Will biotech companies continue 'K-Bio' success?

Have signed 14 out-licensing deals this year… major achievements by Orum Therapeutics‧Alteogen

Demonstrated performance in global pharma developments, focusing on trends in ADC‧autoimmune disease areas

Korean pharmaceutical and biotech companies have successfully outlicensed new drugs in various fields, including cancer, autoimmune disease, and Alzheimer's disease.

 

However, compared to the year before, analysis suggests that the number of out-licensed cases decreased.

 

Despite such a slowdown, companies focusing on global new drug development trends, including Alzheimer's disease treatment and antibody-drug conjugates (ADC), have drawn interest from the industry following achieving grand-size contracts.

 

We analyzed major out-licensing cases from Korean pharmaceutical and biotech companies in 2024 and explored the potential of future out-licensing possibilities for 2025.

 

According to pharmaceutical and biotech companies on December 30, 2024, the number of out-licensing transactions in the Korean pharmaceutical and biotech industry for 2024 was 14.

 

Compared to last year's 18 cases, it is a slight decrease.

 

However, analyzing out-licensed transactions, companies that have achieved this by focusing on global new drug development trends stand out.

 

First, LigaChem Biosciences and Orum Therapeutics have successfully out-licensed for two consecutive years, and becoming blu-chip companies in the pharmaceutical and biotech industry.

 

In October 2024, LigaChem Biosciences and a Japanese pharmaceutical company, Ono-Pharma, signed two technology transfer agreements, including the L1CAM-targeting ADC candidate 'LCB97.' According to the contract between both companies, the specific upfront payment remains undisclosed.

 

Two agreements total over US$700 million (KRW 943.5 billion).

 

L1CAM, targeted by LCB97, is a protein expressed in several solid cancers, including lung cancer, pancreatic cancer, and colorectal cancer.

 

LigaChem Biosciences' proprietary ConjuAll linker was used in the development of LCB97.

 

ADC is made of a linker, a payload, and an antibody.

 

The ConjuAll linker is known to overcome the issue of releasing cytotoxic drugs into the blood and attacking healthy cells.

 

In addition to the LCB97 deal, LigaChem Biosciences and Ono-Pharma signed an agreement to transfer the ADC platform technology designed to target dual targets.

 

Based on the contract, using LigaChem Biosciences' platform technology, Ono-Pharma secured rights to discover·develop ADC candidates for multiple targets.

 

Orum Therapeutics has proven its R&D capacity by successfully out-licensing the DAC platform to global pharmaceutical companies.

 

In July last year, the company signed an out-licensing agreement with the U.S.-based biotechnology company Vertex Pharmaceuticals for its DAC.

 

Orum Therapeutics received a US$15 million upfront payment and will receive up to $310 million in potential option fees, milestone payments per target, and tiered royalties.

 

Notably, the company has succeeded in advancing the development of new drugs for cancer, autoimmune diseases, and Alzheimer's disease.

 

HK inno.

 

N signed a license agreement with Navigator Medicines, a US-based pharmaceutical company, for 'IMB-101,' a novel drug candidate for the treatment of autoimmune diseases.

 

The contract totaled US$940 million (approximately KRW 1.3 trillion), including an up-front payment of US$20 million (KRW 27.6 billion).

 

Navigator Medicines secured global development and sales rights through this agreement, excluding Asia.

 

AprilBio also successfully out-licensed 'APB-R3,' an autoimmune disease candidate, to a US-based new drug developer, Evommune.

 

It has been contracted for up to US$475 million (approximately KRW 655 billion), including a non-refundable upfront fee of US$15 million (KRW 20.7 billion), with a separate royalty payment for sales.

 

Aribio successfully out-licensed 'AR1001,' a new drug candidate for Alzheimer's disease, to a Chinese pharmaceutical company in March 2024.

 

Aribio received an upfront payment of KRW120 billion.

 

The company made an advancement in developing an oral new drug candidate for Alzheimer's disease amid increased interest in Alzheimer's disease treatment following the release of Leqembi (lecanemab).

 

AR1001 targets the underlying causes of Alzheimer’s disease through multimodal mechanisms, such as PDE5 and toxic proteins.

 

This new drug candidate is based on Mvix (mirodenafil), which is similar to Viagra and a treatment for erectile dysfunction.

 

Jai Jun Choung, CEO of Aribio, said, "The global market is closely watching Aribio's AR1001." Choung added, "Since Aribio is the first Korean biotech company to conduct a global phase 3 trial in the field, we are striving to achieve success." Particularly this year, Korean companies have not been limiting their goals in exporting new drug candidates.

 

For instance, 'Alteogen' has achieved multiple successes in out-licensing its technology to change the type of anticancer agent formulation.

 

In November 2024, Alteogen signed an exclusive license agreement with Daiichi Sankyo to develop and sell the new ADC drug 'Enhertu' of a subcutaneous (SC) formulation.

 

The company received a non-refundable upfront payment of US$20 million.

 

Enhertu, an antibody-drug conjugate (ADC) jointly developed by Daiichi Sankyo and AstraZeneca, has been approved for the treatment of HER2-positive breast cancer and gastric cancer.

 

As Enhertu demonstrated to be effective in HER2 mutant NSCLC and HER2-low breast cancer, its indication was expanded.

 

Soon Jae Park, CEO of Alteogen, said, "We will be able to provide an alternative administration route by developing a subcutaneous formulation of Enhertu by signing a partnership with Daiichi Sankyo and using ALT-B4," Park added, "We hope to provide a wide variety of treatment options to patients by utilizing ALT-B4 to numerous treatments in the future." Global pharmaceutical companies with major immunotherapy strive to change conventional injectables to subcutaneous formulations.

 

In this process, Alteogen is co-developing the SC formulation of Keytruda with MSD.

 

It has been reported that Alteogen achieved growth through pursuing the Enhertu formulation change project.

 

Conventional anti-cancer treatments are primarily intravenous (IV) therapy, and the administration takes more than one hour.

 

Anti-cancer treatments of SC formulation are expected to improve patient convenience since they can significantly reduce the administration duration to within 10 minutes.

 

Professor Byoung Chul Cho (Director of the Lung Cancer Center at Yonsei Cancer Hospital) said, "The United States provides incentives to using injections, and the amount of incentives is the same between IV injectable or SC injectable," and explained, "There is no need to maintain IV formulation injectables, which commonly induce injection-associated adverse reactions." With these advancements, companies adopting differentiated strategies in global new drug development trends are likely achieve additional out-licensing cases by 2025.

 

Analysis suggests that the global pharmaceutical industry will likely continue pursuing pipelines in various fields, such as autoimmune diseases, radiopharmaceuticals, cell therapies, and Alzheimer's treatments.

 

If companies, like the case of Alteogen, also pursue a differentiation strategy as an advantage, they are expected to maintain strong competitiveness.

 

Major global pharmaceutical companies, including Vertex Pharmaceuticals, Gilead Sciences, AbbVie, Lilly, Merck, and Sanofi, have actively expanded their pipelines through M&A this year.

 

The largest M&A deal of the year was Vertex Pharmaceuticals's acquisition of Alpine Immune Sciences.

 

A contract worth US$4.9 billion (approximately KRW 7.03 trillion), including milestone achievements, has been signed.

 

Based on the agreement between the two US-based global pharmaceutical companies, Vertex has secured povetacicept.

 

Povetacicept is a bispecific antibody targeting APRIL, which is involved in the proliferation of BAFF for B-cell activation.

 

Vertex also signed an out-licensing agreement with the Korean biotech company Orum Therapeutics.

 

Analysis suggests a high likelihood that global pharmaceutical companies will continue efforts to secure future growth opportunities as patents for their therapies expire, suggesting that Korean pharmaceutical and biotech companies have significant potential for out-licensing.

 

However, investor sentiment has declined in the pharmaceutical and biotech industry this year, posing risks to clinical research efforts and potentially hindering technology export achievements next year.

 

Seung-Kyou Lee, Vice President of the Korea Biotechnology Industry Organization (Korea Bio), said, "In response to the urgent issue of decreased investment in the biotech sector, we strive to actively facilitate domestic and international investor matching and operate a demand-supply company committee." Lee added, "We need measures to identify and support solutions for the business and policy demands of biotech companies working in various fields."