MADRID -- By Kim Chan-hyuk Korea Biomedical Review correspondent -- The annual congress of the European Society for Medical Oncology (ESMO), Europe's largest cancer society, has been underway in Madrid, Spain, since Friday.

As Korean visitors walk through the halls filled with promotional booths for pharmaceutical companies worldwide, they notice a familiar name among the global pharma: Elevar Therapeutics, the U.S. subsidiary of HLB.

Elevar attends the conference as part of the HLB Group and runs an independent booth. It is an active move compared to other Korean pharmaceutical companies and biotechs, which stop at presenting clinical data. Elevar submitted its first NDA (new drug application) for liver cancer for its targeted anticancer drug Riboceranib to the U.S. Food and Drug Administration in May.

Korea Biomedical Review met Elevar Therapeutics CE$O Chong Sae-ho and HLB Group CTO Han Yong-hae, also CEO of HLB Life Sciences, to learn the status of the U.S. FDA approval of Riboceranib and their plans to enter the European market.

KBR: How did you decide to have a booth at the European Society for Cancer Research while waiting for the approval of Riboceranib in the U.S.?

Chong: At the time of the Riboceranib license application, we announced that Elevar would directly distribute and sell it in the U.S. and enter the European market through our partners. We wish to find a European partner by attending this conference and setting up a booth. The business development team is attending the event and conducting many meetings.

In addition, since hepatocellular carcinoma (HCC) treatment is an orphan drug, we are also providing academic information on it at the booth. Visitors can look at “HCC: Experience the Present,” a website that provides information on HCC that Elevar has launched.

Han: Starting with ESMO, we plan to set up a booth at cancer conferences every year. We have reserved a larger booth space for next year's American Society of Clinical Oncology (ASCO), and we believe that Riboceranib will get approval by then. We will also participate in the ASCO Gastrointestinal Cancer Symposium (ASCO GI).

KBR: You recently acquired global rights to the Riboceranib’s combination drug, Camrelizumab, from China’s Jiangsu Hengrui Medicine. What are your expectations?

Chong: We can streamline our discussions with our European partners. Until now, they had to communicate and coordinate with Elevar and Jiangsu Hengrui. Because of this, European companies were reluctant to collaborate. However, with the acquisition of these rights, Elevar will lead the discussion.

Han: We can accelerate the expansion of indications for Riboceranib and Camrelizumab. There are many different types of liver cancer besides HCC, so we will review them and expand the indications to various cancer types. Expanding the indication to preoperative therapy (neoadjuvant) has also become possible. We are in constant communication with Jiangsu Hengrui to expand the indication.

KBR: Besides the designation of a European partner, what other preparations are you making to enter the European market?

Han: At the latest, we plan to apply for marketing authorization from the European Medicines Agency (EMA) this year. It shouldn't take long because we will utilize the data we submitted to the FDA. However, unlike the FDA, the EMA looks more closely at pediatric data. We are preparing for that.

KBR: Besides the NDA submission to the FDA, you have begun preparations for commercialization in the U.S. How far have you come? Also, what are the steps in the U.S. approval process?

Chong: We have expanded our Medical Affairs team to eight people. Our local sales team is about 60 people. That may seem like a small number, but we have access to 3,000 physicians across the U.S. who can write prescriptions for liver cancer treatment. In the U.S., this is no small number, as physicians are located in major clusters.

Besides, we have secured licenses (rights) to sell the drug in 16 U.S. states. In the US, each state has a different system, with some offering pre-approval licenses and others not. A total of 26 states offer pre-approval licenses. We have obtained licenses in 16 of them and applied for licenses in 10 others. We expect to receive them by the end of this year.

Han: We are in constant communication with the FDA. So far, it's been going well. The company has indeed faced difficulties with the FDA in the past, but we have recruited four FDA people for the HLB Group, including Elevar CEO Chong. The company intended to bring in people who have worked with the FDA. This will continue in the future.

KBR: What are your plans to expand into Asia?

Chong: In Japan, we are preparing for bridging clinical trials because clinical data must include Japanese patient data to apply for marketing authorization.

Han: HLB Life Sciences is in charge of the domestic license application. First, we are preparing data to convince the Ministry of Food and Drug Safety based on the data submitted to the FDA. In addition, CG Invites (formerly Crystal Genomics) holds the rights to Camrelizumab in Korea. We are constantly communicating with CG Invites. They are also positive about applying for a license for combination therapy in Korea.

KBR: How did you feel about participating in the European Society for Cancer Research?

Chong: With the Riboceranib data presented at ASCO last year, we compete with global pharmaceutical companies. We are confident that we can compete with existing treatments, including Tecentriq (atezolizumab), Avastin (bevacizumab), and the recently FDA-approved Imfinzi (durvalumab) and Imuudo (tremelimumab).

Han: Recently, the atmosphere in the domestic biopharma industry has been frozen, making it difficult to raise funds and operate. I hope that Elevar and the HLB Group's participation in the ESMO 2023 and the future approval of Riboceranib will be a symbolic event that can break the cold atmosphere.