With the third new CAR-T therapy, 'Yescarta,' obtaining marketing authorization in Korea, market competition for treating relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL) is anticipated.

With Kymriah (tisagenlecleucel) from Novartis Korea being the only option currently reimbursed, the impact of Yescarta, which has shown prominence in the global CAR-T market, is highly anticipated.

Furthermore, with the expected approval of Curocell's next-generation CAR-T therapy, Rimqarto, this year, various factors are expected to be considered in the choice of DLBCL treatments.

The Ministry of Food and Drug Safety (MFDS) announced the marketing authorization for Gilead Sciences Korea's Yescarta (axicabtagene ciloleucel) on the 13th.

Yescarta received authorization for the treatment of 'adult patients with Diffuse Large B-cell Lymphoma (DLBCL) who relapse or are refractory within 12 months of first-line chemoimmunotherapy' and 'adult patients with relapsed or refractory DLBCL and Primary Mediastinal B-cell Lymphoma (PMBCL) after two or more lines of systemic therapy.'

Administration is required to be performed only at certified medical institutions, and certified medical institutions must have tocilizumab readily available on-site.

The authorization also specifies that at least two doses of tocilizumab per patient must be secured before Yescarta administration in case treatment for Cytokine Release Syndrome (CRS) is needed.

Yescarta is currently a leading therapy in the CAR-T treatment market. This is because Yescarta has secured a broader range of indications than Kymriah, which is limited to third-line therapy.

First approved by the U.S. FDA as a third-line therapy in October 2017 and by the EU in 2018, Yescarta has since expanded its scope to include second-line therapy. In 2021, it became available to treat follicular lymphoma.

In terms of sales, its revenue surged by 67%, from $695 million (approximately KRW 966.4 billion) in 2021 to $1.16 billion (approximately KRW 1.6127 trillion) in 2022. The growth continued, reaching $1.498 billion (approximately KRW 2.0827 trillion) in 2023, a 29% increase from the previous year.

However, since the rapid growth of late entrants like Carvykti (ciltacabtagene autoleucel, Janssen) and Breyanzi (lisocabtagene maraleucel, BMS) starting last year, the pace of revenue increase has slowed.

In its recently announced Q2 sales for this year, Gilead reported that Yescarta recorded $393 million (approximately KRW 550 billion), a 5% decrease from the previous year.

The reason for the anticipation surrounding Yescarta is its indication. Kymriah's indication is for 'adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy.'

For this reason, Gilead Sciences Korea is reportedly planning to prepare for reimbursement for the newly approved second-line therapy, rather than the third-line therapy, as Kymriah is already reimbursed for the third-line setting, making reimbursement for Yescarta at this stage less difficult.

While new drugs of bispecific antibodies are receiving approval and reimbursement, CAR-T therapies still hold a preemptive treatment status. If Yescarta receives reimbursement, it is expected to quickly establish itself in the domestic market, given its global influence.

Curocell Prepares for Rapid Commercialization…"Efficacy and Supply Still the Advantages"

Another variable is that Curocell's Rimqarto is awaiting approval. Rimqarto has been selected as the second drug for the Ministry of Health and Welfare's 'Concurrent Application-Evaluation-Negotiation Pilot Program' and is currently undergoing review by the MFDS.

While there are observations that the approval might be delayed beyond the initially expected third quarter due to delays in the review process, as it is the first domestically developed next-generation CAR-T therapy in Korea, the prevailing view is that approval will likely happen within the year.

Once approved, it is expected to have an advantage in reimbursement entry because the reimbursement evaluation and price negotiation will be conducted simultaneously with the MFDS approval application process.

In particular, the company is preparing for rapid commercialization by establishing a comprehensive solution, 'CUROLINK,' which tracks and manages the entire process from prescription to administration in real time.

However, Rimqarto must keep Yescarta's approval in check, as it has the same indication as Kymriah.

Concerning this, Curocell's position is that its competitiveness will remain valid because, when compared to Curocell's Rimqarto, Yescarta, and Kymriah are still inferior in terms of supply period, efficacy, and safety in the domestic market.

A Curocell official stated, "Yescarta's entry into the Korean market and the emergence of other competing products like bispecific antibodies are always open possibilities," and added, "Yescarta still requires sending the patient's blood overseas for CAR-T manufacturing and then re-importing it into Korea, placing it in an inferior position compared to Curocell's Rimqarto in terms of rapid supply."

Furthermore, according to an IR document released by Curocell, Yescarta showed a complete remission in 54% of patients who participated in the clinical trial. In contrast, Rimqarto's clinical trial showed a complete remission in 67% of participants.

The Curocell official explained, "Yescarta's CR rate of 54% was far superior to Kymriah's 40%, which led to a decrease in Kymriah's sales and an increase in Yescarta's sales. However, when Breyanzi, with a CR rate of 53%, entered the market with a similar CR rate to Yescarta, it began to share the market, causing a slight decrease in Yescarta's sales."

And added, "Considering this, Rimqarto's CR rate of 67% is higher than both Yescarta and Breyanzi. Given that this is a one-time reimbursed treatment for late-stage cancer patients, We believe Rimqarto will have a competitive advantage in the market."