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.
2026/06/22
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.
2026/06/22
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.
2026/05/23
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.
2026/05/18
Sonrotoclax (BEQALZI™) Receives FDA Accelerated Approval
Recently, BeOne Medicines Ltd. announced that its independently developed next-generation BCL2 inhibitor sonrotoclax (BEQALZI™) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have previously received at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. This approval not only marks the first approval of a novel BCL2 inhibitor in the United States in the past decade, but also makes sonrotoclax the only BCL2-targeted therapy currently approved in the U.S. for the treatment of mantle cell lymphoma, providing a new therapeutic option for patients with limited later-line treatment choices.
2026/04/24
Revolution Medicines has recently announced interim analysis results from its Phase III RASolute 302 trial evaluating the investigational oral RAS(ON) inhibitor Daraxonrasib (RMC-6236), marking a significant advance in the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC), a disease that has long lacked meaningful therapeutic breakthroughs.
2026/04/24
Bayer’s blockbuster new lung cancer drug “Sevabertinib” has been approved for marketing in China
On April 15, 2026, Bayer announced that the National Medical Products Administration (NMPA) of China had approved the novel targeted therapy drug for lung cancer, Sevabertinib Tablets (brand name: HYRNUO®), for the monotherapy treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations and have previously received at least one systemic treatment. Sevabertinib Tablets are an oral small molecule tyrosine kinase inhibitor (TKI), which had previously been included as a breakthrough therapy by the NMPA’s Center for Drug Evaluation (CDE), and its marketing application was included in the priority review.