Gilead’s obsession with CAR‑T therapies began with its $11.9‑billion acquisition of Kite in 2017. That deal secured Yescarta (axicabtagene ciloleucel), one of only two CAR‑T therapies then approved worldwide, and instantly catapulted Gilead to the forefront of global cell and gene therapy.

In July 2020, the FDA granted accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE‑X19), another CD19‑targeted CAR‑T, for relapsed/refractory mantle cell lymphoma (MCL) in adults. Gilead thus became the first company with multiple approved CAR‑T products.

For years, Yescarta was Gilead’s flagship oncology product, outperforming rivals including Novartis and Bristol‑Myers Squibb. It crossed the $1‑billion sales threshold for the first time in 2022, reaching $1.16 billion; sales rose 24% year‑on‑year to $1.5 billion in 2023 and neared $1.6 billion in 2024. Tecartus contributed $370 million in 2023 and $403 million in 2024.

Gilead once dominated the CAR‑T arena. But as multiple CD19‑targeted CAR‑Ts gained approval, competition intensified, and Gilead’s offerings began to show signs of fatigue. In 2025, Yescarta’s full‑year sales fell 5% to $1.495 billion—its first annual decline since launch. Tecartus also dropped 15% to $344 million.

With its first‑mover advantage in CD19 eroding, Gilead turned to another high‑potential target: BCMA—and the rising star Arcellx.

In December 2022, Gilead (via Kite) partnered with Arcellx, paying $225 million upfront and up to $3.9 billion in milestones for co‑development rights to anito‑cel. At the time, anito‑cel was in Phase II, but its early data showing a 100% overall response rate (ORR) was stunning.

Eleven months later, Gilead doubled down: $85 million in cash plus a $200‑million equity investment secured exclusive rights to the core D‑Domain BCMA‑binding technology behind anito‑cel. Arcellx’s proprietary D‑Domain‑driven autologous CAR‑T design overcomes limitations of conventional cell therapies.

Three consecutive years of sustained investment underscore Gilead’s confidence in the asset—and the full acquisition takes that commitment to its logical conclusion. The deal will also complement Gilead’s existing CD19‑targeted CAR‑Ts, creating a dual‑pillar “lymphoma + myeloma” portfolio to strengthen overall cell therapy sales performance.

For Gilead, acquiring Arcellx is meant to fill the gap in its BCMA CAR-T pipeline. From an industry perspective, this $7.8-billion premium takeover has reaffirmed the immense market potential and core strategic value of BCMA CAR-T therapies.

BCMA (B-cell Maturation Antigen) is a member of the tumor necrosis factor receptor family, mainly expressed on late-stage B cells, short-lived proliferating plasmablasts, and long-lived plasma cells, while absent on naïve B cells, CD34-positive hematopoietic stem cells, and other normal tissue cells. Thanks to its specific expression on late-stage B cells, BCMA has become an excellent diagnostic marker and therapeutic target for various diseases driven by mature B cells and plasma cells, including multiple myeloma and autoimmune diseases.

CAR-T cell therapy is currently one of the most active R&D directions targeting BCMA and has demonstrated remarkable clinical efficacy. Compared with CD19 CAR-T, BCMA CAR-T shows more prominent therapeutic advantages, benefits more patients, and holds the potential for clinical cure.

Unlike CD19 CAR-T, which mainly targets lymphoma and leukemia, although lymphoma has a higher incidence than multiple myeloma, a considerable number of lymphoma patients can be cured with frontline therapy, leaving a relatively limited proportion eligible for CAR-T treatment.

Multiple myeloma (MM), the second most common hematologic malignancy, has more than 180,000 new cases worldwide each year. Despite continuous advances in treatment—from proteasome inhibitors and immunomodulators to CD38 monoclonal antibodies and BCMA-targeted therapies—MM remains incurable, and nearly all patients eventually relapse.

This means that, in theory, almost all multiple myeloma patients could eventually become potential candidates for BCMA CAR-T.

A comparison of sales and growth rates of approved CAR-T products also fully validates the commercial potential of BCMA CAR-T.

The world’s first two CAR-T products, Novartis’s Kymriah and Gilead’s Yescarta, both CD19-targeted, have been on the market for eight years from 2017 to 2025, with a peak sales of approximately $1.57 billion, accompanied by obvious growth stagnation and negative growth in 2025.

In contrast, the growth trajectory of the BCMA sector shows an explosive momentum close to an “interstellar leap.” Carvykti, developed by Johnson & Johnson and Legend Biotech, surpassed $1.887 billion in sales in its third full sales year (2025). Its rapid growth and strong momentum have dwarfed all CD19 products.

This generational gap in growth is one of the key reasons why Gilead paid $7.8 billion to acquire Arcellx and obtain its core asset, anito-cel.

If success in oncology is the “standard performance” of BCMA CAR-T, then its breakthrough in autoimmune diseases (AID) represents a disruptive reshaping of the treatment landscape for autoimmune diseases.

For a long time, autoimmune diseases such as systemic lupus erythematosus (SLE), progressive multiple sclerosis (PMS), myasthenia gravis (MG), and inflammatory myopathies (IMNM) have been regarded as chronic conditions requiring lifelong “management.” Existing treatments, whether steroids or monoclonal antibodies, are essentially “stabilizing” therapies. BCMA CAR-T provides a brand-new therapeutic path for autoimmune diseases.

Last October, clinical research data published in the top international journal Cell provided strong evidence: IASO Biotherapeutics’ equecabtagene autoleucel (Fukesu®) demonstrated significant efficacy and favorable safety in the treatment of progressive multiple sclerosis (PMS).

What does this “dimension-reducing impact” mean? It means that the patient population for BCMA CAR-T is expected to expand from hundreds of thousands of hematologic tumor patients to tens of millions or even hundreds of millions of patients with autoimmune diseases. The scale of this market can no longer be measured by traditional “blockbuster” standards.

Thus, it is clear that the vast horizon of BCMA CAR-T has only just begun to unfold.

However, despite the broad blue ocean, not everyone can ride the waves. As market potential is redefined, will first movers continue to lead with accumulated advantages, or will latecomers overtake with sharper “weapons”?

The solid clinical performance of anito-cel is exactly what underpins Gilead’s heavy bet—it is not just betting on an entry ticket, but on an “ace card” that could reshape the competitive landscape.

According to the iMMagine-1 follow-up data disclosed by Arcellx last year, as of May 1, among 117 patients with a median follow-up of 12.6 months, the ORR was 97%, CR/sCR rate was 68%, 6-month PFS and OS rates were 91.9% and 96.6% respectively, and 12-month PFS and OS rates were 78.8% and 95.2% respectively; median PFS and median OS had not been reached.

In terms of safety, Arcellx stated that no additional treatment-related deaths or ≥ Grade 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) events had occurred since the last data presentation in December 2024.

This BCMA CAR-T therapy, highlighted for its safety profile, is regarded by Gilead as a best-in-class (BIC) product. Coupled with Kite’s mature large-scale manufacturing capabilities and well-established CAR-T commercialization network, Gilead firmly believes that anito-cel can compete in the nearly hundred-billion-dollar CAR-T market.

Among CAR-T therapies for MM, competitors such as BMS’s Abecma lag significantly in efficacy, while Legend Biotech & Johnson & Johnson’s Carvykti will become anito-cel’s main rival. In fact, these two CAR-T therapies are frequently compared in the industry, sparking intense competition between their developers.

In its latest corporate presentation, Arcellx has provided a detailed comparison of efficacy and safety between anito-cel and Carvykti:

• Efficacy: The initial ORR is nearly comparable (96% vs. 97%), but the efficacy gap gradually emerges in subsequent follow-up. For example, the minimal residual disease (MRD) negativity rate sustained for more than 6 months is significantly higher for anito-cel (83% vs. 68%); the 12-month OS rate is also about 5 percentage points higher for anito-cel.
• Safety (Neurotoxicity): CAR-T therapies generally face ICANS risks. Carvykti has a relatively high ICANS rate (17%), accompanied by approximately 17% delayed neurotoxic adverse reactions. In contrast, anito-cel has a significantly lower ICANS rate (8%) with no observed delayed neurotoxicity—an advantage critical to patients’ quality of life.

Based on this, analysts believe that with superior safety data, anito-cel is expected to compete head-to-head with Carvykti in later-line settings, recapture some of Gilead’s lost ground in the CAR-T market, and lay the foundation for advancement to frontline therapy, forming a two-pronged strategy.

Meanwhile, it can form a dual-pillar portfolio of “lymphoma + myeloma” with Gilead’s existing CD19 CAR-T products, improving the overall sales performance of its cell therapy business.

Amid fierce global competition in BCMA‑targeted CAR‑T, Chinese firms are not only participating but making their mark with distinctive strategies.

At the 2025 International Myeloma Society (IMS) Annual Meeting, IASO Biotherapeutics presented 36‑month long‑term follow‑up data from the FUMANBA‑1 trial of Fukesu® (eque‑cel) in R/R MM.

Key findings:

• Among 107 evaluable patients, ORR = 96.3%, with CR/sCR = 83.2%
• In CAR‑T‑naïve patients: ORR = 98.9%, CR/sCR = 88.4%
• Median progression‑free survival (PFS) across 109 treated patients: 30.5 months; in CAR‑T‑naïve patients: 35.9 months
• Median overall survival (OS) not yet reached
• 95.3% (102/107) of evaluable patients achieved MRD negativity, including all who attained CR/sCR; median duration of MRD negativity: 36.5 months

Safety profile:

• Only 1 patient experienced Grade ≥3 cytokine release syndrome (CRS)
• 2 patients reported Grade 1–2 immune effector cell‑associated neurotoxicity syndrome (ICANS)
• No delayed neurotoxicity or secondary malignancies observed

These 3‑year data validate Fukesu®’s durable efficacy and robust safety, laying a strong foundation for its advancement to frontline settings. A Phase III registrational trial for frontline use launched in 2024, poised to unlock broader commercial potential.

Fukesu® has also demonstrated favorable safety in progressive multiple sclerosis—proof that only therapies with exceptional safety can credibly expand into autoimmune indications.

Beyond efficacy and safety, and autoimmune expansion, accessibility is critical for commercial success. Chinese firms like IASO have chosen a differentiated path: focus on emerging markets.

Their strategy: Start from China, leverage Chinese clinical data and manufacturing capacity to cross‑border supply, and first penetrate large emerging markets where global giants have not fully established presence.

Since last year, Fukesu® has been approved in Macau and Hong Kong; filings in Singapore and Saudi Arabia are under review; clinical trials in Japan are underway; and a licensing partnership with South Korea’s GC Cell has been reached, with orphan drug designation in Korea.

The commercial logic:

1. Avoid price barriers in developed markets: Strict price controls in Japan, Europe, etc. (e.g., Carvykti approved in Japan but not launched due to pricing disputes) create openings for Chinese‑manufactured products with competitive cost structures and strong data.
2. Leverage regional spillover: Approval in Saudi Arabia can enable access across the Middle East and North Africa; Singapore approval can extend to parts of Southeast Asia; Brazil and other Latin American markets also hold great potential.
3. Preserve global pricing integrity: Amid pricing pressure in core markets like the U.S. (e.g., Trump‑era policy proposals), consistent global pricing is vital. Reasonable pricing in emerging markets improves access without disrupting core‑market pricing.

While Gilead and Johnson & Johnson battle fiercely in the U.S. and other core markets, IASO has chosen a seemingly indirect but strategically deep route: build on Fukesu®’s strong safety and long‑term efficacy, enter via emerging markets, and gradually penetrate developed markets like Japan and Europe.

This reflects more than a commercial divergence—it is a redefinition of “globalization” by Chinese innovative pharma: True Chinese product “going global” no longer means merely being acquired or licensed by MNCs. It means carving out an independent niche in global pricing and payer ecosystems, and building a cross‑border supply network rooted in China’s supply chain.

The BCMA‑targeted CAR‑T “battle of the titans” is far from decided. But one thing is clear: Future global competition will be a holistic contest of efficacy, safety, production cost, and commercial acumen.

Chinese CAR‑T firms, with their complete industrial chain, efficient clinical development capabilities, and deep understanding of emerging markets, are staking their claim on the global cell therapy map.