[Reporter's View] Keeping up with the Chinese bio industry

The research and development (R&D) capabilities of Chinese pharmaceutical companies are going from strength to strength year after year.

 

Last year, the immuno-oncology drug Loqtorzi, developed by Junshi Biosciences, was approved in the United States.

 

It became the first Chinese immuno-oncology drug to be approved by the U.S.

 

Food and Drug Administration (FDA).

 

While Chinese anti-PD-L1/PD-1-targeted immuno-oncology drugs have been approved within China, this is the first time they have crossed the FDA approval threshold.

 

This year, BeiGene’s immuno-oncology drug Tevimbra was approved by the FDA.

 

Another Chinese drugmaker, Innovent, is also seeking FDA approval for its own immuno-oncology drug sintilimab in partnership with Eli Lilly.

 

The domestic pharma and biotech industry has also launched a number of immuno-oncology drugs, but most of them are still in the pre-Phase II stage.

 

This is in contrast to Chinese companies, which have completed Phase III trials and are closer to global commercialization.

 

China is leading the way in global commercialization not only of immuno-oncology drugs but also of next-generation therapies such as targeted anti-cancer drugs, gene therapies, and nucleic acid therapeutics.

 

On the other hand, Korea has not been able to make a significant impression in the global market outside of biosimilars.

 

In fact, the number of global new drug approvals by Korean pharmaceutical companies is incomparable, far less than that of Chinese pharmaceutical companies.

 

The number of global new drug approvals by Chinese pharmaceutical companies in countries other than the US has also been steadily increasing, receiving approvals for 44 new drugs in 2020, 40 in 2022, and 14 last year.

 

In the United States, 11 Chinese-made drugs have been approved in the past 3 years.

 

In the case of Korean pharmaceutical companies, only 8 new drugs have been approved so far.

 

In terms of clinical trials, China's share grew by 6.1% from 2019 to 2023, while Korea's share grew by only 0.3% during the same period.

 

Government support has played a major role in raising the Chinese pharmaceutical industry's R&D capabilities.

 

The Chinese government has deisgnated the pharma-bio industry as its economic growth engine and has shortened the approval time for drugs by innovating the CFDA’s review system.

 

Examples include priority review drugs, expanding the number of Centers for Drug Evaluation (CDEs), and accepting overseas clinical data.

 

As a result, China's clinical and new drug review time has been reduced by about one-third compared to before 2015.

 

The expansion of China’s insurance reimbursement that increased the number of drugs on the reimbursement list has also worked in favor of Chinese pharmaceutical companies.

 

The Chinese government continues to expand insurance reimbursement coverage of new drugs, and the revenues are being channeled into R&D investments.

 

Korea, on the other hand, has been less successful in supporting R&D.

 

The Yoon Suk-Yeol's government pledged to support bio R&D from the beginning of his administration, pledging to ‘establish a pharma-bio control tower’ to integrate, foster, and support the pharma-bio industry.

 

However, to date, cooperation between the government and the industry has not been active, as the control tower, the Biohealth Innovation Committee, has not been fully operationalized, and regulations restricting the pharmaceutical industry, such as the drug price reduction system and reimbursement adequacy reevaluations, continue to increase.

 

In order to create new global drugs, Korea needs to establish specific regulations and support systems for innovative drug development.

 

It is illogical to expect good drugs to be made while investing less.

 

Only more investment can lay the foundation for the development and launch of new global medicines.

 

The government has budgeted KRW 2.9 trillion for fundamental R&D next year, which is the largest amount ever allocated.

 

It is this reporter’s hope that this will spur the biotech industry to invest in challenging research areas and develop innovative new drugs.