Korean pharmaceutical and biotech companies are using various open innovation tools to raise competitiveness in new drug development in the global market.

In the past, Korean drugmakers conducted research in secrecy due to the risk of technology leakage. But now, they actively get technologies and business ideas from external sources and share their technologies with outsiders. Moreover, they are using this open innovation as a growth strategy for the future.

Their open innovation tools are diverse, including licensing out a pipeline, licensing technology from a biotech startup, and conducting a joint clinical trial.

As open innovation helped companies achieve remarkable clinical results and obtain approval for new medicines, open innovation is not an option but an essential strategy in the pharmaceutical industry.

HanAll, Yuhan win licensing deals through open strategic innovation

HanAll Biopharma’s open innovation involved licensing out a pipeline in phase 1 and 2 trials to an overseas partner firm and jointly developing it, leading to an excellent business outcome.

A good example is the company’s licensing out autoimmune disease treatment HL161 to Roivant Sciences in Switzerland, and dry eye treatment HL036 to Harbour BioMed in China, in 2017.

HanAll’s deal in 2017 was the first to license out a homegrown new antibody-drug in Korea. In addition, as HanAll teamed up with a multinational drugmaker, it was able to get closer to the possibility of developing an innovative therapy.

Roivant Sciences established a subsidiary, Immunovant, to make it handle the development of HanAll’s HL161 exclusively.

Immunovant received FDA approval to conduct a phase 3 study of HL161 to treat myasthenia gravis (MG) and plans to begin a U.S. trial within the second half of this year.

In the Chinese study, Harbour BioMed started the first administration of HL161 in September last year. The company plans to apply for marketing approval after deriving study results.

HanAll’s partnership with Daewoong Pharmaceutical, which became the largest stakeholder of HanAll in 2015, is notable. Using their respective new drug development know-how and technology, the two companies are jointly working on HL036 in the U.S.

The two have conducted a second U.S. phase 3 trial of HL036 to treat dry eye syndrome to confirm the drug’s reproducibility since November 2021. The topline results are expected to be out in the second half of this year.

While existing treatments for dry eye relieved symptoms temporarily, HL036 is expected to cure the disease with a new mechanism.

HanAll and Daewoong have been investing in promising global biotech startups for two consecutive years this year.

In April, the two invested in Turn Biotechnologies, a U.S. biotech firm, to study therapeutics based on cellular reprogramming. The two companies will find long-term cooperation opportunities to develop drugs using a cellular reprogramming platform through the investment.

Last year, the two co-invested in Nurron Pharmaceuticals, a U.S. developer of new therapies for Parkinson’s disease, and Alloplex Biotherapeutics, an anti-cancer cell therapy developer, to secure future growth engines.

HanAll opened a new drug development center in Boston this year to seek open innovation with global partner companies and speed up innovative drug development.

Yuhan Corp.’s open innovation strategy was about introducing a new drug candidate, raising its value, licensing it out to a multinational drugmaker, or developing it jointly.

Leclaza (lazertinib), a treatment for non-small cell lung cancer (NSCLC), is the greatest achievement using this strategy.

Yuhan licensed in lazertinib just before a pre-clinical stage from the original developer Oscotec in 2015. Then, Yuhan raised the new drug candidate’s value through substance optimization, manufacturing procedure development, and pre-clinical and clinical trials. Finally, the company licensed it out to Janssen for 1.4 trillion won ($1.12 billion), drawing keen attention from the pharmaceutical industry.

Korean drugmakers are serious about open innovation because it can shorten the time of clinical trials and raise the probability of successful drug development.

According to a report by the Korea Health Industry Development Institute, it takes around 15 years on average to develop a new drug, which includes five years of finding a candidate substance.

Chong Kun Dang, Hanmi invest in biotech startups

As new drug development technology became the key to competitiveness in the pharmaceutical industry, traditional Korean drug companies and contract manufacturing organizations (CMOs) are shifting focus to innovative drugs instead of importing foreign medicines or making generic copies.

Samsung Biologics aims to secure future competitiveness through investing in biotech startups. The company said it would go beyond CDMO and biosimilars and reinforce capabilities to develop new biopharmaceuticals.

In July last year, Samsung Biologics and Samsung C&T launched a 150 billion Life Science Fund. The fund made the first investment in Jaguar Gene Therapy, a U.S. gene therapy developer.

The two Samsung companies will invest more than 20 billion won in Jaguar Gene Therapy as strategic investors and collaborate with the U.S. company to discover and develop research programs.

Chong Kun Dang achieved a great outcome by investing in an American biotech startup, Cara Therapeutics, in 2012.

Last August, Cara Therapeutics got the FDA nod for CR-845 to treat uremic pruritus.

The treatment was the FDA-approved first-in-class drug in the uremic pruritus treatment market.

Thanks to the investment in Cara Therapeutics, Chong Kun Dang will sell the treatment exclusively in Korea.

Hanmi Pharmaceutical is also actively pushing for licensing in pipelines from biotech startups.

In 2016, the company established Hanmi Ventures, a venture capital firm, to discover and invest in drug candidates.

In 2019, Hanmi licensed in CCR4, oral immunotherapy, from California-based RAPT Therapeutics and started developing it jointly.

In 2020, Hanmi signed an agreement for joint research with Standigm, an AI-driven drug developer.

Industry officials said that sales growth through open innovation is not simply a result of realizing profits.

Inflows of milestone payments through licensing deals and profits from investment in biotech startups can be reinvested in R&D, which can create a sustainable R&D virtuous cycle.

The government and the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) actively support drugmakers’ open innovation.

In March, the government launched Korea Drug Development Fund (KDDF) to help local companies develop globally competitive medicines.

KPBMA joined the Global Therapeutics Alliance (GTA) membership, an international research program across academia and industry by the Milner Therapeutics Institute.

The Milner Therapeutics Institute is an industry-academia collaboration institute established to develop and commercialize innovative drugs. It is considered the largest biopharmaceutical cluster in Europe.