CDMO business is one of our 3 core businesses. CDMO BU is itself mainly providing contracting, developing and manufacturing service for top pharmaceutical companies in the world on various API and intermediates from early stage to generic drug. With the mode of combining synthesis and fermentation together, CDMO reached RMB700 million in 2017.
CDMO BU: Hengdian R&D center mainly engages in the research and commercial manufacturing of the projects from stage of clinical III to commercial; and Shanghai R&D focuses on the research of the projects of pre-clinic or early stage of clinic and FTE business. The manufacturing sites located in Hengdian are specialized in manufacturing API, sites in Shandong specialized in intermediates, and sites in Dongyang and Anhui specialized in fermentation.
Our core chemistry include fluorination reaction (electrophilic fluorination and nuclear fluorination), - 90 ℃ cryogenic, catalytic hydrogenation, halogenation (chlorine, bromide, etc.), anhydrous anaerobic reaction (butyl lithium, grignard...), chiral synthesis, etc., all these reactions have been scaled up to commercial production, and have accumulated rich experience in reaction safety and environmental protection research. In view of the high risk of fluorination reaction, we have established a special automatic fluorination workshop, which can be fully electrolyzed to produce fluorine gas, and can safely control hazardous materials such as hydrogen fluoride and sulfur tetrafluoride.
There is also extensive research on flow chemistry. Now we already have microchannel reactor, venturi loop reactor, the tangential flow pipe reactor available and also have achieved some flow chemistry in commercial size, which greatly improve the reaction yield and product quality, most of all, it solved the security problem from the source.
Through over 20 years’ accumulation and efforts, we have established good cooperative relationships with top pharmaceutical companies all over the world, and a large number of products have passed FDA, PMDA, EDQM inspection. We will, as always, stick to technical innovation and service, take it as our mission to help our customers succeed as much as possible, take the perfect quality and EHS system as our guarantee, and continue to provide service to the world famous pharmaceutical companies. At the same time, we have rich experience in the development and production of advanced veterinary drug. In the future, for CDMO business, we, Apeloa, target to be a leading domestic enterprise of advanced veterinary drug!