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替利珠单抗注射液(特瑞可)
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药明合联拟配股筹资逾13亿港元;深圳为合成生物立法
Group 1: Legislative Developments - Shenzhen has passed the "Regulations on Promoting the Innovative Development of the Synthetic Biology Industry" aimed at addressing challenges in the synthetic biology sector, effective from October 1 [1] Group 2: Healthcare Financing - Quanzhou has initiated a monthly settlement model for medical insurance funds based on Disease Related Groups (DRG), aimed at alleviating financial pressure on medical institutions and enhancing their development [2] Group 3: Drug Approvals - Haisco has received approval for clinical trials of its innovative drug HSK47388 for treating autoimmune diseases, marking a new indication for the drug [3] - Sanofi's drug Trelagliptin has been approved for use in delaying the progression of Type 1 diabetes in patients aged 8 and above [4] Group 4: Capital Market Activities - WuXi AppTec plans to raise over HKD 1.31 billion through a share placement at HKD 58.85 per share, with a maximum of 22,277,000 shares to be placed [5] - Qiyuan Bio has completed nearly RMB 200 million in Series B financing to accelerate pipeline development and commercialization [6] Group 5: Executive Appointments - Haisen Bio has appointed Leo Liu as the new CEO to oversee the company's strategic planning and operational management [7]
从“被动治疗”到“主动干预” 赛诺菲CD3单抗国内获批上市
Group 1 - Sanofi announced the approval of Teplizumab injection (brand name: Trelagliptin) in China for adults and children aged 8 and above with stage 2 type 1 diabetes, aimed at delaying the onset of stage 3 diabetes [1] - Teplizumab is a CD3-targeted monoclonal antibody that protects pancreatic β-cells, potentially delaying the need for long-term insulin treatment by nearly 3 years [1] - The drug was first approved by the FDA in November 2022, marking it as the first and only innovative targeted therapy to delay the onset of type 1 diabetes globally [1] Group 2 - Teplizumab has been included in the fourth batch of encouraged R&D pediatric drugs in China and is set to be implemented in Hainan Boao Lecheng International Medical Tourism Pilot Zone by July 2024 [2] - The approval of Teplizumab in China is expected to benefit a larger patient population, with the first prescriptions in Asia anticipated by June 17, 2025 [2] - Sanofi's Greater China President highlighted the company's commitment to patient-centered innovation and collaboration to enhance the type 1 diabetes prevention and treatment system in China [2]
赛诺菲:首个用于延缓1型糖尿病进展的创新药特瑞可在华获批
Mei Ri Jing Ji Xin Wen· 2025-09-03 06:37
Core Insights - Sanofi announced that its drug, Trelagliptin (trade name: Trelioza), has been approved by the National Medical Products Administration (NMPA) in China for use in children aged 8 and above and adults with type 1 diabetes stage 2, aimed at delaying progression to stage 3 diabetes [2] Company Summary - Sanofi's Trelagliptin is now approved for a new indication in China, which may enhance its market presence and sales potential in the diabetes treatment segment [2] Industry Summary - The approval of Trelagliptin reflects ongoing advancements in diabetes management and treatment options available for patients, particularly in the pediatric and adult populations [2]