YiChang HEC ChangJiang Pharma’s Insulin Aspart Gains NMPA Approval

China-based firm YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced that its in-house developed insulin aspart (specification 3ml: 300 units, refill) has been approved for marketing by the National Medical Products Administration (NMPA). This approval marks a significant milestone in the company’s efforts to expand its presence in the diabetes treatment market.

Insulin Aspart: Fast-Acting and Flexible
Insulin aspart is a fast-acting insulin analogue that takes effect more quickly than human insulin, better controls postprandial blood glucose levels, and reduces the risk of hypoglycemia. It offers a more flexible injection schedule, making it suitable for patients who receive oral hypoglycemic drugs but still have poor blood glucose control.

Market and Sales Performance
Diabetes drugs generated USD 5.22 billion in sales in 2021, up 12% from 2020. Domestic insulin and their analogues accounted for 49% of the market in China. HEC ChangJiang is pivoting towards endocrine and metabolic disease areas, particularly diabetes, with its recombinant human insulin injection and insulin glargine injection already approved for marketing. The company’s insulin aspart 30 injection and protamine recombinant human insulin injection (premix 30R) are awaiting regulatory decisions.

Pipeline and Clinical Studies
HEC ChangJiang is advancing its pipeline with Phase III clinical studies for rongliflozin and liraglutide well underway. These developments highlight the company’s commitment to addressing unmet needs in diabetes management and expanding its portfolio of treatments.

Future Outlook
The approval of insulin aspart by the NMPA underscores HEC ChangJiang’s strategic focus on endocrine and metabolic diseases. With a robust pipeline and ongoing clinical studies, the company aims to enhance its market position and improve outcomes for patients with diabetes.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry