Handok expands its Tenelia combo lineup

Adds clinical trial on its use in combination with ‘Jardiance’

Initiates Phase 1 'HD-P023' trial last year... registers a total of 3 trials

Handok is speeding up the development of a combination drug that combines DPP-4 inhibitor diabetes treatment Tenelia (teneligliptin hydrobromide hydrate)' with SGLT-2 inhibitor 'Jadiance (Empagliflozin).

 

On the 4th, the Ministry of Food and Drug Safety approved an open-label, randomized, empty stomach, single orally administered, two-arm, crossover, Phase I clinical trial to compare and evaluate the safety and pharmacokinetic characteristics of HD-P023 and Tenelia 20 mg and Jardiance 25 mg combination in healthy adults.

 

In 2020, Handok conducted a clinical trial on a triple combination therapy of metformin and empagliflozin and Tenelia, and since last year, it has expanded its development scope to investigate a two-drug combination drug that contains Tenelia and empagliflozin.

 

This is the third time that HD-P023 was approved for a Phase I trial, following approvals in January and June last year.

 

Handok is working on the development of a combination drug for Tenelia, using different doses in each clinical trial.

 

Handok is believed to be making such efforts due to the fact that a large number of generics have been approved upon Tenelia’s patent expiry in October 2022.

 

Domestic companies successfully avoided patent infringement through salt modifications before the expiration of Tenelia’s patent, and forewarned of their entry into the generic market.

 

Currently, 44 items have been approved as generic versions of Tenelia.

 

The patent for the combination drug ‘Tenelia M,' which is a combination of Tenelia and metformin, expired at the same time as that of Tenelia, and the number of approved generic drugs for Tenelia M exceeds 74.

 

As market competition became inevitable with the approval of generics for both the single drug Tenelia and the combination drug Tenelia M, it appears that the company has embarked on the development of a combination drug that can be used with reimbursement with SGLT-2 inhibitors.

 

In particular, since the reimbursement standards for SGLT-2 inhibitor class drugs improved in April 2023, allowing reimbursement of triple-drug therapies such as 'metformin + SGLT-2 + DPP-4' and 'metformin + SGLT-2 + TZD,’ there has been a continuous push for the reimbursement of for two-drug combination therapies as well.

 

According to data Rep Mi-hwa Seo, a member of the Democratic Party of Korea, received from the Ministry of Health and Welfare in January this year, the Ministry of Health and Welfare said it would prepare a plan to improve the reimbursement standards for the two-drug therapy that combine SGLT-2 inhibitor diabetes drugs and DPP-4 inhibitor diabetes drugs.

 

The Ministry of Health and Welfare has finished the Ministry of Food and Drug Safety’s inquiry regarding the request from the Korean Diabetes Association, collected expert opinions from related societies and others, and has stated that it is in discussions with the KDA to prepare additional supplementary data to improve the reimbursement standard.

 

The Ministry of Health and Welfare =, “We will also review whether it is possible to reimburse the combination of SGLT-2 inhibitors and diabetes drugs as one of the two-drug therapies, taking into account the Ministry of Food and Drug Safety’s approval status and the opinions of experts.

 

However, as reimbursement expansion of the diabetes drugs has a significant impact on the finances of the National Health Insurance, it will have to be implemented step by step after ample discussion.” Meanwhile, according to the pharmaceutical market research institution UBIST, the amount of outpatient prescriptions for Tenelia last year was KRW 24.46541 billion and KRW 27.21524 billion for Tenelia M.