On July 9, the CDE official website showed that Sinovent's application for the marketing approval of imipenem-cilastatin sodium fonobactam for injection (hereinafter referred to as imipenem-cilastatin sodium fonobactam for injection) was officially accepted. This world-first new antibacterial drug is intended to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), directly addressing the most difficult problem of drug-resistant bacterial infection in clinical practice.

Compared with other new β-lactamase inhibitors (such as avibactam, relebactam, etc.), this product has a wider and stronger inhibitory activity, and can comprehensively and effectively inhibit the common A, C, and D enzyme activities of Gram-negative bacteria.

Behind this breakthrough is a key breakthrough in the field of drug-resistant bacteria by a Chinese pharmaceutical company that was established only 8 years ago.

In the intensive care unit, hospital-acquired pneumonia and ventilator-associated pneumonia are common life-threatening infections. What is more worrying is that the detection rate of carbapenem-resistant Gram-negative bacteria continues to rise, making the traditional "last line of defense" antibiotics gradually ineffective.

The World Health Organization (WHO) has long listed carbapenem-resistant Acinetobacter baumannii (CRAB), Pseudomonas aeruginosa (CRPA) and Enterobacter (CRE) as the three major drug-resistant bacteria with serious threats. The infection mortality rate caused by these drug-resistant bacteria is extremely high, and clinical treatment options are extremely limited.

The iminexifu that Sinovent applied for listing this time is aimed at this major unmet clinical need. As a new type of β-lactam/β-lactamase inhibitor combination preparation, it can effectively fight against the three major carbapenem-resistant Gram-negative bacilli at the same time, becoming the world's first BL/BLI drug with such a broad-spectrum antibacterial activity.

This application is based on the positive results of the XNW4107-302 international multicenter Phase III clinical study (Reitab Study). This prospective, double-blind, randomized, positive drug-controlled key study covers multiple research centers around the world and enrolled a total of 449 patients.

The results showed that in terms of the primary endpoint, all-cause mortality on day 14, imipenem achieved non-inferiority results. More importantly, the drug showed better results than the control group in terms of clinical treatment success rate and clearance rate of drug-resistant microorganisms.
Sinopharm, an innovative pharmaceutical company founded in 2017, has been active in the industry in recent years.

On May 29, Sinovent announced an exclusive licensing agreement with Japan's Astellas, granting Astellas the overseas rights to its new generation of antibody-drug conjugate XNW27011 targeting CLDN18.2. The total transaction amount exceeded RMB 10.5 billion, becoming one of the important cases of Chinese innovative drugs going overseas this year. According to the agreement, Sinovent will receive a down payment of RMB 935 million.

In February last year, Sinovent successfully completed a RMB 700 million Series E financing, led by Tencent Investment and Guoxin Investment, with participation from several well-known institutions and continued support from old shareholder Loyal Valley Capital.

Currently, the company has 10 products in the clinical development stage, covering three major areas: precision tumor treatment, multidrug-resistant bacterial infection and metabolic diseases.

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