Brukinsa 80mg (Zanubrutinib), the first new drug in Korea by Chinese pharmaceutical company Beijing, has secured MCL indications only with therapeutic clinical trial data (phase 2). This is because there was an expert opinion that according to Article 7, No. 6 of the Regulations on Item Permission, Report, and Review of Medicines, it could replace therapeutic confirmation clinical trial data.

According to the minutes of the Central Pharmaceutical Review Committee on January 21, released by the MFDS on the 3rd, an advisory review on the validity of the requirements for submitting approval data related to rare drugs for MCL treatment was conducted.

At the meeting, it was concluded that "MC