Samsung Bioepis and Celltrion, the leading corporations in domestic biosimilars (copycat versions of biologic drugs), have moved in earnest into new drug development. Their strategy is to expand research and development (R&D) into new drugs based on clinical trial and regulatory approval experience accumulated through the biosimilar business. Attention is on whether the moves by the two companies will become a breakthrough as development of homegrown new drugs remains slow.
According to the industry on the 21st, the two companies are strengthening R&D with next-generation cancer drugs, antibody-drug conjugates (ADCs) and bispecific antibodies, as the core pillars. Both technologies are next-generation anticancer platforms under development by global pharmaceutical companies. An ADC is a therapy that combines a drug with an antibody that seeks out cancer cells to minimize damage to normal cells, and is called a "guided missile for cancer cells." A bispecific antibody grabs cancer cells and draws in immune cells to attack together.
◇Samsung Bioepis focuses on developing a new drug for "bispecific antibody ADC"
At an extraordinary shareholders meeting on the 17th, Samsung Bioepis won approval for a spin-off from its parent Samsung Biologics, paving the way to accelerate new drug development. With this spin-off, the contract development and manufacturing organization (CDMO) business for biologics and the biosimilar business will be separated, and on Nov. 1 Samsung Bioepis Holdings will be launched to build a growth system centered on new drugs.
Samsung Bioepis Holdings plans to establish a subsidiary with Samsung Bioepis by Dec. 14 to develop ADC platform technology. Staffed with internal personnel from Samsung Bioepis, the subsidiary is known to be developing a platform for designing bispecific antibody structures used in ADCs.
The core technologies of ADCs are the antibody that seeks out cancer cells, the drug payload that kills them, and the linker that connects the two. Existing ADC drugs were made with monospecific antibodies, but attaching a bispecific antibody to the payload doubles binding strength, resulting in stronger cancer-cell attack and reduced resistance issues, drawing attention in the global market.
In December 2023, Samsung Bioepis signed a joint research agreement with IntoCell and plans to develop five ADC new drug candidates. Some candidates are currently in preclinical testing. IntoCell holds technologies including linkers and payloads. Samsung Bioepis plans to submit an investigational new drug (IND) application within the year, marking Samsung's first new drug clinical trial.
On the same day, the company also signed a co-development agreement with Frontline, a Chinese biotech holding bispecific-antibody, dual-payload technology. The two companies will jointly develop two new drug candidates. Samsung Bioepis also obtained an exclusive license to apply one of Frontline's payloads to other in-house development programs.
Recently, with the development of a new linker technology that conjugates two types of payloads at different sites, research on dual-payload ADCs has been active. An industry official said, "The bispecific antibody–dual payload technology is like mounting different warheads on a guided missile that targets two objectives at the same time," adding, "It is difficult for cancer cells to defend against attacks from two directions, producing strong synergy and lowering the likelihood of resistance."
Samsung Bioepis is also speeding up hiring for R&D, including in the ADC field. The company has a dedicated research staff of 657, including 172 with doctorates and 249 with master's degrees, and more than 60% of all employees are in R&D.
◇Celltrion expands new drug development to ADCs and multispecific antibodies
Celltrion is also accelerating new drug development, making ADCs and multispecific antibodies, including bispecifics, a next-generation growth engine. A key ADC partner is Pinotbio, which holds linker and payload platform technologies. The two sides signed a deal in 2022 to introduce ADC technology applicable to up to 15 targets.
The two companies jointly developed PBX-7016, a novel camptothecin-derived TOP1 inhibitor payload. This substance damages the DNA of cancer cells and induces cell death. It is being commonly applied to Celltrion's main ADC candidates, CT-P70 and CT-P71.
CT-P70, under development as a treatment for solid tumors, received approval from the U.S. Food and Drug Administration (FDA) in March and from Korea's Ministry of Food and Drug Safety in May, and is in a phase 1 clinical trial. In addition, the company has secured various ADC new drug candidates such as CT-P72 and CT-P73.
Celltrion is also expanding research on bispecific antibody new drugs. In 2022, it teamed up with Abpro Corporation, a U.S. specialist in bispecific antibodies, to jointly develop the bispecific antibody therapy ABP102, and in 2023 it signed a joint research agreement on multispecific antibody new drugs with Siron Therapeutics, a domestic biotech.
The company aims to submit investigational new drug (IND) applications for a total of 13 candidates (nine ADCs and four multispecific antibodies) within the next three years.