CrystalGenomics "Immuno-oncology drug 'Camrelizumab' combination therapy designated as innovative treatment in China"

Domestic Copyright Holder... MFDS Bridge Clinical Trial Application

[Asia Economy Reporter Lee Gwan-joo] The combination therapy of the anticancer drug 'Camrelizumab,' for which CrystalGenomics holds the rights, has been designated as an innovative treatment by Chinese regulatory authorities.

According to Hansoh Pharmaceutical on the 25th, the National Medical Products Administration (NMPA) of China has designated the combination therapy of Camrelizumab and Famitinib for non-small cell lung cancer patients as an innovative treatment.

The combination therapy of Camrelizumab and Famitinib is indicated as a first-line treatment for non-small cell lung cancer patients who are PD-L1 positive and negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK).

Camrelizumab (brand name AiRuika) is a PD-1 targeted immune checkpoint inhibitor developed by Hansoh Pharmaceutical in China. It received NMPA approval as a first-line treatment for non-small cell lung cancer in June 2020.

CrystalGenomics holds exclusive rights in South Korea for clinical development and sales of Camrelizumab, either as monotherapy or in combination therapies, for all cancer types including lung, liver, and stomach cancers.

Currently, clinical trials for approval aimed at commercialization in South Korea are underway. Last month, CrystalGenomics submitted an investigational new drug application (IND) to the Ministry of Food and Drug Safety to evaluate the efficacy and safety of the combination therapy of Camrelizumab with Pemetrexed and Carboplatin as a first-line treatment for non-small cell lung cancer.

The bridging clinical trial refers to the final stage of clinical trials conducted on domestic patients to evaluate and confirm any differences in sensitivity, in order to obtain approval domestically for drugs already approved overseas.

A CrystalGenomics official stated, “We are currently undergoing the review process to obtain approval from the Ministry of Food and Drug Safety for the bridging clinical trial targeting non-small cell lung cancer.”

This content was produced with the assistance of AI translation services.