After a rigorous site check and evaluation of clinical test data, insulin glargine, the human insulin analog developed independently by United Lab using DNA gene recombination technology, is finally granted with the approval document today and will go to market soon. So far, United Lab has become the second and third-generation insulin owner at home and is expected to better serve the domestic diabetics.
A good cure to benefit the country and people
As one of the common drugs for diabetics, domestic human insulin analog is used only by a limited group of people due to its prohibiting price. United Lab is the second manufacturer at home that receives the approval for insulin glargine marketing. Surely it will have an impact on the market and bring convenience and benefit to a wide range of diabetics.
Two generations of Cai have created great significance for marketing
The decade-long effort pays off. This morning, chairman Cai was so excited to see the document that approves the release of the company’s insulin glargine, which represents not only a breakthrough in product, but the outcome of two Cai generations’ dedication and hard effort. During the ten years from the project approval in 2007 to the release in 2017, the hardship and arduousness is imaginable. The comment “Finally comes a good cure that heals the world” made by Mr. Cai Jinle for rh-insulin eight years ago now still seems fresh and clear.
Insist on “quality-centered” for more independent innovations
During the development process, a group of young researchers led by Cao Chunlai, head of United Lab Institute of Biology, clung to the original product for comparative study and insisted on “quality-centered” to make breakthrough and innovation. They created exclusive technology and increased the folding renaturation ratio of protein to the international first level, until a 28-ton fermentation scale was realized, capable of yielding 600kg insulin glargine a year.
Quality meeting European and US Pharmacopoeia, effect as good as the original
By getting this drug approved, United Lab has become an enterprise capable of manufacturing the second and third-generation insulin glargine. In 2010, the rh-insulin “USLIN” released by the company became popular widely among the patients because of its good quality. This time, the approved insulin glargine “USLEN” is still involved with international purification technology and manufacture equipment, with drug quality totally up to United States Pharmacopeia, effect as good as the original.
Notably, there are two prevailing methods for insulin glargine dosage in the pharmaceutical market: the imported “pre-filled injection pen” and domestic “cartridge + injection pen”. To further diversify the product line of insulin glargine, United Lab has introduced the German assembly line of pre-filled injection pen, which provides diabetics with two options: insulin glargine injection cartridge and pre-filled injection pen. This is a more convenient and thoughtful way for patients choose the proper solution depending on their physical conditions.