LG Chem and Samsung Bioepis have each jumped into developing new cancer 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 designated and are nurturing as future growth drivers.
According to the pharmaceutical and biotech industry on the 17th, LG Chem has embarked on developing an innovative anticancer drug targeting an unexplored target. The company said on the 1st that it signed a global exclusive development and commercialization license agreement with Frontier Medicines for the anticancer drug candidate "FMC-220," which is about to enter phase 1 clinical trials.
Samsung Bioepis said it began a phase 1 clinical trial last month for "SBE303," an antibody-drug conjugate (ADC) candidate nicknamed a "guided missile that targets 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 has focused on small-molecule drugs, while Samsung Bioepis has centered on biosimilars, but both companies have opened their wallets to fully pursue anticancer drug development. There is an assessment that they are shifting their business structure from stable revenue to a high-risk, high-return model.
Developing new cancer drugs requires enormous time and expense. From preclinical through phases 1 to 3 and final approval, the success rate is around 1% to 3%, and even on a phase 1 basis it is only 5% to 10%.
But a success can reshape the market landscape. In oncology—anticancer drugs—the share of sales is the largest in the global pharmaceutical market, and a single drug can become a blockbuster generating annual sales in the trillion-won range.
◇ After business reshuffles, anticancer pipelines gain speed
Both LG and Samsung share the trait of having revamped their biotech business structures last year and are continuing moves this year that emphasize 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 the newly established holding company Samsung Epis Holdings.
The two companies differ in strategy and speed for developing new cancer drugs.
LG Chem in 2022 acquired the U.S. cancer drug developer AVEO Oncology for about 800 billion won, instantly securing global capabilities in clinical development, approval, and sales. Rather than simply obtaining candidates, it effectively bought an entire "commercialization platform."
LG Chem is closer to commercialization potential. Ficlatuzumab, a head and neck cancer treatment the company is developing, is in phase 3, where overall survival (OS) is being evaluated.
Fotivda, a kidney cancer treatment, has already succeeded commercially 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 brought in FMC-220 at the phase 1 stage to further strengthen its anticancer pipeline.
Samsung Bioepis is pursuing new drug development based on an ADC platform through joint research with external biotechs. It secures candidates via collaborations with biotech companies such as IntoCell, Aimed Bio, and Proteina, combining them with its own manufacturing and process capabilities.
Samsung Bioepis' anticancer pipeline is in its early stages. "SBE303" has just entered phase 1, and the company is securing multiple other ADC candidates through co-development and at the preclinical stage.
◇ In the phase 1 "sprout," LG targets an unexplored target; Samsung goes after a validated target
Looking at the characteristics of their global phase 1 anticancer candidates, there is an assessment that LG Chem is aiming at an "unexplored target" for which no treatment exists, while Samsung Bioepis has chosen a strategy of adding technological strength to a validated target.
FMC-220, which LG Chem in-licensed, works by restoring function through acting on a specific Y220C mutation of the tumor-suppressor protein p53. p53 is a key protein in cancer suppression, but when mutated, its function is disabled. The Y220C mutation appears in about 1% to 3% of all cancer patients, but due to the protein's structure, drugs have difficulty binding, and it has been classified as an "undruggable" target.
To overcome this limitation, LG Chem applied a covalent-binding-based design. This approach forms an irreversible bond that does not easily dissociate after the drug binds to the target protein, maintaining efficacy for an extended period. While it offers advantages such as improved target-binding durability and efficacy over noncovalent drugs, it also requires precise safety verification that considers potential toxicity from nonselective binding.
By contrast, Samsung Bioepis' SBE303 targets "Nectin-4," which has already been validated as an anticancer target. With an ADC structure that conjugates a cytotoxic drug to an antibody, it selectively attacks only cancer cells.
Nectin-4 is a protein frequently expressed on the surface of cancer cells, and an ADC cancer drug targeting it, Padcev, is already commercialized. Padcev is an anticancer drug developed by Seagen and Astellas, and after Pfizer acquired Seagen in 2023, global rights were allocated and the drug has been sold. Rather than pioneering an entirely new target, Samsung is closer to a "best-in-class" strategy to secure better efficacy and safety on an existing target.
Both companies face formidable challenges. The p53 class that LG Chem is tackling has had limited success cases over decades, and ADCs that Samsung is pursuing are a field where global big pharma companies are competing.
Ultimately, the contest in new drug development comes down to capital strength—the stamina to run a relay—and clinical data.
A biotech industry official said, "The only domestically developed anticancer drug to successfully enter the global market is Yuhan's Leclaza, and even that drug was transferred before late-stage trials," adding, "The very fact that Samsung and LG are taking on the challenge of global new drug development—which requires investments in the trillion-won range—and solving medical grand challenges is highly meaningful."
The official added, "However, in LG Chem's case, prolonged weakness in its petrochemical business could become a burden, and at Samsung Bioepis, the new drug pipeline remains in early clinical stages, meaning it will take considerable time to reach commercialization."