HLB Life Science applies for conditional permit for targeted agent rivoceranib

HLB Life Sciences has applied for a conditional permit for the targeted anticancer drug, rivoceranib, designated as a rare drug for adenoid cystic carcinoma in the development stage by the regulatory authorities in November.

In a public filing on Thursday, the company said it has submitted an application to the Ministry of Food and Drug Safety for the conditional permit of rivoceranib mysylate 100mg and 200mg as treatments for recurrent and metastatic adenoid cystic carcinoma patients.

HLB and its US subsidiary Elevar Therapeutics conducted a phase 2 clinical trial of rivoceranib on 80 adenoid cystic carcinoma patients in Korea and the US HLB has domestic sales rights and part of profit rights in Europe and Japan for rivoceranib.

If the ministry grants the permit, HLB plans to supply the drug to major Korean hospitals to treat patients. However, given it is a conditional permit, the company will also begin a phase 3 clinical trial to prove the new drug’s efficacy and safety additionally.

“Adenoid cystic carcinoma is a rare malignant tumor that accounts for 17 percent of head and neck cancers. It occurs in multiple areas across the salivary glands and is difficult to identify the treatment site, known worldwide as intractable cancer with no cure developed,” the company said.

HLB Life Science CEO Han Yong-hae said, “Adenoid cystic carcinoma has no standard treatments, so patients have a high demand for unmet medical care, and it is very important to launch a new drug quickly.”

Han explained that HLB and Elevar have cooperated and prepared a license application to the Ministry of Food and Drug Safety and the US FDA. As a result, HLB could take one step ahead of its US affiliate to apply for the Korean regulator.

“We will do our best to win approval from the ministry and establish an effective system to supply it quickly and swiftly,” he added.

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