No matter how effective and safe a substance is, if it fails to clear the CMC (chemistry, manufacturing and controls) hurdle, a new drug cannot be approved. Centering on KCMC (Korea CMC Service Industry Association), we will build a public platform and a workforce training system so Korea can build CMC capabilities on its own.
On the 30th at the Korea Science and Technology Center in Gangnam-gu, Seoul, KCMC Innovation Technology Chairperson Lee Sang-rae (Ajou University School of Medicine professor) said, Domestic pharmaceutical and biotech industries have focused only on efficacy and safety, but they have not sufficiently built CMC capabilities, which are the final gateway to new drug approval, diagnosing the situation.
◇ "Even a good new drug won't be approved if it fails CMC"… the hidden bottleneck in drug development
CMC is the process of verifying manufacturing processes, quality and stability to develop a drug candidate into an actual medicine. In Korea, it has received relatively less attention than efficacy and safety research, and a considerable portion has depended on Chinese companies due to the expense burden.
Recently, as the importance of pharmaceutical supply chains and technological sovereignty has grown, led by the United States, and standards for manufacturing and quality verification have been strengthened in the approval process, CMC is emerging as a core competitive edge in the pharmaceutical and biotech industry.
Lee was not originally a CMC expert. After years of researching dementia and Parkinson's disease, building a track record of papers, patents and tech transfer, Lee founded the drug developer Kaiser Bio in 2022 and only then, after jumping directly into new drug development, felt the importance of CMC.
Lee said, When I entered the field of drug development, I found no shortage of cases where projects ran aground over CMC issues at every step from preclinical to clinical and regulatory approval, adding, Because domestic corporations have not sufficiently experienced reaching the approval stage, they have not felt the importance of CMC.
In fact, according to Pharma Manufacturing, a U.S. pharmaceutical and biotech trade outlet, 74% of the cases in which the U.S. Food and Drug Administration (FDA) deferred new drug approvals from 2020 to 2024 and asked corporations for supplementation were due to CMC issues. Alongside efficacy and safety, CMC capability has become a key variable in new drug approval.
Lee especially emphasized that a significant share of new drug development expense goes into CMC. The Chairperson said, If developing one new drug costs 1 trillion won, more than half should be considered used for CMC.
In the field, there are also many cases where considering CMC too late shakes the entire development strategy. Lee said, After completing initial toxicity tests, during the process of preparing approval documents, if the drug is exposed to light, heat or humidity and degrades, new impurities can form, adding, In such cases, regulators demand toxicity data for the newly generated substances as well.
Even if tens of billions of won have already been invested to finish toxicity tests, a situation can arise where testing must effectively start over. Lee said, For a venture, the expense burden grows exponentially, adding, In the end, if you do not consider CMC from the start, the overall new drug development strategy can collapse.
Lee also warned that reliance on China is not merely an expense issue but leads to technology leaks and Data Sovereignty concerns.
Lee said, Efficacy and safety data are results of administration, but core data about the substance itself are in CMC, adding, As corporations in Korea commission work to China, a structure has formed in which important manufacturing and quality data are accumulated overseas.
In fact, some corporations said they even experienced cases in which information similar to their own substances appeared on the websites of local companies after commissioning work in China.
Under the Biosecure Act, implemented in the United States to keep Chinese biotech companies in check, the importance of CMC is growing further. Lee said, The United States is trying to build a safe pharmaceutical supply chain domestically, adding, Verification of manufacturing and quality will inevitably be further strengthened going forward.
◇ To break away from dependence on China, a national platform is needed… KCMC to support workforce and approvals
With this sense of urgency, Lee began actively publicizing the importance of CMC last year and, after about a year of preparation, launched KCMC in Mar. Lee was appointed in Apr. as a civilian member of the National Bio-Innovation Committee, a pan-government control tower overseeing national bio policy, regulation and investment, and is working to bring the CMC issue into the public discourse.
KCMC is chaired by Ajou University professor Kim Su-dong (former dean of the Ajou University Graduate School of Pharmaceutical Clinical Science) and has received formal approval from the Ministry of Science and ICT as an industrial technology research association. In cooperation with the Korea Drug Development Fund (KDDF), it plans to build a full life-cycle CMC ecosystem spanning public platform construction, workforce training and global approvals support.
KCMC has identified as core tasks: ▲ building a public CMC platform ▲ training specialized personnel ▲ establishing a global approvals support system.
Lee said, There are around 20 corporations in Korea that are strong in CMC, but the average age of experts is in the mid-50s, adding, We need to create an ecosystem where younger talent can enter and grow.
Lee emphasized that, because it is difficult for a single corporation to handle every CMC step, a consortium-based public platform is needed.
KCMC plans to create a system in which small and medium-sized CMC corporations and the Osong and Daegu High-Tech Medical Complexes, along with institutions related to drug development, form a network, divide roles by modality (therapeutic delivery method) such as antibody-drug conjugates (ADC) and cell and gene therapies (CGT), and the association supports approvals and regulatory responses.
Lee said, Until now, Korea has had many managers rather than people who actually do hands-on work, adding, It's like there were only ranch owners and no one to raise the cattle. Lee went on, To grow the entire industry, the government must build CMC platforms and workforce training systems in the public sector.
Lee said, No matter how effective and safe a new drug candidate is, if it fails to clear the CMC hurdle, it cannot be approved, adding, Now is the time to accumulate CMC data and talent domestically. CMC is the final puzzle piece that can let Korea's pharmaceutical and biotech sectors take a leap forward.