China-based Everest Medicines (HKG: 1952) has announced its financial and corporate update for the first half of 2023. The company reported a revenue increase of RMB 7.9 million, reaching RMB 8.9 million (USD 1.23 million) for the six-month period. This growth was primarily attributed to the sales of Xerava and Trodelvy before the latter’s return to Gilead. Research and development (R&D) expenses saw a decrease from RMB 345.5 million to RMB 288.5 million. The net loss for the period was reduced from RMB 668.0 million to RMB 423.6 million, a result of various products advancing to registration or commercial stages, as well as the transfer of Trodelvy back to Gilead.
Infectious Disease Portfolio Updates
On March 16, 2023, Everest announced that China’s NMPA approved its NDA for Xerava in the treatment of cIAI in adult patients, marking it as the first product to be commercialized by the company in China. The company anticipates NDA approval for eravacycline for the treatment of cIAI in the Taiwan region in 2023. On August 15, 2023, its partner Venatorx Pharmaceuticals announced that the US FDA accepted the NDA for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for potential treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis. The FDA granted priority review of the NDA with a PDUFA target action date of February 22, 2024.
Renal Portfolio Developments
On February 10, 2023, South Korea’s Ministry of Food and Drug Safety (MFDS) granted Global Innovative product on Fast Track (GIFT) designation to Nefecon for the treatment of primary IgAN. On March 12, 2023, partner Calliditas Therapeutics AB reported positive topline results from a Phase 3 NefIgArd Trial evaluating Nefecon in the treatment of IgAN. On April 6, 2023, Singapore Health Sciences Authority accepted the NDA for Nefecon for the treatment of IgAN in adults at risk of disease progression, with NDA approval expected in 2023. On June 21, 2023, partner Calliditas announced the submission of a supplemental New Drug Application (sNDA) to the U.S. FDA seeking full approval of Tarpeyo (brand name of Nefecon in the US) delayed release capsules for the entire study population from the Phase III NefIgArd study. A marketing approval is expected later this year in China, with the product launch planned for early next year.
Autoimmune Disease Portfolio Progress
On May 17, 2023, the company announced the completion of patient enrollment in a multi-region, multi-center Phase 3 clinical trial of etrasimod in Asia for the treatment of moderate-severe active ulcerative colitis (UC). The NDA, accepted by the U.S FDA in December 2022, is expected for final decision later this year.
Commercialization Team Expansion Plans
Everest Medicines plans to expand its commercialization team later this year and next year to support new drug approvals in the next 18-24 months.-Fineline Info & Tech
