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新诺威(300765.SZ):注射用奥马珠单抗取得药品注册证书

cspc innovation pharmaceutical (300765.SZ): Obtained pharmaceutical registration certificate for injection omalizumab monoclonal antibody.

Zhitong Finance ·  Oct 8 16:03

CSPC Pharma, a subsidiary controlled by CSPC Innovation Pharmaceutical (300765.SZ), announced that it plans to invest in the construction of the "CSPC Pharma JS Bio Large Biopharmaceutical Production Line Construction" and "CSPC Pharma JS Bio ADC New Product Commercial Production Line Construction" projects. The monoclonal antibody production line project is planned to be implemented in the factory area of CSPC Pharma JS Bio Pharmaceutical Co., Ltd. at No. 519 Cangsheng Road, High-tech Zone, Shijiazhuang. Three production lines and supporting material automatic conveying systems, biological wastewater inactivation systems, and new facilities such as automatic detection function islands will be built in JS Bio. Process equipment such as disposable bioreactors, disk centrifuges, chromatography systems, lyophilizers, and filling lines will also be purchased. After the project is completed, the production capacity of the original liquid and preparation of JS Bio monoclonal antibody products will be increased. The total estimated investment of the project is not more than RMB 0.5 billion (inclusive), and the project construction period is expected to be 21 months. The ADC new product commercial production line construction project is also planned to be implemented in the factory area of CSPC Pharma JS Bio Pharmaceutical Co., Ltd. at No. 519 Cangsheng Road, High-tech Zone, Shijiazhuang. Four production lines and supporting centralized weighing, tail gas absorption systems, and biological wastewater inactivation systems will be built in JS Bio. Process equipment such as reactors, disk centrifuges, chromatography systems, and filling lines will also be purchased. After the project is completed, the production capacity of the original liquid and preparation of JS Bio ADC products will be increased. The total estimated investment of the project is not more than RMB 0.4 billion (inclusive), and the project construction period is expected to be 21 months. This investment is conducive to improving the company's industrialization capabilities in the field of innovative biopharmaceuticals and is highly in line with the company's development strategy of building a leading platform for innovative biopharmaceuticals.

According to the Securities Times app, cspc innovation pharmaceutical (300765.SZ) announced that its controlling subsidiary, cspc pharma giant bio-pharma co., ltd. (referred to as "Giant Bio"), recently received the injection of omalizumab monoclonal antibody (trade name: Enzinta) "Drug Registration Certificate" issued by the National Medical Products Administration. This drug is suitable for adult and adolescent (12 years and older) patients with chronic idiopathic urticaria who still have symptoms after using H1 antihistamines.

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