Krestin (PSK) — Competitive Intelligence Brief

Krestin (PSK) (Krestin (PSK)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Immunomodulator. Area: Oncology.

phase 3 Immunomodulator Oncology Small molecule

Target snapshot

Krestin (PSK) (Krestin (PSK)) — Hokuriku-Kinki Immunochemotherapy Study Group. PSK (polysaccharide K) is a fungal-derived immunomodulator that enhances immune cell activity to support anti-tumor responses.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Krestin (PSK) TARGET	Krestin (PSK)	Hokuriku-Kinki Immunochemotherapy Study Group	phase 3	Immunomodulator
BG00012 (DMF)	BG00012 (DMF)	Biogen	marketed	Fumaric acid ester; immunomodulator	Nrf2 (nuclear factor erythroid 2-related factor 2)
Hydroxychloroquine reduced	Hydroxychloroquine reduced	University of Sao Paulo General Hospital	marketed	Antimalarial immunomodulator	Lysosomal function; TLR signaling
Intravenous immune globulin G	Intravenous immune globulin G	Rutgers, The State University of New Jersey	marketed	Immunoglobulin replacement therapy / Immunomodulator	Multiple (polyclonal IgG antibodies targeting various pathogens and self-antigens)
Glatiramer acetate (Copaxone)	Glatiramer acetate (Copaxone)	Federal University of São Paulo	marketed	Immunomodulator; disease-modifying therapy (DMT)	T cell receptor (indirect); myelin basic protein mimic
Drug: Carfilzomib + Lenalidomide + Dexamethasone	Drug: Carfilzomib + Lenalidomide + Dexamethasone	Amgen	marketed	Proteasome inhibitor + Immunomodulatory agent + Corticosteroid combination	20S proteasome (carfilzomib); cereblon/CRBN (lenalidomide); glucocorticoid receptor (dexamethasone)
Hydroxychloroquine Sulfate Loading Dose	Hydroxychloroquine Sulfate Loading Dose	Government of Punjab, Specialized Healthcare and Medical Education Department	marketed	Antimalarial immunomodulator	Toll-like receptors (TLR), lysosomal pH modulation

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Immunomodulator class)

1. Actavis Mid-Atlantic LLC · 1 drug in this class
2. Active Biotech AB · 1 drug in this class
3. Air Force Military Medical University, China · 1 drug in this class
4. Astellas Pharma Inc · 1 drug in this class
5. Bayer · 1 drug in this class
6. Beijing Children's Hospital · 1 drug in this class
7. Cancer Institute and Hospital, Chinese Academy of Medical Sciences · 1 drug in this class
8. Centro de Investigaciones Medicas y Ensayos Clinicos Dr Italo Fabbri · 1 drug in this class
9. Chang Gung Memorial Hospital · 1 drug in this class
10. ALK-Abelló A/S · 1 drug in this class