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

[Asia Economy Reporter Hyunseok Yoo] HL Biopharma announced on the 8th that Hansoh Pharmaceutical has received marketing approval from the China National Medical Products Administration (NMPA) for riboceranib (Chinese name Apatinib) as a second-line treatment for liver cancer.

Following the marketing approval in China in 2014 for gastric cancer third-line treatment (brand name Aitan), riboceranib is now also approved as a second-line treatment for liver cancer, which is expected to significantly expand riboceranib's sales within China.

Liver cancer is the sixth most commonly diagnosed cancer worldwide and ranks fourth in mortality rate. The 5-year survival rate is known to be only 35.6%, about half of the average cancer survival rate of 70.4%. In China, liver cancer is the second most prevalent cancer after lung cancer, with over 50% of global liver cancer patients being Chinese.

Currently, Hansoh Pharmaceutical's marketed gastric cancer third-line treatment 'Aitan' is listed as a health insurance reimbursement item, and its sales have steadily increased from approximately 55 billion KRW in 2015, the year of its first launch, to about 350 billion KRW in 2019.

HL Biopharma is conducting a global Phase 3 clinical trial combining riboceranib with Hansoh Pharmaceutical's immuno-oncology drug camrelizumab, targeting first-line treatment for liver cancer. The company explained that this combination trial is attracting significant attention because both camrelizumab and riboceranib, the drugs used in the combination trial, have individually received marketing approval in China as liver cancer treatments.

An HL Biopharma official stated, "The global Phase 3 clinical trial targeting first-line treatment for liver cancer is progressing very rapidly, with patient recruitment currently in its final stages," adding, "We will sequentially realize the commercialization of riboceranib for indications including gastric cancer, salivary gland cancer, and liver cancer."

Meanwhile, in early December last year, HL Biopharma secured the global rights to riboceranib by acquiring them from the original developer, the US-based AdvanTech. Accordingly, HL Biopharma will begin receiving royalties from Hansoh Pharmaceutical this year, and this approval for liver cancer treatment is expected to lead to increased sales of riboceranib in China and higher royalty income for HL Biopharma.

Hansoh Pharmaceutical is currently conducting Phase 3 clinical trials of riboceranib for treatments of breast cancer, non-small cell lung cancer, and ovarian cancer. An HL Biopharma official explained, "Riboceranib has proven its value and potential as an anticancer drug by receiving marketing approval in China for liver cancer treatment following gastric cancer," and added, "By focusing on various indications such as gastric cancer third-line treatment, for which global Phase 3 trials have been completed, and liver cancer first-line treatment, for which patient recruitment is nearing completion, we will do our best to realize direct sales in addition to royalty income."

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