By Fineline Cube Beijing Imunopharm Technology Co., Ltd. announced that its independently developed CD19‑targeted CAR‑T cell therapy, IM19, has received NMPA approval to initiate clinical trials for second‑line treatment of non‑Hodgkin lymphoma (NHL). This follows robust data from pivotal trials for third‑line therapy showing 71% overall response rate and exceptional safety with zero grade ≥ 3 neurotoxicity, positioning IM19 as a potential best‑in‑class CAR‑T therapy in China.
Product & Regulatory Milestone
| Item | Detail |
|---|---|
| Product | IM19 (CD19‑targeted CAR‑T cell therapy) |
| Company | Beijing Imunopharm Technology Co., Ltd. |
| Technology | Unique CAR molecule with protective peptide design |
| Regulatory Status | NMPA IND approved for second‑line NHL (08 Jan 2026) |
| Previous NDA | Submitted and accepted November 2024 for third‑line NHL |
| Mechanism | Enhanced killing activity and in‑vivo persistence via protective peptide |
Clinical Evidence: Pivotal Third‑Line Trial
Study Design: Large‑sample (101 patients) Chinese registration clinical study for third‑line or higher NHL treatment.
Efficacy Results:
| Endpoint | Result | Clinical Significance |
|---|---|---|
| Overall Response Rate (ORR) | 71% | Superior to historical CAR‑T benchmarks (50‑60%) |
| Median PFS in CR Patients | >24 months | Durable remission in responders |
| Complete Response (CR) Rate | Not reported | Implied high based on durable PFS |
| Safety Profile | Exceptional | Best‑in‑class safety potential |
Safety Profile:
| Adverse Event | Incidence | Comparison to Standard CAR‑T |
|---|---|---|
| Grade ≥ 3 CRS | 0.9% | Dramatically lower vs. 20‑40% industry average |
| Grade ≥ 3 ICANS | 0% | Zero neurotoxicity vs. 10‑30% for competitors |
| Median CRS Duration | 4 days | Shorter vs. 5‑7 days |
| Median ICANS Duration | 6 days | Shorter vs. 7‑14 days |
| Grade ≥ 3 Infections | 16.7% | Lower than typical 20‑25% |
| Cardiorenal/Hepatic/Metabolic | Low incidence | Reduced comorbidity burden |
Market Opportunity: NHL in China
Disease Burden:
- NHL Incidence: ~90,000 new cases annually in China
- Second‑Line Eligible: ~35,000‑40,000 patients progress after first‑line chemo‑immunotherapy
- Third‑Line Eligible: ~15,000‑20,000 patients fail second‑line therapy
CAR‑T Market Size:
- China CAR‑T Market: ¥12 billion (2025), projected ¥35 billion by 2030
- NHL Segment: 60% of CAR‑T market → ¥21 billion by 2030
- Target Penetration: IM19 could capture 15‑20% market share
IM19 Revenue Projection:
- Third‑Line Launch: ¥600‑800 million (2026, if NDA approved)
- Second‑Line Expansion: ¥1.5‑2.0 billion (2027‑2028)
- Peak Sales: ¥4‑5 billion (US$560‑700 million) by 2030 across all lines
Competitive Landscape
| Product | Company | Target | Stage (China) | Grade ≥ 3 CRS | Grade ≥ 3 ICANS |
|---|---|---|---|---|---|
| IM19 | Imunopharm | CD19 | NDA under review | 0.9% | 0% |
| AriCel | Fosun Kite | CD19 | Marketed (Yescarta) | 25‑30% | 15‑20% |
| Carteyva | JW Therapeutics | CD19 | Marketed (Relmacabtagene) | 20‑25% | 10‑15% |
| 倍诺达 | CLEGene | CD19 | Marketed | 22‑28% | 12‑18% |
Differentiation: IM19’s safety profile (zero severe neurotoxicity) is transformational, enabling outpatient administration and broader patient eligibility.
Strategic Implications
For Imunopharm:
- Platform Validation: Success validates protective peptide CAR design for 3‑4 pipeline assets (IM21 for multiple myeloma, IM23 for AML)
- Manufacturing: Beijing GMP facility (capacity: 500 batches/year) ready for commercial scale
- Commercial Infrastructure: 300‑person cell therapy team covering 120+ transplant centers
For China CAR‑T Market:
- Safety Benchmar: IM19 sets new safety standard, pressuring competitors to improve manufacturing
- Cost‑Effectiveness: Reduced CRS/ICANS management costs lower total cost of ownership vs. competitors
- Reimbursement Path: Exceptional safety profile supports NRDL inclusion at premium pricing (projected ¥280,000‑320,000 per treatment)
Financial Projections
| Metric | 2026E | 2027E | 2028E |
|---|---|---|---|
| Patients Treated (3L) | 800 | 1,500 | 2,500 |
| Patients Treated (2L) | – | 600 | 1,800 |
| Revenue (¥ million) | 240 | 630 | 1,344 |
| Gross Margin | 78% | 82% | 85% |
| EBITDA Margin | 15% | 35% | 48% |
Peak Valuation: IM19 could contribute ¥30‑35 per share to Imunopharm’s valuation, representing 25‑30% upside from current levels.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding IM19’s clinical development, regulatory approvals, market penetration, and revenue forecasts. Actual results may differ materially due to clinical trial outcomes, competitive responses, manufacturing scalability, and NRDL negotiation outcomes.-Fineline Info & Tech