Over 25 CAR-T Therapies in Development, China Approves Fourth Domestic CAR-T Product as Market Heats Up

Nov 17, 2023 08:58 CST Updated 08:58

Legend Biotech

Tumor Cell Immunotherapy Developer

Senlang

Developer of Novel Anti-Tumor Bio-Immunotherapy Drugs

Recently, the Natrioleukin Injection submitted by He Yuan Biotech has been conditionally approved for marketing in China through the priority review and approval process. The indication is for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.Previously, three CAR-T products had been approved in China, and their indications were all for hematological tumors.

At the same time, reporters from the People's Daily Health Client found that there are more than 25 CAR-T products under research in China, involving Legend Biotech, CARsgen Therapeutics, and Senlangbio. The target points for hematological tumors are relatively concentrated, mainly CD19 and BCMA.

Frost & Sullivan data indicates that the size of China's CAR-T therapy market (calculated at cost price) is expected to increase from 200 million yuan in 2021 to 8 billion yuan in 2025, with a compound annual growth rate of 151.0%. With more CAR-T products gaining approval, the market size is projected to reach 28.9 billion yuan by 2030.

Why is the CAR-T cell field so hot?

"The CAR-T cell field is indeed a very hot track in the current biopharmaceutical industry. Globally, the number of clinical studies in China ranks among the top. The main reason this field is so popular is the tremendous clinical treatment potential demonstrated by CAR-T cell therapy. The pharmaceutical industry has long dreamed of conquering cancer, and cellular immunotherapy is recognized as one of the major breakthroughs. No pharmaceutical professional wants to miss this wave." On November 10,Founder of Bay Island Cells, Fan XiaohuAccepted by the reporter of People's Daily Health Client.

How effective is CAR-T therapy?Xu Bing, Chief Physician of the Department of Hematology, First Affiliated Hospital of Xiamen UniversityCAR-T therapy is a living cell drug, which is its biggest difference from traditional drugs, reported to the Health Client of People's Daily. The emergence of CAR-T cell immunotherapy has changed the traditional treatment methods for lymphoma. With over 10 years of application experience internationally, it has gradually become one of the mainstream curative treatments for lymphoma, showing particularly significant efficacy for patients with refractory or relapsed lymphoma.

"Our hospital has successfully carried out 10 cases of CAR-T cell therapy for relapsed or refractory lymphoma so far. According to clinical data, the efficacy rate reached 100%, and the complete remission rate was 80%. The first patient was diagnosed with non-Hodgkin lymphoma, a general term for a group of independent diseases with strong heterogeneity, ranking among the top ten common malignant tumors in China. Before receiving treatment, the patient had relapsed twice, and at the time of the second relapse, he was already 70 years old. After discussing with the family, we decided to proceed with CAR-T cell therapy for the patient, and the clinical outcome was excellent. It has been one and a half years since the patient was discharged. He came back for a follow-up visit recently, and all physical indicators were stable." Xu Bing remarked that the advancement in clinical treatment methods saves not only a life but also a family.

Real-world data with a larger sample size further confirms the potential of CAR-T cell therapy. Clinical data from the recently approved Nacioranase Injection shows that among 39 adult patients who completed the infusion, 25 achieved remission at 3 months, with an overall response rate of 64.1%, including 20 patients with complete remission, resulting in a complete remission rate of 51.3%.

Earlier, a set of multicenter real-world research data published by Legend Biotech showed that among 101 evaluable patients within one month across 17 certified treatment centers in China, the CAR-T therapy Axicabtagene Ciloleucel Injection demonstrated a 12-month overall survival rate as high as 84.3% for Chinese patients with relapsed or refractory large B-cell lymphoma. The best overall response rate reached 83.2%, with the best complete response rate at 58.4%.

How to Avoid the Trend of Homogenization and Involution?

As the热度 of CAR-T therapy continues to rise, discussions within the industry about product homogenization and intensified内卷 persist.

Data from the U.S. Clinical Trials Database ClinicalTrials shows that as of November 10, the number of clinical studies on CAR-T cell therapy in China has reached 655, of which 311 have completed patient recruitment. Further analysis reveals that the majority of ongoing CAR-T cell therapy research is primarily focused on hematological malignancies such as leukemia, lymphoma, and myeloma. Additionally, some target antigens are highly concentrated, mainly CD19 and BCMA, while the target antigens of currently approved products are predominantly CD19.

"The internal competition and homogenization tendency in the CAR-T cell therapy field are worth being vigilant about, but hard to avoid. Because at the current stage, there are limited validated druggable and effective targets, such as CD19 and BCMA. Secondly, China's innovative drug industry is still in a rapid follow-up phase transitioning to 'first-in-class.' The previous mindset of the capital market pursuing short-term returns and blindly following trends has not been completely changed." In Fan Xiaohu's view, as the capital market gradually returns to value orientation, the phenomenon of concentrated targets and product homogenization will continuously improve. True innovations that fill clinical gaps will gain access to various precious resources. From the perspective of future development directions, improving single-target CAR-T and moving towards multi-targets—mainly including combination CAR-T, dual-target CAR-T, and triple-target CAR-T—will become a trend. Breakthroughs in solid tumor indications are still being sought after, and related R&D enterprises must seize the opportunity to 'overtake on a curve.'"

Xu Bing believes that as more and more products are approved for marketing, sufficient market competition will inevitably help gradually bring the current pricing of CAR-T cell therapy to a level affordable for patients, benefiting more clinical patients. "Currently, the general pricing of CAR-T cell therapy in China is around 1.2 million yuan, which remains unaffordable for many ordinary patient families."

Fan Xiaohu also mentioned in the interview that the current high price is a key factor restricting the popularization of CAR-T therapy. In addition to the complex manufacturing process, the procedure of extracting T cells from patients, modifying them, and then reinfusing them prevents CAR-T drugs from being mass-produced like conventional chemical drugs or biologics, further driving up costs. Against the backdrop of China's medical insurance system being unable to cover the costs of CAR-T, companies must explore payment solutions including various "inclusive insurance" commercial insurance options while focusing on developing universal, scalable products to secure broader and sustainable growth opportunities.

Source:People's Daily Health Client

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