
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

According to the official website of the National Medical Products Administration, Qilu Pharmaceutical’s Zoledronic Acid Concentrate for Injection (5 ml: 4 mg) has passed the consistency evaluation, making it the first company to achieve approval for this specification. The indications corresponding to this specification are: ① Used in combination with standard antineoplastic therapy for the treatment of skeletal complications in patients with bone metastases from solid tumors and in patients with multiple myeloma. ② Treatment of malignantTumorhypercalcemia caused by.
Zoledronic acid is a third-generation bisphosphonate. Compared with first- and second-generation agents, it demonstrates superior clinical advantages, including more potent anti-resorptive effects and greater efficacy in reducing the incidence of skeletal-related events. It is currently the only bisphosphonate approved worldwide for the treatment of bone metastases from various types of solid tumors and skeletal complications in multiple myeloma. Zoledronic acid has been included in the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Multiple Myeloma (2020.V2) and the Chinese Society of Clinical Oncology (CSCO)Breast CancerClinical Practice Guidelines 2018 V1》and other authoritative domestic and international guidelines and expert consensus recommendations.
According to the PharmaGo database of Medicine Cube, Yangtze River Pharmaceutical Group and Chia Tai Tianqing are currently also applying for consistency evaluation of zoledronic acid injection (5 mL: 4 mg).BioValleyBioon.com)