Samyang BioPharm, the biotech affiliate of Samyang Group, listed on the Korea Exchange's main board (KOSPI) on the 24th following a spin-off. It returns as an independent corporation four years after absorbing the group's pharmaceutical and bio institutional sector in 2021, a move that appears to reflect Samyang Group's view of the growth potential of its bio business and its choice of partitioning.
The listing proceeded via a direct listing after a spin-off from Samyang Holdings, the holding company of Samyang Group, on the 1st. Samyang BioPharm plans to strengthen its research and development (R&D) capabilities and push full-scale technology commercialization, led by its in-house developed gene delivery platform "SENS."
Samyang BioPharm was created in 2011 through a physical split from Samyang Corporation when Samyang Group converted to a holding-company structure. At the time, the group carved out the pharmaceutical business unit into a separate company to make bio a new growth engine.
Leadership at Samyang BioPharm will continue under CEO Kim Kyung-jin, who led ST PHARM for the past seven years. Kim expanded ST PHARM's mRNA business, established a structure centered on oligonucleotide therapeutics, and led a turnaround to profit in 2021. The company is also seen as having laid a foundation for growth by expanding supply of phase 3 clinical trial active ingredients to global pharmaceutical companies. Kim joined Samyang Holdings in June last year, and Lee Hyun-su, chief financial officer (CFO) who worked at Samyang for more than 20 years, will serve as an outside director.
The company's core businesses now are medical devices and oncology-focused contract development and manufacturing (CDMO). In 1993, Samyang succeeded in developing the nation's first absorbable surgical suture and has maintained the No. 1 global market share, while also expanding its aesthetic and medical device lineup, including lifting threads and polymer fillers.
Samyang BioPharm has product lines for seven solid tumors and five hematologic cancers. Notably, it developed "Genexol," a generic of "Taxol," a paclitaxel-based anticancer drug developed by Bristol-Myers Squibb (BMS), and uses it to treat lung, breast, and ovarian cancers, holding more than half of the domestic market for paclitaxel-based anticancer drugs.
Other flagship products include "Femede-S," which improved a lyophilized injection into a liquid injection; "Azarid," which adjusts dosage to East Asians' body surface area and lowers drug costs; and "Renalid," which changed a capsule to a tablet to prevent adhesion to the gastric wall when taken orally. The company recently completed a new anticancer injectables plant capable of producing 5 million vials a year and obtained good manufacturing practice (GMP) certifications in Japan and Europe, and it plans to expand its anticancer drug business.
Samyang BioPharm's sales rose to 112.5 billion won in 2022, 122.7 billion won in 2023, and 138.2 billion won last year, with operating profit steadily increasing to 9.2 billion won, 10.6 billion won, and 19.5 billion won. For the half year to date, it posted 69.8 billion won in sales and 9.4 billion won in operating profit, and it invested 23.3 billion won in R&D, equivalent to 9.89% of last year's sales. The company plans to gradually increase this ratio.
After the partitioning, Samyang BioPharm is focusing on new drug development based on SENS. SENS is a platform Samyang researched for 30 years and developed last year, a technology that precisely delivers genetic materials such as messenger RNA (mRNA) and small interfering RNA (siRNA) to specific cells. For mRNA therapeutics, the "delivery vehicle" that safely carries genetic information into cells is the key technology.
Among the candidates currently in development using SENS, the preventive vaccine "SYP-2246" and the anticancer drug "SYP-2135" are representative. SYP-2135 uses mRNA delivery technology introduced from LG CHEM.
Since April 2023, Samyang BioPharm has been co-developing an mRNA-based anticancer drug with LG CHEM and a gene therapy with Gencore. With the partitioning as a catalyst, the company is expected to pursue more active memorandums of understanding (MOUs) or mergers and acquisitions (M&A) with domestic and overseas companies.
Still, the practical hurdles of new drug development are significant. Pfizer in the United States, GSK plc in the United Kingdom, and Takeda in Japan halted clinical trials for cell and gene therapy (CGT), while Kite, a subsidiary of Gilead in the United States, and Roche's Genentech also successively discontinued large-scale development projects.
Reports of patient deaths in recent clinical trials fueled the pullback. Industry uncertainty grew after a death occurred in trials of "Elevidys," a Duchenne muscular dystrophy (DMD) gene therapy under joint development by Roche and Sarepta Therapeutics in the United States.
An industry official said, "Gene therapies have strong potential for innovation in rare and intractable diseases, but there are structural limits that make immune responses and long-term toxicity hard to predict," adding, "As Samyang BioPharm moves into new development, securing specialized talent and bringing in technology are essential, and considerable challenges are expected during development."