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Orphan Drugs as Strategic Assets: Lifecycle Patterns, Sales Resilience, and Market Impact N55.6761
September 12, 2025
This analysis refutes the misconception of orphan drugs as niche products. Using 2025 Q1 sales data and lifecycle patterns, it demonstrates their long-term revenue resilience and strategic portfolio value.
Rare Disease Drug 101 - What are the Benefits to Apply for and Receive Orphan Drug Designation? Lin Zhang
June 29, 2021
There are many common diseases that affect millions of people across the world. On the other hand, there are so-called rare conditions that affect a small number of people.
Alphamab Oncology Announces Anti-HER2 Biparatopic ADC JSKN003 Obtained Orphan Drug Designation from the U.S. FDA for the Treatment of GC/GEJ PR Newswire
July 29, 2025
Alphamab Oncology announced that anti-HER2 biparatopic antibody-drug conjugate JSKN003 has been granted Orphan Drug Designation by the FDA for the treatment of gastric cancer?and gastroesophageal junction cancer (GC/GEJ).
Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer PR Newswire
March 19, 2025
Shanghai Henlius Biotech announced that FDA has granted ODD for HLX22 for the treatment of gastric cancer.
Henlius Receives Orphan Drug Designation for HLX22 in the U.S. for Gastric Cancer PR Newswire
March 19, 2025
Henlius announced that FDA has granted ODD for HLX22, the company's innovative anti-HER2 mAb for the treatment of gastric cancer.
HanAll Biopharma Announces Orphan Drug Designation for Batoclimab in Japan for Active Thyroid Eye Disease PR Newswire
March 17, 2025
HanAll Biopharma Co., Ltd. announced that Batoclimab has received ODD from the Ministry of Health.
Eleva Receives Orphan Drug Designation in Europe for Proprietary Factor H Therapy in C3 Glomerulopathy (C3G) Biotech Newswire
July 04, 2024
Eleva announced that the European Commission has granted the Orphan Drug Designation for Factor H (CPV-104), the company’s recombinant version of human complement Factor H, to treat C3 Glomerulopathy (C3G).
U.S. FDA Grants Orphan Drug Designation to BCMA CAR-T Cell Therapy Co-Developed by IASO Bio and Innovent prnasia
February 14, 2022
IASO Biotherapeutics ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, and Innovent Biologics, Inc.
IASO, Innovent CART-cell Therapy Gets Orphan Designation contractpharma
February 14, 2022
anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma.
FDA grants orphan drug status to Syros’ myelodysplastic syndrome therapy Pharmaceutical-Technology
February 07, 2022
Tamibarotene is currently being analysed along with azacitidine in the Phase III SELECT-MDS-1 trial.