Beijing Purunao Biotechnology Co Ltd

1. Primary Objective To determine the single-dose PK characteristics of Berretinib Enteric-coated Capsules in patients with mild, moderate and severe hepatic impairment and matched control subjects with normal hepatic function. 2. Secondary Objectives 1. Evaluate the safety and tolerability of Berretinib Enteric-coated Capsules in patients with mild, moderate and severe hepatic impairment and matched control subjects with normal hepatic function; 2. Evaluate the plasma protein binding of Berretinib Enteric-coated Capsules in patients with hepatic impairment and matched control subjects with normal hepatic function; 3. Evaluate the relationship between baseline liver function and PK parameters. 3. Exploratory Objectives To explore the relationship between Berretinib exposure and safety in patients with hepatic impairment and matched control subjects with normal hepatic function.

The efficacy of bereftib was evaluated by confirmed objective response rate (ORR) assessed by an independent review committee (IRC) in patients with locally advanced/metastatic NSCLC and MET exon 14 mutations who had not received prior MET inhibitor treatment.

Main study objectives To investigate the pharmacokinetic characteristics of a single oral administration of 3 capsules of Berretinib Enteric-coated Capsules (test preparation T, specification: 100 mg/capsule) after the production site change or 3 capsules of Berretinib Enteric-coated Capsules (reference preparation R, specification: 100 mg/capsule) before the production site change in healthy subjects under fasting conditions, and to evaluate the bioequivalence between the two preparations. Secondary study objectives To observe the safety of a single oral administration of the test preparation and the reference preparation Berretinib Enteric-coated Capsules in healthy subjects under fasting conditions.