Samsung Bioepis has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 1 clinical trial of an antibody-drug conjugate (ADC) new drug candidate. It has been about three years since Samsung declared in 2022 that its bio business would be a future core industry. Assessments say the so-called "Samsung-style new drug development" has entered full swing.
According to the industry on the 2nd, Samsung Bioepis recently applied to the FDA for a phase 1 IND for an ADC new drug candidate targeting bladder cancer patients. The company is aiming to enter a global phase 1 trial next year and to produce interim results.
ADC, called an "anti-cancer guided missile," is a next-generation cancer therapy that minimizes damage to healthy cells while selectively attacking cancer cells.
The core lies in the antibody that seeks out cancer cells, the drug (payload) that kills them, and the linker that connects the two; when the antibody binds to antigens on the surface of cancer cells, the drug is delivered into the cells and precisely destroys the cancer. As global pharmaceutical companies have raced to secure candidates recently, ADCs have emerged as a key battleground in the anti-cancer drug market.
In the industry, there is an assessment that Samsung's painstaking new drug development efforts have finally entered the stage of becoming reality. After declaring at the end of 2022 that it would "nurture bio as the second semiconductor," Samsung has continued large-scale investments.
Lee Jae-yong, chairman of Samsung Electronics, has held a series of meetings with CEOs of global pharmaceutical companies, and is known to have personally overseen new drug development strategy by meeting several times with Noubar Afeyan, co-founder of Moderna, chairman of Flagship Pioneering (a U.S. bio-focused VC), to seek advice.
In 2021, Samsung C&T, Samsung Biologics, Samsung Bioepis, and Samsung Venture Investment jointly created the 150 billion won Samsung Life Science Fund to accelerate the discovery of promising bio technologies. Of the 11 domestic and overseas companies invested in so far, three are ADC companies. The first domestic investment target in 2023 was Aimed Bio, which develops an FGFR3-targeted ADC.
Samsung's push for new drug development has recently gathered momentum through the spin-off of its contract development and manufacturing organization (CDMO) for biopharmaceuticals and its biosimilar business.
Samsung separated the two businesses and launched Samsung Bioepis Holdings, shifting the center of gravity from a biosimilar-focused structure to one centered on new drug development. Having focused on the biosimilar business for 13 years, Samsung Bioepis is expected to move into developing new drugs such as ADC-based anti-cancer therapies and gene therapies.
Samsung Bioepis has actively sought to build ADC capabilities by leading with an open innovation strategy. In Dec. 2023, it signed a joint research agreement with IntoCell for up to five ADC candidates. In the industry, many expected that IntoCell's linker would be applied to Samsung's first ADC new drug candidate this time.
This year, it began joint development of two ADC candidates with China's Frontline Biopharma, and recently, together with Seoul National University and PROTEINA, it was selected for a national project to develop 10 antibody new drug candidates by 2027, launching a large-scale initiative.
Synergy with EPIS NexLab, another subsidiary under Samsung Bioepis Holdings, is also anticipated. Although it is a small organization of about 10 people, it specializes in ADC- and peptide-based platform technologies, and the platforms it has secured are expected to be widely used for future new drug development as well as joint research and technology licensing with global pharmaceutical companies. Samsung Bioepis will handle the entire development cycle, including clinical trials, approvals, and commercialization, leading to the completion of a new drug value chain within the group, analysts say.
Alongside new drug development, Samsung Bioepis is also expanding its biosimilar pipeline. It is working to develop blockbusters (large-scale medicines with annual sales of $1 billion or more) such as Keytruda and Enhertu, with a goal of launching more than 10 new biosimilars by 2030.
A Samsung Bioepis official said, "Samsung Bioepis Holdings plans to actively identify promising new businesses based on next-generation technologies that will drive future growth through newly established subsidiaries," adding, "We will establish a biotech model that develops various new drug candidates by platformizing highly scalable component technologies and pursues joint development with global pharmaceutical companies."