On February 2, 2023 HLB Life Science, which holds the domestic rights to the targeted anticancer drug ‘Riboceranib’ and some of the profit rights in Europe and Japan, reported the company has applied for conditional product approval for adenoid cystic carcinoma (adenoid carcinoma) for the first time in Korea (Press release, HLB Life Science, FEB 2, 2023, View Source;word=&page=1&v=380 [SID1234649275]).

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HLB Life Science announced on the 2nd through a public notice that it has applied for conditional product approval of riboceranib for ‘patients with recurrent or metastatic adenoid cystic carcinoma’ to the Ministry of Food and Drug Safety.

Adenoid cystic carcinoma, commonly called salivary gland cancer, is a rare disease and an intractable cancer with no proper treatment other than repeated surgery or radiation therapy. It is a very difficult to differentiate in advance because it is histologically very diverse and complex, and it occurs multiple times throughout the salivary glands. It is a very difficult type of cancer to treat as it frequently relapses locally along the nerves or metastasizes remotely to the lungs, bones, intestines, and brain.

HLB’s US subsidiary Elevar Therapeutics and HLB Life Science have conducted a phase 2 clinical trial of riboceranib on 80 patients with adenoid cystic carcinoma in the US and Korea. According to the clinical results announced at the American Society of Cancer (ASCO) (Free ASCO Whitepaper) in June last year, the primary endpoint, objective response rate (ORR), showed 15.1% by the Response Evaluation Criteria (RECIST v1.1) based on the change in tumor size, and 51.7% by the CHOI evaluation criteria that measures the density along with the change in tumor size, confirming its high potential as a treatment for adenomatous polyposis.

The disease control rate (DCR) was 64.4%, and the duration of response (DOR) was 14.9 months. While many anticancer drugs showed low response rates of 0-10% in investigator-directed clinical results for adenomatous polyposis, riboceranib is evaluated to have confirmed high efficacy and safety in a strictly controlled large patient group.

If HLB Life Science receives conditional product approval from the MFDS, it plans to quickly supply riboceranib to major domestic hospitals for the treatment of adenomatous polyposis patients. At the same time, as it is a conditional approval, we plan to immediately begin preparing for phase 3 clinical trials to further prove the efficacy and safety of the new drug.

Rivoceranib was designated as an orphan drug and an orphan drug in development stage for adenoma of the thyroid gland in the United States (February 2021) and Korea (November 2022), respectively.

According to the MFDS guidelines, orphan drugs are subject to accelerated review, so they can be approved and launched with only phase 2 clinical trials, and can enjoy benefits such as clinical trial subsidies, market exclusivity, and conditional sales approval.

Separately, in the United States, Elevar is also finalizing a trial plan for phase 3 clinical trials after conditional approval, and HLB Life Sciences, which holds the Korean rights, has applied for product approval to the Korean MFDS first.

Han Yong-hae, CEO of HLB Life Science, said, "In the case of adenomatoid carcinoma, there is no standard treatment, so it is a representative cancer with high unmet medical needs among patients, and the rapid launch of a new drug is very important." He continued, "HLB Life Science and Elevar have been working together to apply for approval from the MFDS and the FDA, respectively, but HLB Life Science completed its preparations one step ahead and has now applied for approval of the new drug. We will do our best to receive conditional product approval from the MFDS, and we will establish a systematic system to ensure a fast and stable supply of riboceranib in the future."