Daewoong Pharmaceutical announced on June 30 that it has received approval from the Ministry of Food and Drug Safety for its active pharmaceutical ingredient (API) form of 'BMP-2 (Bone Morphogenetic Protein-2),' a protein that promotes bone regeneration.
This approval is significant as it officially recognizes a domestic bone regeneration solution capable of meeting the demands of an aging society. In 2013, Daewoong Pharmaceutical succeeded in localizing and mass-producing BMP-2 protein by applying its proprietary Escherichia coli production technology. The company was recognized by the World Health Organization (WHO) for its technological capability and originality, and was granted the international nonproprietary name (INN) 'Nebotermin.' Since then, the protein has been produced and managed at pharmaceutical standards at Daewoong Pharmaceutical's biopharmaceutical manufacturing facility. With this latest API approval, the company's manufacturing and quality control standards have now been officially certified.
This approval is not only an acknowledgment of Daewoong Pharmaceutical's BMP-2 manufacturing technology. It is also highly meaningful in that it provides patients who struggle with poor bone healing after fractures or disc surgery with a safer and more effective treatment option. Previously, imported BMP-2 proteins or products based on them were used. However, Daewoong Pharmaceutical has localized the protein with its own technology, met pharmaceutical-grade quality standards, and obtained API approval. This establishes a foundation for domestic patients to receive safer and more cost-effective treatments.
Furthermore, this case marks the first time in Korea that API approval has been granted for 'BMP-2 as a single ingredient.' Given the complex and sophisticated manufacturing processes and the high level of quality control required for protein-based biomaterials, this achievement is recognized as the result of passing rigorous regulatory procedures. It serves as comprehensive proof of technological prowess, quality reliability, and regulatory compliance, and is expected to become a significant milestone in the domestic biopharmaceutical development sector.
BMP-2 is a protein that induces the differentiation of stem cells into osteoblasts at bone defect sites, playing a key role in new bone formation. In particular, Daewoong Pharmaceutical's BMP-2 is produced using Escherichia coli, offering higher productivity and superior cost competitiveness compared to animal cell-derived proteins.
BMP-2, which plays such a crucial role in bone regeneration, is already being applied in various bone substitutes in clinical practice. A representative example is CGBio's 'NOVOSIS.' NOVOSIS is a bone substitute containing Daewoong Pharmaceutical's BMP-2, and it is the second such product in the world and the first in Korea to use this protein. In addition, in April, 'NOVOSIS PUTTY,' which combines BMP-2 with CGBio's next-generation bone substitute, received the first-ever clinical trial plan approval for a Korean combination medical product from the U.S. Food and Drug Administration (FDA), accelerating its global expansion.
The global BMP-2 market is growing rapidly due to aging populations, an increase in bone-related diseases, and rising demand for tissue regeneration. According to the global market research firm Market Research Intellect, the global BMP-2 market size is expected to reach approximately $850 million (about KRW 1.1 trillion) in 2024 and about $1.5 billion (about KRW 2 trillion) by 2033.
NOVOSIS is the only product in Korea to use Daewoong Pharmaceutical's BMP-2, which has been approved as an API, thereby ensuring high quality standards and manufacturing reliability. Based on this, it is said to have superior quality competitiveness compared to other products.
With this approval, Daewoong Pharmaceutical and CGBio are expected to accelerate the development of a wide range of musculoskeletal medical products by combining BMP-2 with various scaffolds such as ceramics and hydrogels. These products could be applied not only to spinal fusion, but also to fractures, dental implants, and orthopedic and dental bone substitutes.
Park Sungsoo, CEO of Daewoong Pharmaceutical, stated, "The API approval for BMP-2 demonstrates not only our technological capability but also trust in our entire production and quality management system. Going forward, we expect to expand our musculoskeletal medical product lineup through convergence with various scaffolds and to accelerate our entry into global markets."
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