Iminesiru for Relebactam

Part 01 Essential Information

【Trade Name】RECARBRIO

【Original Characteristics】White to pale yellow sterile powder

【Validity】3 years

【Store Condition】 Store RECARBRIO vials at temperatures between 20°C and 25°C, with permissible fluctuations within the range of 15°C to 30°C

【Specification】Each bottle contains 1.25 g of the following: 263 mg of Ralipartat hydrate (containing 250 mg Ralipartat), 530 mg of Imipenem hydrate (containing 500 mg Imipenem), and 531 mg of Cisatracitan sodium (containing 500 mg Cisatracitan).

【Component Information】

Imipenem hydrate

Formula Weight：317.36

CAS：74431-23-5

Chemical Formula：C12H17N3O4S

Structural Formula:

Cilastatin Sodium

Formula Weight：380.43

CAS：81129-83-1

Chemical Formula：C15H26N2O5S

Structural Formula：

Rulibatan Hydrate

Formula Weight：366.39

CAS：1174020-13-3

Chemical Formula：C12H20N4O6S

Structural Formula：

【Usage And Dosage】

Typically, for adults, the dosage is 1.25 g per dose (Relebent 250 mg, Imipenem 500 mg, or Cisatracetafuran 500 mg), administered four times daily; each dose should be infused over 30 minutes via intravenous drip.

【Indication】

Indicated for the treatment of the following infections caused by susceptible Gram-negative bacteria.

（1）Hospital-acquired pneumonia and ventilator-associated pneumonia (HABP/VABP).

（2）Complex urinary tract infections, including pyelonephritis (cUTI), are indicated for patients for whom alternative treatment options are limited or unavailable.

（3）Patients with complex intra-abdominal infections (cIAI) who have limited or no alternative treatment options.

PART 02 Product Superiority

Yasiril was approved in the United States on July 17,2019; on June 4, 2020, the U.S. FDA approved an expanded indication for Yasiril; in February 2020, it received approval in the European Union; on May 12, Merck & Co. announced that Imxisiril for injection had been launched in China.

Studies have demonstrated that rulibactam in combination with imipenem has no effect on the pharmacokinetic profiles of either drug, and both exhibit similar half-lives. When imipenem, cisatracitan, and rulibactam are administered concomitantly, rulibactam protects imipenem from degradation by certain serine β-lactamases (such as SHV, TEM, CTX-M, P99, PDC, and KPC), inhibits AmpC activity, restores the susceptibility of *Pseudomonas aeruginosa* to imipenem, and reinstates the activity of imipenem against non-susceptible Gram-negative pathogens; however, Recarbrio is not susceptible to metallo-β-lactamases (MBLs) — Enterobacteriaceae producing MBLs have long been recognized as multidrug-resistant pathogens in clinical practice.

PART 03 Active Pharmaceutical Ingredient (API) Registration Status

（1）Imipenem API：

Companies using DMF

The CDE official website already lists 8 registered enterprises, 6 of which have converted to A-shares.

（2）Cisstatin Sodium Active Pharmaceutical Ingredient：

Companies using DMF

The CDE official website already lists 8 registered enterprises, 6 of which have converted to A-shares.

（3）Rulibatan API: The DFM List and the CDE official website currently do not contain API registration information; for the partner's sterile API project, progress has reached the validation stage.

PART 04 Preparations Approval Status

Registration Category: Class 4 Chemical Drugs

（1）Domestic approval: None

（2）International Approval:

(3) International Regulatory Submission (Already Listed)

Part 05 Contact Us

We provide full-process formulation development services for Imine Xirui (Class 4 chemical drug) for injection.

Proficient in the formulation and manufacturing process of the Imipenem + Cisatracitan + Rulibactam compound sterile powder, with demonstrated capabilities for pilot-scale upscaling and commercial-scale production conversion.

For the core active pharmaceutical ingredient Rilabatamab, our sterile API has progressed to the validation stage, enabling us to collaboratively address related regulatory reviews.

We can provide comprehensive formulation process development and technology transfer services.

We welcome inquiries and collaborations.