HLB "We Will Definitely Obtain Approval for Liver Cancer Drug"... Annual General Meeting Concludes

On the 31st, HLB held its 40th regular general shareholders' meeting at the Daejeon Convention Center in Yuseong-gu, Daejeon Metropolitan City. Following the shareholders' meeting, the company conducted an investor presentation and a shareholders' meeting to update on management status, introduce new pipelines, and strengthen communication with shareholders by sincerely answering their various questions.

Jin Yang-gon, Chairman of HLB Group and the chairperson of the shareholders' meeting, once again expressed a strong determination to secure FDA approval for the liver cancer drug. Chairman Jin stated, "The day after our partner, Hansoh Pharmaceutical, received the Complete Response Letter (CRL), we requested a 'Post Action Letter (PAL)' from the U.S. Food and Drug Administration (FDA) to confirm specific deficiencies," adding, "We are sharing this with our U.S. subsidiary, Elevar, and both companies are closely communicating and responding swiftly." He emphasized, "We will promptly identify the required supplements, reapply for approval, and obtain approval as quickly as possible."

At the meeting, four agenda items were approved as originally proposed: approval of the financial statements and consolidated financial statements, appointment of Han Yong-hae as an inside director and Yang Chung-mo as an outside director, appointment of Yang Chung-mo as an audit committee member, and approval of the director remuneration limit. The agenda item regarding approval of the executive retirement allowance regulations was voluntarily withdrawn by the company for reconsideration after the new drug approval.

During the investor presentation, Jang Jin-woo, Vice President in charge of IR, explained the company's management status, stating, "This year, three group companies?HLB, HLB Therapeutics, and HLB Innovation?are scheduled to announce significant achievements related to new drug pipelines," and added, "If positive results are achieved, it will have a favorable impact on the corporate value of the entire group."

Following this, Han Yong-hae, the Group Chief Technology Officer (CTO), introduced the competitiveness of the newly introduced pipeline, the FGFR2 inhibitor 'Lirapugratinib.' HLB plans to apply for FDA approval of Lirapugratinib as a second-line treatment for cholangiocarcinoma by the end of this year.

CTO Han explained, "Lirapugratinib is a superior new drug substance that selectively inhibits FGFR2 and has been designated as a breakthrough therapy by the FDA, which means it will receive expedited and priority review benefits during the approval process." He continued, "We have secured data showing an approximately 4-month extension in median overall survival compared to existing treatments, and if approved, it is expected to become a 'best-in-class' drug."

Chairman Jin Yang-gon personally led the shareholders' meeting for about an hour and a half. During the meeting, shareholders asked questions regarding the progress and future plans for the FDA reapplication of the liver cancer drug and the expansion of indications for Rivoceranib. Chairman Jin showed a firm commitment to obtaining approval for the liver cancer drug as quickly as possible. Chairman Jin and other HLB executives sincerely answered shareholders' questions and communicated candidly with them.

Baek Yoon-gi, CEO of HLB, said, "We will do our best to show a more developed image at next year's shareholders' meeting."

This content was produced with the assistance of AI translation services.