China-based oncology specialist 3D Medicines (HKG: 1244) has released its financial report for the first half of 2023, highlighting significant revenue generated by envafolimab, a programmed death-ligand 1 (PD-L1) antibody capable of subcutaneous injection. The product has been covered under 32 city-level insurance schemes (HuiMinBao) and has seen rapid uptake, resulting in RMB 352.6 million (USD 48.7 million) in sales, marking a 70.3% year-on-year (YOY) increase.
Envafolimab’s Market Performance and Insurance Coverage
Envafolimab’s inclusion in multiple city-level insurance schemes has contributed to its rapid market penetration and sales growth. The product’s performance during the period underscores its potential in addressing unmet medical needs in oncology and the company’s strategic focus on expanding access to innovative treatments.
Clinical Development and FDA Approvals
The development of envafolimab continues with a clinical trial assessing its use against irresectable locally advanced or metastatic DNA mismatch repair deficiency (dMMR) solid tumors, which commenced during H1’23. The trial involves the enrollment of 200 patients from 69 centers across 8 countries. The US FDA issued an approval for the drug in 2022, further validating its potential in the treatment of certain cancers.
Pipeline Updates and Anticipated Milestones
3D Medicines’ product pipeline is robust, with several key developments. The GAS6-AXL recombinant fusion protein batiraxcept (3D229) is expected to obtain marketing approval in China through a bridging study. Galinpepimut-S (3D189), an antitumor peptide vaccine, has shown positive results in a Phase I study for blood cancer in China, with a Phase III study anticipated to begin before the end of 2023. Additionally, 3D185, an FGFR/CSF-1R inhibitor, has received orphan drug designation (ODD) from the FDA for gastric cancer and gastroesophageal junction carcinoma and is set to enter a Phase I dosage escalation study.-Fineline Info & Tech
