With Gilead Sciences' Yescarta anticipated to be approved in Korea this year and Korean biotechs accelerating the development of their own CAR-T therapies, the Korean CAR-T market --dominated by Novartis' Kymriah -- may undergo a seismic shift.

Currently, Novartis' Kymriah (tisagenlecleucel) and Janssen's Carvykti (ciltacabtagene autoleucel) are the only two CAR-T therapies being prescribed in Korea.

Not only do Kymriah and Carvykti have different indications for approval in Korea, but they also have different prescription performances due to different reimbursement statuses.

While Kymriah was the first CAR-T therapy to be approved and reimbursed in Korea, Carvykti has not yet won health insurance coverage.

Kymriah was approved in Korea for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) after relapse or second relapse following transplantation in pediatric and young adult patients up to 25 years of age; relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic therapies; and relapsed or refractory vesicular lymphoma as a third-line treatment.

Carvykti is authorized in Korea for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies.

While Kymriah is the only CAR-T therapy to enter the reimbursement system in Korea, the situation is different overseas.

In the global market, Gilead's Yescarta has already surpassed Kymriah's sales and is leading the CAR-T therapy market. This is because regulators in other countries have approved Yescarta for a broader range of indications.

The FDA-approved indications for Yescarta include relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) after two or more prior systemic therapies; and relapsed or refractory DLBCL within 12 months of first-line chemoimmunotherapy. Compared to Kymriah, which is limited to third-line treatments, Yescarta's indication range is much broader.

As of last year, Yescarta's global sales totaled $1.6 billion, surpassing Kymriah's $443 million. Although it is not actively prescribed in Korea, Carvykti's global sales of $963 million make it the second-highest-grossing CAR-T therapy after Yescarta.

In this situation, Gilead is reportedly considering whether to apply for reimbursement for the third-line treatment already approved for Kymriah in Korea or to seek an expanded scope of reimbursement to include second-line treatments.

Many Korean biotechs are also seeking approval for CAR-T therapies.

Rimqarto Inj. (anbal-cel), a CAR-T treatment candidate developed by Korean biotech Curocell, is expected to be approved by the end of the year. It was selected as a target drug for the Ministry of Food and Drug Safety's advanced biopharmaceutical expedited processing system, the Global Innovative Product Fast Track System (GIFT), and is also one of the Ministry of Health and Welfare's No. 2 drugs for the parallel permit-reimbursement evaluation-pricing pilot project.

“We are carrying out procedures to obtain a license within this year,” said Kim Gun-soo, CEO of Curocell.

AbClon, which is also developing CAR-T therapy, is in the process of completing phase 2 clinical trials for AT101. The company plans to speed up the approval process by establishing a collaboration system for joint development and commercialization with Chong Kun Dang. “We are taking steps to win expedited approval for AT101 by the end of June,” said Lee Jong-seo, CEO of AbClon.

The domestic CAR-T market faces changes depending on the scope of the health insurance coverage of Yescarta and the timing of Curocell's Rimqarto reimbursement, observers said.