Fuzhou, China—Haixi Pharma (HKEX: 02637.HK, or the "Company") is pleased to announce that the Investigational New Drug (IND) application for HXP089, discovered and developed by the Company, for the treatment of glioblastoma has been accepted for review by the National Medical Products Administration (NMPA).
HXP089 is a next-generation selective multi-target small-molecule drug candidate developed on Haixi Pharma's proprietary small-molecule drug discovery platform—the MultiSel-Opt platform.
The R&D design of HXP089 is guided by the innovative concept of " delivering synergistic therapeutic effects through multiple mechanisms of action within a single molecule." Through precise optimization of the molecular structure, HXP089 achieves coordinated modulation of multiple key disease pathways, aiming to overcome the limitations of traditional single-target drugs in the treatment of complex tumors. Furthermore, throughout the molecular design process, the R&D team consistently focused on tissue distribution and target-site exposure, resulting in a final candidate compound with strong blood-brain barrier (BBB) penetration capability.
Dr. Kang Xinshan, Founder, Chairman and Executive Director of the Company, stated:
"Glioblastoma is one of the most challenging malignancies in clinical practice, characterized by poor patient prognosis and high recurrence rates, with a long-standing lack of breakthrough therapeutic advances. To address this significant unmet clinical need, the Company continues to increase its investment in innovative R&D, aiming to develop differentiated and competitive novel therapies through its proprietary technology platform.
HXP089 is one of the key R&D achievements of the Company's MultiSel-Opt platform, representing years of innovative exploration and technical expertise by the R&D team. The acceptance of this IND application is not only an important milestone for the HXP089 program, but also further validates the value and potential of the Company's innovative R&D platform.
We look forward to working closely with the NMPA throughout the review process. Going forward, we will efficiently advance the clinical development of HXP089, striving to bring new treatment options to patients with glioblastoma as soon as possible, while continuing to strengthen our innovation platform and global development capabilities to create greater value for patients worldwide."
About Glioblastoma
Glioblastoma (GBM) is a malignant tumor originating from glial cells. According to the 2021 fifth edition of the WHO Classification, GBM specifically refers to glioblastoma, IDH-wildtype, CNS WHO Grade 4. It is the most common and most aggressive primary malignant tumor of the adult central nervous system (CNS), accounting for 13.7% of all primary brain and other CNS tumors and 52.2% of all primary malignant brain tumors. The incidence rate is approximately 3–5 per 100,000, with males affected at 1.6 times the rate of females. Incidence increases with age, with the highest rates observed in the 70–74 age group.
Currently, the first-line standard of care for GBM involves maximal safe surgical resection followed by concurrent chemoradiotherapy with temozolomide and adjuvant temozolomide. However, even with the best available multimodal treatment, the median overall survival (OS) is only 14.6–16 months, with a 5-year survival rate of less than 10%. Nearly all patients eventually experience tumor recurrence or progression. Treatment options after recurrence are limited, and there is currently no consensus on a highly effective standard-of-care regimen for recurrent disease. Post-recurrence survival is further shortened, with a median OS typically not exceeding 5–7 months, representing a significant unmet clinical need. HXP089, with its unique single-molecule multi-target design concept and strong blood-brain barrier (BBB) penetration capability, has the potential to offer patients a new treatment option.
About Haixi Pharma
Fujian Haixi Pharmaceutical Co., Ltd. (“Haixi Pharmaceutical”, 02637.HK) was founded in 2012 as a commercial-stage innovative pharmaceutical company covering the entire industrial chain of R&D, clinical research, manufacturing and commercialization. The company was successfully listed on the Main Board of The Stock Exchange of Hong Kong Limited on October 20, 2025, and was included in the Hong Kong Stock Connect on March 9, 2026.
Our company adheres to the development philosophy of “Generics empower innovation, innovation drives the future”, by generating stable cash flow through its generic drug consistency evaluation business, it continuously invests in the R&D of original innovative drugs to achieve sustainable development.
