By Fineline Cube 
Hangzhou Bio‑Sincerity Co., Ltd. (SHE: 301096) announced today that its BIOS‑0625 tablet, a Class 1 small‑molecule innovative drug, has received clinical trial approval from China’s National Medical Products Administration (NMPA) for the treatment of ulcerative colitis (UC).
Deal & Development Highlights
| Item | Detail |
|---|---|
| Drug | BIOS‑0625 (tablet) |
| Indication | Ulcerative colitis (moderate‑to‑severe) |
| Regulatory Milestone | NMPA clinical‑trial authorization (Phase I/II) |
| Mechanism of Action | Novel, first‑in‑class target not addressed by any approved UC therapy worldwide |
| Company | Hangzhou Bio‑Sincerity (SHE: 301096) |
| Announcement Date | 11 Nov 2025 |
| Next Steps | Initiate Phase I safety study in China, followed by Phase II efficacy trials; potential global IND filing in 2026 |
Scientific & Market Context
- Unmet Need: Current UC treatments (5‑ASA, biologics, JAK inhibitors) do not address the new molecular pathway targeted by BIOS‑0625, leaving a therapeutic gap for patients who are refractory or intolerant to existing options.
- Competitive Landscape: No approved small‑molecule drugs worldwide target this mechanism, giving Bio‑Sincerity a first‑to‑market advantage if clinical data confirm efficacy and safety.
- Strategic Impact: The NMPA approval validates Bio‑Sincerity’s in‑house discovery platform and positions the company to attract partnering interest from multinational pharma seeking novel UC assets.
Financial & Investor Implications
- R&D Funding: The company plans to allocate RMB 150 million (≈ US$21 million) from its cash reserves to accelerate the BIOS‑0625 program, with additional financing under consideration for later‑stage trials.
- Share Reaction: Bio‑Sincerity’s A‑shares rose ≈ 3.2 % in early trading following the announcement, reflecting investor optimism about the pipeline‑centric milestone.
- Outlook: Successful Phase I/II outcomes could enable global IND submissions and open pathways for co‑development or licensing deals, potentially adding multi‑billion‑dollar valuation upside.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the development timeline, regulatory expectations, and commercial potential of BIOS‑0625. Actual results may differ due to risks including clinical trial outcomes, regulatory approvals, and market acceptance.-Fineline Info & Tech