Celltrion Pharm has moved closer to launching Godex Max Tablets, the successor to its flagship drug, Godex Capsules.

Market insiders are watching with interest to see if the company can revitalize itself through the launch of a new drug, given its somewhat disappointing sales performance last year.

On Monday, Celltrion Pharm released its 2023 business report, announcing that the company completed the development of its hepatotonics candidate “CTP-JB02” last year and is preparing to launch it in Korea. This is a step forward from the 2023 semi-annual report in August last year, which stated that it was “under license review.”

CTP-JB02 is a tablet formulation of Celltrion Pharm's existing hepatotonics, Godex Capsule, which was approved by the Ministry of Food and Drug Safety (MFDS) under the name Godex Max Tablet in May last year. The indication is the same -- liver disease with elevated Serum Glutamic Pyruvate Transaminase (SGPT).

Godex Max Tablets are characterized by doubling the content of ingredients compared to Godex capsules. As a result, the dosage and formulation have been changed from two capsules to one tablet per day. Celltrion Pharm expects to improve patient compliance by improving the convenience of taking tablets while maintaining the same active ingredients as Godex Capsules.

Regarding ingredients, the bioactive L-carnitine has been separated from the carnitine orotate, which was the main ingredient in Godex Capsules. The orotate has been salted to napadisilate. For vitamin B12, cyanocobalamin has been replaced with cyanocobalamin 100-methoxyacid.

The industry also pays attention to whether Celltrion Pharm, timed with the release of Godex Max Tablets, will be able to recover its prescription performance with the launch of Godex Capsule’s follow-up. In 2022, Celltrion Pharm fell into the crisis of Godex Capsule’s expulsion from the reimbursement list.

The Pharmaceutical Reimbursement Evaluation Committee of the Health Insurance Review and Assessment Service (HIRA) once decided it inappropriate for reimbursement. However, the committee accepted the drugmaker’s appeal and maintained Godex Capsule on the health insurance benefit list. In the process, the price of Godex Capsule dropped from 356 won to 312 won (from $0.26 to $0.32).

According to Celltrion Pharm’s 2023 balance sheet, the company recorded 388.8 billion won in sales, 36.1 billion won in operating profit, and 21.3 billion won in net profit. Sales increased by 0.71 percent year over year, but operating income and net income decreased by 5.5 percent and 18.09 percent, respectively.

Celltrion Pharm attributed its profit decline to the impact of Covid-19’s downgrade to an endemic. It intensified competition in the generic market while emphasizing that sales of its flagship product, Godex, grew 11 percent to 69.1 billion despite a drug price revaluation.

In addition, Celltrion Pharma launched four generics last year: the antiviral drug Famcivir Tablets (famciclovir), the antihypertension drug Cantacan Tablets (candesartan cilexetil), the Cantaplus Tablets (candesartan cilexetil and hydrochlorothiazide), and the Cellmistar Tablets (amlodipine and telmisartan).

"Last year, we continued to perform solidly in the sales of our flagship, such as Godex and Remsima," a company official said. "This year, we will continue to grow our flagship products and do our best to expand sales by launching competitive new products.”

Celltrion Pharm’s business report states that the company is developing a new synthetic drug, CT-K200. It is a three-drug combination drug for treating hyperlipidemia and hypertension, combining rosuvastatin and ezetimibe, which are used to treat hyperlipidemia, and amlodipine, which is used to treat hypertension.

Celltrion Pharm received approval for its Phase 3 IND (Investigational New Drug) application for CT-K2002 from the MFDS in 2021 and is conducting clinical trials. Based on UBIST data last year, Celltrion Pharm estimated the amlodipine market at 230.1 billion won and the rosuvastatin and ezetimibe combination market at 622.7 billion.

However, even if Celltrion Pharm successfully commercializes CT-K2002, prescription competition is expected to be fierce after its launch. Domestic pharmaceutical companies are moving beyond three-drug combination products and introducing four-drug combination products.

On the other hand, CT-L2002, which, along with CTP-JB02 and CT-K2002, is always listed in the pipeline of improved new drugs in the synthetic drug sector, saw its license transferred last year. Celltrion Pharm co-developed CT-L2002, a combination drug for treating hyperlipidemia, with Ahngook Pharmaceutical and has cited atorvastatin drugs as its competitor.