三迭纪
三迭纪提交中国首款3D打印药物T20j(阿哌沙班片)上市申请
三迭纪提交T20j（阿哌沙班片）上市申请，这是中国首款3D打印药物。申报紧随全国首张3D打印药品生产许可，并凸显与礼来、勃林格殷格翰、默克、BioNTech的全球合作。
SDW Editor
Triastek
Triastek Files China’s First 3D-Printed Drug NDA: T20j (Apixaban)
Triastek has submitted an NDA for T20j, China’s first 3D-printed drug, marking a regulatory milestone. The filing follows approval of the nation’s first 3D-printing drug manufacturing license and comes alongside Triastek’s broad 3D-printed pipeline and global pharma collaborations.
FDA批准
全球首个治疗荨麻疹！诺华BTK抑制剂瑞米布替尼获批在美上市
诺华Rhapsido®（瑞米布替尼）获FDA批准，成为全球首个用于CSU的口服BTK抑制剂；中国已获批5款BTK抑制剂，主要用于血液肿瘤，尚未涉及慢性荨麻疹。今年3月6日，1类新药瑞米布替尼片的上市申请已在中国纳入优先审评。
Rhapsido
Novartis’ Rhapsido® (remibrutinib) FDA-Approved as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria
Novartis’ Rhapsido® (remibrutinib) receives FDA approval as the first oral BTK inhibitor for chronic spontaneous urticaria (CSU). Filed in EU, Japan, and China (priority review).
Crystalys Therapeutics
诺和诺德领投 Crystalys 2.05 亿美元融资 助推卫材痛风药多替诺雷欧美临床
诺和诺德支持的 Crystalys Therapeutics 完成 2.05 亿美元融资，推进多替诺雷欧美 III 期临床。该款每日一次的 URAT1 抑制剂已在中国及亚洲获批，即将面向缺乏二线治疗选择的欧美痛风患者。
Crystalys Therapeutics
Crystalys Launches With $205M to Advance Dotinurad Globally, Already Approved in China by Eisai
Novo-backed Crystalys Therapeutics raised $205M to advance dotinurad into global Phase 3 trials. Already approved in China and Asia, the once-daily URAT1 inhibitor will target U.S. and European patients with unmet need for second-line gout therapy.
Met-097i
Metsera公布MET-097i IIb期顶线数据，辉瑞73亿美元收购加速全球III期临床启动
Metsera发布超长效GLP-1候选药MET-097i在VESPER-1和VESPER-3 IIb期临床数据：28周注射最高体重下降14.1%，耐受性良好。VESPER-1总中断率仅2.9%。基于此，全球III期临床将于2025年底启动，同时支撑辉瑞73亿美元收购布局。
Met-097i
Pfizer’s $7.3B Obesity Gamble Pays Early with MET-097i Phase 2b Success
Pfizer’s $7.3 billion acquisition of Metsera is backed by new Phase 2b data for MET-097i, an ultra-long-acting GLP-1 candidate showing 14% weight loss and promising tolerability. Phase 3 initiation is slated for late 2025. Monthly dosing could give Pfizer an edge in the obesity race.
HPV疫苗
首个国产 HPV 四价疫苗“爱薇佳”获批，完成全系列国产化
国家药监局批准首个国产四价 HPV 疫苗爱薇佳（国药集团）上市，继国产二价和九价之后，中国市场第二个获批四价疫苗，适用于 18–45 岁女性，覆盖 HPV 6/11/16/18 型。
Quadrivalent HPV Vaccine
Aiweijia: China’s First Domestic Quadrivalent HPV Vaccine Completes Full Homegrown HPV Lineup
NMPA has approved China’s first domestic quadrivalent HPV vaccine (Aiweijia) from Sinopharm’s CNBG. Following the launch of domestic bivalent and nine-valent vaccines, and after Merck’s Gardasil, it is the second quadrivalent on the Chinese market, targeting HPV 6/11/16/18 for women aged 18–45.
甘李药业
甘李药业携手巴西Fiocruz与Biomm签署10年胰岛素本土化协议
甘李药业与巴西Fiocruz、Biomm签署10年技术转让与供应协议，推动胰岛素在巴西的本土化生产。协议金额≥30亿元人民币，助力PDP计划和糖尿病公共健康保障。
Gan & Lee
China’s Gan & Lee to Localize Insulin Production in Brazil via 10-Year Partnership
Gan & Lee Pharmaceuticals signs a landmark 10-year Technology Transfer and Supply Agreement with Fiocruz and Biomm to localize insulin glargine production in Brazil’s PDP program, securing ≥ RMB 3 billion in supply and boosting public health access.