Tebipenem

Infections caused by drug-resistant Gram-positive bacteria, Gram-negative bacteria and anaerobic bacteria are the core difficulties in the treatment of clinical severe infections. Some drug-resistant bacteria have insufficient sensitivity to existing carbapenem drugs, and there is an urgent clinical need for new treatment options with both broad-spectrum antibacterial activity and high safety. Tebipenem is an oral carbapenem antibiotic, which exerts its antibacterial effect by inhibiting the synthesis of bacterial cell walls. It has excellent activity against a variety of common pathogenic bacteria including penicillin-resistant Streptococcus pneumoniae and Haemophilus influenzae. It is mainly clinically used for the treatment of otorhinolaryngological infections, respiratory tract infections and urinary tract infections in children. It is the world's first oral carbapenem drug approved for use in children, which can greatly reduce the compliance burden of intravenous administration in children with severe diseases.

The global market size of oral carbapenem drugs is approximately USD 320 million, with a compound annual growth rate of 7.8% in the past 3 years. Among them, tebipenem is the fastest-growing variety in this segment, accounting for more than 40% of the market share. At present, there is no generic drug of this variety launched in China, and only the original research product is available in some regions. The annual sales at the terminal of public medical institutions have exceeded RMB 120 million. With the continuous upgrading of demand for pediatric antibacterial drugs, the market growth rate is expected to remain above 15% in the next 3 years, and the space for generic development is considerable.

The original research enterprise of tebipenem is Meiji Seika Pharma Co., Ltd. of Japan, with the trade name Omefin. Its core compound patent expired in 2021, and the formulation patent in China expired in 2023. The main dosage form approved for the original research product is oral dry suspension, with a specification of 10% (100mg/1g). This variety has been included in the Japanese Orange Book Reference Preparation Catalog, and is also listed as a reference preparation by the FDA. Up to now, a number of enterprises in China have submitted DMF registration applications for tebipenem API, and there is no domestic formulation variety approved for marketing. The original research formulation obtained the import approval from the National Medical Products Administration in 2021. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for tebipenem API, covering all categories such as synthesis process impurities, degradation impurities and enantiomers. Most products have sufficient stock reserves. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the full-process R&D needs such as API registration and declaration, quality research and stability investigation.