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太平洋医药日报:赛诺菲靶向纳米抗体新药CABLIVI在华获批
Xin Lang Cai Jing·2025-11-07 06:28

Market Performance - The pharmaceutical sector experienced a slight decline of -0.03% on November 6, 2025, underperforming the CSI 300 index by 1.46 percentage points, ranking 21st among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical research outsourcing (+0.98%), other biological products (+0.14%), and hospitals (+0.13%) showed positive performance, while offline pharmacies (-0.92%), medical consumables (-0.62%), and vaccines (-0.46%) lagged behind [1] - Top three gainers in individual stocks were Wanzhe Co., Ltd. (+9.99%), Hefei China (+9.97%), and Hualan Biological Engineering (+8.53%); top three losers were Renmin Tongtai (-9.98%), Sunflower (-7.99%), and Shutaishen (-6.62%) [1] Industry News - Sanofi announced that its innovative drug, injectable Cablivi (caplacizumab), has received approval from the National Medical Products Administration (NMPA) in China for the treatment of adult and adolescent patients (aged 12 and above, weighing at least 40 kg) with acquired thrombotic thrombocytopenic purpura (aTTP) [2] - Cablivi is a nanobody drug targeting von Willebrand factor (vWF), which works by blocking the binding of vWF to platelets, thereby inhibiting spontaneous platelet adhesion, preventing microthrombus formation, and providing a more efficient and safer treatment option for patients [2] Company News - Guobang Pharmaceutical (605507) announced an employee stock ownership plan aimed at raising a total of no more than 185 million yuan, with the total number of shares not exceeding 10% of the company's total share capital [3] - Fuxiang Pharmaceutical (300497) reported that it successfully passed the FDA's cGMP on-site inspection from August 11 to 14, 2025, and received the FDA's Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) result [3] - Hualan Biological Engineering (301093) announced that its pen-type syringe aluminum cap has recently passed the CDE technical review and is now listed as "A" status on the CDE platform for raw materials, excipients, and packaging materials [3] - Shanghai Pharmaceuticals (601607) reported that its subsidiary, Changzhou Pharmaceutical Factory, received notification from the FDA that its abbreviated new drug application (ANDA) for Ticagrelor has been approved for marketing, which is expected to positively impact the company's expansion into overseas markets [3]