Biopharma industry welcomes amendment to high-tech regenerative medicine law – with caveats

Korean biopharma companies are showing high expectations and interest in the amendment to the Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals that passed the National Assembly in February.

They expected the revised law to revitalize regenerative medicine and biopharmaceutical research and speed up the development of cell and gene therapy (CGT), according to industry sources.

Previously, only patients with rare or refractory diseases participating in clinical trials could receive advanced regenerative medicine at the developmental stage. However, the amendment will allow patients who are not clinical participants to have treatment opportunities through the “advanced regenerative medicine clinical research,” the sources said.

Companies including CHA Biotech, GI Cell, CGBio, and NKMAX have welcomed the amended law.

Against this backdrop, Bio Korea 2024, held at COEX in Seoul last Friday, organized a panel discussion to discuss the industry's expectations and outlook for the law's revision. Won Sung-yong, director of GC Cell’s Research Center; Sohn Hyun-jung, head of clinical development at ViGenCell; Hong Sung-sang, managing director at ENCell; and Lee Joo-yeon, director of Xcell Therapeutics’ Research Center, participated in the discussion.

"The amendment to the Advanced Regenerative Medicine Act is an opportunity to provide more advanced biopharmaceuticals to patients and a great opportunity to speed up the development of therapies. We expect the market for advanced biopharmaceuticals to expand as patient groups and indications are segmented," GC Cell’s Won said.

Commenting on the opportunity to provide regenerative medicine to more patients, ViGenCell’s Sohn said, "We can generate revenue by supplying drugs. Unlike commercial clinical trials, the 'clinical studies' results cannot be used to apply for a product license, but safety data can be obtained cheaply."

ENCell’s Hong said, "Since companies and research facilities without cell processing facilities cannot produce advanced biopharmaceuticals themselves, they will entrust contract development and manufacturing (CDMO) companies to manufacture more drugs for clinical trials, which will naturally increase the sales of advanced biopharmaceutical CDMO companies."

Xcell Therapeutics’ Lee said, "Despite the growth of the advanced biopharmaceutical market, there have been hurdles at the approval stage. As this is resolved, the growth of the backward industries, such as small parts (materials, parts, and equipment) required for developing and producing advanced biopharmaceuticals, is expected. We are also looking forward to the development of domestic biopharmaceutical media."

On the other hand, participants agreed that there are also challenges that the industry needs to work together to solve.

The panelists pointed out that companies should ensure product safety and quality control to ensure that the expansion of the regenerative medicine provision due to the law's revision does not lead to indiscriminate research or treatment. The panelists also called for an active role in the review committee for advanced regenerative medicine and advanced biopharmaceuticals under the Ministry of Health and Welfare.

"The most problematic part is safety. Since it is administered to humans, it is necessary to establish not only QC (quality control) but also CMC (chemistry, manufacturing and quality control),” Won said. “In our case, we have a strategy to enter clinical studies first for pipelines that have been proven safe by clinical trials or have already been approved for investigative new drugs (INDs)."

Won continued, "There must also be a good standard for its effectiveness before it can be used in patients for therapeutic purposes. The committee should do a good job of developing regulations that both the industry and patients can understand."

Sohn agreed, saying, "Quality control is necessary. The council should thoroughly manage quality control issues. The problem is that some companies cannot keep up with changes in the law or strengthening of regulatory standards. In such cases, external consulting firms or legal and regulatory experts are necessary to understand the company's status."