sales of carvykti reached $710million in the third quarter, an increase of 35.5% year on year; The cumulative sales in the first three quarters reached US $1.964 billion, up 47.4% year on year.

Johnson & Johnson management pointed out in the earnings conference call that the growth of carvykti was due to its application expansion in earlier treatment lines and the continuous expansion of the treatment center network. At present, the product has covered more than 20 markets worldwide. According to the sales performance in the first three quarters, carvykti's annual sales are expected to exceed US $2.7 billion, close to the US $3billion annual sales forecast previously given by Johnson & Johnson.

Although the performance is still growing, the market response to this report card is relatively flat. On October 14, the stock price of legendary biology rose by 6.49%, but still fell by more than 70% compared with the historical high.

Since it was first approved in 2022, carvykti has been catching up and has become the car-t therapy with the highest sales in the world in 2025. Legendary biology also reiterated the peak sales expectation of carvykti of 5billion US dollars this year.

However, investors are obviously more concerned about the challenges facing carvykti than the unfulfilled long-term goals.

How the growth of the U.S. market continues, how the cooperative relationship between Johnson & Johnson and legendary biology will affect the product competitiveness, and whether the next generation car-t can open up new market space will all affect the long-term value of carvykti.

How far carvykti can go is not only a problem for legendary biology, but also for the whole car-t industry.

01. The growth of carvykti is shifting

Carvykti's most noteworthy change is that the growth structure is changing.

In the past, the U.S. market has always been the base of carvykti. In the second quarter of 2026, the global sales of carvykti was $657million, including $472million from the U.S. market and $185MILLION from markets outside the United States.

In the third quarter, the US market sales were still $472million, basically unchanged month on month; Markets outside the United States increased to $238million, up 85.3% year-on-year and 28.6% month on month.

This means that the overseas market is becoming a new growth engine for carvykti. As the products are approved in more countries and regions and the commercial network is gradually rolled out, the large volume of markets outside the United States is expected to provide new increments for the overall sales.

However, the logic of carvykti's growth lies not only in the large overseas volume, but also in the forward shift of the treatment line.

Carvykti is a single infusion cell therapy. Compared with the treatment scheme requiring continuous drug administration, its characteristic is that patients have the opportunity to obtain durable remission after receiving treatment, and do not need to continue to receive the same drug. Therefore, although the sales volume of the U.S. market is basically flat on a month on month basis, it cannot be judged that its patient growth has stalled.

From the perspective of indication expansion, carvykti is still advancing to earlier treatment lines.

In 2024, FDA extended the scope of application of carvykti to eligible patients with relapsed or refractory multiple myeloma who had received at least first-line treatment. The second move forward of the treatment line means that the product is no longer only for patients who have undergone multiple rounds of treatment and have limited options, but has the opportunity to enter a larger front-line treatment market.

Legendary biological management said on the conference call in the second quarter of 2026 that at present, more than 70% of carvykti's sales in the United States come from second-line to fourth line treatment. According to the disclosure, at present, the proportion of second-line and third line treatments in the total sales has been close to half.

From the perspective of patient size, there is indeed more room for imagination in the front-line market. Legend once pointed out that more than 100000 patients worldwide are receiving second-line treatment, and there are still a large number of unmet clinical needs for second-line and third-line treatment.

However, large patient pool does not mean high conversion rate.

The commercialization of car-t is different from traditional drugs. Patients should not only meet the requirements of indications, but also go through the links of referral, evaluation, cell collection, production and reinfusion. The distribution of treatment centers, patients' physical conditions, waiting time, and doctors' judgment of different treatment options may affect the final treatment choice.

A real-world study on car-t treatment of relapsed or refractory multiple myeloma showed that more than half of the doctors interviewed said that 31% to 50% of the patients who met the conditions for car-t treatment were not referred. The main reasons for non referral included patient selection (52.9%), poor physical status or high degree of weakness (47.1%), heavy burden of comorbidities (41.2%), and advanced age (41.2%).

Even if patients have been referred, the geographical accessibility of treatment remains an obstacle. Among the 72 patients who received carvykti treatment included in the study, 55.6% traveled more than 30 miles to the treatment center, and 27.8% of the patients moved for treatment.

Johnson & Johnson also pointed out that some patients prefer to receive treatment in community medical institutions for various reasons, which may not have the ability to carry out car-t treatment.

Therefore, carvykti's expansion into the front-line market is not simply a step forward in its indications. It also needs to change the treatment habits of doctors, improve the referral network, expand the coverage of treatment centers, and enable more patients to complete the whole treatment process.

This also determines the next growth logic of carvykti: the overseas market continues to expand, while the US market needs to translate the potential of patients with earlier treatment lines into actual sales. Whether the two curves can go up at the same time will directly affect how far away they are from the peak sales of 5billion dollars.

02. Johnson & Johnson is both a promoter and a source of competitive pressure

Another variable that deserves attention comes from Johnson & Johnson, who has cooperated with legendary biology for many years.

In 2017, Johnson & Johnson's Janssen signed a global cooperation agreement with legendary biology to jointly develop, produce and sell BCMA targeted car-t therapy lcar-b38m, later known as carvykti. Since then, Johnson & Johnson has played an important role in late product development, registration and application, and global commercialization.

However, with the increasing improvement of Johnson & Johnson's product portfolio in the field of multiple myeloma, investors began to pay attention to the other side: Johnson & Johnson is not only an important promoter of carvykti's commercialization, but also a source of competitive pressure for carvykti at this stage.

Johnson & Johnson has a deep layout in the field of multiple myeloma. In addition to carvykti, there are also the cornerstone product darzalex (targeting CD38), and two bispecific antibodies, tecvayli (targeting BCMA and CD3) and talvey (targeting gprc5d and CD3).

In the third quarter of 2026, tecvayli's global sales reached 774million US dollars, a year-on-year increase of 56.7%; Talvey's sales reached US $497million, a year-on-year increase of 58.3%.

At the latest performance teleconference, the management of Johnson & Johnson emphasized that the company was "unmatched" in multiple myeloma product portfolio and R & D pipeline, and about 80% of patients would receive some kind of therapy from Johnson & Johnson during the treatment process.

This layout is also changing the competitive environment of carvykti.

In July 2026, Johnson & Johnson released the research data of monumental-6. The combination of tecvayli and talvey showed strong curative potential in the treatment of second-line multiple myeloma, which means that the dual antibody combination therapy is entering the core treatment market of carvykti.

According to the research data, the joint program reduced the risk of disease progression or death by 89% and the risk of death by 62%. As a reference, carvykti reduced the risk of disease progression or death by 71% and the risk of death by 45% in the second-line treatment data of cartitude-4 study.

It should be emphasized that the two studies are not head to head trials, and there are differences in the enrollment population, control protocol, study design and follow-up time, so we cannot simply compare these data and judge which protocol is better.

However, the combination of tecvayli and talvey has at least released a clear signal: dual antibody combination therapy is competing for the front-line treatment market that used to be regarded as the advantage of car-t.

What deserves more attention is the change of treatment narrative.

In the conference call in the second quarter of this year, Johnson & Johnson used "potential for cure" to describe the relevant combinations of tecvayli. This statement has attracted attention because durable remission and potential cure have always been important value narratives of car-t therapy. Now the dual antibody combination program has also begun to try to enter this field.

This means that the competition faced by carvykti is no longer just the competition of drug delivery convenience, treatment cost or treatment center coverage, but also the redefinition of long-term efficacy and treatment goals.

However, this does not mean that J & J will actively weaken carvykti. Johnson & Johnson emphasized that different therapies in its multiple myeloma product portfolio are complementary and can serve different treatment stages and patient needs.

For legendary biology, the real challenge is not how many products J & J will launch, but whether carvykti can continue to prove its irreplaceable clinical value in J & J's increasingly rich product portfolio.

03. Management reshuffle how will legendary creatures fight?

The competition of dual antibody combination regimen is heating up, and carvykti needs to continue to prove its long-term efficacy advantage.

On September 25, legendary biology released the five-year follow-up data of carvykti. In cartitude-2 study cohort a, 10 of 20 patients with relapsed or refractory multiple myeloma who had received first-line to third line therapy were still alive without disease progression five years after receiving a single infusion, and did not receive maintenance therapy; The five-year overall survival rate of this cohort was 69.2%.

Compared with the treatment scheme requiring continuous administration, if one infusion can bring lasting remission, it can reduce the long-term medication burden of patients.

In addition, despite the strong data performance, it is unlikely that the combined scheme will completely replace carvykti in the second-line position in the short term, and the core constraint is the sequential treatment strategy.

It is generally believed in the industry that most gprc5d targeted drugs such as talvey will still be applied in the back-line treatment. The guidelines of the International Myeloma Working Group (IMWG) also make it clear that when patients meet the conditions of car-t and dual antibody treatment at the same time, car-t should be used preferentially, because early T cells have better adaptability, and previous dual antibody exposure may affect the manufacture of car-t.

However, in any case, legendary biology is bound to face more fierce market competition in the future, which also gives another interpretation of the recent management adjustment of legendary biology.

On July 22, Huang Ying proposed to resign as CEO and director to the board of directors, and officially resigned on July 24. Huang Ying joined legendary biology as a CFO in 2019, leading the company to list on NASDAQ; He took over as CEO at the end of 2020 and participated in promoting the global commercialization of carvykti.

Huang Ying's professional experience spans R & D and capital markets. In his early years, he served as the chief scientist of the Chemical Research Department of Schering plough, and later transferred to Wall Street as an analyst of the biomedical industry. He used to be the head of biotechnology stock research at Bank of America Merrill Lynch. During his tenure, legendary biology completed the transformation from an R & D company to a global commercial product.

On September 15, legend announced the appointment of Ingrid Zhang, the former chief business officer of Novartis international, as the new CEO. Zhang Ying has served in Novartis for a long time. She served as president of Novartis China, President of Novartis innovative drugs China and President of Novartis China. Later, she was promoted to chief business officer of Novartis international business and was responsible for the global commercial listing strategy.

At the end of September, Josh Schwartz also joined legendary biology as senior vice president. He worked for Bristol Myers Squibb for many years and participated in the establishment of health system liaison and pathological diagnosis liaison teams to support the launch of opdivo, yervoy and other products; After joining Baiji in 2022, he served as the vice president of medical affairs in North America, responsible for the medical affairs organization in the United States and Canada, covering the blood tumor and solid tumor product lines.

This group of personnel changes points in the same direction: legendary biology needs to further strengthen its commercial operation and medical affairs capabilities.

Zhang Ying's global commercialization experience helps the company cope with the challenges of doctor education, payer communication and global market operation when carvykti penetrates into earlier treatment lines; Josh Schwartz's experience in hematological oncology medical affairs and academic communication helps strengthen the accumulation and dissemination of long-term survival data and real-world evidence.

Of course, the management resume is not equal to the achievement. The real test is whether the new team can translate its clinical advantages into higher patient penetration and continue to consolidate carvykti's competitive position in the context of Johnson & Johnson's increasingly rich product portfolio.

04. The next battle of legendary biology is also the next battle of car-t

Carvykti provided the commercialization foundation for legendary biology, but the growth of a single product ultimately has boundaries. To reduce the dependence on carvykti, whether the next generation car-t can open up new technology and market space will become increasingly important.

From the perspective of industry, traditional car-t still faces three core limitations: complex individualized production process, limited treatment delivery capacity, and difficulty in breaking through the efficacy in solid tumors. The exploration of the next generation car-t is also changing from simply optimizing the efficacy to changing the production mode, dosing route and indication range.

The first route is universal car-t.

Traditional autologous car-t needs to collect the patient's own cells, and then transfuse them after in vitro transformation and expansion. Allogeneic car-t attempts to use donor cells for mass production in order to shorten waiting time and improve supply efficiency. However, allogeneic cells may cause immune rejection, and the durability and safety of cells in vivo also need to be solved.

Legendary biology has laid out a variety of allogeneic cell therapies, including lb2404 (CD19 × CD70) car- γδ T cell therapy for relapsed or refractory autoimmune diseases, and lb2405 (CD19 × BCMA) car-nk therapy for autoimmune diseases; In addition, there is lb2302 (CD20) car- γδ T-cell therapy for relapsed or refractory B-cell non Hodgkin lymphoma. These projects are still in early clinical development.

Their potential value lies in trying to shift car-t from a product "made for each patient alone" to a cell therapy that can be produced in advance and supplied on demand. However, whether this route can be established still depends on whether the efficacy, safety, durability and large-scale production can pass the Customs at the same time.

The second route is car-t in vivo.

If general-purpose car-t attempts to solve the efficiency problem of individualized production, then in vivo car-t attempts to fundamentally change the manufacturing process: no longer take out the patient's cells for transformation in vitro, but directly deliver the relevant load to the patient, so that the cells can obtain the car expression ability in vivo.

The lb2501 of legendary biology is exactly the exploration in this direction. Early clinical data published in June 2026 showed that in the higher dose group of 6 patients with relapsed or refractory B-cell non Hodgkin lymphoma, the objective response rate was 100%, and the complete response rate was 83.3%. However, lb2501 still needs to verify its safety, duration of remission and performance in different patients through larger studies.

On October 15, legendary biology announced that FDA had approved the ind application of lb2501.

If the path of car-t generation in vivo is further verified, there will be opportunities to reduce the traditional cell collection and in vitro manufacturing links, reduce the complexity of treatment delivery, and provide new solutions for improving accessibility.

The third route is car-t for solid tumors.

The clinical success of car-t has long focused on hematological tumors. Compared with hematological tumors, solid tumors have problems such as target heterogeneity, tumor microenvironment inhibition, and normal tissue injury, which make it more difficult to develop.

In June 2026, China approved sutri cel from Keji pharmaceutical for eligible patients with advanced gastric cancer or adenocarcinoma of the gastroesophageal junction, becoming the world's first car-t therapy approved for solid tumors. This does not mean that the technical difficulties of car-t in solid tumors have been solved, but at least it indicates that new breakthroughs are emerging in the indication boundaries of car-t.

Legendary organisms have also laid out the direction of solid tumors. Lb1908 is an autologous car-t therapy targeting claudin 18.2, which is targeted at recurrent or refractory gastric cancer and pancreatic cancer. At present, it has reached the primary endpoint and is in the patient follow-up stage. Lb2102 targets DLL3 for small cell lung cancer and large cell neuroendocrine cancer, and has reached an exclusive license agreement with Novartis.

- write at the end -

Carvykti's success or failure will not be written in a sales statement. For legendary biology, what it wants to verify is whether a technological breakthrough can grow into a business system that continues to win.

The real end is not how much a certain drug is sold, but who first turns the "individualized cure" into an accessible, affordable and large-scale standard treatment. Until that day, all peaks are just a prelude.

Reference link:
1 Real-world treatment patterns and outcomes of patients treated with commercial chimeric antigen receptor T-cell therapy for relapsed/refractory multiple myeloma； Current Medical Research & Opinion
2 Why Legend Biotech stock fell 10% despite record Carvykti sales； Fierce Pharma
3 Legend remains bullish on Carvykti growth despite threat from J&J’s Tecvayli； Fierce Pharma
4. Johnson & Johnson set off new changes in blood tumors; Amino observation
5. How long will legend fall? Talk about legends before the Johnson & Johnson telephone conference; Alpha biotech
6. Johnson & Johnson Q3 has a revenue of US $25.4 billion, and car-t products approach us $710million in a single quarter; 21st Century Business Herald