Regulatory Developments - The National Medical Products Administration (NMPA) held a meeting on post-market regulation of medical devices, emphasizing the need for a balance between safety and industry vitality while planning for 2026 [1] - The NMPA approved the long-acting growth hormone injection, Nozeyou®, developed by Novo Nordisk, marking it as the first international original long-acting growth hormone for children in China [4] - Changchun High-tech's subsidiary, GenSci, received acceptance for a clinical trial application for GenSci141 ointment, which aims to address various hormonal deficiencies in children [5] - Jiukang Bio announced the acquisition of medical device registration certificates for two diagnostic kits, enhancing its product line in the in vitro diagnostic sector [6] Market Activities - Suzhou Tongxin Medical Technology's IPO application was accepted, with plans to raise 1.064 billion yuan for various projects including the production base for implantable left ventricular assist devices [8][9] - Zhendong Pharmaceutical announced a partnership to establish a fund focused on investments in the biopharmaceutical sector, contributing 30 million yuan as a limited partner [11] Corporate Changes - Baihua Pharmaceutical is planning a change in control, leading to a temporary suspension of its stock trading [10] - *ST Changyao is under investigation for alleged financial misconduct, which may lead to a forced delisting due to false financial reporting [18]

九强生物公告，公司及全资子公司北京美创新跃医疗器械有限公司近日收到北京市药品监督管理局颁发 的《医疗器械注册证》。产品名称为丙氨酸氨基转移酶测定试剂盒（丙氨酸底物法）和D-二聚体测定 试剂盒（胶乳免疫比浊法），注册类别为Ⅱ类，注册证有效期自批准之日起至2030年12月21日和2030年 12月18日。上述产品医疗器械注册证的取得，丰富了公司在体外诊断生化及血凝细分领域产品线的品 种，有利于进一步提升公司的核心竞争力和市场拓展能力，对公司未来的经营将产生积极影响。 ...