At present, we have established a sound R&D system covering several technical segments for pre-clinical research on bio-macromolecular protein drugs: ① upstream fermentation, expression; ② downstream extraction and purification; ③ preparation; ④ testing technology development; ⑤ quality assurance (QA). Meanwhile, we have preliminarily established professional teams for animal experiments, clinical research, international and domestic registration and declaration, and realized the construction of a complete system of new drug preclinical research, registration and declaration, clinical research and marketing and production.