Samsung Biologics CEO John Rim said on the 9th that the company has completed order contracts with four of Japan's top 10 pharmaceutical corporations and is in final talks with one more.
Rim said at the "BioJapan 2025" roundtable held in Yokohama, Japan, that "we have already collaborated with these corporations for a long time," adding, "we will fully expand our CDMO (contract development and manufacturing organization) business in Japan going forward." He said, "In particular, we will focus on the areas of antibodies, ADCs (antibody-drug conjugates), and CDO (contract development), where local pharmaceutical companies are showing interest."
Samsung Biologics has so far signed contracts with 17 of the world's top 20 pharmaceutical companies, centered on the United States and Europe. It officially announced for the first time this time that it has also secured clients in Japan. At BioJapan 2024, it disclosed that contract talks were underway, but did not formalize specific order results.
Samsung Biologics has obtained a total of 18 manufacturing approvals from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). Of these, 12 were received in the past three years, accelerating the pace of supply expansion in the Japanese market. The company demonstrated its intent to target the Japanese market by setting up its first solo booth at BioJapan this year. It is also pursuing a strategy to broaden contact points with Asian clients by opening a Tokyo sales office earlier this year.
◇ Targeting the Japanese market strong in ADCs and stem cells
Rim said, "Japan is the world's No. 3 pharmaceutical market, with high medical standards and a leading edge in innovation," adding, "it is particularly strong in ADCs and cell and gene therapy (CGT)."
In fact, Daiichi Sankyo of Japan, together with AstraZeneca of the United Kingdom, developed the ADC anticancer drug "Enhertu," which is leading the global market with annual sales exceeding 4 trillion won. ADCs, called "guided missiles" that target cancer cells, are a treatment technology that attaches a drug to an antibody to deliver it precisely to cancer cells only. They can reduce adverse effects on normal cells while maximizing therapeutic effects.
Japan is also leading the global stem cell market. Yamanaka Shinya, a professor at Kyoto University in Japan, discovered induced pluripotent stem cells (iPS cells) and won the 2012 Nobel Prize in Physiology or Medicine. iPS cells revert mature cells to an embryonic stem cell state that can grow into all human cells. Embryonic stem cells are obtained from fertilized eggs, but iPS cells are not, allowing ethical controversy to be avoided. The Japanese government has actively supported stem cell research while greatly easing regulations on stem cell therapies to spur commercialization.
To respond to local characteristics in Japan, Samsung Biologics became the first in the bio industry to introduce a country-specific talent development program. The plan is for employees to learn culture and business practices firsthand on the ground and share them with headquarters, building a customized consultation framework that reflects Japanese business culture.
Samsung Biologics entered the CDMO market about a year later than competitors such as Fujifilm of Japan and WuXi Biologics and WuXi AppTec of China, but narrowed the gap through rapid capacity expansion. On 4th, Plant 5 began operations, giving it the world's largest production capacity of 784,000 liters (L).
Thanks to this, the company achieved a cumulative order aggregates of 5.2435 trillion won so far this year, nearly matching last year's total order aggregates (5.4035 trillion won) in eight months. Since its founding, cumulative order totals have surpassed $20 billion (28.48 trillion won).
The company plans to continue increasing its production capacity. It aims to complete a second bio campus by 2032 to reach total capacity of 1,324,000 L. Rim said, "We are reviewing several domestic and overseas candidate sites and appropriate scale with a target completion in 2027, and the outline, including the region and schedule, will emerge within the year."
◇ New organoid service for drug testing also launched
Technology development and entries into new businesses are also continuing. Building on its existing antibody and ADC capabilities, the company is advancing antibody-oligonucleotide (AOC) technology and preparing to enter the CDO business by establishing a dedicated adeno-associated virus (AAV) laboratory. Oligonucleotides, synthetic genetic materials, are key raw materials for mRNA therapies, and when combined with antibodies that find targets, they can improve the accuracy and efficiency of treatment.
Recently, the company also entered the clinical research organization (CRO) business and launched the "Samsung Organoid" service, which tests drug candidates using organoids (organoid; organ-like structures). Organoids are cultured from stem cells into three-dimensional structures resembling organs and are called mini-organs. This technology can verify responses to drug candidates faster and more ethically than human cells grown flat in culture dishes or laboratory animals. As the U.S. Food and Drug Administration (FDA) has decided to phase out mandatory animal testing, related demand is growing.
On the day, Samsung Biologics also unveiled a new CMO (contract manufacturing organization) brand, "ExellenS™." With "equivalency" and "speed" as core values, it embodies the aim to build a rapid production and supply system while maintaining the same quality and process standards at all plants worldwide.
Rim said, "We will apply an optimized production design to all new plants to supply high-quality biopharmaceuticals when global clients need them."