Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorization application for SHR‑2004 injection, a Category 1 innovative drug and novel humanized monoclonal antibody targeting Factor XI (FXI), intended to prevent venous thromboembolism (VTE) in adult patients undergoing elective knee replacement surgery. No drug with the same target has been approved to date.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | NMPA (China) |
| Application Type | Marketing authorization application (NDA) – accepted |
| Product | SHR‑2004 injection (intravenous, humanized monoclonal antibody) |
| Classification | Category 1 innovative drug |
| Target | Factor XI (FXI) / activated FXIa |
| Indication | Prevention of VTE in adults undergoing elective knee replacement surgery |
| Pivotal Evidence | Study No. SHR‑2004‑301 — multicenter, randomized, double‑blind, active‑controlled Phase III |
| Announcement Date | 15 Sep 2026 |
| Review Timeline | Not disclosed |
Drug Profile & Mechanism of Action
- Molecule: SHR‑2004 — a novel humanized monoclonal antibody administered by intravenous injection.
- Target: FXI and activated FXIa in the intrinsic coagulation pathway; first in class, with no same‑target drug approved to date.
- Mechanism: SHR‑2004 selectively binds to FXI and FXIa, inhibiting the activation of FXI by upstream FXIIa and thrombin, thereby suppressing the intrinsic coagulation pathway and blocking the coagulation cascade at its amplification step.
- Scientific Rationale: FXI inhibition is designed to decouple antithrombotic protection from hemostasis — a mechanistic hypothesis pursued globally as the next frontier beyond DOACs and low‑molecular‑weight heparins.
Clinical Evidence – Pivotal Phase III (Study SHR‑2004‑301)
| Endpoint / Attribute | SHR‑2004 (90 mg single IV dose) | Comparator | Result |
|---|---|---|---|
| Design | Multicenter, randomized, double‑blind, active‑controlled | Enoxaparin | 1,165 subjects undergoing elective total knee arthroplasty (TKA) |
| Primary Efficacy — VTE Incidence at Day 12 post‑TKA | 51 % relative reduction vs. enoxaparin (P < 0.0001) | Enoxaparin | Prespecified superiority endpoint achieved |
| Absolute VTE Incidence Rates | Not disclosed | Not disclosed | — |
| Safety | Good safety and tolerability reported | — | Detailed AE profile not disclosed |
The pivotal study evaluated a single 90 mg intravenous dose of SHR‑2004 in patients undergoing elective TKA and demonstrated statistically significant and clinically meaningful superiority over enoxaparin — the standard‑of‑care prophylaxis — while maintaining a favorable safety and tolerability profile.
Market Impact & Outlook
- First‑Mover Position: With no same‑target drug approved to date, SHR‑2004 is poised to become the first approved FXI‑targeting therapy in China — and among the earliest globally — should the NDA be granted.
- VTE Prophylaxis Market: Orthopedic surgery volumes in China continue to rise with an aging population; the elective knee replacement setting alone represents a large, protocol‑driven prophylaxis market currently dominated by LMWHs and oral factor Xa inhibitors.
- Single‑Dose Convenience: A one‑time preoperative IV administration could simplify perioperative thromboprophylaxis workflows versus daily injections or multi‑day oral regimens, with potential adherence and hospital‑operation advantages.
- Competitive Landscape: Hengrui joins a global race among major pharmas developing FXI/FXIa inhibitors; SHR‑2004’s antibody approach and positive active‑controlled Phase III data strengthen its differentiation.
- Pipeline Momentum: The NDA acceptance adds another late‑stage innovative asset to Hengrui’s Category 1 portfolio, reinforcing its transition toward a globally competitive innovative‑drug platform.
- Next Steps: NMPA review outcome and potential approval timeline not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the regulatory review, potential approval and commercialization of SHR‑2004 injection for VTE prevention, including expectations based on Phase III trial results. Actual outcomes may differ materially due to risks including regulatory review decisions, post‑marketing safety requirements, competitive dynamics, and market adoption of FXI‑targeted therapies.-Fineline Info & Tech
