370 Billion Invested in R&D Including 'CJRB-101'
CJ Bioscience is raising a large amount of capital to embark on research and development (R&D) of microbiome new drugs.
On the 23rd, CJ Bioscience announced that out of the 65 billion KRW secured through a paid-in capital increase, 37.6 billion KRW will be invested in pipeline clinical development. Specifically, 13.1 billion KRW will be invested in the microbiome-based immuno-oncology drug candidate ‘CJRB-101’, and 6 billion KRW in the inflammatory bowel disease treatment ‘CLP-105’. Additionally, 18.5 billion KRW will be used for the development of new drug candidates and platform technologies acquired from the UK-based 4D Pharma in March.
The microbiome, which CJ Bioscience is focusing on, refers to the collection of various microorganisms such as bacteria and viruses living in the human body. The microbiome is known to be beneficial not only for digestion but also for immunity and brain health. It helps facilitate smooth digestion while lowering cholesterol levels, regulating blood sugar, and aiding the production of brain neurotransmitters. Furthermore, as various diseases such as obesity, colitis, and cardiovascular diseases have been linked to different types of microbiomes, many bio companies are developing new drugs utilizing this.
CJRB-101 is an immuno-oncology targeted drug candidate secured by CJ Bioscience, which received approval from the U.S. Food and Drug Administration (FDA) earlier this year for clinical trial plans (IND) for Phase 1 and Phase 2. Last month, at the ‘American Association for Cancer Research (AACR) 2023’, one of the world’s top three cancer conferences, CJRB-101’s anticancer effects and mechanisms of action were presented for both monotherapy and combination therapy with Keytruda (active ingredient pembrolizumab). CLP-105, targeting inflammatory bowel disease, aims to submit its Phase 1 clinical trial plan in the second half of next year.
In the United States, the world’s largest pharmaceutical market, the first oral microbiome therapy has already been approved. At the end of last month, U.S.-based Seres Therapeutics received FDA approval for ‘Vowst (SER-109)’. Vowst was approved as a treatment to prevent recurrence of Clostridium difficile infection (CDI). In South Korea, besides CJ Bioscience, companies such as Gobio Lab and Genome & Company are also developing microbiome therapies.
The microbiome has a wide range of applications beyond healthcare, including cosmetics and agriculture. According to Mirae Asset Securities, the global microbiome market is expected to grow from $6.18 billion (approximately 8.13 trillion KRW) in 2022 to $10.09 billion (approximately 13.27 trillion KRW) by 2026, at an average annual growth rate of 13.1%. Among this, the human microbiome market used for therapeutics, diagnostics, and probiotics is predicted to grow about sixfold from $269.8 million (approximately 355 billion KRW) in 2023 to $1.37 billion (approximately 1.8 trillion KRW) in 2029.
The expansion potential of the microbiome therapeutic field is also noteworthy. Since microbiome therapies are just beginning to receive FDA approval and the market is still in its early stages, there is potential for expansion into additional applicable diseases. Mi-hwa Seo, a researcher at Mirae Asset Securities, said, "Although the probability of clinical failure remains, the potential for expansion upon success is high," adding, "It is important to pay attention to clinical trials in neurological diseases where treatments do not yet exist, rather than areas where therapies are already available."
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