Another Chinese-Origin Blockbuster Drug Joins the $1B Club—But There’s an Awkward Truth Behind the Milestone

The "Billion-Dollar Club" of global blockbuster drugs has welcomed another member from China.

On October 15, Johnson & Johnson announced its Q3 financial report for 2025: the CAR-T therapy Cilta-cel developed in collaboration with Legend Biotech.Sales in the third quarter of this year reached 524 million US dollars，Set a new high in a single season。

In the first and second quarters of this year, the sales of Cilta-cel reached $369 million and $439 million, respectively. Adding up the first three quarters, the total sales of this CAR-T product have reached $1.332 billion.Becoming the second domestically produced anticancer drug to cross the $1 billion threshold after Zanubrutinib。

According to this growth trend, Legend Biotech's previous forecast to achieve operational break-even by the end of 2025 should not be difficult to realize. Legend Biotech mainly relies on the U.S. market, which is a task that China-based CAR-T companies cannot replicate.

Legend Biotech's Profitability on the Horizon

When Cilta-cel was licensed to Johnson & Johnson,Discussed a relatively rare revenue-sharing ratio.: Overseas markets each account for 50% of the revenue and costs, while in the Greater China market, Legend Biotech assumes 70% of the revenue and costs, and Johnson & Johnson assumes 30%.

Therefore, the sales revenue of Cilta-cel disclosed by Johnson & Johnson can only partly be reflected in Legend Biotech's financial statements. For instance, in the second quarter report this year.Cilta-cel generated total sales of $439 million, with Legend Biotech receiving $219 million in collaboration revenue.The figures show that sales are basically all overseas.

Legend Biotech has not yet achieved profitability. The 2025 interim report shows a net loss attributable to shareholders of $2.263 billion, or $16.9 million excluding the impact of exchange rate changes, compared to a net loss of $87.76 million for the same period last year. However, with the rapid increase in sales revenue from Cilta-cel, Legend Biotech is getting closer to its goal of profitability.

In the second quarter of this year, excluding one-time impacts such as exchange rate losses,Legend Biotech has successfully turned a profit for a single quarter.At the earnings conference, Huang Ying, CEO of the company, projected that Cilta-cel monotherapy will reach breakeven by the end of 2025, and Legend Biotech as a whole will achieve profitability in 2026, excluding foreign exchange gains or losses.

Based on the sales performance in the third quarter, Legend Biotech's target should be achievable. In the third quarter, the sales of Cilta-cel reached 524 million US dollars, and Legend Biotech can roughly confirm an income of 250 million US dollars. If various costs remain at the level of about 250 million US dollars as in previous quarters,As long as CAR-T sales take a step forward in the fourth quarter, Legend Biotech's profitability will be within sight.

This is not yet the ceiling for Cilta-cel; previouslyLegend Biotech and Johnson & Johnson once predicted that the future peak sales of Cilta-cel would be at least $5 billion.

Currently, it is only approved for the second-line treatment of multiple myeloma in the U.S. market. In order to move ciltacabtagene autoleucel to the first-line treatment, Johnson & Johnson and Legend Biotech have jointly launched a global multi-center Phase III clinical trial named Cartitude-5.

The closer the treatment is to the front line, the more patients will receive its treatment. To meet the production capacity supply situation, Legend Biotech plans to expand to a production capacity of 10,000 doses by the end of 2025.Strive to double this year's commercial supply to 4,000 people and double revenue to $2 billion.

Growth Driven by the U.S. Market

In the financial report, Johnson & Johnson attributed the strong sales performance of Cilta-cel to its continuous promotion worldwide.Especially in the U.S. market,Its Q3 sales increased from $258 million to $396 million, marking a significant growth of 53.3%.

This is not surprising, as the payment from U.S. commercial insurance has provided CAR-T with commercial confidence. Currently, the pricing of Cilta-cel in the U.S. has alreadyFrom the initial $465,000 to $549,700, not only far exceeding the price of CAR-T cell therapy drugs in China, which cost millions of yuan,，It is also one of the most expensive CAR-T products globally.

Legend Biotech previously revealed,More than 7,500 patients have been treated with Cilta-cel.，This is completely different from the situation in China. Currently, at least seven CAR-T therapies have been approved in the Chinese market, but most are mired in commercialization difficulties.

Take JW Therapeutics as an example, the company's revenue in the first half of the year was 106 million yuan,But its revenue from CAR-T therapy was only 81 million yuan,Based on the current average price of CAR-T therapy in China, which is around one million yuan, the number of patients covered by Relma-cel Injection in the first half of the year may be less than 100.

Actually, the sales of Legend Biotech's Cilta-cel in China have been mediocre. In August 2024, Cilta-cel was approved for marketing in China for the treatment of adult patients with relapsed or refractory multiple myeloma. However, in less than a year, Legend Biotech decided to back out. In June this year, according to reports by multiple media outlets,Legend Biotech has disbanded its sales and marketing team in China.

This is not surprising. The cost of CAR-T therapy, which can easily reach millions, is hard for ordinary people to afford out-of-pocket. However, medical insurance has an invisible threshold of "no negotiation for 500,000 yuan, no entry for 300,000 yuan." Under the existing payment system, CAR-T therapy simply cannot complete a commercial closed loop in China.

In the future,The commercialization hope of CAR-T therapy in China may rest on the commercial insurance catalog.。On September 20, the National Healthcare Security Administration announced that the expert review for the first edition of the commercial insurance innovative drug list has been completed. It is reported that all five CAR-T drugs have passed the expert review and are expected to be included in this year's National Reimbursement Drug List and the commercial insurance innovative drug list.

By reporter Taozhi Fang

Editor: Jiang Yun, Jia Ting

Operation｜Nian Thirteen

Illustration｜Visual China

Statement: Original content by Jian Shi Ju, please do not reprint without permission.

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