It has been confirmed that Boryung's new small cell lung cancer drug Zepzelca has received conditional approval only with phase 2 clinical data.

Based on the Ministry of Food and Drug Safety's notice, anti-cancer drugs have been subject to conditional approval for phase 3 since January this year, and the revision of the Pharmaceutical Affairs Act has clarified the criteria for conditional approval only with phase 2 data.

The HIRA benefit evaluation will be available if the company applies for conditional approval. If the adequacy is evaluated in the HIRA, it can be converted into a reimbursed drug through drug price negotiations with the NHIS. Until the benefit is applied, patients will b