Zein Biotechnology Co., Ltd., founded in 2001, is a national high-tech enterprise engaged in the construction of a full-life cycle management service system for drugs. We take MAH (Marketing Authorization Holder) as the core to support the registration and marketing of MAH drugs and commercial delivery with the compliance management and key technical service capabilities for the whole process of drug development, manufacturing, transaction promotion and post-marketing studies of drugs.
After 20 years of development, we have been approved to establish the “Chongqing Chiral Drugs Engineering Technology Research Center”, “Chongqing New Drug Design Engineering Technology Research Center” and “Chongqing Postdoctoral Research Workstation”. We established the national-level “Drug Advanced Manufacturing Technology National and Local Joint Engineering Research Center” together with Chongqing University. At present, the industrial achievements include 33 new drug certificates, 51 production approvals, 11 foreign invention patents (including 2 in the United States, 2 in Europe, 1 in Japan, 2 in South Korea and 1 in India) and 36 domestic invention patents.
We have built a R&D platform consisting of Liangjiang Medicine, Liujiang Pharma, Lanjiang Pharmaceutical and a clinical test research platform represented by Gerui Clinical Research Center Co., Ltd. (a Phase BE/I clinical research center that meets the GCP standards of the National Medical Products Administration) to provide integrated services for drug development and drug clinical research. We have built a CMO industrial service platform with our Changshou API Production Base and Jinfeng Preparations Production Base as the core, both of which were built in accordance with the new Chinese GMP, international cGMP and the latest safety and environmental standards. Changshou API Production Base covers an area of 82,000 square meters, and Jinfeng Preparations Production Base covers an area of 49,000 square meters. The capacity of API exceeds one hundred tons, and the preparations production lines cover normal-release and sustained-release capsules, granules, tablets and other dosage forms.
We focus on the R&D, production and sales of drugs for metabolic system, central nervous system, respiratory system and heart and cerebral vessels and have a number of domestic first generic and exclusive products and a number of varieties for declarations in China and the United States. Among them, orlistat products (ingredient+ preparations) have been ranked first in the world and the total sales of orlistat capsules such as “Youngsure” exceeded RMB1.4 billion; Tropisetron hydrochloride injection has occupied the top market share in China for years, donepezil hydrochloride tablets won the bid for the second batch of national medical insurance centralized procurement products and other exclusive products (Suplatast tosilate granules, ropinirole hydrochloride tablets) also have good market performance. At the same time, we also actively expand the integration of new retail and traditional retail development.
In order to accelerate our layout in whole field of pharmaceutical industry, we take the "international advanced manufacturing capability + non-profit research and evaluation organization + biological medicine transformation special fund" as our main line to build three supporting platforms, and actively promote the manufacturing of antibodies and recombinant protein drugs in cooperation with BINEX, a leading international company from South Korea in the field of biopharmaceuticals. We also actively promote the biotechnology training center and pilot scale test platform with Cytiva (formerly GE Healthcare Life Sciences Division) and cooperate with excellent domestic companies to introduce R&D and pharmaceutical technology for traditional Chinese medicine, to help realize the industrialization of high-value pharmaceutical products such as macromolecular drugs represented by antibody drugs and new vaccines, cell therapy and modern Chinese medicine in Chongqing, and to rapidly enhance the high-level development of the local pharmaceutical industry.
Straight tree from healthy heart, benevolence orientation in drugs production. Zein Biotechnology will focus on building a full life cycle management service system for drugs, take MAH as the core to provide more professional, efficient and reliable services, create better drugs to satisfy the public’s pursuit of life health.