By Fineline Cube 
Sihuan Pharmaceutical Holdings Group Ltd. (HKG: 0460) announced today that NG‑350A, a clinical‑stage oncolytic immunotherapy licensed from Akamis Bio via its subsidiary Xuanzhu Biopharmaceutical Co., Ltd., has been granted Fast‑Track Designation by the U.S. Food and Drug Administration (FDA). The designation covers the treatment of locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR) function.
What NG‑350A Brings to the Market
- Mechanism – NG‑350A is an intravenously administered oncolytic virus engineered on Akamis’ proprietary T‑SIGn platform. Inside the tumor, it drives expression of a CD40‑agonist monoclonal antibody, activating antigen‑presenting cells (APCs) in the tumor microenvironment and draining lymph nodes. This cascade recruits T‑cells and initiates a robust anti‑tumor immune response.
- Clinical Evidence – In the FORTITUDE (monotherapy) and FORTIFY (pembrolizumab combination) studies, NG‑350A demonstrated a consistent safety and tolerability profile, coupled with evidence of tumor‑selective delivery, viral replication, and transgene expression.
- Strategic Positioning – The Fast‑Track status accelerates the regulatory review process, potentially bringing this novel therapy to patients with LARC sooner than the typical pathway.
Key Partnerships and Funding
- Licensing Structure – The license for NG‑350A was obtained by Xuanzhu Biopharmaceutical, a subsidiary of Sihuan, from Akamis Bio.
- Financial Backing – Akamis Bio, a clinical‑stage oncology company, secured USD 60 million in financing led by Sedgwick Yard in December 2024 and entered a collaboration with Sunshine Lake Pharma for Greater China rights to NG‑350A.
- Global Reach – The Fast‑Track designation in the U.S. complements Sihuan’s existing global strategy to expand its oncology portfolio in both developed and emerging markets.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech