China-based oncology specialist 3D Medicines (HKG: 1244) has announced receiving orphan drug designation (ODD) status from the US Food and Drug Administration (FDA) for its pipeline drug candidate 3D185. The designation was granted for the drug’s potential use in treating gastric cancer and gastroesophageal junction carcinoma (GC/GEJ). This marks the second ODD status for 3D185, following its previous approval for use in cholangiocarcinoma in October last year.
3D185: Mechanism and Clinical Development
3D185 is a small molecule inhibitor targeting fibroblast growth factor receptor (FGFR) 1-3 and colony-stimulating factor-1 receptor (CSF1R). Its anti-tumor activity has been verified at the pre-clinical level. The drug is currently undergoing a Phase I study to assess its safety and tolerability in patients with advanced solid tumors who have failed previous standard therapies. The orphan drug designation underscores the potential of 3D185 to address significant unmet needs in the treatment of rare cancers.
Market Landscape and Competitive Environment
The overall annual incidence of FGFR-related solid tumors has increased globally from 4.4 million in 2016 to 4.9 million in 2020, with a compound annual growth rate (CAGR) of 3.0%, and is projected to reach 6.8 million by 2035. In China, the incidence reached 1.4 million in 2020, with a CAGR of 2.6% from 2016 to 2020, and is expected to rise to approximately 1.9 million by 2035. The market for FGFR inhibitors is growing, with approved drugs including Johnson & Johnson’s Balversa (erdafitinib), Incyte’s Pemazyre (pemigatinib), and BridgeBio/Helsinn’s Truseltiq (infigratinib). Other competitors include Taiho Pharma’s futibatinib and Bayer’s rogaratinib. In China, 3D Medicines is competing with companies such as Zai Lab, HutchMed, InnoCare Pharma, Abbisko Therapeutics, and Betta Pharma.
Future Outlook
The receipt of orphan drug designation for 3D185 highlights 3D Medicines’ commitment to advancing innovative therapies for rare cancers. With growing market potential and a competitive landscape, 3D Medicines is well-positioned to drive the development of 3D185 and address significant unmet needs in gastric cancer and gastroesophageal junction carcinoma. The company’s ongoing clinical studies and strategic focus underscore its dedication to improving patient outcomes in oncology.-Fineline Info & Tech
