Milestone

The notification letter for drug license collection of "Tucidinostat/Chidamide; Kepida tablets" has been issued by TFDA.

-"Tucidinostat; Kepida tablets“ developed by GNTbm and classified as a domestic new chemical entity drug, has been approved by TFDA. The first approved indication is “Tucidinostat combined with Exemestane for the treatment of women with hormone receptor positive and HER2-negative advanced or metastatic breast cancer”
-GNTbm has completed its Series C capital raise.

-The Israel patent of GNTbm-CC-01, a new drug combination for tumor microenvironment regulation, has been granted.
-The US patent of new anti-cancer drug GNTbm-38, a NCE independently developed by GNTbm, has been granted.

- GNTbm has completed its Series B capital raise.
-The Taiwan patent of Tucidinostat/Chidamide and Celecoxib Anti-Cancer Combination has been granted.

-The DMF of API “Tucidinostat/Chidamide" has been approved by TFDA.
-The research outcomes of a new drug combination of cancer immunotherapy, independently developed by GNTbm, was published in the "International Journal of Molecular Sciences" (IJMS).
The published title is: Tucidinostat/Chidamide Plus Tyrosine Kinase Inhibitor Remodel the Tumor Immune Microenvironment and Reduce Tumor Progression when Combined with Immune Checkpoint Inhibitors in Naive and Anti-PD-1 Resistant CT26-Bearing Mice.

GNTbm signed a contract with Formosa Laboratories Inc. for the manufacturing process development of GNTbm-38, a new chemical entity of anti-cancer drug.

-GMP certificate for API “Tucidinostat/Chidamide" has been granted by TFDA.
-The patent “A PHARMACEUTICAL COMBINATION AND METHOD FOR REGULATION OF TUMOR MICROENVIRONMENT AND IMMUNOTHERAPY” was granted by Japan patent office.

GNTbm was invited to give an oral presentation at the 26th Taiwan Joint Cancer Conference (2022 TJCC), for the following topics:
1.Mechanism of HDACi Tucidinostat in HR+ Advanced Breast Cancer 
2.Tucidinostat in Combination with Exemestane in Taiwanese Patients with HR+ Advanced Breast Cancer 

-The new drug combination CT-01for the second-line treatment of intermediate and advanced HCC has obtained IND approval by TFDA
-GNTbm's anti-breast cancer new drug Tucidinostat was granted by TFDA to exempt the Bridging Study in Taiwan
-The BE study of GNTbm's anti-breast cancer new drug Tucidinostat has been approved by TFDA.

The research outcomes of CC-01 new drug combination, a tumor microenvironment modulator independently developed by GNTbm, was published in Scientific Reports.
The published title is：CC-01 (Tucidinostat/Chidamide plus Celecoxib) modifies the tumor immune microenvironment and reduces tumor progression combined with immune checkpoint inhibitor.

GNTbm submitted to TFDA the IND of the Phase Ib/II trial of Tucidinostat combined with Regorafenib (CT-01) for the treatment of advanced HCC

GNTbm submitted the NDA of Tucidinostat to TFDA for the treatment of HR+/Her-2- advanced breast cancer

GNTbm submitted the NDA of Tucidinostat to TFDA for the treatment of relapsed or refractory peripheral T-cell lymphoma.

Completion of PCT patent application of new generation of tumor microenvironment regulator---GNTbm-CT-01.

Completion of supplementary procedures for classification as a public company.

Capital was increased to NTD 18, 565 million.

Capital was increased to NTD 15,165 million.

The TFDA approved compassionate use of chidamide tablets manufactured in Taiwan for treatment of patients with recurrent/refractory peripheral T-cell lymphoma.

Phase III clinical trial of advanced breast cancer completed the last patient's recruitment.

Obtained a Small Business Innovative Research award from the Small and Medium Enterprise Administration, Ministry of Economic Affairs (Project Title: To develop the picolinamide-based epigenetic immunomodulator in tumor microenvironment).

signed a contract with TSPC Inc. to sale chidamide product for two indications of PTCL and BC in Taiwan.

GNTbm signed a contract with SinPhar Inc. to manufacture chidamide-Tablet in Taiwan.

Obtained TFDA approval to conduct Phase III clinical studies on the treatment of ER+, HER-2- patients with late-stage breast cancer with combination of chidamide and exemestane in Taiwan.

-Conducted research on matched pairs of chidamide in Taiwan: a retrospective study to compare OS of PTCL patients in Taiwan was conducted in three medical centers.
-GNTbm signed a contract with Formosa Laboratories Inc. to manufacture chidamide-API in Taiwan.

Obtained a Small Business Innovative Research award from the Small and Medium Enterprise Administration, Ministry of Economic Affairs (Project Title: Using Vaucarrin drug delivery platform to develop targeted anti-cancer drugs) (Project No：1Z1050497)

Introduced strategic investment from investment partners; capital reached 71.88 million new Taiwan dollar.

Applied for two PCT patents: Complex COMPRISING Metallic Nanoparticle, linkerS and ANTIBODIES and PH-SENSITIVE LINKERS FOR DELIVERING A THERAPEUTIC AGENT

Passed the new biotech company review by Industrial Development Bureau, MOEA.

Registered on Go Incubation Board for Startup and Acceleration Firms (GISA), Stock code: 7427

Obtained the Small Business Innovative Research grant awarded by the Small and Medium Enterprise Administration, Ministry of Economic Affairs (Project Title: Development of the new drug delivery platform using unique dithio-heterocyclic linkers to bind nano-gold and doxorubicin).

Establishment of Great Novel Therapeutics Biotech & Medicals Corporation (GNTbm)

Obtained an exclusive license to market the anti-cancer target drug Chidamide, developed by Chipscreen Ltd (Shenzhen, China), and its research and development in Taiwan through technology transfer.

Establishment of GNT Biotech Corporation