바이오스펙테이터

by Sungmin Kim

2020 was an important year for Samsung Biologics to make its name known to the industry as a ‘global CMO’. In the crisis of the COVID-19 pandemic, Samsung Biologics signed a CMO contract for Corona-19 antibody treatment with Eli Lilly and GSK, demonstrating its ability to respond to ‘massive demands with its competitive price and speed’. Last year, the company won orders worth about $1.7 billion (about 1.85 trillion won) as it gained momentum from CMO businesses such as anti-cancer drugs, immunocancer drugs and autoimmune diseases.

There was also an important milestone. In response to the explosive increase in CMO requests, Samsung Biologics has also begun construction of the fourth plant with a capacity of 256,000 liters, the world's largest production facility. It reported a series of deals with South Korea's Biotech in its newly expanded CDO - CDMO business, and opened an R&D center in San Francisco to expand its CDO business. It is also planning to enter Boston, Europe, and China sequentially.

Based on these achievements, Samsung Biologics, which started 2021, unveiled its mid- long term vision for the next decade for the first time. Samsung Biologics announced the title of "Growth for the Next Decade" at the JP Morgan Healthcare Conference on the 13th (local time). Samsung Biologics has held an announcement on the main track, a section for announcing major global companies for five consecutive years until this year.

The JPM 2021 announcement also drew attention in that it was the first debut stage announced in public since John Rim, the new president (CEO) of Samsung Biologics, took office last month.

"We want to expand our business in three dimensions over the next decade and diversify our portfolio," said John Rim, “First of all, we are going to expand production capacity by constructing 2nd Bio Campus to expand capacity. We will expand our business scope from CDMO to biosimilars and new drugs. In terms of geography, we will expand to other markets such as Asia, the United States, Europe, and China.

It is also planning to diversify its portfolio into new modality beyond its business centered on antibody drugs. "We will invest in pipeline and platform technology through open innovation," said CEO John Rim. "We will expand into new businesses in cell and gene therapy(G&CT), vaccine and virus vector areas."

After CEO John Rim announced at the JPM, questions about its differentiation and performance in response to the COVID-19 pandemic, the reason for the construction of the fourth plant, and its business expansion continued for more than 20 minutes, showing keen interest in the industry.

Growth in 2020 was high… achieved 47 CMOs, $1.7 Billion Orders

President John Rim emphasized, "Even in the challenging situation of COVID-19 last year, Samsung Biologics has achieved all three goals proposed by JPM in 2020." ▲Orders for more than 60% of CAPA for the 3rd plant ▲Expansion of the 4th plant ▲Construction of a CDO lab in the US. In particular, the 3rd plant achieved orders close to full capacity.

The CMO business is also gaining momentum. Based on the number of products ordered, △27 in 2018 → △35 in 2019 → △47 in 2020. President John Rim said, “Last year, the total amount of CMO orders was $1.7 billion, and we signed contracts for more than 12 products. $500 million for Plant 1 and 2 and $1.2 billion for Plant 3.” He said, “We have signed a CMO contract with GSK, AstraZeneca, Gilead, and Lily through a new partnership with Global Big Pharma.” It has been further expanded from the existing Roche, BMS, Janssen, and UCB.

Samsung Biologics' competitiveness shined in the COVID-19 situation. President John Rim said, “During the COVID, we have proved 100% orders at customer requests, and there was no disruption in supply chain management (SCM). We signed the contract with Lily for the order of the first COVID-19 antibody which received FDA EUA and completed the tech-transfer in 3 months.”

3 Reasons with prospects for sustainable growth of CMO...Why is the construction of Plant 4 started?

It is expected that the CMO business will continue to grow in the future in three aspects. First, President John Rim said, “Big Pharma is investing intensively in R&D rather than manufacturing. In addition, due to the COVID-19 pandemic, dual sourcing is increasing for product supply and risk management.”

Second, the area of therapeutic development is expanding. President John Rim said, “The monoclonal antibody drug is rapidly growing in cancer, autoimmune diseases, and neurological diseases. In particular, in the field of neurological diseases, the final sale of Biogen’s ‘Aducanumab’ is scheduled to be decided on March 7. In addition, Lilly recently announced the success of phase 2 clinical trials of ‘Donanemab’ for Alzheimer's disease.”

Third, the biotech industry continues to grow. "There are currently about 9,000 small biotechs, and it is expected to increase to 12,000 by 2025. As a result, clinical and commercialization volume continues to grow, predicting a bright outlook for the CMO market and increasing demand," said CEO John Rim.

Following this trend, construction of the fourth plant began with the goal of operating the entire plant in 2023. Asked about the critical trigger for the construction of the world's largest 4th plant. John Rim said, "The decision was made as the customer's requests increased. Capacity of the third plant is almost full. Considering the current project with customers, the amount of orders is expected to increase significantly in three to five years. In addition, orders have increased in many areas, including anti-cancer and immune drugs, as well as COVID-related products during the COVID 19 pandemics. The CMO market continues to grow.”

When asked about the order of products related to Alzheimer's disease, President John Rim said, "There is no cure for Alzheimer's disease in our products and Portfolio, and it has nothing to do with the construction of the 4th plant," adding, "However, if we estimate demand at a time when the Alzheimer's disease treatment, Aducanumab, is on the market, we need 280,000 liters, given the production yield, assuming that there are 50 million Alzheimer's patients worldwide and 10 percent of them are treated. This is a big opportunity and a favorable situation for us.

3 keywords for this year? CMO, CDO, and biosimilar

What keyword will Samsung Biologics pay attention to in 2021? First of all, it is predicted that it will continue to grow continuously in CMO business. "We expect the number of product project orders to increase from 47 to 58 this year, and the number of regulatory approval will increase from 76 to 100," said John Rim. It also expands the capacity of drug products (DPs) to maximize CMO capabilities.

CDO services are also expected to increase. It is expected that the number of CDO orders in Korea will increase from 20 in 2020 to about 40 this year and 60 in between 2022 and 2024. It also plans to expand from Boston to other markets such as Europe and China.

Its goal is to strengthen its leadership in the field of biosimilars. "The biosimilar business has submitted documents for the third phase of clinical trials for Lucentis biosimilar and plans to release several other biosimilar products in a few years. It has been doing well in sales and has made $790 million in sales upon operating the plant 3 since 2018. Operating profit rate has been 25 percent since the third quarter of this year."

Lastly, President John Rim said, "We can say we focused on stabilizing our business and expanding our production volume rapidly for the past 10 years. For the upcoming 10 years, we will become a global comprehensive bio company by expanding our production scale, business portfolio, and global base at the same time."