
Medical Device R&D and Manufacturer

June 30, 2025
eMedClub News
The research and development of innovative drugs has entered「Differentiation」Times, from following(Follow)To Lead(First), whoever can define the next innovation is likely to become a high-quality target actively chosen by resources in the tide of the times.
And this kind of「Selected」`, is itself the best footnote to a company's value!`
Multinational pharmaceutical companies(MNC)has always been a key window for observing industry trends. At the 30th European Hematology Association(EHA 2025)At the annual meeting, Johnson & Johnson announced the CD20 dual-target CAR-T therapy JNJ-4496(C-CAR039)Phase 1b Clinical Data Causes a Stir: In Relapsed/Refractory Large B-Cell Lymphoma Patients Who Received First-Line Treatment and Were Untreated with CAR-T Cell Therapy(R/R LBCL)Among the patients,Objective Response Rate in Patients Receiving 75 Million CAR-T Cells Treatment(ORR)Achieve100%, Complete Remission(CR)Rate80%, showing significantly superior data compared to existing CD19 single-target therapies.
This pipeline stems from the global collaboration between Johnson & Johnson and Cellular Biomedicine Group (CBMG) reached in 2023, and the Johnson & Johnson website has further included it.「Annual sales peak exceeding $5 billion」The heavyweight pipeline matrix - how does CBMG win the bet of giants with innovation and gain such high expected market potential?

▲ Source: Johnson & Johnson Official Website
Johnson & Johnson's Bold Bet: Dual-Target Technology and the Two-Way Validation of Commercial Value
2021 American Society of Clinical Oncology(ASCO)At the conference, Cellular Biomedicine Group (CBMG) announced preliminary data of C-CAR039 for the first time, which targets relapsed or refractory(R/R)B-cell Non-Hodgkin Lymphoma(B-NHL)The ORR of the patients reached 92.6%, and the CR rate reached 85.2%, far exceeding the 58% CR rate of single-target CAR-T therapy at that time. In 2023, Johnson & Johnson secured a global collaboration with an upfront payment of $245 million, marking the therapy's transition from technological breakthrough to accelerated commercialization.
C-CAR039 is the world's first CD19/CD20 bispecific CAR-T,Aiming to address the recurrence challenge in 65% of patients due to antigen loss in single-target therapies through a dual-target design.It is designed as a novel second-generation dual-target CAR-T containing the 4-1BB domain, capable of targeting and eliminating CD19/CD20-positive tumor cells, and may address common resistance mechanisms in relapsed or refractory diseases.
The latest data from a four-year clinical follow-up in China shows that C-CAR039 achieved an ORR of 91.5% and a CR rate of 85.1% in all R/R B-NHL patients, with a 48-month overall survival period.(OS)The rate was 65.4%; among 43 cases of large B-cell lymphoma(LBCL)In patients, the ORR and CR rates were 90.7% and 86.0%, respectively; and ≥3 grade cytokine release syndrome(CRS)The incidence rate is only 2.1%, with safety superior to similar products.
▲ High response rates were observed even in patients with aggressive lymphoma.
NHL is one of the most common hematologic malignancies, with an estimated 544,000 new cancer cases and 260,000 cancer deaths globally in 2020. Among these, Diffuse Large B-Cell Lymphoma (DLBCL)...(DLBCL)Accounting for one-third. Up to 30-40% of patients will relapse or become refractory after first-line treatment, with a poor prognosis, highlighting an urgent need for new treatment methods.
Cancer Immunology ResearchAn article titled「T cells expressing CD19/CD20 bi-specific chimeric antigen receptors prevent antigen escape by malignant B cells」The article points out,The probability of antigen escape through spontaneous mutation and the selective proliferation of antigen-negative tumor cells decreases as the number of antigens recognizable by CAR-T cells increases. Constructing T cells capable of recognizing multiple antigens is a potential strategy to prevent antigen escape.
CD20 is a specific membrane protein antigen on the surface of B cells, which is expressed on most B-cell non-Hodgkin lymphoma cells but not on stem cells, pro-B cells, normal plasma cells, or other normal tissues. Over 90% of B-cell lymphomas express CD20, making it an ideal target molecule for NHL.
Based on the findings from the Phase 1b study of JNJ-4496, Johnson & Johnson concluded that:「The study results were consistent with those of C-CAR039 and superior to the data from currently approved CD19 CAR-T therapies, supporting further development of JNJ-4496 for the treatment of relapsed/refractory large B-cell lymphoma.」
In the field of CAR-T cell therapy, Johnson & Johnson has a highly successful collaboration case. The BCMA CAR-T cell therapy Carvykti, co-developed with Legend Biotech in the area of multiple myeloma, achieved remarkable sales of $963 million in 2024, marking a 92.7% increase from previous years, and is expected to surpass $1 billion in sales this year.
The collaboration between Johnson & Johnson and Legend began with an encounter at the 2017 ASCO Annual Meeting. Four years later, Johnson & Johnson again encountered a domestic cell therapy development company at ASCO —— CBTM, selecting the latter's CD20-targeted CAR-T cell therapy. At that time, Johnson & Johnson had already missed the opportunity to be a pioneer in the B-cell lymphoma field with cell therapy, as giants like Novartis, Gilead, and BMS had successively launched CD19 CAR-T drugs. However, the emergence of C-CAR039 allowed Johnson & Johnson to keenly detect a signal for a potential reversal.
Now Johnson & Johnson's official website data shows that CD20 CAR-T has been included in its「$5 billion pipeline." Insiders couldn't help but ask,Will CBMG Be the Next Legend?
Recently, its CD20-targeted CAR-T therapy C-CAR066, co-developed with Johnson & Johnson, has also achieved remarkable clinical research progress. A single-arm Phase I study on C-CAR066 for R/R LBCL patients who have received anti-CD19 CAR-T treatment, initiated by Tongji Hospital affiliated with Tongji University, was published in the American Journal of Hematology in October 2024. The results showed that among the 14 patients successfully infused with C-CAR066, the ORR was 92.9%, with 57.1% achieving complete remission, and four patients maintaining complete remission for over 30 months. The median progression-free survival for all patients was...(PFS)was 9.4 months, median overall survival(OS)Up to 34.8 months.
▲ Image Source: Company Official Website
According to the pipeline information on the CIBIAM official website, based on the CD20 target, a CD20/BCMA bispecific CAR-T therapy called C-CAR168 has been developed for autoimmune diseases. Recently, the early clinical data of C-CAR168 for treating autoimmune diseases was presented at the 16th International Congress on Systemic Lupus Erythematosus.(LUPUS 2025)Published above, 7 cases of refractory patients(6 cases of lupus nephritis, 1 case of multiple sclerosis)The dosing data shows,4 Cases of Lupus Nephritis with 6-Month Follow-Up(LN)All patients achieved SRI-4 response, with 2 cases of complete renal remission.`, and its safety is excellent, with no CRS or ICANS above grade 3.`
Notably, C-CAR168 did not select the widely used CD19 as the target but instead chose CD20. Since CD20 is not expressed in neural tissues, it may avoid CD19-related neurotoxicity. C-CAR168 adopts a fully humanized scFv antibody structure, reducing the immunogenicity risk associated with traditional mouse antibody structures.
In addition to safety and efficacy data, the in-depth mechanistic studies conducted by the research team have, for the first time, demonstrated in human autoimmune patients that CAR-T can induce "reconstruction" of the immune system. C-CAR168 achieves immune system reconstruction by eliminating pathogenic B cells and plasma cells ——Nearly one month after treatment, the pathogenic cells in the patient's peripheral blood almost disappeared, and the B cell lineage was reconstituted into a polyclonal newborn B cell population predominantly exhibiting a naïve phenotype., which indicates that a brand-new immune system is being gradually established.
In May 2025, the U.S. FDA granted C-CAR168 Regenerative Medicine Advanced Therapy (RMAT) designation.(RMAT)Approved for the treatment of refractory systemic lupus erythematosus and lupus nephritis.
In the field of autoimmune diseases, Cibiom has specially established an Immunology and Inflammatory Diseases Scientific Advisory Board.(SAB), to accelerate the clinical development of products in this field. According to reports, the four main expert members of SAB have a combined total of over 100 years of scientific research and clinical experience in the field of autoimmune diseases.
In the field of hematological tumor treatment, another CAR-T cell therapy A-CAR028 under development by Cellular Biomedicine Group (CBMG) has not disclosed its specific target on the official website pipeline. Public information reveals that it is an autologous CLL-1/CD33 CAR-T cell therapy being developed for the treatment of relapsed/refractory acute myeloid leukemia.
Currently, the CAR-T therapies for AML being developed globally mainly focus on targets such as CD33, CD123, and CLL-1, with most still in the early stages of clinical trials. Targeted CLL-1 CAR-T has already shown promising therapeutic outcomes in small-scale clinical trials, and multi-target CAR-T therapies have also demonstrated enhanced efficacy, providing more sustained tumor control. Therefore, A-CAR028 remains a promising contender.
Breakthrough in the Blockbuster Matrix: From Hematological Tumors to Solid Tumors
Johnson & Johnson has created Legend Biotech, but Johnson & Johnson has not only Legend, but also CBMG; and CBMG is not just about Johnson & Johnson. Its innovative pipeline is flourishing in multiple areas, building a strong...「Blockbuster Matrix」。
▲ Image Source: Company Official Website
For solid tumors, CIBIAM has deepened cooperation with AstraZeneca., developed a targeted GPC3(Glypican 3)The autologous CAR-T cell therapy C-CAR031, a CAR-T cell therapy targeting STEAP2.
In April this year, Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University School of Medicine announced that Professor Lu Shun, the leading figure of the oncology department and the director of Shanghai Pulmonary Tumor Clinical Medical Center, is the principal investigator.(PI)The world's first targeted GPC3 autologous CAR-T cell therapyC-CAR031 for the Treatment of Advanced Squamous Cell Lung CancerThe clinical study has successfully completed the first patient dosing. In November 2024, C-CAR031 will be used forTreatment of GPC3+ Advanced/Recurrent Hepatocellular Carcinoma(HCC)The Phase I/II clinical study has completed the first subject dosing at the First Affiliated Hospital of Zhejiang University School of Medicine.
C-CAR031 is an autologous, armored, GPC3-targeted CAR-T cell therapy, designed「Equipment」TGFβ was modified to resist the immunosuppressive microenvironment and enhance its efficacy. In December 2023, CBT and AstraZeneca signed a co-development agreement for C-CAR031. According to the terms of the agreement, CBT and AstraZeneca will jointly develop and commercialize C-CAR031 in China, and CBT received an upfront payment.
2024 American Society of Clinical Oncology(ASCO)At the annual meeting, Professor Liang Tingbo's team from the First Affiliated Hospital of Zhejiang University School of Medicine orally presented the first-in-human IIT research results of C-CAR031., this therapy has demonstrated preliminary manageable safety and positive anti-tumor activity in heavily pretreated advanced HCC patients. Data shows that as of March 14, 2024, the disease control rate in 24 advanced HCC patients was...(DCR)Up to91.3%, ORR reached56.5%。
「Technology + Industrial Chain Synchronized Layout」The Underlying Code of Innovation
If the pipeline layout represents a company's explicit competitive edge, then innovation is the underlying code that drives all operations. However, innovation is not about wild imagination or empty talk. For an innovative pharmaceutical enterprise, innovation stems from every link in research and development, production, and collaboration.
CIBOMAN, established in 2010, is now 15 years old. In the chapter "Weizheng" of The Analects, this age is referred to as...「The Age of Aspiration」Cao Zhi mentioned in the article "Eulogy for Emperor Wu",「Years in the making, planning for the future.」
From the forward-looking selection of targets, breakthroughs in technology platforms, to high standards in production processes, and further to the openness of cross-field collaboration, CIBIAM has integrated the core logic of "addressing unmet clinical needs" into the synchronized layout of technology + industry chain.
Taking 5 years as a timeline node for a company's development process, the growth journey of Cellular Biomedicine Group (CBMG) is quite noteworthy. Five years after its establishment, the company successfully landed on NASDAQ, becoming...「The First Stock of Cell Therapy in China"; delisted and privatized seven years after its IPO, returning from the US stock market; to this day, it has also becomeGlobally UniqueA cell therapy company recognized by Johnson & Johnson, AstraZeneca, and Novartis simultaneously.
During its listing on the US stock market, CBMG successively signed cooperation agreements with GE Healthcare, Thermo Fisher, and Novartis.
In April 2017, CBMG (Westerman) andGE Healthcare Signs Strategic Cooperation Framework Agreement, The two parties established a joint laboratory at CBMG's Shanghai Zhangjiang GMP production base to jointly develop high-quality industrial production processes for CAR-T cells and stem cells, aiming to collaboratively research and develop a highly integrated and automated cell preparation system. In November of the same year, CBMGCollaborated with Thermo Fisher Scientific to establish the "Joint Cell Therapy Technology Innovation and Application Center"」, taking the lead in launching the CAR-T cell industrial automation system in China, and building an internationally leading diversified cell therapy biopharmaceutical R&D platform.
These two strategic partnerships fully demonstrate CBMG's leading position and strong capabilities in the field of cell therapy and GMP manufacturing. Through collaborations with GE Healthcare and Thermo Fisher, CBMG not only enhances its independent production capacity but also lays a solid foundation for the rapid transition of its cell therapy products from laboratory research to industrial-scale production, effectively driving continuous innovation and development in the field of cell therapy.
In 2021, Cellular Biomedicine Group (CBMG) delisted from the US stock market and subsequently completed a Series A financing round in September of the same year, led jointly by Sequoia Capital, AstraZeneca-CICC Healthcare Investment Fund, and Yunfeng Capital, raising a total of $120 million. The proceeds from this round of financing were mainly used to advance C-CAR039.(CD20/CD19 CAR-T Therapy)In clinical research in China and the United States, etc.
In May 2023, Janssen Pharmaceuticals reached an agreement with Cellular Biomedicine Group.$245 million upfront paymentThe global exclusive cooperation to jointly develop and commercialize the next-generation novel CAR-T cell therapies C-CAR039 and C-CAR066 for the treatment of non-Hodgkin's lymphoma. The collaboration terms were expanded and revised in December of the same year. Johnson & Johnson now holds the rights to these two leading cell therapies globally.(Including China)The commercial rights, and announced on its official website the expectation of annual sales exceeding 5 billion US dollars, showing Johnson & Johnson's certainty and confidence in its future commercial potential.
Of course, this confidence does not come out of thin air; more底气 comes from the product's excellent clinical performance and mature工艺体系.
In April 2024, the Phase II construction of CIBOMAN's CAR-T commercial production base began. After the expansion, itsThe total area of GMP production facilities will exceed 20,000 square meters, dedicated to the commercial production of CIBOMAN's future products., to meet the rapidly growing market demand for CAR-T therapy.
Conclusion
When the industry is still trapped in single-point technological breakthroughs, CBMG ("Dual-Target Innovation + Full Industry Chain Capability"Breakthrough Achieved: From the commercial validation of Johnson & Johnson's $5 billion pipeline, to AstraZeneca's solid tumor collaboration and RMAT designation in the autoimmune field; from GE/Thermo Fisher's automated process development, to Novartis' strategic investment."CBMG's 15-Year "Path of Aspiration," is a microcosm of China's innovative pharmaceutical companies transforming from technology followers to standard definers.
In the era of innovative drug differentiation, the value network woven by Cellular Biomedicine Group (CBMG) with its full industry chain capabilities may be heralding the transition of cell therapy from「"Lab Miracle" Towards「The Next Inflection Point of "Inclusive Healthcare".
References:
1. Public information such as the official website of Cibiem
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