The results of the ADME study commissioned by U.S. CRO are in line with expectations. GNTbm expects to complete the API, formulation, pharmacokinetics, toxicology pharmacokinetics and safety toxicology next year, and aim to file for IND in the U.S., China and Taiwan by the end of next year. In order to accelerate the clinical trial of its own new drug and pre-clinical development of GNTbm-38, GNTbm completed a B round of capital raising at the end of September this year, issuing a total of 6,455,000 common shares at NT$31 per share, raising NT$200 million, which will accelerate the clinical phase Ib/II trial of its own new drug portfolio CT-01 for the treatment of patients with intermediate and advanced liver cancer. The new drug, CT-01, will be used to accelerate the clinical phase Ib/II trial of the new drug, which will treat patients with intermediate and advanced liver cancer, and will be available at seven medical centres in Taiwan, including Taipei Veterans General Hospital, NTU Hospital, NTU Cancer Center, Lin Kou Chang Gung Hospital, China Medical University Hospital, National Cheng Kung University Hospital and Kaohsiung Chang Gung Hospital.

GNTbm-38, a new mechanism of oncology immunotherapy, has completed its ADME study today and the results are in line with expectations. GNTbm-38 is a novel, small molecule, orally administered, Epigenetic Immunomodulator drug candidate developed by GNTbm, which is mainly used to modulate the tumour microenvironment. In total, it is protected by patents in more than 50 countries.

As for the registration of Tucidinostat/Chidamide (Kepida in Taiwan), a new drug for HR+/Her-2 advanced breast cancer indications, which is patented by an international pharmaceutical company, the review is still ongoing and a letter of approval for Tucidinostat/Chidamide has been obtained one by one. The new drug is currently under review and has already been approved by the FDA, including: exemption from bridging test, BE equivalence test, API flupyrimidine drug certificate and DMF, etc.