GenScript Biotech, a world-renowned provider of life sciences R&D and manufacturing services, announced the sales results of its subsidiary Legend Biotech's blockbuster product CARVYKTI® (Cilta-cel) in the fourth quarter of 2023. According to the data, the product achieved global sales of $159 million in the fourth quarter of 2023, a year-on-year increase of 194%. At the same time, full-year sales in 2023 exceeded US$500 million, a year-on-year increase of 276%, and the sales performance was in line with expectations.
It is understood that chita-cel is a chimeric antigen receptor (CAR) T-cell immunotherapy with two single-domain antibodies targeting B-cell maturation antigen (BCMA), which is mainly used for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM). Since its launch, the product has been widely used worldwide with excellent efficacy and safety, and more than 2,000 patients worldwide have been treated with chidate-cel cel, providing a new treatment option for patients with multiple myeloma.
At the same time, new progress has been made in advancing the application for the expansion of the indication of cilta-cel frontline. According to the company's announcement, Legend Biotech has formally submitted the results of the pivotal Phase 3 CARTITUDE-4 study to the Advisory Committee of Health Authorities to support its expansion of cilta-cel in the front-line treatment of relapsed or refractory multiple myeloma.
The U.S. Food and Drug Administration's (FDA) Oncology Drug Advisory Committee (ODAC) will review the supplemental biologics license application supporting cilta-cel for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior therapy, including proteasome inhibitors and immunomodulators. The exact date of the meeting will be announced in the Federal Registry. In addition, the European Medicines Agency's (EMA) Advanced Therapies Committee (CAT) will convene a Scientific Advisory Group on Oncology (SAG-O) to review submissions supporting the expansion of cilta-cel.
Adrian Bot, Chief Scientific Officer and Executive Vice President of R&D at Capstan Therapeutics, who participated in the CAR-T commercialization discussions, was optimistic about the huge potential and exciting development prospects of the CAR-T field at the GenScript Biotech Global Industry Forum focused on cell and gene therapy in San Francisco in January. In the next five to six years, we are expected to see the first CAR-T cell therapy approved for non-tumor indications, which is very exciting. We will also see a rethinking and redesign of CAR vectors, CAR structures, and related concepts. In order to truly meaningfully address solid tumors, we need to do this, and that could happen in the next 10 years. ”
Multiple myeloma is known to be the second most common hematologic cancer. In mainland China, the age of onset of patients is mostly over 60 years old, and the incidence rate is also on the rise. Public studies have shown that compared with Western countries, most of the MM patients in China have progressed to an advanced stage at the time of diagnosis, and the number of high-risk patients is higher. At present, multiple myeloma is still an incurable disease, and with the increase of recurrence, the difficulty of treatment increases, which seriously deepens the burden of patients and affects the quality of life, and there is an urgent need for new treatment methods. As research continues to advance in multiple myeloma around the world, our first-line expanded indication application for cilta-cel will be approved, bringing new treatment options to more patients."
It is worth mentioning that Legend Biotech's performance in the capital market is also quite impressive. In May 2023, Legend Biotech entered into a subscription agreement with LGN Holdings Limited, a Hillhouse Capital company, valued at approximately $22.2 million. In a month between April and May last year, Legend Biotech raised approximately $584.9 million. This series of actions fully demonstrates the strong confidence of the capital market in Legend Biotech and its optimistic expectation of its future development.
In addition to the autologous CAR-T product cilta-cel, Legend Biotech has also made positive progress in other areas of research and development. In January, the company announced that Legend Biotech had completed an exclusive global license agreement with Novartis for Legend Biotech's specific chimeric antigen receptor T cell (CAR-T) therapies targeting DLL3, including its autologous CAR-T cell therapy candidate LB2102. Under the agreement, Legend Biotech will receive a $100 million cash advance and will be eligible for up to $1.01 billion in clinical, regulatory and commercial milestone payments and tiered royalties. This is considered to be another large overseas deal achieved by Legend Biotech after the successful hand-in-hand between cell therapy products and Johnson & Johnson.
Legend Biotech delivered significant sales growth in the fourth quarter and full year of 2023 thanks to the outstanding performance of cilta-cel and widespread recognition in the global market. In the future, Legend Biotech will continue to devote itself to the R&D and commercial development of tumor immune cell therapies to bring more treatment options and hope to patients.
About GenScript Biotech Co., Ltd
GenScript Biotech Co., Ltd. (HK.1548) is a leading global provider of life sciences R&D and manufacturing services. Rooted in solid gene synthesis technology, GenScript has established four major platforms: life science services and products platform, biopharmaceutical contract development and manufacturing (CDMO) platform, industrial synthesis product platform, and comprehensive global cell therapy platform.
GenScript was founded in 2002 in New Jersey, USA, and established its R&D and manufacturing headquarters in Nanjing, China in 2004. In 2015, GenScript was listed on the main board of the Hong Kong Stock Exchange, with legal entities in China, Hong Kong, the United States, Japan, Singapore, the Netherlands, Ireland, the United Kingdom, South Korea and Belgium. The business scope covers more than 100 countries and regions around the world, providing high-quality, convenient and reliable services and products to more than 200,000 customers.
As of June 30, 2023, GenScript had more than 6,400 employees worldwide. GenScript has a number of intellectual property rights, including more than 240 granted patents and more than 900 patent applications, as well as a high density of technical secrets.
Adhering to the corporate mission of "making people and nature healthier with biotechnology", GenScript is committed to becoming the world's "most trusted biotechnology company". As of June 30, 2023, GenScript's services and products have been cited in more than 85,100 academic journals reviewed by international peers worldwide.
For more information, please visit GenScript's official website https://www.genscript.com.cn/