HLB Life Science's 'Livoseranib' Applies for Conditional Approval in South Korea

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Photo by HLB Life Science

[Asia Economy Reporter Chunhee Lee] HLB Group has applied for domestic approval of the targeted anticancer drug 'Rivoceranib' currently under development.

HLB Life Science, which holds the domestic distribution rights and partial revenue rights in Europe and Japan for Rivoceranib, announced on the 2nd that it has applied to the Korean Ministry of Food and Drug Safety for conditional marketing authorization of Rivoceranib for "patients with recurrent or metastatic adenoid cystic carcinoma."

Adenoid cystic carcinoma (ACC), an adenoid cystic carcinoma, is a rare disease commonly referred to as salivary gland cancer. It accounts for 17% of head and neck cancers and occurs multifocally throughout the salivary glands. The characteristics of the treatment area are challenging, with local recurrence along nerves and frequent distant metastases to the lungs, bones, viscera, and brain. Globally, no effective treatment has been developed, and aside from repeated surgeries or radiation therapy, there is no suitable treatment, making it a refractory disease.

HLB's U.S. subsidiary Elevar and HLB Life Science conducted a Phase 2 clinical trial of Rivoceranib on 80 ACC patients in the U.S. and Korea, and presented related results at the American Society of Clinical Oncology (ASCO) in June last year. According to the results, the primary endpoint, objective response rate (ORR), showed a response rate of 15.1% based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), which measures tumor size changes, and 51.7% based on the CHOI criteria, which measures both tumor size and density, confirming the potential of Rivoceranib as a treatment for ACC. The disease control rate (DCR) was 64.4%, and the duration of response (DOR) was 14.9 months.

HLB Life Science plans to rapidly supply Rivoceranib upon receiving conditional marketing authorization, while conducting post-marketing surveillance and safety monitoring to manage product risks. Additionally, as this is a conditional approval, a Phase 3 clinical trial will also be conducted to further demonstrate the efficacy and safety of the new drug.

Rivoceranib was designated as an orphan drug in the development stage for ACC in Korea last November. Being designated as an orphan drug includes benefits such as expedited review, approval and launch based on Phase 2 clinical trials alone, clinical trial subsidies, market exclusivity, and conditional sales authorization.

Han Yonghae, CEO of HLB Life Science, stated, “ACC is a representative cancer type with high unmet medical needs due to the lack of standard treatment methods, making the rapid launch of new drugs very important. We will do our best to obtain conditional marketing authorization from the MFDS and establish a systematic system to ensure that Rivoceranib can be supplied quickly and stably in the future.”