DPP-4 Inhibitor Landscape Shifts as Vildagliptin Tablet, a Volume-Based Procurement Drug, Gains Fourth Domestic Approval

By Wei Weiyang

The drug approval notice released on July 13 indicated that Nanjing Sanhome Pharmaceutical’s Class 4 generic drug, Vildagliptin Tablets, has been approved for marketing, making it the fourth domestically produced version of this product. Moreover, this product was also included in the local volume reporting list for the third batch of centralized procurement.

Vildagliptin is an oral DPP-4 inhibitor used to lower blood glucose levels in patients with type 2 diabetes. It has a low risk of inducing hypoglycemia and does not affect patient body weight.

The originator of vildagliptin is Novartis, with sales reaching $1.297 billion in 2019. In August 2011, vildagliptin was approved in China for use in combination with metformin when glycemic control is inadequate with metformin monotherapy.

Currently, in addition to Novartis, the vildagliptin generics from Hansoh, Qilu, and Beijing Tide have all been approved for marketing and are deemed to have passed the consistency evaluation. In the volume reporting list for the third batch of centralized procurement, the oral immediate-release formulation of vildagliptin was included, making it the first DPP-4 inhibitor antidiabetic drug subject to centralized procurement.

Currently, five DPP-4 inhibitors are marketed in China: sitagliptin (originally developed by Merck & Co., with a generic version from Chia Tai Tianqing Pharmaceutical already launched), saxagliptin (originally developed by AstraZeneca, with a generic version from Aosaikang Pharmaceutical already launched), vildagliptin (originally developed by Novartis, with generic versions from Hansoh Pharmaceutical, Qilu Pharmaceutical, and Beijing Tide Pharmaceutical already launched), alogliptin (originally developed by Takeda Pharmaceutical, with generic versions from Deyuan Pharmaceutical, Zhongtian Pharmaceutical, and Yabao Pharmaceutical already launched), and linagliptin.

Since the five aforementioned DPP-4 inhibitors were included in the National Reimbursement Drug List in 2017, their market share among oral hypoglycemic agents surged in 2018, rising from 7.9% in 2017 to 14.3% in 2018, representing a year-on-year growth rate of up to 97%. It is predictable that DPP-4 inhibitors will exert a certain substitutive effect on traditional oral hypoglycemic agents in the future.

Currently, the top three oral hypoglycemic agents by market share—acarbose (included in the second batch of centralized procurement), metformin (third batch), and DPP-4 inhibitors (third batch)—have all been incorporated into the centralized procurement program, which aligns with national policy directives.

In October 2019, four departments, including the National Health Commission and the National Healthcare Security Administration, issued the “Guiding Opinions on Improving the Outpatient Medication Reimbursement Mechanism for Hypertension and Diabetes among Urban and Rural Residents.” The document explicitly stipulates that for antihypertensive and hypoglycemic medications prescribed on an outpatient basis to patients with these two chronic conditions, priority shall be given to drugs listed in Category A of the latest National Basic Medical Insurance Drug Catalog, national essential medicines, products that have passed the consistency evaluation, and winning bids from centralized volume-based procurement.

Reasonably determine and dynamically adjust the medical insurance payment standards for medications used to treat the “two diseases” based on their generic names. Actively promote centralized volume-based procurement of pharmaceuticals, adopting a model that exchanges volume for price and integrates tendering with procurement. For drugs included in the scope of volume-based procurement, determine the payment standards for drugs with the same generic name based on the winning bid prices from centralized procurement.

It is foreseeable that an increasing number of medications for the “two chronic diseases,” which account for significant expenditures in the national medical insurance fund, will be included in centralized volume-based procurement. Wuhan has already taken the lead in launching volume-based procurement for insulin, with a total procurement volume reaching 1.7057 million units. However, due to insufficient domestic competition for certain insulin products, centralized procurement is expected to remain primarily conducted at the local level.

Public data shows that among the five DPP-4 inhibitors, sitagliptin holds the largest market share, followed by saxagliptin. However, due to insufficient competition between these two drugs, they were not included in the third batch of centralized procurement. Currently, no generic versions of linagliptin have been approved in China. Although three generic versions of alogliptin have been approved, they cannot yet be marketed and sold domestically due to unresolved patent disputes.

Currently, only vildagliptin’s patent has expired and competition is robust. Its inclusion in the third batch of centralized procurement is expected to enable rapid volume expansion at low prices, allowing it to capture market share from the other four drugs in the same class and simultaneously drive proactive price reductions for comparable products. As centralized procurement becomes normalized, the market landscape for these four domestic products is poised to undergo significant changes in the future.