Breakthrough in Self-Developed Long-Acting Insulin Brings Hope to 900 Million Diabetics

On January 23, HengRui Pharma announced that the application for the marketing authorization of Shudi Insulin Injection (INS068) has been accepted by the National Medical Products Administration. This product marks the first self-developed long-acting insulin analogue in China.

The marketing application is primarily based on positive results from two pivotal Phase III clinical trials (Studies 301 and 302). These trials assessed the efficacy and safety of Shudi insulin injection compared to glargine insulin in adults with type 2 diabetes mellitus (T2DM) who had poor glycemic control while on basal insulin or oral hypoglycemic agents. The 301 study enrolled 423 participants, while the 302 study included 513 participants.

Both studies were successfully completed in December 2024. Results showed that after 26 weeks of treatment, Shudi insulin maintained a similar reduction in glycated hemoglobin (HbA1c) compared to glargine insulin, whether used alone or in conjunction with oral hypoglycemic agents. Moreover, the safety and tolerability profiles of Shudi insulin were favorable, with adverse events resembling those of glargine, and incidences of hypoglycemia, particularly nocturnal hypoglycemia, slightly lower than those observed with glargine. Both studies met their primary endpoints.

Diabetes is a metabolic syndrome characterized by high blood sugar levels due to insulin secretion defects and/or inadequate insulin action. In 2021, the global population of diabetics reached 537 million, with approximately 140 million cases in China, making it the country with the highest number of diabetes patients. Projections indicate that by 2045, the global count may rise to 783 million, with China accounting for 170 million. T2DM constitutes over 90% of all cases, primarily resulting from insulin resistance and progressive decline in pancreatic β-cell function. If left uncontrolled or poorly managed, high blood sugar can lead to irreversible vascular complications, including retinopathy, renal failure, myocardial infarction, stroke, and amputation.

The treatment of T2DM currently employs a comprehensive management model that includes dietary control, exercise, blood sugar monitoring, diabetes education, and pharmacotherapy. Lifestyle interventions serve as foundational treatment measures, and as T2DM progresses, it often necessitates a combination of different classes of hypoglycemic agents. Clinical guidelines recommend initiating insulin therapy when blood sugar levels remain uncontrolled after treatment with one or more oral agents. For newly diagnosed T2DM patients exhibiting significant hyperglycemic symptoms or ketosis, a short-term insulin intensification regimen is the preferred option.

Shudi insulin injection is HengRui Pharma's self-developed long-acting insulin, characterized by its steady onset, prolonged duration of action, and lower risk of nighttime hypoglycemia. To date, approximately 34.88 million yuan has been allocated to the development of Shudi insulin-related projects.

Globally, similar products have already received approval, including Novo Nordisk's Tresiba® and Sanofi's Toujeo®. According to the Nextpharma database, global sales of Tresiba® and Toujeo® combined reached $2.3 billion in 2023.