On March 17, 2025, Shanghai Mengke Pharmaceutical Co., Ltd. (hereinafter referred to as "Mengke Pharmaceutical", 688373.SH) released its 2024 annual report. In 2024, the company will achieve an operating income of 130 million yuan, a year-on-year increase of 43.51%, and the commercialization process of its core product contezolid tablets will be steadily advanced, while a number of milestone breakthroughs have been made in the pipeline under development.

The commercialization potential of the core product contezolid tablets continues to be released

As the first new generation of oxazolidinone antibacterial drugs independently developed and commercialized by Mengke Pharmaceutical, the sales revenue of contezolid tablets (trade name: Youxitai) will reach a new high of 130 million yuan in 2024, a year-on-year increase of 43.51%, promoting the steady growth of the company's operating income. At present, contezolid tablets have covered 582 hospitals across the country, and 150 have achieved formal access and batch temporary procurement. The company has also successfully launched a new packaging specification of 12 tablets in a single box, and introduced an agent sales mechanism, with dual packaging specifications sold at the same time, to further meet the flexible medication needs of patients, which is expected to further increase the market penetration of the product.

In terms of clinical recognition, it has also continued to improve, with 14 clinical research projects initiated by post-marketing investigators. In 2024, 46 new medical evidence-based accumulation and academic construction achievements will be added, and it is worth mentioning that the "Expert Consensus on the Treatment of Drug-resistant Tuberculosis with Contezolid" was first published online, providing a new treatment strategy and scientific basis for the clinical treatment of drug-resistant tuberculosis.

The R&D pipeline has blossomed in multiple places, and the global layout has been promoted in an orderly manner

Adhering to the "innovation-driven" strategy, Mengke Pharmaceuticals has made milestone progress in a number of clinical and preclinical projects in 2024, covering acute infection, chronic infection, and oncology.

In the field of acute infection, MRX-4, as a water-soluble prodrug of contezolid tablets, has successfully completed its phase III clinical trial in China and reached the primary efficacy endpoint. At the same time, the global multi-center phase III clinical trial of MRX-4 sequential contezolid tablets for injection in the treatment of diabetic foot infection is also progressing steadily, and has been approved to be carried out in nearly 20 countries at home and abroad, with a total of 324 patients enrolled.

In addition, the Phase I clinical trial of MRX-8 as a novel polymyxin antimicrobial drug for the treatment of gram-negative bacterial infections has also been successfully completed in China. The results of the study showed that the exposure of MRX-8 in humans at the clinical dose of MRX-8 administered once a day is expected to achieve the desired efficacy against infections caused by Escherichia coli, Pseudomonas aeruginosa and Acinetobacter baumannii.

In the field of chronic infection, MRX-5, a new benzborozole antimicrobial for the treatment of non-tuberculous mycobacterial infections, successfully completed its phase I clinical trial in Australia and met the expected goals. The results of the study showed that MRX-5 demonstrated a favorable safety, tolerability, and pharmacokinetic profile in a healthy adult population. In addition, the results of the Food Effects Study showed that food did not affect the exposure of active ingredients in the body.

MRX-5 also received orphan drug designation from the FDA in December 2024, accelerating its global development process. At the same time, MRX-5 has also been approved by the National Medical Products Administration to conduct clinical trials in China, and the company will initiate a Phase I clinical trial of MRX-5 in China in 2025.

While maintaining its core competitiveness in the field of anti-infection, Mengke Pharmaceutical has also actively expanded into non-infectious fields such as solid tumors, and developed innovative biological drugs and targeted therapy drugs through peptide drug conjugates and antibody drug conjugates (ADC) technology platforms. Based on the company's self-developed new camptothecin toxin, it is expected to reduce the toxicity of ADC drugs by adjusting the pharmacokinetic properties of the toxin in vivo while maintaining or improving its anti-tumor activity. At present, the company's first ADC drug candidate has completed the druggability evaluation and successfully entered the preclinical development stage. (Zou Yi).