HLB Plans to Launch 5 Anticancer Drugs Within 5 Years... 'Cheong Signal'

[Asia Economy Reporter Yoo Hyun-seok] HL Biotech announced on the 11th that a green light has been turned on for the goal of "launching five anticancer drugs within five years," as it has completed the global Phase 3 trial of rivoceranib as a third-line treatment for gastric cancer and is preparing an NDA.

A company official stated, "Hansoh Pharmaceutical, which holds the rights to rivoceranib in China, successfully completed the Phase 3 clinical trial of rivoceranib as a second-line treatment for liver cancer and has applied for marketing approval," adding, "Since Hansoh Pharmaceutical obtained marketing approval for rivoceranib as a third-line treatment for gastric cancer in 2014 and started sales, it has now expanded the indication to liver cancer treatment and applied for marketing approval after six years."

Along with this, camrelizumab, an immune checkpoint inhibitor from Hansoh Pharmaceutical that is undergoing combination clinical trials with rivoceranib for multiple indications, received marketing approval from the National Medical Products Administration (NMPA) of China as a second-line treatment for liver cancer.

Currently, HL Biotech is conducting a global Phase 3 trial targeting first-line treatment for liver cancer with the combination of "rivoceranib + camrelizumab" through the U.S. company Elevate. Both drugs have shown favorable clinical results in China, achieving either marketing approval or marketing approval application. This indicates a green light for HL Biotech’s global Phase 3 trial for first-line liver cancer treatment.

Additionally, HL Biotech is conducting a global Phase 2 clinical trial for sarcomatoid carcinoma, an indication with no current treatment. With the first patient enrolled in the U.S., HL Biotech is advancing toward its bio pipeline and the goal of "launching five anticancer drugs within five years" set by the company. Last year, HL Biotech announced the development and indication expansion plan for rivoceranib, stating, "Starting with third- and fourth-line gastric cancer, we will launch five anticancer drugs within five years, including first-line liver cancer, sarcomatoid carcinoma, second-line gastric cancer, and third-line colorectal cancer treatments."

Currently, the third- and fourth-line gastric cancer treatments are preparing NDA and are expected to be launched next year. The first-line liver cancer treatment is in global Phase 3 trials with progress exceeding 20%. The sarcomatoid carcinoma treatment began enrolling the first patient in the U.S. this week; as it is a rare disease, conditional marketing approval application is possible upon completion of the clinical trial. Meanwhile, second-line gastric cancer and third-line colorectal cancer treatments are in Phase 1/2a clinical trials.

A company official explained, "In addition, the combination therapy with Opdivo for sarcoma treatment recently completed patient recruitment and may be a candidate for launch," adding, "There is also a rumor of a global Phase 3 trial for first-line gastric cancer treatment in combination with Hansoh Pharmaceutical’s camrelizumab, so the indications for rivoceranib may further increase."

HL Biotech’s strategy is to expand indications based on multiple clinical trial results conducted by Hansoh Pharmaceutical, which holds the Chinese rights (Chinese name Apatinib) for rivoceranib. Among these, Hansoh Pharmaceutical has applied for marketing approval to the NMPA for second-line liver cancer treatment and has announced approval for Phase 3 clinical trials for combination therapies targeting non-small cell lung cancer, ovarian cancer, HER2-negative breast cancer, and triple-negative breast cancer (TNBC). Additional new indications for HL Biotech’s rivoceranib are expected.

On the 27th of last month, HL Biotech secured a new pipeline by deciding to invest in and acquire Immunomic Therapeutics, a U.S. bio company developing cell therapy and immuno-oncology platforms. Immunomic is conducting a Phase 2 clinical trial for glioblastoma (brain tumor) and plans to apply for approval as an innovative drug if favorable results are obtained at the scheduled completion in the second half of this year. Immunomic is also developing a new therapeutic vaccine for glioblastoma, ITI-1001, and recently announced completion of a pre-IND meeting for Phase 1 clinical trials.

Last year, HL Biotech’s plan to launch five anticancer drugs within five years was limited to five indications of rivoceranib. A company official said, "Considering the current situation, not only are the five indications actively progressing, but the possibility of expansion has increased due to additional marketing approvals and clinical trial plans by Hansoh Pharmaceutical," adding, "With the investment in Immunomic securing a new pipeline, HL Biotech can expect more than 10 products beyond the 'five anticancer drugs within five years' goal."

In particular, HL Biotech acquired global royalty rights, including China, from Advancen, the developer of rivoceranib, on the 27th of last month. Therefore, the increase in sales due to the expansion of indications by Hansoh Pharmaceutical is expected to directly lead to increased profits for HL Biotech, thereby raising the company’s corporate value.

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