Shanghai-based Cell Therapy Firm Huadao Biopharma Files for IPO with Breakthrough Affordable CAR-T Drug
Huadao Biopharma
Developer and Manufacturer of Cell-Based Immunotherapy Drugs
Recently, according to information disclosed on the website of the China Securities Regulatory Commission (CSRC), HuaDao CAR-Tcell (Shanghai) Biomedical Co., Ltd. (hereinafter referred to as "HuaDao Biomedical" or "the Company") has registered for coaching and filing with the Shanghai CSRC Bureau. The coaching institution is Ping An Securities Co., Ltd.
It is reported that HuaDao CAR-Tcell, founded in September 2017, is a national high-tech enterprise focusing on the cell therapy field and committed to the research, development, and innovation of the entire industrial chain technology for cell drugs. Since its establishment, HuaDao CAR-Tcell has always adhered to the mission of "making cell drugs affordable for ordinary Chinese people." In recent years, CAR-T cell therapy, as a revolutionary tumor immunotherapy, has shown remarkable efficacy in the field of hematological malignancies. However, its exorbitant cost has become a significant barrier between patients and their hope for life — similar drugs in the international market are generally priced at over $400,000 (approximately RMB 2.8 million), and even among domestically approved products in China, prices often hover around RMB 1.2 million, far exceeding what an average family can afford. This "astronomical drug price" dilemma greatly limits patient access to treatment.
Against this backdrop, China's local innovative forces are attempting to break this deadlock, transforming CAR-T therapy from a "luxury" into an accessible treatment option for ordinary patients. It has been revealed that HuaDao CAR-Tcell submitted its first marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in 2025 for its CAR-T cell drug targeting refractory and relapsed non-Hodgkin lymphoma. This gene-cell therapy drug, fully independently developed in China, is expected to be priced at only 230,000–250,000 RMB after its launch, significantly lower than the current price of approximately 1.2 million RMB for similar products in China and the international average price of over 400,000 USD. This pricing strategy directly addresses the long-standing issue of patients being unable to afford the treatment, fulfilling the company’s founding commitment to "develop cell therapies affordable for the common people in China."
Supporting this inclusive pricing is HuaDao CAR-Tcell's breakthrough in technology and production models. The company adheres to full-industry-chain independent innovation — from core equipment, consumables to basic reagent raw materials, all are self-developed. On June 27, 2023, its key CAR-T cell industry technologies and equipment passed the CDE-associated review, making HuaDao CAR-Tcell the only enterprise in China to achieve full industrial chain autonomy for CAR-T. More crucially, HuaDao CAR-Tcell has introduced industrial thinking into the highly personalized field of cell therapy. Relying on its self-developed fully automatic, fully enclosed, unmanned cell preparation platform, HuaDao CAR-Tcell has overcome the bottleneck of traditional CAR-T production, which heavily relies on manual operations and open environments. This not only significantly reduces contamination risks and human errors but also greatly enhances the company’s production capacity. Theoretically, it can flexibly expand production according to clinical needs, with a production capacity over 50 times higher than the current international mainstream processes, truly achieving “produce as much as needed.”
Since 2024, HuaDao CAR-Tcell has significantly accelerated its pace. The company has fully launched the construction of multiple industrial bases across China, including the East China Shanghai Songjiang Base, Southwest Chongqing Bishan Base, Central Plains Henan Zhengzhou Base, and Northeast Jilin Changchun Base. It is comprehensively advancing the innovative research and development as well as the scaled and intelligent production of cell drugs, further enhancing the self-reliance and controllability of China's biopharmaceutical industry chain. This effort aims to achieve the domestic production and independent pricing of CAR-T cell therapy products in China, enabling more patients to access and afford high-quality cell drugs. According to reports, after the completion of Phase I of the intelligent CAR-T cell drug production base in Xiaokunshan Town, Songjiang, Shanghai, its annual processing capacity will reach 9,000 people/portions.
E.N.D
ForPromote Cooperation and Technical Exchange in the Cell and Gene Therapy IndustryThe "Cell and Gene Therapy Field" team of the WeChat Official Account media platform has established a Cell and Gene Therapy Exchange Group. Press and hold the QR code below to add the editor's WeChat and join the group. Due to the large number of applicants, please include the following when adding WeChat: Institution/Enterprise—Major/Position—Name. If you are a PI/Professor/Manager or above, please also indicate.
Statement:ReferenceInVolumeComeSource: Official Media/Online News, This PublicPublic AccountAiming atKnowledge sharing: We remain neutral regarding the content, statements, and opinions in reprints or shared materials. Relevant content is for readers' reference only.