Weitao Biotech has raised over $50 million in Series A financing. The in vivo CAR-T using the LNP route has published preliminary human data.

Text by | Hu Xiangyun

Edited by | Hai Ruojing

36Kr learned that Weitao Biotech has recently completed Series A and Series A+ financing rounds, with a cumulative fundraising amount exceeding $50 million. The two rounds of financing were led by Zhengxin Valley Capital and Decheng Capital respectively, and co - invested by OrbiMed, Hankang Capital, Eisai Innovation Inc., Jianfa Emerging Investment, as well as existing shareholders such as Qiming Venture Partners, Shunxi Fund, and Xingze Capital.

It is understood that the funds raised in Weitao Biotech's Series A round will be mainly used to advance the clinical process and registration application of the core drug pipeline GT801, as well as to expand the R & D team and build the platform.

Weitao Biotech was spun off from Shali Biotech in 2025. The latter is mainly engaged in the development of tumor - infiltrating lymphocyte (TIL) therapy, and its core product has entered Phase II clinical trials. Dr. Liu Yarong, the founder and CEO of Shali Biotech/Weitao Biotech, graduated from the University of Southern California in the United States and has more than 10 years of experience in the field of cell and gene therapy (CGT).

Liu Yarong introduced that the initial choice to work on TIL was because it is one of the few cell - therapy approaches that have the potential to make breakthroughs in the field of solid tumors and have entered the commercialization stage. During this process, Shali Biotech's understanding of the mechanism of action of immunotherapy in different diseases has also deepened, and it has accumulated R & D capabilities from "in - vitro engineering" to "in - vivo engineering". Therefore, it has gradually begun to explore the next - generation immunotherapy methods through the in - vivo CAR - T approach. This is the background for Shali Biotech to spin off its in - vivo CAR - T assets and operate independently in the form of Weitao Biotech.

Since the second half of 2025, multinational pharmaceutical companies such as Eli Lilly, AbbVie, and Bristol - Myers Squibb have successively acquired overseas in - vivo CAR - T companies, with a cumulative disclosed amount exceeding $14 billion, which has also sparked the R & D enthusiasm of Chinese CGT companies for this track. According to Dingxiangyuan Insight data, currently, there are more than 180 in - vivo CAR - T pipelines under research globally, about half of which are from China. In the fierce competition, the ability to accumulate more sample data faster and create differentiation largely determines the future of enterprises.

Liu Yarong also admitted: "Last year, a practical consideration for spinning off Weitao Biotech was that the in - vivo CAR - T products using the LNP (lipid nanoparticle) route are more suitable for use in fields such as autoimmunity. The clinical development, team structure, and resource allocation for such indications are significantly different from those for developing traditional oncology pipelines. If we were to advance them within a single system, it might not be the most efficient and reasonable arrangement. So we chose to separate this part of the capabilities, and through separate financing and team configuration, we can make it more focused and progress faster."

The LNP delivery route that Weitao Biotech is betting on is one of the mainstream development paths for in - vivo CAR - T therapy. It mainly encapsulates in - vitro synthesized mRNA in LNP and delivers it to T cells in the human body after administration. This process does not require genomic insertion, so it has better safety. At the same time, the effect can be adjusted through dosage and administration frequency, and repeated administration is supported, which gives it a natural advantage in diseases that require long - term management, such as autoimmune diseases.

From the perspective of technical reserves, Weitao Biotech has focused on accumulating three aspects of capabilities: First is the in - vivo delivery ability, especially how to achieve precise delivery to T cells, which includes both the screening of targeting antibodies and the design of site - specific and quantitative coupling between LNP and antibodies. This part directly determines the balance between transduction efficiency and off - target control.

Second is expression regulation. Weitao Biotech has systematically optimized the mRNA sequence and structure to ensure that CAR expression in the body can last for a sufficient time while remaining controllable. This is the key foundation for the LNP route to enter clinical practice. Finally, it is the understanding of the in - vivo immune system, including the expansion, persistence of T cells in the body, and the optimization of the safety window.

Liu Yarong believes that at this stage, Weitao Biotech has established a complete "in - vivo cell engineering platform" rather than just the ability for a single product. "Currently, the competition threshold in the in - vivo CAR - T track is constantly increasing. The competition is no longer about a single product but the entire technical system and execution ability. Therefore, we believe that in the future, enterprises that can succeed in this field need to have several elements simultaneously: First is a solid underlying technology, including delivery, expression, and immune regulation; second is a complete clinical development ability; third is the ability to understand and layout different technical paths."

Currently, based on the LNP delivery route, Weitao Biotech's core pipeline GT801 has completed the preliminary pre - clinical and early - stage clinical data readout. It is reported that a core feature of GT801 is that it can be administered repeatedly and the dosage is controllable, which gives it a better chance to develop into a platform - type product across multiple indications.

At the American Association for Cancer Research (AACR) Annual Meeting in late April this year, the clinical data released by Weitao Biotech showed that in patients with B - cell hematological malignancies and autoimmune diseases, GT801 can induce high - level CAR expression and CAR+ T - cell expansion, and the feasibility of repeated administration was verified. The preliminary efficacy showed that significant B - cell clearance was observed in the peripheral blood, bone marrow, and lymph nodes of hematological malignancy patients; patients with autoimmune diseases also showed deep B - cell clearance and improvement in the disease activity index.

In addition, when talking about the changes in the financing environment of the in - vivo CAR - T track in the past year, Liu Yarong said that at this stage, investment institutions are paying more attention to "specific data and capabilities". "One is whether in - vivo delivery and expression can be truly verified, and the other is whether there is platform expansion ability. An important reason why Weitao Biotech was able to complete the financing smoothly is that it is not just a product line but an in - vivo engineering platform that can be continuously expanded, which has been recognized by investors."