April 17, 2026
Source: drugdu
32
On April 9, 2026, Dongyangguang Pharmaceutical's protamine human insulin mixed injection (30R) pre-filled specification officially received marketing approval from the National Medical Products Administration (NMPA) of China. This approval further enriches the company's drug product pipeline in the field of diabetes and brings more and more convenient insulin medication options to diabetic patients in China.
This product uses a classic premixed ratio of 30% soluble human insulin (short-acting) + 70% protamine human insulin (intermediate-acting). The dosage form and specifications are precisely matched to clinical needs, eliminating the need for frequent combination therapy, effectively simplifying treatment plans, helping patients achieve more stable blood glucose control, and improving their quality of life.
▶ Optimize insulin concentration and injection dosage scale: Precise blood sugar control
It can match the individualized dosing needs of patients with different weights and blood glucose fluctuations, avoiding the inconvenience of large-dose injections and the dosage error problems when fine-tuning small doses, thus significantly improving the accuracy of medication.
▶Pre-filled pen formulations are extremely easy to use, requiring only three injection steps and are ready to use immediately: improving compliance.
It eliminates the need to replace cartridges or maintain injection pens, simplifying the operation process and avoiding the risks of mechanical wear, dosage deviation, and contamination caused by improper installation and repeated use. Furthermore, it eliminates cumbersome steps such as venting and adjustment, reducing the difficulty of operation for patients with poor vision, reduced hand dexterity, or the elderly, thus helping to improve medication adherence.
▶ Compact and lightweight, easy to pack and adaptable to most life scenarios: improves quality of life
Pre-filled pen formulations are portable and can be injected anytime, eliminating the need for additional syringes and other consumables. They are suitable for various scenarios such as work and travel, breaking through the limitations of traditional injections and making diabetes management more convenient and reassuring, thus improving the patient's treatment experience and long-term prognosis.
Currently, diabetes has become the third leading cause of serious harm to human health worldwide, after cancer and cardiovascular disease. Standardized long-term treatment is crucial for patient prognosis. Dongyangguang Pharmaceutical has been deeply involved in the field of diabetes treatment for many years and has built a complete product line of insulin and biosimilars. It is one of the few companies globally with the capability to develop and industrialize a full range of insulin products.
To date, the company has launched five insulin and analogue products, including recombinant human insulin, glargine insulin, aspart insulin, aspart 30 insulin, and protamine human insulin mixed injection (30R). All five products have been included in the national centralized drug procurement program, effectively reducing the burden of medication costs for patients and improving drug accessibility.
Leveraging its comprehensive competitiveness in insulin R&D and production, the company's Business Application (BLA) for glargine insulin in the United States is currently in the final stages of FDA review and is expected to be launched in the United States in 2026. Dongyangguang Pharmaceutical is expected to become the first company to launch glargine insulin in the United States with an exemption from Phase III clinical trials, and also the first Chinese company to launch an insulin product in the United States, promoting high-quality domestically produced insulin to the global market.
Under the national centralized drug procurement policy, Dongyangguang Pharmaceutical's insulin series products are becoming the trusted choice of more and more diabetic patients due to their core values of "safety, convenience and economy". The approval of the pre-filled specification of protamine human insulin mixed injection (30R) is an important supplement to the product portfolio in the field of diabetes treatment.
In the future, Dongyangguang Pharmaceutical will adhere to the strategy of maximizing domestic centralized procurement, internationalizing emerging markets, and differentiating product layout. It will focus on the research and development of ultra-long-acting insulin and compound preparations, continuously improve patient medication adherence, help achieve more stable blood sugar control and multiple metabolic benefits, and provide more effective and accessible treatment options for diabetic patients in China and around the world.
https://mp.weixin.qq.com/s/q8_sudFRySwvvl0wnmaYQQ
By editoryour submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.