China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced that it has received an orphan drug designation (ODD) from the National Medical Products Administration (NMPA) for its docetaxel (albumin-bound) in gastric cancer, including esophagogastric junction cancer.
Product Profile
The product uses innovative human albumin encapsulation technology to deliver docetaxel nanoparticles into the patient’s body. This technology eliminates the need for hormone pretreatment before injection, reducing infusion-related allergic reactions. It significantly increases the drug’s in vivo exposure, enhancing safety, efficacy, and patient compliance.
Clinical Data
- The maximum tolerated dose (MTD) is 125 mg/m2, higher than the 75 mg/m2 for ordinary docetaxel injections.
- In vivo exposure at the proposed clinical dose is 2.8 times that of ordinary injections.
- The objective response rate (ORR) for second-line treatment in gastric cancer patients is 40%, double that of ordinary injections.
- The product’s efficacy is not affected by hormone use when combined with PD-1/PDL-1 antibodies, as no hormone pretreatment is required.
Clinical Trials
The product is undergoing multiple pivotal clinical trials in China and is currently in Phase I clinical study in the US.-Fineline Info & Tech
