On May 12, the official website of the Guangdong Provincial Drug Administration released an articleannouncement, announced the list of the third batch of key biopharmaceutical industry innovation service projects, key enterprises, and key regional innovation service lists.Listed companies on the Science and Technology Innovation BoardSinovac PharmaceuticalsIts wholly-owned subsidiary, Shenzhen Kexing Pharmaceutical Co., Ltd., is on the list of innovative drugs, the SHEN26 project of oral new crown small molecule drugs.
The announcement shows that there are two main application conditions for this batch of key innovative drug projects: in accordance with the “Measures for the Administration of Drug Registration”, the drugs that are included in the breakthrough therapy drug procedure, the conditional approval procedure, the priority review approval procedure, and the special approval procedure are listed on the market. Registration items; those that comply with the “Administrative Measures for Drug Registration” and the provisions of drug registration classificationtraditional Chinese medicineinnovative drugs, chemical drugs and innovative drugsBiological productInnovative drug listing registration project.
In February this year, Shenzhen Kexing signed a cooperation agreement with Shenzhen Antaiwei Biopharmaceutical Co., Ltd. to jointly develop a novel coronavirus polymerase (RdRp) inhibitor SHEN26. The project plans to conduct Pre-IND in May, and the company has confirmed Phase 1 clinical research institution, and cooperate with clinical trial CRO companies, including phase 1 clinical program, ethics review and other preliminary work.
It is understood that the “Guangdong Provincial Drug Administration’s Biopharmaceutical Industry Key Projects, Key Enterprises, and Key Areas Innovative Service Management Measures” will be officially released by the Guangdong Provincial Drug Administration in 2021, aiming to continuously optimize the business environment and serve the province’s biological The innovation and development of key projects, key enterprises and key regions in the pharmaceutical (including cosmetics) industry will help the comprehensive and high-quality development of the biopharmaceutical industry. The key project categories are divided into innovative drug projects,innovative medicalEquipment items and cosmetic items.
(Article source: ChinasecuritiesReport · China Securities Network)
Article source: China Securities Journal China Securities Network
Responsible editor: 33
Original title: Kexing Pharmaceuticals: Shenzhen Subsidiary’s New Crown Oral Drug was selected into the third batch of “Triple” innovative service list in Guangdong Province
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