HLB, a biotech firm, said Tuesday that it would apply for conditional permission for its targeted anticancer drug, rivoceranib. HLB, an affiliate of the HLB Group, holds the domestic sales right of rivoceranib.
According to industry sources, HLB plans to apply to the Ministry of Food and Drug Safety Ministry in the first quarter of next year for the conditional approval of rivoceranib to treat adenocarcinoma based on its phase 2 clinical trials.
Last Thursday, the ministry designated rivoceranib as a rare drug in the development stage to treat metastatic or recurrent adenocarcinoma.
The designation as a rare medicinal product is one of the conditions for applying for conditional approval. The applicants undergo the ministry’s review based on efficacy and safety shown in phase 2 clinical trials. However, the applicants should present results by conducting phase 3 clinical trials in the future.
won the ministry’s approval for phase 2 clinical trials of rivoceranib for recurrent or metastatic adenocarcinoma in November 2019. The domestic medical institutions that conduct the trial include Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, and the National Cancer Center.
When businesses apply for designation as rare medicinal products, the ministry screens them and, if they meet the conditions for designation, announces their designation through public notices.
be designated as rare medicines, the drugs should target diseases with domestic patients of 20,000 or fewer, and win recognition for their development plans, including clinical trial plans, as rare drugs aim to treat diseases for which proper treatment methods and drugs have not been developed, or show significant improvement in safety and efficacy than existing drugs based on their pharmaceutical mechanism or non-clinical trials.
“Adenocarcinoma urgently needs the development of treatment. Rivoceranib has proven excellent treatment effects on 80 percent of patients with very poor pre-treatment prognosis. We are certain that it would win approvals as a new drug in Korea and the U.S.,” CEO Han Yong-hae said. “We will quickly push ahead with the approval process for patients who have few good options after surgery or radiotherapy.”
However, the designation as a rare drug does not necessarily mean the grant of domestic conditional approval, according to a ministry official.
“Even if a drug is designated as a rare drug in the development stage, that does not mean the food and drug safety ministry gets involved in the clinical trials through consulting or other means,” the official said. “The ministry’s role is to manage the safety of clinical trial drugs targeting the human body."
The official added that the ministry approves clinical trials, but the development depends on the company's capabilities.
Rivoceranib is HLB’s second medicinal product that has won the ministry’s designation as a rare drug in the development stage, following pyrotinib (targeting HER2 mutated exon 20 inserted non-small cells lung cancer patients previously treated with platinum-based chemotherapy).
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