Practice Insights
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
2026年4月16日，美国联邦巡回上诉法院推翻先前判决，重启梯瓦制药公司对礼来公司提起的专利侵权诉讼。此前，麻萨诸塞州联邦法院法官曾撤消陪审团裁定的1.765亿美元赔偿，并认定相关专利无效。
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.
2026/04/24
On April 16, 2026, the U.S. Court of Appeals for the Federal Circuit revived a patent infringement lawsuit filed by Teva Pharmaceutical Industries against Eli Lilly and Company, overturning a prior decision by a Massachusetts federal judge that had invalidated the patents and set aside a $176.5 million jury verdict in Teva’s favor.
2026/03/24
Alectinib Demonstrates Significant Efficacy in Elderly Patients with Rare ALK Mutations
Recently, the University of Tokyo Hospital reported a case of an 80-year-old patient with metastatic lung adenocarcinoma[1]. Initial PCR testing did not detect ALK rearrangement, but RNA sequencing revealed the presence of an EML4-ALK fusion transcript containing a premature stop codon. Although the classic fusion protein could not be translated via conventional mechanisms, IHC confirmed expression of a truncated ALK protein. After two months of treatment with alectinib, both cancerous lymphangitis and liver metastases significantly shrank, and serum tumor markers markedly decreased, demonstrating that atypical ALK fusions can still be sensitive to ALK-TKIs, offering new insights for precision therapy.
2026/03/24
Dolutegravir Sodium Tablets” from Aidea Pharma has been approved in China
On March 15, 2026, Aidea Pharma announced that its Dolutegravir Sodium Tablets (brand name: Tivicay) had been approved for marketing in China. The product was registered and applied for as a Class 4 chemical drug, and its approval was deemed to have passed the generic drug quality and efficacy consistency evaluation. Dolutegravir Sodium Tablets are an HIV-1 integrase strand transfer inhibitor (INSTI) and are currently a core first-line treatment drug in the global HIV infection treatment field. The approved indication for Aidea Pharma’s Dolutegravir Sodium Tablets is for use in combination with other antiretroviral drugs to treat adult and pediatric patients aged 12 and above with human immunodeficiency virus (HIV) infection.
2026/03/01
Novo Nordisk Faces Class Action Lawsuit Over Monopoly of Diabetes Drug Victoza
On January 23, 2026, Novo Nordisk faced a class action lawsuit in New York federal court, accused of abusing its patent rights to maintain its market monopoly over the diabetes drug Victoza.
2026/03/01
Roche Announces Phase III Results for Fenebrutinib
Roche recently released results from the Phase III FENtrepid study evaluating its Bruton’s tyrosine kinase (BTK) inhibitor fenebrutinib in patients with primary progressive multiple sclerosis (PPMS). The data indicate that the study met its primary endpoint, demonstrating non-inferiority to the approved therapy ocrelizumab (Ocrevus) in delaying disability progression. This represents a notable development in the PPMS treatment landscape, where therapeutic advances have been limited in recent years. The company stated that it plans to compile Phase III data in both PPMS and relapsing multiple sclerosis (RMS) and submit regulatory filings in the first half of this year.