AZ-China joint venture Dizal tests drug in Korea

MFDS approves phase 1/2 protocol on June 5 testing 44 patients in Korea

Currently Takeda and Hanmi are testing EGFR and HER2 targeted therapies in Korea

Dizal Pharma, a joint venture company by AstraZeneca and a Chinese firm, is initiating a clinical trial in Korea on non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) or human epidermal growth receptor 2 (HER2) mutation.

 

The pharmaceutical industry is paying a close attention on the Chinese company’s clinical trial, as Hanmi Pharmaceutical and Takeda are also developing a treatment targeting both patient groups either with EGFR mutation or HER2 mutation.

 

On June 5, Korea’s Ministry of Food and Drug Safety (MFDS) has approved of the transnational phase 1/2 clinical trial protocol on 'DZD9008,' submitted by a global clinical CRO firm Covance Korea.

 

The clinical trial aims to confirm the safety, tolerability, pharmacokinetics and antitumor activity of DZD9008 in advanced NSCLC patients with EGFR or HER2 mutation.

 

DZD9008 is an investigational anticancer agent in development by a Chinese-based company, Dizal Pharma.

 

The pharmaceutical company is a joint venture company by a global pharmaceutical company AstraZeneca and China Future Industry Investment Fund (FIIF).

 

In April last year, China’s National Medical Products Administration (NMPA) approved a clinical protocol on DZD9008, and soon after the joint venture company submitted an Investigational New Drug Application.

 

EGFR mutation is frequently expressed in NSCLC patients and HER2 mutation in breast cancer patients.

 

Targeted therapies for respective cancer types have been developed.

 

However, a drug to cover both patient groups with EGFR or HER2 mutation has not been approved to date.

 

In Korea, clinical trials on Hanmi Pharmaceutical’s poziotinib (phase 2 trial on NSCLC patients with EGFR or HER2 exon 20 mutation) and Takeda’s mobocertinib (phase 1/2 trial testing EGFR/HER2 inhibitor in NSCLC patients) are in progress at the movement.

 

The clinical trial on DZD9008 would call for 44 participants in Korea (180 participants worldwide) and conducted in Catholic University of Korea—St.

 

Vincent’s Hospital, National Cancer Center, Seoul Samsung Medical Center, Seoul National University Hospital and Seoul Asan Medical Center.

 

So far, none of Chinese-based pharmaceutical company has made it in Korean market, and even a finished product from China is rare to find.

 

But a couple of Chinese pharmaceutical companies are reportedly conducting clinical trials in Korea.