Korea Pharma-Bio Briefs: Celltrion, SK Bioscience, Hugel, Alteogen, CHA Hospital

Celltrion said Sunday that a U.S. Trump administration measure announced April 2 on “adjusting imports of pharmaceuticals and pharmaceutical ingredients into the United States” has effectively removed tariff-related impacts on its business.

Under the measure, a 100% tariff will be imposed on imports of patented drugs and related ingredients that are not produced in the United States or are not covered by U.S. government drug-price negotiations. South Korea, however, is expected to face a 15% tariff on pharmaceuticals in consideration of existing trade agreements, Celltrion said.

Celltrion said the move eliminates any sales impact on its biosimilar products in the U.S., allowing it to run sales and marketing strategies more steadily. It plans to build up a step-by-step local production base so products sold in the U.S. can be made at its Branchburg plant in New Jersey, as it responds to future biosimilar policy changes.

For Zymfentra, an infliximab subcutaneous formulation sold in the U.S. as a new drug, the drug substance will be produced at the Branchburg facility, the company said, adding it has completed technology transfer for Zymfentra production. Celltrion said it ultimately aims to manufacture all products sold in the U.S. at local plants.
 

SK Bioscience said Sunday it has hired Vice President Ma Sang-ho, a research project management specialist in infectious diseases, as head of research support in its Bio Research Division.

Ma earned a doctorate in pharmacy from Sungkyunkwan University and a master’s and bachelor’s degree in chemistry from Hankuk University of Foreign Studies, the company said. He has worked across nonclinical and clinical development projects for drugs and vaccines at organizations including the Korea Health Industry Development Institute, GC Green Cross and JW Pharmaceutical.

SK Bioscience said Ma will help elevate its research and development capabilities based on his field experience and expertise. It said it has set up an integrated research management process under the research support office, including teams for research planning, bio regulatory management, nonclinical support and GCLP.

The company said it plans to strengthen project management functions and open innovation, building support across the full cycle from research planning and regulatory response to nonclinical work and GCLP operations. It said the goal is to speed development and improve the completeness of its mid- to long-term pipeline while strengthening execution at each project stage.
 

Hugel said Sunday it has obtained two international certifications for information security management: ISO/IEC 27001 and ISO/IEC 27701.

ISO/IEC standards are jointly set by the International Organization for Standardization and the International Electrotechnical Commission. ISO/IEC 27001 sets requirements for an information security management system, while ISO/IEC 27701 extends that framework to personal information protection.

Hugel said it first obtained ISO/IEC 27001 last year and has now passed a follow-up audit, demonstrating the stability and continued operation of its security management system. It said the new ISO/IEC 27701 certification brings its personal data protection system in line with global standards.

“Information security and personal data management are becoming more important as we expand in global markets,” said Lee Sang-gyu, an executive director in Hugel’s compliance support division. He said the company plans to further develop security systems to global levels.
 

Alteogen said Sunday it has declared this year the first year of ESG management and will step up efforts to build and execute a sustainability framework aligned with global standards.

The company said it has been building an organization-wide ESG system to respond proactively to major regulatory and disclosure changes, including the European Union’s Corporate Sustainability Reporting Directive and Corporate Sustainability Due Diligence Directive, as well as discussions on introducing domestic sustainability disclosure standards.

Alteogen said it has created an ESG committee and a working-level consultative body, and formed a dedicated organization that includes specialists in policy, verification and environmental fields.

It said it is establishing execution foundations across ESG areas, including a carbon-neutral roadmap based on science-based targets, response systems for CDP and EcoVadis, ISO-based environmental and occupational safety and health systems, and reporting frameworks based on GRI and ISSB standards.

On the environmental front, Alteogen said it launched the “Alteogen Blue Action” campaign focused on biodiversity conservation. It said it plans to expand ecosystem conservation activities tied to local communities, employee participation programs, and efforts on resource circulation and carbon reduction in stages.

In governance, Alteogen said it completed structural changes. It said it finalized the establishment of an audit committee at its regular shareholders meeting on March 31 and expanded the share of outside directors on its board to more than half.
 

CHA Hospital said Sunday it signed a memorandum of understanding with LG CNS at the infertility center of Magok CHA Hospital to cooperate on addressing South Korea’s low birthrate.

Attendees included Han Se-yeol, head of the infertility center at Magok CHA Hospital; Yeo Un-pyo, administrative office director; Ko Young-mok, an executive director and chief human resources officer at LG CNS; and Kim Tae-sang, who is in charge of the smart city business, the hospital said.

Under the agreement, the two sides will cooperate in areas including infertility treatment, fertility testing such as anti-Mullerian hormone level checks, and support for egg freezing, CHA Hospital said. The hospital said it plans to improve access to infertility treatment for LG CNS employees as part of efforts to address the low birthrate.

CHA Hospital quoted Han as saying the group is working with domestic and overseas institutions to expand opportunities for infertility treatment and contribute to addressing the low birthrate. He said he hopes LG CNS employees can receive treatment more comfortably in an optimal environment, citing the facility’s accessibility in Magok.