Manufacturing Base

DS Facility

We have established our own global GMP-compliant manufacturing facilities, which meet both clinical and commercial production demands to quantity, quality and dosage form of our product candidates. We currently have four active drug substance production lines up to a total capacity of 1,600L, including three 200L and one 1,000L disposable bioreactors. We have successfully completed over 30 production batches of immunocytokines, mAbs, bsAbs and fusion proteins, which fulfilled the needs for performing preclinical studies, pilot production of antibody drugs and conducting early phase clinical trials. We have completed the installation of a production line for 5,000L bioreactor capacity, which is currently under qualification. When putting into operation, it will enable us to manufacture our drug candidates for Phase III clinical trials and commercialization in-house. Our drug product facility includes one commercial-scale liquid injection filing production line and one commercial scale lyophlized powder production line, which enables us to prepare biological products into various dosage forms according to different needs.

DP Facility

Our filling line and lyophilization line, also designed in compliance with the requirements of FDA, EMA, and NMPA, enable aseptic production of high-quality drug products for clinical trials and commercial use.

Notably, the critical areas of the filling line achieve Class A cleanliness with laminar airflow system, and the surrounding areas, including the non-critical areas of capping (Class C cleanliness) and filling (Class B cleanliness), vial washing area (Class C cleanliness), and instrument sterilization area (Class C cleanliness), also provide environmental assurance for a successful production.

With our strong GMP-compliant capability in R&D and DS and DP manufacture, and sophisticated GMP management and manufacture experiences, we are competent to fast track our products from R&D to BLA, maximally reduce the risks and costs from process and manufacture site changes, and make our products more commercially competitive.

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