the treatment of obesity or hyperalgesia. This is the third large-scale phase clinical study of Bofang advertising peptide in the field of obesity/overweight. This study will adopt a monthly formulation plan of subcutaneous injection once every four weeks, aiming to explore the clinical potential of Bofangrupeptide injection in weight control and maintenance.
The core direction of the CTR20254659 study registered on the Drug Clinical Trial Registration and Information Disclosure Platform is to explore the weight impact and safety characteristics of Bojige Peptide Injection after 24 weeks of continuous treatment when administered once a month. The study was led by Professor Ji Linong from Peking University People's Hospital, with the primary endpoint being the specific change in weight and percentage change of participants compared to baseline after 24 weeks of treatment.
Regarding the indication of obesity or overweight, Ganli Pharmaceutical has previously initiated two Phase I clinical trials, GRADUAL-1 and GRADUAL-2, for Bofangrutide Injection. It is worth noting that in the GRADUAL-2 study, Bofanglutide injection set a global record. It is the first GLP-1RA drug to carry out a head to head parallel control test with Novoying (Smeglutide 2.4mg) among Chinese adult obese/overweight subjects with or without type 2 diabetes mellitus. The aim of this study is to comprehensively evaluate and verify the efficacy and safety of Bofangrupeptide injection in obese or overweight patients, and to investigate its comprehensive improvement effect on various metabolic indicators and cardiovascular risk factors.
The newly launched phase clinical study (GRADUAL-3) will serve as an important advancement in the series of studies, further exploring the potential value of Bofangrupeptide injection in weight control and maintenance when administered once a month. The research team hopes to improve patients' medication compliance by reducing injection frequency and optimizing treatment convenience, thereby improving the problems of weight rebound and decreased efficacy that often occur in the long-term treatment of GLP-1RA drugs.
