GBM, the most common and highly malignant primary brain tumor, is responsible for approximately 54.7% of all gliomas. It is characterized by invasive growth, which renders complete surgical resection difficult to accomplish. Additionally, GBM is prone to recurrence following surgical intervention; once it becomes recurrent, the available treatment options are extremely limited, and the prognosis for affected patients is very poor. The mOS of patients with recurrent GBM typically ranges from only 6 to 9 months, and the five-year survival rate is less than 5%.

How to prolong patients' PFS and OS while improving their QOL is recognized as a major therapeutic challenge in the field of neuro-oncology. At present, no standardized chemotherapy regimen has been established for recurrent glioblastoma following standard treatment; only feasible clinical trials or alternative options can be appropriately selected in accordance with clinical guidelines, resulting in significant unmet needs in the clinical management of this disease.

A keynote report was delivered at the conference by Director Li Wenbin, Principal Investigator (PI) from the leading unit of the clinical trial.

Against this grim backdrop, new hope has been brought by the research findings on CHA for Injection developed by Jiuzhang Biotech. CHA for injection is a Class 1 innovative small-molecule natural drug with anti-tumor immune activity, extracted from natural plants and manufactured in accordance with chemical drug standards. Its emergence is no accident; it is supported by a profound scientific research foundation: in 2016, it was listed as a "Major New Drug Discovery" special project under the national "13th Five-Year Plan" National Science and Technology Major Project by the National Health Commission of China (NHC); in 2025, it was designated as a "Beijing-Tianjin-Hebei Disruptive Project" by the Beijing-Tianjin-Hebei National Technology Innovation Center.

Systematic studies on the molecular mechanism underlying the anti-tumor effect of chlorogenic acid have been conducted by the research team led by Academician Jiang Jiandong, Director of the Institute of Materia Medica, Chinese Academy of Medical Sciences. It has been found that CHA is a natural active substance with multiple pathways and multiple targets, and its anti-tumor effects are exerted through two mechanisms: metabolic immune regulation and cell-induced differentiation.

The data released at this year's ESMO Congress was derived from a randomized, controlled, open-label, multicenter Phase II/III clinical study (Study CTR20181644) designed to evaluate the safety and efficacy of Chlorogenic Acid for Injection in the treatment of recurrent Grade IV GBM. Beijing Tiantan Hospital, Capital Medical University, was designated as the leading institution for this clinical study, with multiple Grade A tertiary hospitals in China participating in the study. The reported data indicates that for the overall population of patients with recurrent GBM, compared with lomustine (CCNU) in the control group, non-inferiority of Chlorogenic Acid for Injection (developed by Jiuzhang Biology) was achieved in the Full Analysis Set (FAS), with a 12% reduction in the risk of death; meanwhile, significant superiority was demonstrated in the Per-Protocol Set (PPS), with a 37% reduction in the risk of death.

Furthermore, CHA for Injection also exhibited breakthrough advantages in subgroup populations: in the subgroup with efficacy-sensitive genotypes (MGMT promoter methylation-positive or TERT gene mutation), significant superiority was observed in both the FAS and PPS, with a 50% reduction in the risk of death; in the subgroup with high tumor burden (total cross-sectional area > 3000 mm²), significant superiority was also observed in both the FAS and PPS, with a 55% reduction in the risk of death.

It is understood that in addition to glioma—for which clinical trials are currently underway—CHA for Injection (developed by Jiuzhang Biotech) has also been shown to exhibit potential efficacy against various tumors (e.g., squamous cell carcinomas, prostate cancer, and colorectal cancer) in preclinical studies.

The birth of a major innovative achievement is closely associated with the long-term commitment and strategic layout of the R&D entity, as well as the strong support of the industrial ecosystem in the region where the entity is situated.

Founded in 1999, Jiuzhang Biotech has been consistently dedicated to the research and development of innovative drugs with independent intellectual property rights derived from CHA. It is a pharmaceutical innovation enterprise integrating scientific research, production, sales, and health services. To date, the company has obtained 82 authorized invention patents. In addition to the core innovative drug pipeline, the company has also successfully developed related products applied in the big health sector, thereby establishing a diversified product portfolio.

The recognition from this year's ESMO Congress has been established as a new starting point for Jiuzhang Biotech to accelerate its development.

The breakthrough achieved by Jiuzhang Biotech is also a microcosm of the vigorous development of the biomedical industry in Chengdu High-Tech Zone.

At present, Chengdu High-Tech Zone has systematically established a total of more than 160 full-life-cycle functional platforms covering drug discovery, preclinical research, clinical research, pilot-scale production, and industrialization. A diverse range of strategic platform resources have been aggregated there, including the first national pilot demonstration base for the transfer and transformation of achievements under the National Science and Technology Major Project for Major New Drug Discovery, the first national demonstration platform for the transfer and transformation of health and medical science and technology achievements, Chinese only National Precision Medicine Industry Innovation Center, and the first demonstration base for verification and evaluation of domestic equipment and instruments in Southwest China. On this fertile ground for innovation and entrepreneurship, the launch of 12 Class 1 new drugs has been facilitated by Chengdu High-Tech Zone to date, and more than 130 Class 1 new drugs are in the clinical research phase, with sustained innovation momentum.

In the future, Chengdu High-Tech Zone will continue to prioritize the initiative titled "Optimizing Quality and Upgrading, Building the Park with Distinctive Features, Empowering for Efficiency, and Filling the Park with Enterprises". It will target key links and fields such as the R&D and production of pharmaceutical and medical device products, continuously optimize the policy environment, improve supporting elements, facilitate the acceleration of R&D for innovative pharmaceutical and medical device products, foster new industrial growth points and new advantages in international competition, and provide important support for accelerating the construction of a world-class high-tech industrial park.

Information Source: Bureau of Biomedical Industry, Chengdu High-Tech Zone

Editor: Li Kaixin