By Fineline Cube Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for TABOSUN (ipilimumab N01 injection; IBI310), a first‑in‑class domestic CTLA‑4 monoclonal antibody, to be used in combination with the PD‑1 inhibitor sintilimab as neoadjuvant treatment for adult patients with stage IIB‑III resectable microsatellite instability‑high (MSI‑H) or mismatch repair deficient (dMMR) colon cancer.
Regulatory Milestone
| Item | Detail |
|---|---|
| Approval Authority | NMPA (China) |
| Product | TABOSUN (ipilimumab N01 injection) |
| Mechanism of Action | CTLA‑4 monoclonal antibody |
| Indication | Neoadjuvant therapy + sintilimab for stage IIB‑III resectable MSI‑H/dMMR colon cancer |
| Approval Date | 25 Dec 2025 |
| Significance | World’s first approved dual‑IO neoadjuvant regimen for MSI‑H/dMMR colon cancer; first domestic anti‑CTLA‑4 mAb in China |
Drug Profile & Strategic Position
- Discovery & IP: Fully in‑house discovery by Innovent; strengthens its sintilimab‑centric immuno‑oncology franchise
- Differentiation: Unlike imported CTLA‑4 inhibitors (e.g., Bristol‑Myers Squibb’s Yervoy), TABOSUN is manufactured and priced for the China market, offering potential cost advantages for hospital procurement
- Combination Rationale: Dual checkpoint blockade (CTLA‑4 + PD‑1) has shown superior pathological response rates in MSI‑H/dMMR tumors, which are highly immunogenic
Clinical Evidence – NeoShot Phase 3 Trial (NCT05890742)
| Endpoint | Result (TABOSUN + Sintilimab) | Comparator (Direct Surgery) |
|---|---|---|
| Trial Design | Randomized, controlled, multicenter, pivotal Phase 3 | Direct radical surgery |
| Evaluable Patients | 50 (interim analysis) | 50 (interim analysis) |
| Pathological Complete Response (pCR) Rate | 82.0 % (41/50) | Not applicable |
| Safety Profile | No significant increase in Grade ≥ 3 adverse events vs. surgery alone | Baseline surgical risk |
| Key Secondary Endpoints | Median DFS and OS under follow‑up; data expected H2 2026 | – |
The trial met its primary efficacy endpoint with a pCR rate that positions the regimen as a potential standard‑of‑care for this molecular subtype.
Market Impact & Commercial Outlook
- Incidence: China reports ~520,000 new colorectal cancer cases annually; MSI‑H/dMMR prevalence is ~12‑15 % of stage II‑III cases, translating to ~70,000 eligible patients per year
- Revenue Forecast: Innovent projects peak sales of ¥2.5‑3.0 billion (US$350‑420 million) by 2028, assuming 40‑50 % market share in the neoadjuvant MSI‑H segment and NRDL inclusion by 2027
- Competitive Landscape: No approved neoadjuvant immunotherapy for colon cancer in China; TABOSUN+sintilimab has a 3‑year first‑mover advantage over potential rivals
- Pricing Strategy: Expected WAC of ¥80,000‑90,000 per treatment course (≈ US$11,200‑12,600), ~30 % below imported PD‑1+CTLA‑4 regimens
Forward‑Looking Statements
This brief contains forward‑looking statements concerning Innovent’s revenue expectations, market penetration, and clinical development plans for TABOSUN. Actual outcomes may differ due to regulatory, competitive, and reimbursement dynamics.-Fineline Info & Tech