South Korea

Under the new drug approval innovation measures, Korea will cut the review and approval period of new drugs to 295 days from 420 days and increase the number of expert reviewers to enhance review capabilities.

While Korean biopharma companies’ out-licensing deals have remained lackluster in the past couple of years, activity around emerging modalities, led by ADCs, have been increasing in line with global trends.

As investor sentiment around Korean biopharma IPOs and financings remained tepid in the second quarter, companies turned to other ways of raising money, including rights offerings. But there are signs of recovery and upcoming catalysts, while on the M&A front Boryung divested a vaccine subsidiary to a private equity consortium. 

As it reported mixed second-quarter earnings, South Korea's pharma industry is increasingly turning to obesity pipeline assets. Meanwhile, leadership disputes among family members within Hanmi are resurfacing.

A novel stem cell therapy for Parkinson’s disease developed by a Korean firm has shown what Citeline analysts describe as "very promising" early clinical results at a low dose after one year.

After acquiring a majority stake in ProteoVant last year, South Korea's SK Biopharm is continuing to hunt for new modalities and is now moving into the hot radiotherapeutics area through a deal with Full-Life Technologies.

The second quarter in South Korea was marked by the return of several assets by licensing partners, including Thea Open Innovation, which gave back rights to two ophthalmic programs in-licensed from OliX. Merck & Co. also cancelled a co-research deal with Artiva Biotherapeutics.

A research fellow at South Korea's Science and Technology Policy Institute talked at a recent seminar about the key funding, management and other challenges faced by the domestic biotech sector to sustain growth, and how these contrast with the situation in the US.

It has been a busy few weeks for Celltrion – a Korean approval for omalizumab biosimilar Omlyclo, three biosimilar supply contracts with France’s largest pharmaceutical procurement group, and new long-term data for subcutaneous infliximab.

SK pharmteco CEO Joerg Ahlgrimm talks to Scrip about the "excitement" at BIO, potential CDMO shifts amid the US BIOSECURE Act, and the Korean CDMO's focus on business as usual as it seeks to diversify and grow.

Long-running protests by South Korean doctors against government reforms, including raising medical school admissions, continue to intensify with a one-day rally by community doctors and the threat of an indefinite walkout later this month. The pharma industry is also feeling the impact on clinical trials and sales. 

Bukwang and subsidiary Contera have become the latest to fail to progress a novel Parkinson's therapy to late-stage trials after a Phase II miss, although several other Korean firms remain in the race for the challenging indication, albeit mainly in Phase I-II.

Syntekabio CSO HeaKyoung Cho talks to Scrip how the AI-driven drug development situation in Korea compares with global trends and what the domestic industry needs to do to survive rising competition at home and abroad.

Biocon has added to its roster of liraglutide partners by striking a fresh deal in Korea with Handok for the chronic weight management treatment.

The US approval of HLB and Hengrui’s liver cancer combination therapy looks set to be delayed after the FDA issues a CRL related mainly to CMC data, but the two companies appear positive on a quick resolution to the setback given a lack of other efficacy or safety concerns.

South Korea’s clinical trial approvals rebounded in 2023, but remained lower than the peak levels in 2020-21 amid then robust R&D activity related to COVID-19. Last year's tally showed a mix of single-country and multinational trials and reflected the ongoing dominance of oncology in industry pipelines.

The US Food and Drug Administration and the European medicines regulatory network, which includes the European Commission, the European Medicines Agency and 30 national agencies, are now WHO-Listed Authorities under a framework launched in 2022.

As South Korea's doctors continue their long-running protest against a government plan to raise the medical student quota at universities, the walk-outs may be beginning to take a toll on the pharma industry, with many large firms reporting weak earnings in the last quarter.

Korean bioventures join an inaugural matching event with Japanese pharma firms at Shonan iPark, amid rising hopes for further bilateral partnerships based on respective R&D capabilities.

Hanmi’s head of new product development elucidated the leading Korean pharma firm’s digital healthcare strategy at a recent domestic forum, including plans for the country’s first medicine/DTx combo, and shared views on what is needed to improve the domestic regulatory and market environment.