바이오스펙테이터

by Sungmin Kim

Yuhan plans to launch a new non-small cell lung cancer (NSCLC) drug called “Lazertinib” in domestic market next year as a market authorization holder in Korea. Lazertinib is a drug that has better side effects profile with the enhanced CNS activity compared to “Tagrisso,” a competitive drug marketed as a third-generation EGFR TKI drug.

Park Jae-hong, manager of Yuhan's IR team, said at the KHIDI Bio investment forum hosted by the Korea Health Industry Development Institute on the 1st, “Recently, many companies in Korea are making global technology exports. Yuhan is the only company that has achieved more than $100 million in milestones alone from Jassen. Janssen and Yuhan Corp. are predicting the success of Lazertinib highly. And we are looking for an opportunity to launch Lazertinib, a new drug for lung cancer, first in the domestic market from next year.

Yuhan Corporation is evaluated as a company that possesses the triangle of balanced R&D, strategic investment and technology transfer performance among domestic pharmaceutical companies. It is also a key force for Yuhan Corporation to grow into an innovative pharmaceutical company.

First, regarding the R&D sector, Park emphasized that "Yoohan Corporation's R&D strategy is, in a word, an open innovation strategy." A figure shows that the number of innovative new drug pipeline projects undertaken by the company in 2015 was 14, mostly in the early stages, but increased to 30 in 2020, and it has global competitiveness.”

"We have strengthened our competitiveness in areas such as diabetes, hyperlipidemia, digestive and non-alcoholic fatty hepatitis (NASH) with the will and determination of management team," Park said. "On the other hand, we have adopted long-acting technologies in targeted anti-cancer drugs and immuno-cancer drugs, and strategies to grow by introducing technology from the outside for the platform of microbiome and artificial intelligence (AI) drugs."

Based on this strategy, Yuhan has invested more than 500 billion won in R&D over the past five years. The figure includes all of its own R&D, the introduction of foreign materials, and biotech investment. The specific yearly investment amount is △71.5 billion won in 2015 → △85.2 billion won in 2016 → △101.6 billion won in 2017 → △110.5 billion won in 2018 → △1324 billion won in 2019.

In particular, the field that Yuhan Corporation has strengthened itself is NASH, and externally, it has focused on targeted anticancer drugs. Another keyword in the future is immunotherapy. "We have internally secured a number of immunotherapy pipelines, and we expect to see results in the field of immunotherapy drugs."

Yuhan Corporation has been active in strategic investment as well as material introduction from the beginning. Earlier, it made a lot of investments in biotech, such as Genexine, Pharmabcine, Neoimmuntech, Genosco, and GI-Innovation. The amount of strategic investments alone has reached 363 billion won since 2015, with 31 investment companies. The purpose of investment can be divided into ▲securing new technologies (165 billion won), ▲entering new businesses (160 billion won), and ▲pioneering new markets (38 billion won). Park added, "We estimate that the value of the strategic investment that has been carried out so far will reach about 600 billion won."

Finally, its performance is expected also from technology exports. Yuhan Corporation has achieved a total of five technology exports from 2018 to this year, and the total scale is about 4 trillion won. In summary, starting with Spine Biopharma of the U.S. in 2018, it has licensed out Lazertinib to Janssen in the same year, NASH treatment at Gilead and Boehringer Ingelheim in 2019, and functional gastrointestinal disease treatment at Processa Pharmaceuticals of the U.S. this year.

"The most important and advanced projects among these is Lazertinib, and in addition to the $50 million down payment, we have received a total of $35 million and $65 million each for the first and second milestones this year." “We are currently conducting the global phase 3 clinical trials with Lazertinib mono and the combined treatment."

First, as a global combination treatment clinical trial, Janssen started a phase 3 clinical trial in which its EGFR/cMET dual antibody 'Amivantamab' and Lazertinib were co-administered in about 1,000 patients as the first line treatment for non-small cell lung cancer. The clinical results have also been encouraging. This year, the result of a phase 1 clinical trial prescribed by the European Society for Clinical Oncology (ESMO) as a first-line treatment for non-small cell lung cancer showed that all patients showed a response rate, confirming that the objective response rate (ORR) was 100%.

In addition, Yuhan Corporation is conducting phase 3 clinical trials for 380 patients worldwide with Lazertinib alone, and clinical trials are actively underway in Korea. According to the results of phase 1 clinical trial published by ASCO this year, when Lazertinib was administered to patients with non-small cell lung cancer with the T790M mutation, the ORR was 57.9%, and the median survival time (mPFS) was 11 months. It is similar to Tagrisso. As a differentiation point of Lazertinib, the clinically grade 3 or higher side effects were 6%, and the intracranial disease control rate (IDCR) was 90.6% in lung cancer patients with brain metastases.

"Jassen will submit an application for a new drug license (NDA) to the U.S. Food and Drug Administration (FDA) in 2023, and expects to form a market of about 1 trillion won in annual sales," said Park. “We also expect our sales to grow to 10 trillion won in the future. We aim to sell it in Korea next year ahead of U.S.. Apart from the amount of technology exports and sales milestones, running royalty is also included, so we are expecting a technology revenue fee of hundreds of billions of billion won each year according to sales, and the value of the company will grow rapidly.”

Second, regarding the NASH candidate “YH25724,” which was transferred to Boehringer Ingelheim, Park said, “We are currently in phase 1 clinical trial, and we expect to receive the first milestone around the first half of next year. YH25724 is a GLP-1/FGF21 dual agonist.

Third, the milestone of the chemical-based NASH treatment licensed out to Gilead is also expected. Manager Park explained, "We expect to receive the first milestone by deriving candidate materials in the first half of next year." Furthermore, Yuhan plans to actively carry out licensing overseas beyond domestic biotech based on the technology transfer performance. To this end, it established local subsidiaries in Australia and the United States, and plans to purchase licenses based on this.