Practice Insights
2026/08/14
Recently, Otsuka Pharmaceutical announced the complete 24-month results from the Phase 3 VISIONARY study of VOYXACT® (sibeprenlimab), a selective APRIL inhibitor. The results showed that the annualized eGFR slope from Week 4 through Week 104 was +0.3 mL/min/1.73 m²/year in patients treated with VOYXACT, compared with -4.2 mL/min/1.73 m²/year in the placebo group, representing a between-group difference of 4.5 mL/min/1.73 m²/year (P<0.0001). At 24 months, eGFR had increased by 1.3 mL/min/1.73 m² from baseline in the VOYXACT group, while it had declined by 7.9 mL/min/1.73 m² in the placebo group, resulting in a between-group difference of 9.2 mL/min/1.73 m² (P<0.0001).
2026/07/21
Recently, the U.S. Food and Drug Administration (FDA) approved Gedatolisib, a pan-PI3K/mTOR inhibitor developed by Celcuity, for use in combination with fulvestrant, with or without palbociclib, for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−), locally advanced or metastatic breast cancer who have disease progression following at least one prior line of endocrine therapy in the metastatic setting and whose tumors do not harbor PIK3CA mutations. This approval makes Gedatolisib the first FDA-approved therapy capable of simultaneously inhibiting all Class I PI3K isoforms (α, β, δ, and γ) as well as mTORC1 and mTORC2, providing a new targeted treatment option for patients with PIK3CA wild-type HR+/HER2− advanced breast cancer.
2026/07/21
Sanofi's subcutaneous formulation of isatuximab has been approved by the FDA
On July 9, 2026, the US Food and Drug Administration (FDA) approved the subcutaneous injection formulation of Sanofi’s isatuximab-irfc (brand name Sarclisa Escena) for use in combination with standard regimens in the treatment of adult patients with relapsed/refractory multiple myeloma (MM), covering all existing indications for intravenous (IV) formulations.
2026/06/23
石药集团欧意药业的注射用紫杉醇（白蛋白结合型）（Ⅱ）在中国获批上市
2026年6月15日，石药集团欧意药业有限公司的注射用紫杉醇(白蛋白结合型)(Ⅱ)(研发代号：SYHX2011)获得国家药品监督管理局批准上市。该产品是全球首款速溶型白蛋白结合紫杉醇制剂，依托自主创新的处方与制备工艺，斩获中美欧多国专利授权。作为化药2.2类改良型新药，它在疗效、安全性与临床使用便捷性上实现全面升级，填补了传统白蛋白紫杉醇的多项临床短板，标志着石药集团在抗肿瘤纳米制剂领域实现技术突破，也为晚期乳腺癌患者带来更优质的化疗新选择。
2026/06/23
近日，国家药品监督管理局(NMPA)正式批准天广实生物(Beijing Mabworks Biotech Co.，Ltd.)自主研发的奥妥珠单抗β注射液(商品名：倍捷欣®，研发代号：MIL62)新增适应症，用于治疗具有疾病进展风险的原发性膜性肾病(pMN)成人患者。此次获批不仅使MIL62成为全球首个针对原发性膜性肾病获批上市的靶向治疗药物，也标志着我国在肾脏疾病创新药研发领域取得重要突破。
2026/06/22
On June 15, 2026, the injectable paclitaxel (albumin-bound) (II) (R&D code: SYHX2011) developed by CSPC Ouyi Pharmaceutical Co., Ltd. was approved for marketing by the National Medical Products Administration. This product is the world’s first instant-release albumin-bound paclitaxel formulation, relying on independently innovated formulas and preparation processes, and has obtained patent authorizations from multiple countries including China, the United States, and Europe. As an improved new drug of chemical drug category 2.2, it achieves comprehensive upgrades in efficacy, safety, and clinical convenience, filling multiple clinical shortcomings of traditional albumin-bound paclitaxel. It marks a technological breakthrough for CSPC Pharmaceutical Group in the field of anti-tumor nano-formulations and brings a new, higher-quality chemotherapy option for patients with advanced breast cancer.
2026/06/22
Obinutuzumab Beta Approved for Primary Membranous Nephropathy
Recently, China's National Medical Products Administration (NMPA) approved a new indication for obinutuzumab beta injection (trade name: Beijiexin®, development code: MIL62), an innovative biologic independently developed by Beijing Mabworks Biotech Co., Ltd. The drug is now indicated for the treatment of adult patients with primary membranous nephropathy (pMN) who are at risk of disease progression. This approval makes MIL62 the world's first approved targeted therapy specifically indicated for pMN and represents a significant milestone in the development of innovative therapies for kidney diseases in China.
2026/05/23
欧盟最高法院判定Meta使用新闻文章应支付出版商 补偿金
意大利通信管理局机构(AGCOM)规定，在线平台使用新闻文章摘要片段应支付出版商补偿金。Meta公司认为，意大利上开规范与欧盟版权法赋予出版商的权利不符。随后，意大利法院就相关法规解释请求欧盟法院裁决。
2026/05/23
The EU’s top court rules that Meta must compensate publishers for using news articles
Italy’s communications authority (AGCOM) stipulated that online platforms must compensate publishers for the use of snippets from news articles. Meta argued that the Italian regulation was incompatible with the rights granted to publishers under EU copyright law. The Italian court subsequently sought clarification from the Court of Justice of the European (CJEU) regarding the interpretation of the relevant regulations.
2026/05/18
AbbVie’s CD20×CD3 bispecific antibody has been approved for marketing in China
On May 15, 2026, the official website of the National Medical Products Administration (NMPA) announced that Epcoritamab, a drug application submitted by AbbVie, was approved for marketing. The drug, when combined with Rituximab and Lenalidomide, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). (Acceptance number: JXSS2500127/8). This application had previously been included in the priority review process, indicating the speed of approval.