Gan&Lee Pharmaceuticals (603087.SH): CHMP Grants Positive Opinion for Marketing Authorization Application (MAA) of Insulin Glargine Injection (Ondibta®) in EU

Stock News

2025/11/13

Gan&Lee Pharmaceuticals (603087.SH) announced that the company and its wholly-owned European subsidiary, Gan&Lee Pharmaceuticals Europe GmbH, recently received notification from the European Medicines Agency (EMA). The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Marketing Authorization Application (MAA) for Insulin Glargine Injection (brand name: Ondibta®).

CHMP recommended that the European Commission (EC) approve Ondibta® as a biosimilar to Lantus SoloStar for the treatment of diabetes in adults, adolescents, and children aged 2 years and above. The CHMP's recommendation will proceed to the EC review stage for marketing authorization of Ondibta® in the EU, Iceland, Liechtenstein, and Norway. A final decision is expected in early next year.

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The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Marketing Authorization Application (MAA) for Insulin Glargine Injection (brand name: Ondibta®).\nCHMP recommended that the European Commission (EC) approve Ondibta® as a biosimilar to Lantus SoloStar for the treatment of diabetes in adults, adolescents, and children aged 2 years and above. The CHMP's recommendation will proceed to the EC review stage for marketing authorization of Ondibta® in the EU, Iceland, Liechtenstein, and Norway. A final decision is expected in early next year.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}