Maohang Biotech’s differentiated approach is evident in its choice of disease areas. Both MT027, which targets B7H3, and MT026, which targets IL13Ra2, have glioma as their first-in-indication. Explaining this decision, Shang Xiaoyun said: "We chose glioma as our first-in-indication because there remains a huge unmet clinical need in this field, and cell therapy, as a 'living drug', has unique advantages for intracranial tumors." In his view, developing innovative drugs—especially "ultimate therapies" like cell therapy—must focus on genuine unmet clinical needs. Unlike hematologic malignancies, where multiple successful products have been launched, advanced solid tumors present a host of urgent clinical challenges, creating a platform for new technologies to deliver value.

After settling on solid tumors as its focus, Maohang Biotech further explored how to maximize the unique properties of cell therapeutics. "A cell therapeutic is a living drug," Shang Xiaoyun emphasized. "Its 'liveliness' is reflected in its ability to proliferate and self-propel: it can not only recognize targets but also actively chemotax, infiltrate, and persist in tumor lesions—an advantage unmatched by any small molecule, large molecule, or even gene therapy drug." "This characteristic endows cell therapy with unique potential in addressing solid tumors with special anatomical and immune microenvironments such as glioma. It opens up the possibility of designing rational pathways to enable therapeutic cells to cross physiological barriers (e.g., the blood-brain barrier) that are insurmountable for traditional drugs, acting directly and continuously on the core of the tumor."

Based on this, Maohang Biotech set its sights on two major "hard nuts to crack": pancreatic cancer and glioma. Ultimately, it chose glioma as its initial battleground, taking into account the verifiability of the target biological mechanisms, the high correlation between preclinical models and human diseases, the pressing survival rate bottlenecks, and glioma’s role as an ideal model to validate cell therapy’s efficacy against immunosuppressive microenvironments.

Glioma is the most common primary intracranial tumor. Classified into four grades by the WHO, grades I and II are low-grade gliomas, while grades III and IV are high-grade gliomas. In China, the annual incidence of glioma is 5 to 8 per 100,000 people, and its 5-year mortality rate is second only to pancreatic and lung cancer among systemic tumors, with the incidence still rising year by year.

Currently, glioma treatment is dominated by surgical resection, supplemented by a combination of radiotherapy (fractionated external beam irradiation), chemotherapy, tumor treating fields therapy, and other modalities. There are no targeted drugs that can bring significant clinical benefits to glioma patients.

Amid the fierce global competition in the cell therapy track, Maohang Biotech’s choice of this more arduous yet potentially broader differentiated path is underpinned by a clear strategic rationale for corporate development. Shang Xiaoyun pointed out that for small biotechs, selecting a rare or refractory tumor with a relatively well-defined patient population and more assessable clinical endpoints helps to efficiently validate the technology platform and products. This ensures the lead product can advance to key clinical stages as quickly as possible, laying a foundation for subsequent expansion into indications with larger market scales.

Having defined its core research focus, Maohang Biotech adopted a dual pipeline strategy of validated robustness and innovative potential in antigen target selection.

"The most prominent difference between solid tumors and hematologic malignancies lies in the high heterogeneity of their antigen targets—unlike the highly concentrated and well-defined targets in hematologic malignancies. For this reason, we selected broadly applicable targets for glioma," noted Shang Xiaoyun in a comparative analysis.

MT026 targets IL13Rα2, a biomarker with the longest research history and largest patient dataset in glioma CAR-T studies, with investigations dating back to the early 2000s.

Shang Xiaoyun explained that this target was chosen as the company’s first for safety as the top priority: "We opted for a target with relatively high and specific expression, as well as clinical validation from other researchers—safety is paramount for us."

In contrast, MT027 targets B7H3, a promising immune checkpoint biomarker that has garnered significant attention following PD-L1. Expressed in approximately 80% of human tumors, B7H3 boasts broad applicability potential. Its unique attribute is its expression not only on tumor cells but also on tumor-associated macrophages and neovascular vessels within the tumor microenvironment.

"This means it can target both the tumor itself and the tumor microenvironment, featuring a dual mechanism of action. That is why we selected this highly promising, broad-spectrum target for solid tumors as our second focus," Shang Xiaoyun pointed out.

This distinctive advantage also paves the way for the future indication expansion of MT027. In the interview, Shang Xiaoyun revealed that Maohang Biotech is conducting investigator-initiated trials (IITs) for brain metastatic tumors, including lung cancer brain metastases and breast cancer brain metastases.

Currently, with the U.S. FDA’s approval for MT027 to initiate a Phase II clinical trial, Maohang Biotech has achieved a substantial breakthrough in addressing the global challenge of allogeneic CAR-T therapy for solid tumors. As the world’s first off-the-shelf CAR-T product to advance to a registrational Phase II clinical trial in solid tumors at the fastest pace, this milestone also marks a major step forward for the entire cell therapy industry in exploring the "uncharted territory" of solid tumor treatment.

Notably, in a highly forward-looking technological leap ahead of its registrational clinical trial, MT027 has fully established and locked in a non-viral gene editing manufacturing process—a departure from the lentiviral or retroviral vectors commonly used in the industry.

Shang Xiaoyun stated that the adoption of non-viral gene editing is a proactive strategic choice for the company to embrace next-generation cell therapy manufacturing technologies. Compared with traditional viral vector-based methods, this technological approach offers potential advantages in manufacturing process controllability and product purity consistency, while also opening up new possibilities for the long-term safety management of cell products.

This process also presents notable technical barriers, requiring the synchronous, efficient, and precise completion of gene knockout and knock-in during editing—an extremely challenging feat. Leveraging its team’s profound expertise and accumulated experience in gene editing, Maohang Biotech has built a core technological barrier in this field.

At present, MT027 remains the company’s top priority for advancement. The primary task for 2026 is to initiate and steadily progress its international multicenter Phase II clinical trial, with the goal of enrolling patients as expeditiously as possible.

Meanwhile, MT026 has accumulated a robust body of early clinical data, laying a solid foundation for subsequent clinical filings and strategic collaborations.

In addition, Maohang Biotech has laid out pipelines targeting more broad-spectrum biomarkers such as HER2 and EGFR to address the issue of antigen target heterogeneity in solid tumors, with potential exploration of multi-target combination therapies in the future.

Maohang Biotech has a clear and focused strategy for the future. In the short term, the company will concentrate its resources on advancing the Phase II clinical trial of MT027, while simultaneously exploring its efficacy in lung cancer and breast cancer brain metastases—a disease area with a far higher incidence than primary brain tumors and enormous market potential.

For the long term, Shang Xiaoyun has outlined a more ambitious vision: "Taking glioma as an example, through our research and development efforts, we aim to turn this disease, with a 5-year survival rate of less than 5%, into a manageable chronic condition." Overall, Maohang Biotech plans to leverage combination therapies of two to three products to deepen its expertise in the intracranial tumor field and achieve a fundamental breakthrough in disease control rate, with subsequent expansion into non-oncological areas. "We are also conducting early-stage technological exploration in autoimmune diseases and other disorders," he added.

Faced with the current investment boom in in vivo CAR-T development, Shang Xiaoyun offered a calm analysis of the irreplaceable long-term value of UCAR-T.

First is the special requirement for local administration scenarios: "Intracranial tumors demand local drug delivery. In vivo CAR-T is administered intravenously, and the antibodies produced are hardly able to cross the blood-brain barrier into the cranium. Direct intracranial injection of vectors has proven to be highly inefficient." Thus, for primary or metastatic brain tumors, UCAR-T, which enables direct local administration, holds a distinct advantage.

Second is the pivotal role of T cell quality: "Treating solid tumors requires more extensive genetic modification of T cells. Healthy, highly functional T cells are crucial for controlling solid tumors." UCAR-T utilizes T cells derived from healthy donors, which are significantly superior in quality and function to the exhausted endogenous T cells of patients. This may be the key determinant of therapeutic efficacy when combating the highly immunogenically heterogeneous solid tumor microenvironment.

From targeting the most challenging solid tumors, to selecting differentiated targets and adopting a non-viral manufacturing process, and then to rapidly advancing its product into a global Phase II clinical trial, Maohang Biotech’s development path clearly embodies its differentiated innovation philosophy of taking on the hard nuts to crack.

At a time when capital has grown more rational and the demands for genuine innovation have become increasingly stringent, Maohang Biotech’s story demonstrates that Chinese biotechs are fully capable of competing at the forefront of global cutting-edge therapeutics through profound scientific insights, a clear clinical strategy, and highly efficient execution.