According to Zhitong Finance App, Genting Xinyao (01952) issued an announcement. China National Drug Administration (NMPA) has approved the addition of 100 mg of ijia® (injectable ylacycline hydrochloride). Ijia ® is the world's first and only fully synthetic fluorocycline antimicrobial drug (as of November 2026). It has the characteristics of broad antimicrobial spectrum, strong antibacterial activity, accurate clinical efficacy, and good safety. It has been recommended by many domestic and foreign guidelines and consensus for empirical treatment of complex abdominal infections (CiAI) and as a clinical choice for the treatment of multi-drug-resistant bacterial infections. The Eiga ® 50mg specification was approved in China in 2023 to treat complicated abdominal infections in adults. The approval of the 100mg specification is an important milestone in improving the company's product layout and expanding commercialization potential, reflecting the company's ability to efficiently promote product registration based on clinical needs.
Eiga ® uses a weight-based dosing regimen. The recommended dose is 1 mg/kg, every 12 hours. The new 100mg specification provides clinical with more flexible and convenient specification options, helps reduce drug preparation operations and drug waste during treatment for some patients, and further enhances the convenience of clinical medication use. At the same time, approval of the 100mg specification will further enhance the supply guarantee capacity of Yiga® in the Chinese market and better meet clinical needs.
The company's global production base in Jiashan has obtained a production license and will guarantee stable supply from the source. The company is actively promoting the localized production of Iga®, and the technology transfer is progressing smoothly. Among them, the Iga ® 50 mg dosage form has completed process verification. Relying on the Jiashan production base, the company continues to promote production capacity building and upgrading, accelerate the localized production process of commercialized innovative products such as Weisipin® and Starbital® around the product portfolio in the core therapeutic field, and simultaneously promote the production layout of APIs to continuously improve the production system from APIs to proprietary pharmaceuticals. In the future, the Jiashan production base will further enhance the capacity allocation and production and supply coordination capabilities, enhance the stability and resilience of the supply chain, and provide support for the company's long-term development.
Ijia ® (injectable eracycline hydrochloride) is the world's first fluorocycline antibacterial drug. It is suitable for treating complex abdominal infections (CiAi) in adults, and has broad-spectrum antibacterial activity against multidrug-resistant gram-negative bacteria, gram-positive bacteria, anaerobic bacteria, and atypical pathogens.
Ijia ® has been recommended by the “American Society of Surgical Infectious Diseases Guidelines for the Management of Celiac Infections”, multiple global treatment guidelines issued by the American Society of Infectious Diseases (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as a treatment plan for multiple drug-resistant gram-negative bacterial infections, including carbapenem resistance. It has also been recommended by China's “Expert Consensus on Multidisciplinary Diagnosis and Treatment of Common Surgical Celiac Infections” and “Guidelines for the Diagnosis, Treatment and Prevention of Carbapenemicen-Resistant Gram Negative Bacteria”.
Iga ® has now been approved for listing in the US, the European Union, the United Kingdom, Singapore, and Hong Kong, China. In March 2023, China's State Drug Administration officially approved the new drug marketing license application for Iga®, and successfully commercialized it in mainland China in July of the same year, providing new treatment options for patients with complicated abdominal infections in China.