South Korean pharmaceutical HLB Co. is poised to venture into new therapeutic areas, including chimeric antigen receptor T cell, or CAR-T cell therapy, and a glioblastoma treatment, according to Chairman Jin Yang-gon.

“HLB is ready to ramp up its drive for new drug pipelines using the lessons learned from Riboceranib’s success,” Jin said in his interview with the Maeil Business Newspaper.

Rivoceranib is a small-molecule, oral tyrosine kinase inhibitor that selectively targets vascular endothelial growth factor receptor 2 (VEGFR-2), a crucial pathway for tumor angiogenesis. HLB’s U.S. subsidiary, Elevar Therapeutics, has the global rights to the drug except in China, where the rights and clinical trials were licensed to Jiangsu Hengrui Medicine Company Limited, the country’s largest local pharmaceutical company.

HLB said that Elevar will continue to play a pivotal role in seeking approval for the U.S. market. “Following 15 years of hard work, HLB received a notification in July that the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) to approve Rivoceranib for review,” Jin said.

Rivoceranib is also the first anti-cancer therapy to enter the FDA’s review process in Korea.

“Despite the previous skepticism, HLB was able to achieve these results thanks to our dedicated stakeholders,” Jin said, adding, “The clinical data from hundreds of thousands of patients obtained by Jiangsu Hengrui Medicine Company, also played a part.”

In its application, HLB is seeking FDA approval for Rivoceranib in combination with Camrelizumab, an Anti-PD-1 inhibitor also under clinical development by the Chinese pharmaceutical. Jin noted the results from a phase-3 study of Rivoceranib plus Camrelizumab involving 543 patients in 13 countries that showed improved overall survival duration.

“The potential adverse effects of the target cancer therapy can be reduced in combination with Rivoceranib.”

HLB has initiated preparations for effectively marketing Rivoceranib in the United States. “In January, HLB hired a marketing and sales team of professionals with experience from multinational pharmaceutical companies and we have already obtained marketing authorization in six states,” Jin said.

“I believe it will take up to two years to secure a global network after we get the FDA approval, which we expect sometime next spring.”

HLB is ramping up its efforts to develop more drug pipelines in addition to Rivoceranib.

“The company has been expanding these pipelines with active mergers and acquisitions over the past four years,” Jin said. HLB acquired Immunomic Therapeutics, Inc. in 2020 and Verismo Therapeutics, Inc. in 2021.

Immunomic Therapeutics, Inc. is a developer of immune cell therapy and vaccines, and Verismo Therapeutics specializes in the development of CAR-T cell therapies, while Verismo Therapeutics is a biotech startup founded by a group of researchers from the University of Pennsylvania that developed Kymriah, a CAR-T immunotherapy from Novartis International AG.

“While CAR-T therapies are known for their efficacy in liquid tumors, HLB has been focusing on a cell therapy indicated to treat solid cancers, such as liver cancer,” Jin concluded.

By Kang Min-ho and Han Yubin

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]