HLB "Lenvatinib Applies for Approval as Second-Line Liver Cancer Treatment in China"

[Asia Economy Reporter Yoo Hyun-seok] HL Biopharma announced on the 9th that China’s Hansoh Pharmaceutical has applied for marketing approval of rivoceranib (Chinese name Apatinib, brand name Ai Tan) as a second-line treatment for liver cancer to the National Medical Products Administration (NMPA) of China.

Hansoh Pharmaceutical has completed a Phase 3 clinical trial in China for rivoceranib monotherapy as a second-line treatment for liver cancer. Currently, rivoceranib is marketed in China as a third-line treatment for gastric cancer, and if marketing approval is granted for liver cancer as a second-line treatment, it is expected to lead to increased sales of rivoceranib in China and serve as a case of significant indication expansion. Additionally, Hansoh Pharmaceutical announced that “multiple Phase 3 clinical trials based on rivoceranib for breast cancer, non-small cell lung cancer, ovarian cancer, and others have been approved and will be conducted.”

In 2018, rivoceranib generated sales of 1.7 billion yuan (approximately 300 billion KRW) in China as a third-line treatment for gastric cancer, and sales in 2020 are expected to reach 3 billion yuan (approximately 550 billion KRW). The company expects that if marketing approval is granted for liver cancer as a second-line treatment, rivoceranib’s sales in China will increase significantly.

With the application for marketing approval of rivoceranib as a liver cancer treatment following gastric cancer in China, the company expects that, aside from the expanded value of rivoceranib, HL Biopharma’s royalty income will also be greatly impacted. HL Biopharma acquired the global royalty rights, including China, from Advancen, the developer of rivoceranib, on the 27th of last month. Therefore, the increase in sales due to Hansoh Pharmaceutical’s indication expansion will directly lead to an increase in HL Biopharma’s royalty income.

Jang Jin-woo, director of HL Biopharma, said, “If rivoceranib receives marketing approval as a second-line treatment for liver cancer in China, it is expected to be a green light for Elevar’s ongoing global Phase 3 clinical trial for liver cancer,” adding, “Hansoh Pharmaceutical has conducted numerous clinical trials on rivoceranib over 15 years since 2005, and recently has been attempting various combination therapies. It appears to have reached a tipping point where results are emerging after a long period, so additional outcomes are anticipated.”

Director Jang emphasized, “As indication expansion and various clinical trials come into visible results, rivoceranib’s value will rise, and HL Biopharma’s royalty income is expected to continue increasing. It is also expected to have a very positive impact on various ongoing negotiations, including license-out discussions.”

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