event: Anke Biotech announced at noon on January 2 that the company's shareholding company, Bosheng Ji'anke, received the “Notice of Acceptance†from the Food and Drug Administration, and the G-Technology of Boss Gianco “targeted CD19 autochimeric antigen receptor T cell transfusionâ€. The “Injection†clinical trial application was accepted by the General Administration on December 28, 2017. Comments: Precision Medicine : CAR-T declaration enters the first echelon The clinical application acceptance of Bosheng Gianco's CAR-T therapy marks the company's successful entry into the first echelon of domestic CAR-T declaration (Nanjing Legend, Shanghai Hengrun Dasheng, Keji Bio and Galaxy), and is also in the field of precision medicine . The layout gradually landed. Berson Gianco has established a 2,000-square-meter CAR-T cell production workshop and a complete quality control system and quality control facilities and equipment in line with GMP requirements, which can fully meet the clinical test requirements of CAR-T cell products. At the same time, Berson Gianco is actively developing CAR-T products for T-cell acute lymphoblastic leukemia (T-ALL) and solid tumors such as lung cancer and pancreatic cancer. R & D: Growth hormone water injection dosage form entered the priority review, HER2 clinically in the forefront of the country While the company's growth hormone powder dosage form continues to maintain a high growth rate of 50%, the water injection dosage form has been included in the limited review and is expected to be launched in the first half of this year to ensure the rapid growth of the growth hormone plate. At the same time, HER2 monoclonal antibody has officially launched Phase III clinical trials, and the progress is at the forefront of the country. Earnings forecast and rating In recent years, the company has adhered to biopharmaceutical-based, precision medicine and Chinese and Western medicine as the development strategy of the two wings: 1) the main growth hormone continues to grow; 2) the precision medicine field has achieved PD-1, CAR-T and oncolytic virus The frontier therapy layout, through the acquisition of Sino-German Union to enter forensic testing, participate in the clover gene, upstream gene sequencer supplier Hubei 371, etc., forming a one-stop system from instruments, reagents to technical services. We expect EPS/0/0.53/0.68 yuan for 2017/2018/2019, corresponding to the current share price PE of 50/39/31 times, maintaining the company's “Buy†rating. risk warning New technology research and development risks; M&A integration is lower than expected risk; policy change risk. (China Net) Drug intermediates,Pharmaceutical intermediates,Intermediates APIS NANYANG CHENGPENG PHARMACEUTICAL CO.,LTD , https://www.chppharm.com
Anke Bio: CAR-T declaration was accepted, and precision medicine gradually entered the stage