[Photo and Text by Kim Saemi, Edaily Reporter] “KSBL aims to compete in the global market by integrating technology, production, and sales networks, particularly in the field of complex generics—which are difficult to manufacture—and specifically in the area of nano-anticancer drugs.”

Shin Seong-seop, Chief Operating Officer (COO) and Executive Vice President of KSBL, recently shared these aspirations in an interview with PharmEdaily, Edaily’s premium pharmaceutical and biotech content platform.

Global Competitiveness of 'SNA-001,' a Nanoparticle Anticancer Drug with High Manufacturing Difficulty, on the Rise

#KSBL, a subsidiary of Kukje, is pursuing entry into the global finished pharmaceutical market with its nanoparticle anticancer drug SNA-001. KSBL was established in 2023 as a joint venture between SN BioScience and Kukje.

SN BioScience provides nanoparticle anticancer drug technology and its pipeline. Kukje Pharmaceutical combines its capabilities in Good Manufacturing Practice (GMP), production, Supply Chain Management (SCM), and Drug Master File (DMF) accumulated through its Active Pharmaceutical Ingredients (API) business. The company has established a strategy to enter the global market by leveraging production cooperation with #Dong-A ST and the local regulatory approval and sales networks of partners in each country.

SNA-001, KSBL’s core pipeline, is a nanoparticle anticancer drug formulated as albumin-bound paclitaxel. SNA-001 is positioned as a generic version of the original drug, Abraxane.

According to Executive Vice President Shin Seong-seop, conventional paclitaxel, due to its poor solubility, carried the risk of side effects such as hypersensitivity reactions caused by the use of solvents. Albumin-bound paclitaxel is regarded as a formulation that utilizes albumin to enhance drug delivery and overcome the limitations of conventional paclitaxel.

What Executive Vice President Shin emphasizes is that this is not a simple generic but a “complex generic” with a high manufacturing difficulty. He stressed, “The global market for standard generics is already dominated by products from low-cost manufacturing countries like India, making it difficult for latecomers to compete,” adding, “We must develop a complex generic that requires formulation implementation, scale-up, and quality stability to be competitive overseas.”

The key to the SNA-001 project also lies in formulation stability and commercial-scale production. For albumin-bound paclitaxel, simply using the same active ingredient is not enough. Particle size, stability, manufacturing reproducibility, and maintaining quality after scale-up are considered critical.

Executive Director Shin stated, “Albumin-bound anticancer drugs have a high manufacturing complexity, and it is difficult to manage quality variations during the transition to mass production,” adding, “Since introducing the technology, KSBL has been focusing on the development of pharmaceutical manufacturing and quality control (CMC) necessary for commercial production and global approval.”

A business model linking technology, production, and sales networks… “Playing the role of stringing beads”

To this end, KSBL is collaborating with Dong-A ST to establish a production base. KSBL will utilize Dong-A ST as a contract manufacturing organization (CMO) to establish a global supply system for SNA-001.

The business model is structured more as a combination of finished product exports and sales through local partners than a simple technology transfer. Dong-A ST handles manufacturing, while KSBL, as the export entity, coordinates approval and sales strategies with partners in each country. In short, the strategy involves rapidly developing proven pharmaceuticals into complex generics and then quickly converting them into sales by leveraging contract manufacturing and overseas partner networks.

He explained, “Dong-A ST possesses global GMP manufacturing capabilities, and our overseas partners have a need to expand their anti-cancer drug portfolios,” adding, “KSBL plays a role in coordinating product development, regulatory support, supply and licensing agreements, and global marketing at the center of the value chain.”

He added, “Just as the saying goes, ‘Even a string of pearls is worthless unless it is strung together,’ the ability to execute—linking technology, production, and sales networks into actual business—is crucial.”

Overseas expansion is also Executive Director Shin’s area of expertise. He previously served as a senior researcher at Daewoong Pharmaceutical’s Central Research Institute, headed business development (BD) at Pangenomics (now Helixmith), and oversaw overseas operations for the pharmaceutical division at Samyang Holdings. Executive Director Shin has accumulated over 20 years of experience in the overseas business and marketing of anti-cancer drug raw materials and finished pharmaceuticals, and has a track record of conducting business in over 50 countries, including the U.S., Europe, Japan, China, Southeast Asia, the Middle East, North Africa, Russia, and Latin America.

Building on this network, KSBL plans to expand supply and licensing agreements for SNA-001 to Southeast Asia, Europe, Japan, and the U.S. KSBL is currently preparing for regulatory approval and market launch based on existing partnerships with Kalbe in Southeast Asia and AqVida in Europe. The company is also exploring opportunities to expand partnerships in Japan, the U.S., the Middle East, and South America.

"Turning Technology into Business"... Aiming for an Early Commercialization Model

He noted, “Once the first product is established in the market, the costs and time required for subsequent products to enter the market are significantly reduced,” adding, “Securing an anti-cancer drug sales network and regulatory approval experience through early partnerships will also help with future portfolio expansion.”

KSBL also sees significant sales potential for SNA-001. Global sales of Abraxane reached approximately 2.3 trillion won in 2023. The use patent expires in 2026.

Assuming SNA-001 captures 20% of the global Abraxane market, the total sales volume is estimated to be approximately 460 billion won. However, considering revenue sharing with manufacturing, technology, and distribution partners, KSBL’s share of sales is estimated to be around 100 billion won annually at most.

Starting with SNA-001, KSBL is also reviewing new product lines—such as treatments for rare cancers and non-opioid analgesics—that can be integrated into its existing CMO manufacturing facilities and global network.

Executive Director Shin stated, “I do not believe that a model requiring long-term, large-scale clinical trials, like that of novel biopharmaceuticals, is the only solution,” adding, “There are areas where we can generate revenue more quickly by combining proven drugs with advanced formulation technology, stable production, and a global sales network.”

He continued, “KSBL’s goal is to establish itself as a company that transforms technology into business and generates profits quickly.”