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NordiFlex
NordiFlex is a monoclonal antibody that targets the PD-1 receptor.
NordiFlex is a monoclonal antibody that targets the PD-1 receptor. Used for Non-small cell lung cancer, PD-L1 positive, Head and neck squamous cell carcinoma.
At a glance
| Generic name | NordiFlex |
|---|---|
| Sponsor | TJ Biopharma Co., Ltd. |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By binding to PD-1, NordiFlex prevents the interaction between PD-1 and its ligands, thereby releasing the brakes on the immune system and allowing it to attack cancer cells more effectively. This mechanism is thought to be responsible for the drug's anti-tumor activity.
Approved indications
- Non-small cell lung cancer, PD-L1 positive
- Head and neck squamous cell carcinoma
Common side effects
- Pneumonitis
- Hypothyroidism
- Fatigue
Key clinical trials
- Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency (PHASE2, PHASE3)
- A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency (PHASE3)
- A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency (PHASE1)
- Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents (PHASE4)
- A Single Dose Trial in Growth Hormone Deficient Children Investigating Safety, Pharmacokinetics and Pharmacodynamics of Long Acting Growth Hormone (PHASE2)
- Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™
- Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NordiFlex CI brief — competitive landscape report
- NordiFlex updates RSS · CI watch RSS
- TJ Biopharma Co., Ltd. portfolio CI