By Fineline Cube Chongqing Pharscin Pharmaceutical Co., Ltd. (SHE: 002907) announced that China’s National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for HSN002066C1 tablets. The selective PARP7 inhibitor is authorized for Phase I clinical trials as a monotherapy for advanced solid tumors, marking Pharscin’s first Class 1.1 innovative drug to enter clinical development.
Regulatory Milestone
| Item | Detail |
|---|---|
| Company | Chongqing Pharscin Pharmaceutical Co., Ltd. (SHE: 002907) |
| Product | HSN002066C1 tablets |
| Drug Class | Class 1.1 innovative drug (first for Pharscin) |
| Regulatory Action | NMPA IND approval |
| Indication | Advanced malignant solid tumors (monotherapy) |
| Mechanism | Selective small‑molecule inhibitor of PARP7 (poly ADP‑ribose polymerase 7) |
| IP Status | Independently developed with full intellectual property rights |
| Administration | Oral |
Drug Profile – HSN002066C1
- Target: PARP7 – a mono‑ADP‑ribosyltransferase involved in DNA damage response, immune regulation, and cellular stress pathways
- Class: Selective small‑molecule inhibitor (distinct from PARP1/2 inhibitors like olaparib)
- Selectivity: Potent and highly selective for PARP7 vs. other PARP family members
- Innovation Status: First‑in‑class PARP7 inhibitor from Pharscin; first Class 1.1 asset in company’s pipeline
- Development Stage: IND‑approved; Phase I initiation pending
Preclinical Evidence
| Parameter | Finding | Implication |
|---|---|---|
| Oral Bioavailability | High exposure levels in murine models | Supports once‑daily oral dosing in humans |
| Monotherapy Efficacy | Significant tumor growth inhibition | Single‑agent potential across solid tumor types |
| Combination Potential | Enhanced activity in combination settings | Opportunity for synergistic regimens with chemotherapy, immunotherapy, or targeted agents |
| Tumor Model Breadth | Activity across various tumor models | Broad applicability in diverse malignancies |
Strategic Implications
- Pipeline Validation: IND approval validates Pharscin’s internal R&D capabilities and establishes a pathway for future Class 1.1 innovative assets.
- PARP7 Differentiation: Unlike marketed PARP1/2 inhibitors used in BRCA‑mutant cancers, PARP7 inhibition represents a novel mechanism with potential in immuno‑oncology and DNA damage response combinations.
- Full IP Control: Complete intellectual property ownership enables Pharscin to pursue global licensing opportunities or retain full commercial rights in key markets.
- Solid Tumor Focus: Initial monotherapy development in advanced solid tumors provides broad patient access for Phase I dose‑finding, with potential to narrow to biomarker‑selected populations in later stages.
Market Context
- PARP Inhibitor Evolution: The PARP inhibitor market is expanding beyond PARP1/2 to PARP7, PARP14, and other family members, with emerging roles in immune modulation and synthetic lethality beyond BRCA mutations.
- China Oncology Innovation: NMPA’s rapid IND approval reflects China’s supportive regulatory environment for novel target mechanisms and domestically developed innovative drugs.
- Competitive Landscape: Pharscin joins a growing field of PARP7 developers; early clinical data will be critical for establishing differentiation and partnership attractiveness.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding clinical trial initiation, safety and efficacy outcomes, and commercial potential for HSN002066C1. Actual results may differ due to risks including Phase I dose‑limiting toxicities, competitive program advancements, and manufacturing scale‑up challenges.-Fineline Info & Tech