Fengxun Biotech Advances In Vivo CAR-T Platform with First Clinical Data Expected in Q2 2026

Source: Securities Daily Network

By reporter Jin Wanxia of this newspaper

Reporter learned recently from DeliNova Therapeutics (hereinafter referred to as "DeliNova") that its self-developed multi-dimensional optimized in vivo CAR-T technology platform has achieved a key breakthrough, showing certain industrialization prospects. It is reported that this technology is expected to break the traditional CAR-T therapy's challenges of "difficult preparation and high cost," bringing the possibility of cost reduction for advanced anti-cancer drugs that typically cost millions of yuan per injection.

DeliNova Therapeutics CEO Kaikai Shi revealed in an interview with reporters that based on this technology platform, the company’s candidate drug GI-001 for blood tumors will soon initiate its first-in-human clinical trial (IIT), with the first set of clinical data expected to be available in the second or third quarter of 2026. Preclinical data shows that the product demonstrates significant advantages in both tumor clearance ability and safety.

Data shows that while CAR-T therapy has demonstrated remarkable efficacy in the field of hematological tumor treatment, its commercialization path has long been constrained by complex production processes. The traditional "ex vivo preparation" model requires extracting patient cells, expanding them in vitro, and then reinfusing them, with a cycle lasting 2 to 4 weeks and single-treatment costs often exceeding one million yuan. The high cost and long waiting period have resulted in many patients missing the optimal treatment window due to insufficient payment ability or disease progression.

"The next breakthrough in the industry lies in 'off-the-shelf' and 'universal' solutions," said Shi Kaikai. DeliNova Therapeutics has taken a different approach by adopting an "in vivo preparation" model, which reconstructs the traditional logic of CAR-T therapy.

According to reports, this technological approach does not require the removal of patients' cells from the body. Instead, it directly completes the genetic modification and activation of T cells in the patient’s body through a single intravenous injection of a viral vector. This breakthrough compresses the weeks-long ex vivo production process into a single intravenous infusion lasting less than 30 minutes, with the potential to achieve standardized drug production. This means that treatment costs could be significantly reduced, and the therapy could become "ready-to-use," greatly improving the accessibility of the drug.

In addressing the delivery challenges, DeliNova Therapeutics has also built a certain technological barrier. Shi Kaikai stated that the vector developed by the company, after special modification, can specifically target T cells, effectively avoiding the risk of off-target cell infection; its safety is significantly superior to traditional therapies, greatly reducing the incidence of adverse reactions such as cytokine release syndrome (CRS). "In the future, the company plans to further unlock the value of its technology through overseas licensing and other means, promoting China's original innovative technology to benefit the global market," Shi Kaikai said.

Currently, DeliNova Therapeutics' pipeline advancement has entered the fast track. In addition to GI-001, the GI-002 product for solid tumors is also planned to initiate clinical enrollment in 2026. The rapid development of the company is inseparable from strong capital injection. To date, the company has received investments from several well-known institutions such as CAS Star, Legend Capital, and Hanyuan Assets.

A relevant person in charge of CAS Star told reporters that the originality and safety of technology are the core indicators for institutions to evaluate early-stage biotech companies. "The technological foundation of DeliNova Therapeutics originates from the laboratory of Professor Cai Yujia at the Institute of Systems Biomedicine, Shanghai Jiao Tong University. The team's numerous publications in top-tier journals such as *Nature* provide solid academic endorsement for the company." The person in charge believes that DeliNova Therapeutics transforms customized cell therapy into standardized drug formulations through in vivo gene editing technology, aligning closely with the industry trend of making cutting-edge therapies more accessible.

(Editor: Sun Qian)