Following its recognition as a 'Breakthrough Therapy Product in China,' its inclusion in the 'National Key Small Giant Program for Specialized, Refined, and Innovative Technologies' and the 'Disruptive Technology Library of the Beijing-Tianjin-Hebei National Technology Innovation Center,' and its receipt of the 'Excellent Award in the 2025 National Disruptive Technology Competition,' the '2025 Beijing-Tianjin-Hebei National Technology Innovation Center Tianjin Center Construction Special Project,' and the '2025 Tianjin Municipal Major Biomedical Science and Technology Project,' Accendatech overseas clinical trials have reached a new starting point.

It is reported that on December 16, 2025, the Phase II DIPG/DMG clinical trial of Suntech Power's CONNECT2110 (registration number NCT06838676) in the United States was initiated in multiple US hospitals and enrolled its first pediatric patient. At least 19 hospitals worldwide will participate in this clinical trial, with a planned enrollment of 60 subjects, demonstrating the global interest of Suntech Power's new drug among pediatric brain tumor surgeons. Suntech Power expresses its sincere gratitude to these hospitals and doctors for their support!

In addition, it is reported that Accendatech has just completed a business development (BD) transaction with Hefei Yifan Biopharmaceutical Co., Ltd. Under the agreement, Accendatech and Yifan Pharmaceutical will commercialize ACT001 for the treatment of small cell lung cancer brain metastases in East Asian markets such as China (including Hong Kong SAR, Macao SAR, and Taiwan) and Southeast Asia, with an initial payment of RMB 100 million, a cornerstone investment of RMB 100 million or a milestone payment of RMB 50 million (choose one), a two-digit share of net sales revenue, and a two-digit share of licensing revenue outside of China.

Regarding ACT001 and DIPG

ACT001 is the world's first dual inhibitor of NF-κB and STAT3 to enter Phase III clinical trials. As a next-generation immunomodulatory agent, ACT001 has undergone multiple independent clinical trials for brain tumors, including several Phase I and II trials both domestically and internationally for glioblastoma (GBM), diffuse midline glioma (DMG)/diffuse endopontine glioma (DIPG) in children, completed Phase Ib/IIa clinical trials for solid tumor brain metastases, a Phase IIb clinical trial for lung cancer brain metastases, and an ongoing Phase III trial for small cell lung cancer brain metastases (expected to receive Breakthrough Therapy designation in China in January 2025). These studies suggest that ACT001 has the potential to synergize with tumor radiotherapy, chemotherapy, and immunotherapy, and also align with the trend of significantly prolonged patient survival revealed in these trials. Data from the recently completed Phase II clinical trial of ACT001 in combination with radiotherapy for newly diagnosed DIPG patients in China also supports this benefit trend (data pending publication). The CDE has implicitly approved ACT001 for Phase III clinical trials for the treatment of DIPG.

Childhood DIPG is a subtype of DMG. Although both contain mutations at the H3K27 site, DIPG has a worse prognosis than DMG. Its location in the pons and its invasive growth pattern make it one of the most malignant and rapidly progressing tumors. Currently, there are no marketed treatments for DIPG. After years of research and development, the first drug for DMG treatment, ONC201/Modeyso, has recently been launched overseas under a conditional marketing authorization, priced at approximately $285 per tablet. However, in Phase III clinical trials, this drug excluded DIPG patients with a long-term expectation for innovative drugs, indicating that drug development for DIPG malignant gliomas still has a long way to go. Extensive preclinical and clinical trial data suggest that DIPG has a basis for clinical response to radiotherapy, chemotherapy, and immunotherapy under certain conditions.

Therefore, oral small molecule drugs like ACT001, which have a good safety profile and potential for synergistic effects with radiotherapy, chemotherapy, and immunotherapy, have unique development and application value in the drug development of DIPGs. The initiation of the CONNECT2110 clinical trial in the United States is also an important part of Accendatech overall DIPG pipeline research plan. Other milestones include ACT001 obtaining U.S. Orphan Drug Designation, Rare Disease Designation, and Fast Track designation in the DIPG field.

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