Shanghai RAAS opens a second Phase 2 test of SR604 in Factor VII deficiency
The subcutaneous replacement therapy adds a 12-patient bleeding-rate study in China as Shanghai RAAS runs three SR604 trials across coagulation disorders at once.
Executive Summary
- Shanghai RAAS Blood Products has registered a Phase 2 exploratory trial of its Factor VII replacement injection SR604 in patients with congenital coagulation Factor VII deficiency, a rare bleeding disorder with no dedicated approved treatment.
- The study is small, open-label, and single-arm, built to characterize bleeding-rate reduction and safety rather than to support registration on its own.
- SR604 is already being tested in overlapping coagulation trials from the same sponsor, making this the latest of several parallel efforts to expand the molecule's use.
- The field around Factor VII replacement is populated by approved agents used in adjacent bleeding disorders, but none carries an approved label for this specific congenital deficiency, leaving the therapeutic gap open.
The trial
The study, listed under NCT07711158, will enroll an anticipated 12 patients aged 12 to 65 with historical or screening Factor VII activity below 10% and at least two treated bleeding events in the three months before enrollment. It is open-label with a single treatment arm, delivering SR604 by subcutaneous injection, and is not yet recruiting as of the registration date. The primary endpoint is treated overall annualized bleeding rate measured through 28 weeks of treatment, with secondary measures covering menstrual bleeding rate, joint bleeding rate, quality-of-life scores, and patient satisfaction. The trial is not designated registrational and carries a primary completion date of February 1, 2027, with a full completion date of December 1, 2027. NCT07711158A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII DeficiencyNCT07711158
Portfolio pattern
Shanghai RAAS runs SR604 in at least three registered trials at once: this new Factor VII deficiency study, a Phase 2 trial in hemophilia A completing its safety cohort assessment in December 2026, and an earlier study in healthy participants and hemophilia patients that is nearing completion in September 2026. The sponsor's total portfolio spans three trials, two recruiting and one not yet recruiting. Running the same molecule across multiple bleeding-disorder populations concurrently is consistent with a broad development strategy for a single replacement-therapy asset rather than a single-indication bet. A+1A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII DeficiencyJul 17, 2026A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII DeficiencyNCT07711158
The competitive frame
Congenital Factor VII deficiency has no FDA-approved dedicated therapy: the labeled Factor VIIa concentrate on the U.S. market explicitly excludes congenital Factor VII deficiency from its indication, limiting its use to hemophilia A or B patients with inhibitors. The broader Factor VII replacement field includes prothrombin complex concentrates and recombinant Factor VIIa products from Takeda, Novo Nordisk, Octapharma, and CSL Behring, but these are approved for anticoagulant reversal or hemophilia settings, not this congenital deficiency. Within the specific Factor VII target class, only three industry trials are active, two of them SR604 studies from Shanghai RAAS and one testing Hemab ApS's Sutacimig in a different Factor VIIa-directed program, making Shanghai RAAS the largest sponsor of testing volume in this narrow class. A bleeding-rate reduction that holds up as SR604's other concurrent trials mature would be the signal that distinguishes replacement therapy from the off-label use of agents approved for adjacent bleeding disorders.
What the readout tests
With 12 patients, no control arm, and an open-label design, the trial is built to characterize SR604's effect on bleeding frequency and its safety and immunogenicity profile in a population defined by very low native Factor VII activity, not to produce a comparative efficacy claim. Secondary endpoints tracking anti-drug antibody incidence and pharmacokinetic parameters alongside the annualized bleeding rate measure will shape whether the sponsor can move toward a larger, potentially registrational program in this indication. NCT07711158A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII DeficiencyNCT07711158
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