LG Chem and Samsung Bioepis have each jumped into developing anticancer drugs with a "success rate in the 1% range." These companies are the core engines driving the pharmaceutical and biotech businesses that the LG and Samsung groups have picked as future growth drivers and are nurturing.
According to the pharmaceutical and biotech industry on the 17th, LG Chem has embarked on developing an innovative anticancer drug targeting an uncharted target. The company said on the 1st that it signed a global exclusive development and commercialization license agreement with Frontier Medicines in the United States for the anticancer drug candidate "FMC-220," which is about to enter a phase 1 clinical trial.
Samsung Bioepis said it began a phase 1 clinical trial last month for "SBE303," an antibody-drug conjugate (ADC) anticancer drug candidate dubbed a "guided missile that locks onto cancer cells." This is the first new drug candidate the company is developing. The phase 1 trial will enroll 149 patients with advanced solid tumors worldwide through July 2030.
Until now, LG Chem focused on synthetic drugs, and Samsung Bioepis focused on biosimilars, but both companies have opened their wallets to ramp up anticancer drug development. Observers say they are shifting from stable revenue businesses to a high-risk, high-reward structure.
Developing new anticancer drugs requires massive time and expense. From preclinical through phases 1 to 3 to final approval, the success rate is around 1% to 3%, and even based on phase 1 it is only 5% to 10%.
But a success can reshape the market. In oncology, that is, anticancer drugs, the share of sales in the global pharmaceuticals market is the largest, and a single medicine can become a blockbuster drug generating annual sales in the trillions of won.
◇ Following business reshuffles, anticancer pipelines accelerate
LG and Samsung share a common thread: after revamping their biotech business structures last year, they are continuing moves this year that put more weight on anticancer drug development. Last year, LG Chem sold its aesthetics business, including fillers within its Life Sciences division, to VIG Partners. Samsung Bioepis executed a spin-off from Samsung Biologics and was incorporated as a subsidiary of newly established holding company Samsung Epis Holdings.
The strategies and speeds of the two companies' anticancer drug development differ.
In 2022, LG Chem acquired AVEO Oncology, a U.S. biotech developing anticancer drugs, for about 800 billion won, instantly securing global capabilities in clinical development, approvals and sales. Rather than simply obtaining candidates, it effectively bought the entire "commercialization platform."
LG Chem is a step closer to potential commercialization. Ficlatuzumab, a head and neck cancer therapy under development, is in phase 3, where overall survival (OS) is being evaluated.
Fotivda, a kidney cancer treatment, has already been commercialized in the United States and is in a phase 3 trial to expand its use as a second-line therapy. In addition, the company has now brought in the phase 1 asset FMC-220, further strengthening its anticancer pipeline.
Samsung Bioepis is pursuing new drug development based on an ADC platform through joint research with external biotechs. It is securing candidates through collaborations with companies such as IntoCell, Aimed Bio and Proteina, and combining them with its own manufacturing and process capabilities.
Samsung Bioepis' anticancer new drug pipeline is in the early stages. "SBE303" has just entered phase 1, and the company is also securing multiple ADC candidates through co-development and at the preclinical stage.
◇ In phase 1 "seedling" stage, LG targets uncharted targets, Samsung goes after validated targets
Looking at the characteristics of the anticancer drug candidates in global phase 1, LG Chem is aiming at an "uncharted target" for which no therapy exists, while Samsung Bioepis is seen as choosing a strategy of adding technological strength to a validated target.
FMC-220, which LG Chem has brought in, works by restoring function through action on the specific Y220C mutation of the tumor suppressor protein p53. p53 is a key protein in suppressing cancer, but when it mutates its function is neutralized. The Y220C mutation appears in about 1% to 3% of all cancer patients, but due to the protein's structure, drug binding is difficult, and it has been classified as an "undruggable" target.
To overcome this limitation, LG Chem applied a covalent-binding-based design. After the drug binds to the target protein, it forms an irreversible bond that does not separate easily, maintaining efficacy for a long time. While this approach can increase target-binding persistence and efficacy compared with noncovalent drugs, it also requires precise safety verification that considers the potential for toxicity from nonselective binding.
By contrast, Samsung Bioepis' SBE303 targets "nectin-4," which has already been validated as an anticancer target. In the ADC structure, a cytotoxic drug is attached to an antibody to selectively attack only cancer cells.
Nectin-4 is a protein that frequently appears on the surface of cancer cells, and an ADC anticancer drug targeting it, Padcev, has already been commercialized. Padcev is an anticancer drug developed by Seagen and Astellas; after Pfizer acquired Seagen in 2023, global rights were allocated and it is being sold. Rather than pioneering a completely new target, Samsung is closer to a "best-in-class" strategy, seeking better efficacy and safety against an existing target.
Both companies face formidable challenges. The p53 class targeted by LG Chem has had limited successes over decades, and the ADC field Samsung is tackling is one where global big pharma companies are competing.
In the end, the contest in new drug development comes down to capital strength—the stamina for a relay—and clinical data.
A biotech industry official said, "Leclaza from Yuhan is the only domestically developed anticancer drug to successfully enter the global market, and even that was transferred before late-stage clinical trials," adding, "The very fact that Samsung and LG are taking on the challenge of global new drug development—which requires investments in the trillions of won—and tackling medical grand challenges is highly meaningful."
The person added, "However, in the case of LG Chem, prolonged weakness in the petrochemicals business could become a burden, and for Samsung Biologics, its new drug pipeline remains in early clinical stages, meaning it will take considerable time to reach commercialization."