By Fineline Cube 
TJ Biopharma (Hangzhou) Co., Ltd. and Jumpcan Holdings Group announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved a bioequivalence (BE) clinical trial for locally manufactured Eftansomatropin alpha injection, advancing the companies’ comprehensive localization strategy for the first and only long‑acting fusion protein growth hormone in China.
Regulatory & Development Milestone
| Item | Detail |
|---|---|
| Product | Eftansomatropin alpha injection (long‑acting growth hormone) |
| Technology | Patented hyFc fusion protein (human GH + human immunoglobulin) |
| CDE BE Trial Approval | Acceptance No.: CXSL2500596 (Dec 2025) |
| Import Drug Application (IDL) Withdrawal | JXSS2400105 ( voluntarily withdrawn to prioritize local NDA) |
| Collaboration Origin | Strategic partnership signed Nov 2021 |
| Localization Status | Technology transfer and process optimization completed; production capacity fully ready |
Technology Profile: hyFc Fusion Platform
- Mechanism: Covalently fuses recombinant human growth hormone to a modified human immunoglobulin Fc fragment, creating a stable, long‑acting biologic
- Key Advantages:
- Extended Half‑Life: Enables once‑weekly dosing vs. daily injections
- Preserved Bioactivity: Maintains full GH receptor binding and signaling
- Manufacturing Scalability: Fusion protein design allows cost‑effective production in CHO cells
- Patient Convenience: Reduces injection frequency, improving adherence and quality of life
Strategic Localization Rationale
Import→Local Pivot: Withdrawing the IDL and pursuing a localized New Drug Application accelerates regulatory approval timeline by 12‑18 months and positions the product for:
- NRDL Negotiation: Local manufacturing qualifies for 2026‑2027 National Reimbursement Drug List inclusion
- Cost Competitiveness: Domestic production reduces unit cost by 40‑50% vs. imported equivalent
- Supply Chain Security: Eliminates import dependencies and cold‑chain logistics risks
- Market Access: Enables hospital listing in Tier 2‑3 cities where import biologics face procurement barriers
Clinical Path & Market Opportunity
BE Trial Design: Single‑center, randomized, double‑blind study comparing pharmacokinetic/pharmacodynamic equivalence between imported and locally produced Eftansomatropin alpha in 120 pediatric GHD patients; primary endpoint: AUC₀‑ₜ and C_max ratio 90% CI within 80‑125%.
| Milestone | Target Date | Significance |
|---|---|---|
| BE trial completion | Q3 2026 | Data supports local NDA submission |
| NDA filing | Q4 2026 | Accelerated review pathway (Category 1) |
| NMPA approval | Q3 2027 | First locally made long‑acting GH |
| Commercial launch | Q4 2027 | Capture peak sales season |
Market Size: China’s growth hormone market reached ¥9.2 billion in 2025, with long‑acting GH segment growing at 30% CAGR but comprising only 8% of total prescriptions, indicating massive conversion potential from daily injections.
| Parameter | 2027E | 2030E |
|---|---|---|
| Pediatric GHD patients | 310,000 | 340,000 |
| Long‑acting GH penetration | 12% | 25% |
| Eftansomatropin peak share | 35% | 45% |
| Projected annual sales | ¥850 million | ¥2.1 billion (US$120‑295 million) |
Competitive Landscape
| Product | Company | Half‑Life | Stage | Annual Cost (¥) |
|---|---|---|---|---|
| Eftansomatropin alpha | TJ Biopharma / Jumpcan | 7‑10 days | BE trial | ¥35,000‑40,000 (projected) |
| Jintropin (daily) | GeneScience | 0.5 days | Marketed | ¥45,000‑60,000 |
| Somapacitan | Novo Nordisk | 7 days | Phase 3 (China) | ¥55,000‑70,000 |
| Lonapegsomatropin (Skytrofa) | Ascendis Pharma | 7 days | Approved (US/EU) | ¥70,000+ (import) |
Differentiation: Eftansomatropin’s hyFc fusion offers potentially longer half‑life and lower immunogenicity vs. PEGylated competitors, while local manufacturing ensures pricing advantage and NRDL access.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Eftansomatropin alpha’s regulatory timeline, market penetration, and revenue projections. Actual results may differ due to BE trial outcomes, competitive responses, and NRDL negotiation dynamics.-Fineline Info & Tech