China-based biotech RemeGen (HKG: 9995) reported RMB 349 million (USD 50.5 million) in revenue for H1 2022, a 1,094.8% year-on-year surge, driven by sales of its two marketed products: Aidixi (disitamab vedotin), a HER2-targeted ADC for cancer, and Taiai (telitacicept), a fusion protein for autoimmune diseases.
Product Approvals and Trials
- Telitacicept: Conditionally approved in China in March 2021 for systemic lupus erythematosus (SLE). A Phase II study in myasthenia gravis (MG) concluded in China in February 2023, and a Phase III trial in U.S. SLE patients is enrolling.
- Disitamab Vedotin: Conditionally approved in June 2021 for third-line HER2+ gastric cancer. Received IND approvals in China for perioperative bladder cancer (with toripalimab) and HER2+ GC/GEJ (with RC98).
R&D and Financials
RemeGen’s R&D spending rose 37.7% YOY to RMB 450 million in H1 2022, while net losses increased 10.2% to RMB 489 million. The firm is advancing 14 clinical trials globally, including U.S. studies for telitacicept in SLE.-Fineline Info & Tech
