Reasons and policy analysis on why Trelagliptin is not yet sold in the domestic market

Trelagliptin (Trelagliptin) is a long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor, mainly used for blood sugar management in patients with type 2 diabetes. It has the advantage of maintaining blood sugar stability when taken once daily, improving patient compliance. However, although trotagliptin has been widely used in foreign markets, its sales in the domestic market are still subject to certain restrictions, mainly related to the approval progress, drug pricing and medical insurance inclusion policies.

From a policy and approval perspective, one of the reasons why troagliptin has not yet been fully launched in China is that the drug registration and approval cycle is long. Although domestically produced trotagliptin succinate has been approved and put on the market, it needs to go through clinical trial data review, drug quality assessment and marketing authorization. During the approval process, the safety, effectiveness and comparability of the drug with existing domestic treatment options need to be fully evaluated, which makes the promotion of troagliptin in the domestic market more cautious.

From the analysis of price and medical insurance policy, the domestically produced trotagliptin marketed in China has not yet been included in the medical insurance reimbursement system, making the actual burden on patients higher. In comparison, the original Japanese version of troagliptin that has been launched in overseas markets is priced at more than 1,000 yuan per box, while the price of the Laotian and Bangladeshi versions of generic drugs is more affordable, with the price of the Laotian version ranging from 100 to 600 yuan. The ingredients of these overseas generic drugs are basically the same as those of the original drugs, providing an economically feasible alternative for domestic patients who are not yet covered by medical insurance. However, one still needs to be careful about the purchasing channels and the authenticity of the drugs.

From the perspective of market and clinical demand, trolagliptin has not yet been widely sold in China, which is also related to clinical usage habits and competition with existing drugs. Domestic drugs such as metformin, other DPP-4 inhibitors and GLP-1 receptor agonists have formed mature markets, and doctors tend to choose drugs with clinical experience. In addition, the lack of coverage by medical insurance also affects the willingness of patients and medical institutions to use it. With the optimization of future approval policies, the advancement of medical insurance negotiations and the improvement of the quality of domestic drugs, the accessibility and market prospects of trolagliptin in the country are expected to gradually improve, providing more treatment options for patients with type 2 diabetes.

Reference link:https://www.drugs.com