EVEREST MED (01952): Additional 100mg specification of Iygia approved by China's National Medical Products Administration

EVEREST MED (01952) announced that the National Medical Products Administration (NMPA) of China has approved an additional 100mg specification of Iygia (eravacycline for injection). As of November 2026, Iygia is the world's first and only fully synthetic fluorocycline antibacterial agent, characterized by a broad antibacterial spectrum, potent antibacterial activity, confirmed clinical efficacy, and a favorable safety profile. It has been recommended by multiple domestic and international guidelines and consensus statements for the empirical treatment of complicated intra-abdominal infections (cIAI) and as a clinical option for the treatment of multidrug-resistant bacterial infections. The 50mg specification of Iygia was approved in China in 2023 for the treatment of complicated intra-abdominal infections in adults. The approval of the 100mg specification represents an important milestone for the Company in optimizing its product portfolio and expanding commercialization potential, reflecting the Company's strength in addressing clinical needs and efficiently advancing product registration. Iygia utilizes a weight-based dosing regimen, with a recommended dose of 1mg/kg administered every 12 hours. The addition of the 100mg specification provides a more flexible and convenient dosing option for clinical use, helping to reduce drug preparation operations and liquid waste during treatment for some patients, further enhancing clinical convenience. Meanwhile, the approval of the 100mg specification will further strengthen the supply assurance capability of Iygia in the Chinese market to better meet clinical demand. The Company's global manufacturing base in Jiashan has obtained a production license, which will ensure supply stability from the source. The Company is actively advancing the localized production of Iygia, with technology transfer progressing smoothly, and the process validation for the 50mg dosage form of Iygia has been completed. Leveraging the Jiashan manufacturing base, the Company continues to advance the construction and upgrading of production capacity, accelerating the localization of commercialized innovative products such as Velsipity and Ximluci around its core therapeutic area product portfolio, while simultaneously advancing the layout of active pharmaceutical ingredient (API) production to continuously improve the production system from API to finished drug. In the future, the Jiashan manufacturing base will further enhance capacity allocation and production supply coordination, strengthen supply chain stability and resilience, and provide support for the Company's long-term development. Iygia (eravacycline for injection) is the world's first fluorocycline antibacterial drug, indicated for the treatment of complicated intra-abdominal infections (cIAI) in adults, with broad-spectrum antibacterial activity against multidrug-resistant Gram-negative bacteria, Gram-positive bacteria, anaerobes, and atypical pathogens. Iygia has been recommended by the Surgical Infection Society (SIS) Guidelines for the Management of Intra-Abdominal Infections, and multiple global treatment guidelines issued by the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as a treatment option for multidrug-resistant Gram-negative bacterial infections, including carbapenem-resistant infections. It has also been recommended by China's Expert Consensus on Multidisciplinary Diagnosis and Treatment of Common Surgical Intra-Abdominal Infections and the Guidelines for the Diagnosis, Treatment, and Prevention of Carbapenem-Resistant Gram-Negative Bacterial Infections. Iygia has been approved for marketing in the United States, the European Union, the United Kingdom, Singapore, and Hong Kong, China. In March 2023, the NMPA of China officially approved the new drug application for Iygia, and in July of the same year, it was successfully commercialized in mainland China, providing a new treatment option for patients with complicated intra-abdominal infections in China.