On July 27, the State Food and Drug Administration issued a notice, Hunan Xiangzhong Pharmaceutical Co., LTD. Sodium valproate tablet and Beijing Sihuan Kebao Pharmaceutical Co., LTD. Olotadine hydrochloride tablet are the category of the third national review, successfully realized the curve overtaking!
The clinical studies of the two projects were completed by Duzheng Biology "One-stop" (co-established by the third Xiangya Hospital of Central South University and Hunan Provincial Institute of Occupational Disease Prevention and Control, in charge of the recruitment of Shetong Intelligent, in charge of the SMO service, and in charge of the data management and statistical analysis of the weightech data).
Sodium valproate is a broad spectrum antiepileptic drug without nitrogen, which is the market leader of antiepileptic drugs in China. It is effective for all types of minor seizures, myoparoxysmal epilepsy, localized grand seizures, grand seizures and mixed epilepsy, and is mostly used for various types of epilepsy that are ineffective with other antiepileptic drugs. In 2019, sales of sodium valproate in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as China's public medical institutions) exceeded 2 billion yuan, according to Milet data.
Ololuta is a H1 receptor blocker, which is clinically used for pruritus associated with allergic rhinitis, urticaria, skin diseases (eczema, dermatitis, pruritus, pruritus, psoriasis vulgaris, pleomorphic erythema exudate). According to Milet data, the sales data of Olotadine in domestic sample hospitals in 2019 was 110 million yuan, with a year-on-year growth of 49.29%; In the first three quarters of 2020, the company achieved sales of 86.53 million yuan.
Duzheng Biotechnology has been providing high-quality and professional "one-stop" service for the clinical research of drugs and medical devices for the global biomedical enterprises with efficient recruitment and management of subjects, rich clinical resources, strict quality management and risk control system, and perfect information system guarantee. Help enterprises break through r&d bottlenecks and seize priority markets.