HONG KONG – Aiming to accelerate its biopharmaceutical R&D and marketing approvals, South Korea's Ministry of Food and Drug Safety (MFDS) and Ministry of Health and Welfare recently announced the Proposal of Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act had passed the country's National Assembly plenary session at the beginning of August and will come into force in a year's time.

The main thrust of the new act consists of four goals: introducing a fast track for advanced biopharmaceutical screening and authorization; expanding opportunities for rare and obstinate disease treatment; supporting clinical research into regenerative medicine; and strengthening the safety system for biopharmaceutical production. The government has defined advanced biopharmaceuticals as biological drugs using living cells, organisms or genes, such as cell therapy, gene therapy and tissue-engineered products.

The new fast track system will support marketing approval of biopharmaceutical products in three ways.

First, it will allow the authorization process to begin earlier, with drugmakers able to submit data for screening before the drug is completely developed. Second, biopharmaceuticals for rare and obstinate diseases can get screening priority. Finally, some treatments for cancers and rare diseases would be eligible for marketing approval based on phase II data, under the condition that the drug must prove its effectiveness and will be launched after carrying out phase III.

Generally, new drug R&D in South Korea takes 12 to 15 years. The new act is expected to shorten that process to between three to four and a half years.

The government also will build a support system for regenerative medicine clinical research. Korea has yet to allow stem cell therapy due to safety issues, which has prompted many Korean patients with cancers and obstinate diseases to go to China to receive treatment.

Based on the new act, stem cell therapy will be available under limited conditions. The therapy must be carried out for clinical research and on patients with cancers and obstinate diseases. The government will designate the medical institutes permitted to use stem cell therapy after strict screening and authorization. To prevent recruiting patients for profit, the medical institutes will not be able to charge the patients. Instead, the government will support the entire cost of the clinical research.

Safety concerns

The new act, however, has raised a number of safety concerns, related to worries that a fast marketing approval might not ensure the production of safe drugs. There's also the recent cell and gene therapy scandal involving Invossa-K, a product manufactured by Korean drugmaker Kolon Tissuegene Inc. that gained approval in Korea in 2017 for treating osteoarthritis of the knee. The MFDS later discovered that the company fabricated the drug's ingredient data and revoked the marketing license. (See BioWorld, June 5, 2019.)

To strengthen the safety system, the Korean government will set up regulations for human cell inspection and management businesses. It will also build a set of standards for biopharmaceuticals manufacturing and quality management, as well as requiring the drug companies and hospitals to track patients' records over the long term. If the therapy originates from stem cells or animal cells, and causes abnormal reactions, patients' conditions must be tracked under the law.

Some Korean companies, especially cell therapy and gene therapy developers targeting obstinate diseases, are expected to benefit from the act.

Medipost Co. Ltd., a stem cell biotech based in Seongnam City developing Pneumostem as a preventive treatment of bronchopulmonary dysplasia for premature infants, has completed a phase II trial in Korea and phase I/II trial in the U.S. The therapy has been designated as an orphan drug by the FDA and the EMA. The company can now apply for the fast track approval system in South Korea.

Cha Biotech Co. Ltd., a leading cell therapy developer, also based in Seongnam City, is carrying out seven clinical trials testing products based on pluripotent stem cells, adult stem cells and immune cells. All its candidates are targeting rare or obstinate diseases such as Stargardt macular degeneration, intermittent claudication and Alzheimer's disease. Cha has completed phase II testing for two of its adult stem cell-originated treatments, so the act may speed up their marketing approval.

"For the stem cell therapy developers in Korea, the fast track supporting law will accelerate marketing their products and treating patients with rare and obstinate diseases. In particular, the companies carrying out clinical trial phase II or III will be able to launch their products early," a spokesman at the Korea Biomedicine Industry Association told BioWorld.

Some experts are opposed to the act, however, insisting the new law may harm patients' health.

"The act does not secure drug safety but only focuses on technology innovation and commercialization," a spokesman at the Korean Pharmacists for Democratic Society told BioWorld. "Biopharmaceuticals as well as stem cell therapies must be produced under strict criteria. But the nonstanding committee of the government is in charge of clinical research authorization, which means the regulations will be too weak to guarantee safety."

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