SK Bioscience "COVID-19 Vaccine Approval in First Half... Entry into Cell and Gene Therapy Market"

Ahn Jae-yong, President of SK Bioscience, is speaking at the SK Bioscience online press conference held on the 31st.

[Asia Economy Reporter Lee Chun-hee] SK Bioscience has reaffirmed its plan to complete domestic approval of 'GBP510,' the first domestically developed COVID-19 vaccine, within the first half of this year. In addition, the company announced its intention to utilize 1.6 trillion KRW of its own funds in various ways such as mergers and acquisitions (M&A), technology transfers, and product introductions to explore new growth engines like cell and gene therapies (CGT).

At a press conference held on the afternoon of the 31st to mark the first anniversary of its initial public offering (IPO), SK Bioscience President Ahn Jae-yong unveiled a new vision to become an innovative global partner in vaccines and biosciences.

President Ahn evaluated that significant progress had been made over the past year in all five areas mentioned at the time of listing one year ago. At that time, SK Bioscience announced plans in five areas: ▲a two-track strategy for COVID-19 vaccines through contract manufacturing (CMO) and in-house development ▲establishment of global production bases ▲securing platform technology ▲expansion into CGT ▲building global vaccine supply capabilities.

The most notable achievement among these areas is undoubtedly the COVID-19 vaccine. The company is developing 'GBP510,' a recombinant protein vaccine likely to become the first domestically produced COVID-19 vaccine. The Phase 3 clinical trial is in its final stages, and recently, a pre-purchase agreement for 10 million doses was signed with the Korea Disease Control and Prevention Agency. President Ahn emphasized, "We expect to receive approval within the first half of this year as originally planned." He also expressed pride in contributing to public health by supplying COVID-19 vaccines domestically for the first time through the AstraZeneca (AZ) vaccine while serving as a CMO for AZ and Novavax vaccines.

President Ahn also addressed concerns that even if GBP510 is approved and launched amid the likely transition from the COVID-19 pandemic to endemic status, it might be difficult to translate this into actual sales. He stated, "Although Korea's vaccination rate is high, 36% of the global population has yet to receive even the first dose," emphasizing that "GBP510 still has a significant role to play in global health." He revealed plans to seek approval from the UK, Europe, and the World Health Organization (WHO) within this year.

Furthermore, he disclosed strategies to prepare for the actual endemic phase: ▲a multivalent vaccine capable of responding to multiple variants ▲a combo vaccine combining COVID-19 and influenza ▲a universal vaccine effective against any variant ▲a nasal spray for prevention and treatment, aiming to continue addressing the post-COVID-19 market and public health needs with various next-generation vaccine forms.

Regarding SK Bioscience's key business area of contract development and manufacturing (CDMO), he highlighted the advantage over other market challengers by stating, "Since vaccine factory construction takes 2 to 3 years, production must occur at existing facilities," and announced the company's intention to challenge not only EU-GMP but also the U.S. Food and Drug Administration (FDA) cGMP standards. President Ahn said, "I want to declare here that we have decided to pursue cGMP certification," adding, "This signifies not only qualitative progress but also scalability."

However, the other four areas have yet to show clear results. In this regard, President Ahn expressed a strong commitment to pursue more concrete plans.

Regarding vaccine technology, he admitted, "Before COVID-19, we believed we had the technology to produce all types of vaccines, but we realized we lacked messenger RNA (mRNA) technology," and stated that the company will actively seek to acquire mRNA technology while also working on diversifying formulations.

Ahn Jae-yong, President of SK Bioscience, is explaining SK Bioscience's plans to enter the cell and gene therapy (CGT) market at an online press conference held on the 31st.

In particular, President Ahn showed enthusiasm for entering the CGT technology field, which has recently become a hot topic in the bio industry. Given the company's existing commercialization capabilities with viral vectors, it plans to actively expand into CGT technology.

In this process, he revealed the intention to aggressively pursue mergers and acquisitions (M&A) or secure technologies and products by leveraging SK Bioscience's cash mobilization capacity of up to 5 trillion KRW. President Ahn stated, "We currently have 1.6 trillion KRW in cash on hand and expect to raise 5 to 10 trillion KRW in investment funds, including internal funds," and mentioned a shift in perspective, saying, "With global asset prices falling due to recent events like Russia's invasion of Ukraine, this is a golden opportunity for SK Bioscience considering M&A."

Regarding M&A, President Ahn identified ▲mRNA technology ▲attractive vaccine products ▲CGT technology and validated CGT products as key targets, and added that to achieve 'glocalization,' the company plans to establish joint ventures (JVs) worldwide and invest at a level equivalent to building second and third factories.

He also disclosed plans to break ground on the 30,000㎡ 'Songdo Global R&PD (Research & Process Development) Center' in Incheon Songdo within this year and complete it in 2024, while continuing to strengthen production capacity by acquiring an additional 99,130㎡ site near the current Andong L House for expansion.

During the Q&A session, concerns were raised about competition within the SK Group as SK Pharmteco, a fellow affiliate, has been investing consecutively in GCT CDMO, including acquiring France's Iposketch and becoming the second-largest shareholder of the U.S. CBM. President Ahn responded, "Pharmteco started as a CMO company, and Bioscience began with vaccines but naturally expanded into the adjacent CGT field," and dismissed concerns by stating, "Since the CGT market itself is a continuously growing large market, if each does their best, there will be more synergy than conflict."

Regarding the recent stock price decline, he expressed regret, saying, "The price has dropped about 50% from its peak, and we feel sorry," and mentioned, "We are considering share buybacks and bonus issues as good ways to maximize corporate value." However, he added, "Our priority is to invest in growth first," and concluded, "We will implement various measures in a timely manner that shareholders and investors can agree with."

This content was produced with the assistance of AI translation services.