GLP-1药物适应人群再度拓展，美国多肽配制政策更新

诺和杰^®（依柯胰岛素司美格鲁肽注射液）适用人群拓展至口服降糖药控制不佳成人2型糖尿病人群

IcoSema^® (insulin icodec/semaglutide injection) target populations expanded to adults with type 2 diabetes inadequately controlled with oral antidiabetic drugs

EN

Novo Nordisk announced that the supplemental application for marketing authorization for a new indication of IcoSema^® (insulin icodec/semaglutide injection) was approved by the National Medical Products Administration (NMPA). This approval further extends the target populations to adults with type 2 diabetes whose blood glucose remains inadequately controlled with oral antidiabetic therapy. These patients may receive treatment with this product in combination with oral antidiabetic drugs, in addition to diet and exercise. China has become the first country in the world to have the Post-OADs indication approved.

诺和盈^®长期体重管理适应症更新，覆盖更多中国超重和肥胖人群

The indications for long-term weight management of Wegovy^® have been updated to cover more overweight and obese patients in China

EN

Wegovy^® (semaglutide injection) has received an updated approval from the National Medical Products Administration (NMPA) for its long-term weight management indication, further expanding the target population. It is indicated for long-term weight management in adult patients in conjunction with diet control and increased physical activity. The applicable baseline BMI criteria are ≥28 kg/m², or 24 kg/m² ≤ BMI < 28 kg/m² with at least one weight-related comorbidity. In parallel, an updated storage requirement was also approved. Before the first opening, the product can be stored for up to 48 hours in an environment between 2 ℃ and 30 ℃.

礼来减重口服GLP-1药物orforglipron获欧洲药品管理局推荐批准

Lilly's oral weight-loss GLP-1 receptor agonist orforglipron has received a positive recommendation for approval from the European Medicines Agency

EN

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on Lilly's oral small-molecule GLP-1 agent orforglipron (brand name: Foundayo), recommending its approval for weight management in adults and the treatment of type 2 diabetes. This is the second oral weight-loss medicine recommended by the CHMP, following Novo Nordisk's oral Wegovy.

Retatrutide治疗阻塞性睡眠呼吸暂停（OSA）的两项3期临床试验结果发表

The results of two Phase 3 clinical trials of Retatrutide for the treatment of obstructive sleep apnea (OSA) have been published

EN

The New England Journal of Medicine (NEJM) published the results of two Phase 3 clinical trials conducted by Eli Lilly on retatrutide, a triple‑receptor agonist currently in development, for the treatment of obstructive sleep apnea (OSA). The studies showed that retatrutide significantly reduced the apnea–hypopnea index (AHI), improved breathing disturbances during sleep, and lowered body weight in patients irrespective of type 2 diabetes status. In patients without diabetes, the AHI was reduced by up to 34.3 events per hour, and by up to 25.4 events per hour in those with type 2 diabetes; both exceeded the placebo group's reduction of 9.9 events per hour.

诺和诺德CagriSema临床三期试验REDEFINE 1数据结果公布，女性患者68周平均减重25%

Novo Nordisk’s Phase 3 REDEFINE 1 trial results for CagriSema announced: female patients achieved an average 25.0% weight loss over 68 weeks

EN

At The Menopause Society Annual Meeting held in San Diego, USA, Novo Nordisk presented two post-hoc analyses of the Phase 3 REDEFINE 1 trial of the weight-loss drug CagriSema. Approximately two-thirds of participants in REDEFINE 1 were women. Among the 2,309 women who completed the treatment, those treated with CagriSema 2.4 mg/2.4 mg for 68 weeks achieved an average weight loss of 25.0%, compared with 3.0% in the placebo group. Stratified by menopausal stage, premenopausal, perimenopausal, and postmenopausal women lost 26.7%, 24.8%, and 23.1%, respectively.