Siltartoxatug Injection - Recombinant Anti-tetanus Toxin Monoclonal Antibody

Country: Hong Kong
Contact: HongKong DengYue

Active Ingredient:Siltartoxatug (recombinant fully human native IgG1 monoclonal antibody targeting tetanus toxin, formerly known as TNM002 or TT069).

Mechanism of Action:Specifically binds to key functional sites on the AB fragment of tetanus toxin, neutralizing it and preventing toxin entry into neural cells for passive immunization against tetanus.

Indication:Emergency prophylaxis of tetanus in adults (post-exposure, especially for tetanus-prone wounds in individuals with incomplete/uncertain vaccination history).

Dosage Form:Injection (intramuscular single dose).

Strength/Dosage:10 mg per dose (as used in phase 3 trials; superior to 250 IU human tetanus immunoglobulin (HTIG) in achieving protective anti-tetanus neutralizing antibody levels ≥0.01 IU/mL rapidly).

Key Advantages:

First-in-class recombinant monoclonal antibody (no reliance on human or equine plasma, avoiding supply shortages and pathogen transmission risks).
Faster onset: Protective antibody levels achieved more rapidly (e.g., superior at 12 hours post-administration).
Longer duration: Sustains protective levels longer than traditional HTIG.
Safety: Comparable adverse event profile to HTIG (no serum sickness, no need for pre-skin testing).
Production: Produced in Chinese hamster ovary (CHO) cells via recombinant biotechnology for high specificity, potency, consistency, and scalability.

Development Status:Approved in China (NMPA, 2025, trade name: 新替妥 / Xintituo or Sintetol); Breakthrough Therapy designation; Phase 3 trial results published in Nature Medicine (2025).

Manufacturer/Developer:Zhuhai Trinomab Pharmaceutical Co., Ltd. (using proprietary HitmAb® platform).