爬坡研究的样品的生产企业包括江苏万高药业股份有限公司(以下简称：江苏万

Manufacturers of samples for climbing studies include Jiangsu Wangao Pharmaceutical Co., Ltd. (hereinafter referred to as Jiangsu Wangao), with batch numbers: A20-160801 (20mg), A40-160801 (40mg) and A120-160801 (120mg). <br>The batch number of the API used is AST2818-160616, and the manufacturing enterprise is Jiangsu Ailisi Biopharmaceutical Co., Ltd. (hereinafter referred to as Jiangsu Ailisi). <br>Based on the results of the Phase I clinical study, the specifications of the Phase II clinical samples were determined to be 40 mg and 120 mg. The manufacturer is Shanghai Xuantai Haimen Pharmaceutical Co., Ltd. (hereinafter referred to as Shanghai Xuantai), and the batch numbers are: B139A11801D (40mg) and B139B11801D (120mg). The batch number of the raw material used is AST2818-170612, and the manufacturer is Jiangsu Ailisi. <br>Based on the results of the Phase II clinical trial, the market specification of this product was finally determined as a 40 mg tablet based on (C28H31F3N8O2). <br>Subsequent development of the production process, scale-up and production process verification of the specification were carried out.

The samples studied by the climbing samples include Jiangsu Wangao Pharmaceutical Co., Ltd. (hereinafter referred to as: Jiangsu Wangao), batch numbers: A20-160801 (20mg), A40-160801 (40mg) and A120-160801 (120mg).<br>The raw material batch number used is AST2818-160616, the production enterprise is Jiangsu AlistIS Biopharmaceutical Co., Ltd. (hereinafter referred to as: Jiangsu Ayles).<br>Based on the results of Phase I clinical studies, the specifications of clinical samples used in Phase II were determined to be 40mg and 120mg, and the production company was Shanghai Xuantai Haimen Pharmaceutical Co., Ltd. (hereinafter referred to as: Shanghai Xuantai), with batch numbers: B139A11801D (40mg) and B139B11801D (120mg). The batch number AST2818-170612 is used in the raw material, and the production enterprise is Ayles, Jiangsu Province.<br>Based on the results of Phase II clinical trials, the product's market specification was finally determined to be a tablet with a 40mg (C28H31F3N8O2).<br>Subsequent production process development, amplification and production process verification of this specification.

The sample manufacturers of the climbing study include Jiangsu wangao Pharmaceutical Co., Ltd. (hereinafter referred to as "Jiangsu wangao"), batch numbers: a20-160801 (20mg), a40-160801 (40mg) and a120-160801 (120mg).<br>The batch number of API used is ast2818-160616, and the manufacturer is Jiangsu Ellis biomedical Co., Ltd. (hereinafter referred to as Jiangsu Ellis).<br>Based on the results of phase I clinical research, the specifications of phase II clinical samples were determined to be 40mg and 120mg, and the manufacturer was Shanghai xuantai Haimen Pharmaceutical Co., Ltd. (hereinafter referred to as Shanghai xuantai), with batch numbers of b139a11801d (40mg) and b139b11801d (120mg). The batch number of API used is ast2818-170612, and the manufacturer is Jiangsu Ellis.<br>Based on the results of phase II clinical trial, the product's marketing specification was finally determined as 40mg tablet based on (c28h31f3n8o2).<br>Subsequently, the specification was developed, enlarged and verified.