新藥研發項目R&D Programs

以 肝臟疾病治療為核心，拓展核酸新藥與505(b)(2) 新藥開發專案 Liver Disease Treatment at the Core, Alongside 505(b)(2) Drug Development Programs

現階段聚焦ASO核酸新藥應用於肝細胞癌（HCC）術後微量殘留疾病之治療；同時透過 505(b)(2) 法規路徑推進新藥開發專案，建立公司多元的產品化基礎。 We currently focus our ASO nucleic acid drug platform on treating minimal residual disease (MRD) following hepatocellular carcinoma (HCC) resection. In parallel, we're advancing new drug development programs through the 505(b)(2) regulatory pathway.

研發項目與候選藥物篩選

研發項目Pipeline

產品/計畫Program 開發策略Development Approach 適應症Indication 目前階段Current Stage 預計IND時間Projected IND Timing
TERT HCC MRD 自研 ASO 核酸新藥，
搭配 ctDNA 液態切片檢測平台Proprietary ASO nucleic acid drug, paired with the ctDNA liquid biopsy detection platform		 肝細胞癌（HCC）術後MRDHCC post-surgical MRD 臨床前試驗
(Preclinical Test)Preclinical Test		 規劃中Planning
505(b)(2)_HCC MRD 既有藥物劑型改良，
搭配 ctDNA 液態切片檢測平台Formulation improvement, paired with the ctDNA liquid biopsy detection platform		 肝細胞癌（HCC）術後MRDHCC post-surgical MRD 臨床前試驗
(Preclinical Test)Preclinical Test		 規劃中Planning
505(b)(2)_Gel 既有藥物劑型改良（凝膠劑型）Formulation improvement (gel formulation) 非腫瘤適應症Non-oncology indication 臨床前試驗
(Preclinical Test)Preclinical Test		 規劃中Planning
TERT HCC MRD
開發策略 自研 ASO 核酸新藥，搭配 ctDNA 液態切片檢測平台
適應症 肝細胞癌（HCC）術後MRD
目前階段 臨床前試驗
預計IND時間 規劃中
505(b)(2)_HCC MRD
開發策略 既有藥物劑型改良，搭配 ctDNA 液態切片檢測平台
適應症 肝細胞癌（HCC）術後MRD
目前階段 臨床前試驗
預計IND時間 規劃中
505(b)(2)_Gel
開發策略 既有藥物劑型改良（凝膠劑型）
適應症 非腫瘤適應症
目前階段 臨床前試驗
預計IND時間 規劃中

以 肝細胞癌（HCC）術後 MRD 為核心，發展治療手段Focused on HCC Post-Surgical MRD, Advancing Two Independent Treatment Approaches

我們聚焦肝細胞癌（HCC）術後微量殘留疾病（MRD）此一關鍵臨床課題，透過 ctDNA 液態切片檢測及早揪出肝癌手術後高復發風險的病患，並發展兩項獨立的治療手段因應：TERT HCC MRD 為自主研發之 ASO 核酸新藥，鎖定端粒酶（TERT）標的；505(b)(2)_HCC MRD 則為既有上市藥物之劑型改良，透過 505(b)(2) 法規路徑推進。兩項計畫技術路徑各自獨立，互不相依，共同建構公司在 HCC 術後 MRD 領域的治療布局。 We focus on hepatocellular carcinoma (HCC) post-surgical minimal residual disease (MRD) — a critical clinical challenge — using ctDNA liquid biopsy to identify patients at high risk of recurrence after HCC surgery early. We're advancing two independent treatment approaches in response: TERT HCC MRD, a proprietary ASO nucleic acid drug targeting telomerase (TERT); and 505(b)(2)_HCC MRD, a formulation improvement of an existing marketed drug advanced through the 505(b)(2) regulatory pathway. Both programs follow independent technical paths, together forming our treatment strategy in HCC post-surgical MRD.

檢測分層Stratification 伴隨式診斷分層Companion Diagnostic ctDNA 篩檢分層ctDNA-based screening
標靶治療Targeted Therapy TERT ASO 標靶治療TERT ASO Therapy 陽性患者主動投藥Administered to ctDNA-positive patients
動態監控Dynamic Monitoring 動態 ctDNA 監控Dynamic ctDNA Monitoring 早期療效替代指標Early efficacy surrogate

505(b)(2) 開發項目505(b)(2) Development Programs

我們透過 505(b)(2) 法規路徑，在既有藥物安全性數據基礎上，推進兩項獨立之新劑型開發專案：505(b)(2)_HCC MRD 為既有藥物之劑型改良，搭配 ctDNA液態切片檢測平台，用於肝細胞癌術後微量殘留疾病之治療；505(b)(2)_Gel 為既有藥物之劑型改良（凝膠劑型），聚焦非腫瘤適應症。兩案皆由台基核團隊主導配方測試、臨床前開發與法規申請，獨立於核酸新藥開發之外，同時作為公司近期產品化與營收基礎。 Through the 505(b)(2) regulatory pathway, and building on the existing safety data of marketed drugs, we're advancing two independent new formulation development programs: 505(b)(2)_HCC MRD pairs a formulation improvement with the ctDNA liquid biopsy detection platform for HCC post-surgical MRD; 505(b)(2)_Gel is a gel formulation improvement for a non-oncology indication. Both are led by CoGentide's team, serving as a near-term path to commercialization and revenue.

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