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股价新高!创新药“牛股”带队,多家上市公司官宣“优先审评”

Core Viewpoint - Shuyou Shen's subsidiary, Beijitai, has received priority review status from the National Medical Products Administration (NMPA) for its product STSP-0601, which is intended for the treatment of bleeding in adult patients with hemophilia A or B with inhibitors, marking a significant advancement in the drug's approval process [2][3]. Company Developments - Shuyou Shen's stock price surged nearly 190% over a 10-day period, reaching a peak of 34.49 yuan per share, the highest since 2016, following the announcement of the priority review [4]. - The company has 13 major R&D projects in clinical research stages, focusing on unmet therapeutic needs, including monoclonal antibodies and protein drugs [4]. - The capitalized R&D expenditure for STSP-0601 (with inhibitors) is reported at 85.16 million yuan, while for STSP-0601 (without inhibitors) it stands at 10.89 million yuan [3]. Industry Context - The NMPA has also granted priority review status to other companies, including He Yu and Ke Ji Pharmaceuticals, indicating a broader trend in the industry towards expedited drug approvals [5][6]. - He Yu's drug ABSK021 has received multiple recognitions, including breakthrough therapy designation from the NMPA and FDA, and has seen a significant revenue increase due to licensing agreements [6][7]. - Ke Ji's product, a CAR-T cell therapy candidate, has also been recognized by the NMPA and FDA, highlighting the growing focus on innovative cancer treatments within the industry [7].