SUNSHINE PHARMA (06887): Pre-filled specification of recombinant human insulin mixed injection (30R) obtained approval for marketing by the China National Medical Products Administration.

Sunshine Pharma (06887) announced that the group's independently developed insulin mixture injection (30R) pre-filled with human albumin has officially obtained market approval from the China National Medical Products Administration. The approval further enriches the company's product line in the field of diabetes, providing Chinese diabetes patients with more convenient insulin treatment options. The product uses a classic pre-mixed ratio of 30% soluble human insulin (short-acting) and 70% human albumin insulin (intermediate-acting), accurately matching clinical needs in terms of formulation design and specification configuration. It simplifies treatment by eliminating the need for frequent combination therapy, helping patients achieve more stable blood sugar control and improving quality of life. (1) Optimizing insulin concentration and injection dose scale: Accurate glycemic control It can meet the individualized dosing needs of patients with different body weights and blood sugar fluctuation characteristics, avoiding the inconvenience of large dose injections and dosage errors during small adjustments, significantly improving dosing accuracy. (2) Pre-filled pen-type dosage form is easy to use, with three-step injection, ready to use: Improving compliance There is no need to change cartridge bottles or maintain injection pens, simplifying operation steps and avoiding mechanical wear, dose deviations, and contamination risks caused by improper installation and repeated use. At the same time, it eliminates the tedious steps of air purging and debugging, reducing the operational difficulties for patients with poor vision, decreased hand flexibility, or elderly patients, helping to improve medication compliance. (3) Compact and lightweight, easy to carry in bags for various life situations: Improving quality of life The pre-filled pen type dosage form can be carried around and injected at any time, without the need to carry additional injection devices, suitable for various scenarios such as workplaces and travel, breaking the traditional injection scene restrictions, making diabetes management more convenient and reassuring, improving the treatment experience and long-term prognosis of patients. Currently, diabetes has become the third most serious chronic non-communicable disease globally, following cancer and cardiovascular diseases, and standardized long-term treatment is crucial for the prognosis of patients. The group has been deeply involved in the field of diabetes treatment for many years and has built a complete line of insulin and biosimilar products, making it one of the few companies globally with the ability to research and industrialize the full range of insulin products. The group's independently developed five insulin products - recombinant human insulin injection, insulin glulisine injection, liraglutide insulin injection, liraglutide insulin 30 injection, and human albumin insulin mixture injection (30R) have all been approved for marketing, and all five products have been selected in the national drug centralized procurement, effectively reducing the medication burden on patients and improving drug accessibility. With comprehensive competitiveness in insulin research and production, the group's liraglutide insulin is in the process of applying for market authorization (BLA) in the United States, with the potential to become the first enterprise to market liraglutide insulin in the U.S. by exemption from phase III clinical trials. It also has the potential to become the first Chinese enterprise to market insulin products in the U.S., promoting domestically produced high-quality insulin to the global market. In the context of the national drug centralized procurement policy, the group's insulin series products are becoming the preferred choice for an increasing number of diabetes patients based on their core values of "safe, convenient, and cost-effective." The approval of the pre-filled specification of the human albumin insulin mixture injection (30R) is an important supplement to the product portfolio in the field of diabetes treatment. In the future, the group will stick to a strategy of maximizing national drug centralized procurement, internationalizing in emerging markets, and differentiating product layouts. It will focus on research and development of ultra-long-acting insulin and compound formulations, continuously improving patient medication compliance, helping achieve more stable blood sugar control and multiple metabolic benefits, and providing more effective and accessible treatment solutions for Chinese and global diabetes patients.