Practice Insights
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.
2026/03/01
The new indication for BTK inhibitor “Pirtobrutinib Tablets” has been approved in China
On February 12, 2026, Eli Lilly announced that its BTK inhibitor “Pirtobrutinib Tablets” had been approved for marketing in China for a new indication, specifically for adult chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have undergone at least one systemic treatment regimen including a Bruton’s tyrosine kinase (BTK) inhibitor. In China, Pirtobrutinib was first approved for marketing in October 2024 for the third-line treatment of MCL. This approval marks the second indication for the drug in China.
2026/01/26
The Supreme Court made a favorable ruling on the patent of Semaglutide compound
On December 31, 2025, the Supreme People’s Court of China issued a final judgment in the administrative dispute case regarding the invalidity of the patent for Novo Nordisk’s Semaglutide core compound (CN200680006674.6, with a protection period until March 20, 2026), confirming the validity of the patent; This means that the previous judgment of the Beijing Intellectual Property Court upholding the validity of the Semaglutide compound patent is supported ((2023) Jing 73 Xing Chu No. 1324).
2026/01/26
FDA Formally Accepts NDA for Pimicotinib in the Treatment of TGCT
Recently, Abbisko Therapeutics announced that the New Drug Application (NDA) for pimicotinib hydrochloride capsules, a novel orally administered small-molecule CSF-1R inhibitor independently developed by the company for the systemic treatment of tenosynovial giant cell tumor (TGCT), has been formally accepted for review by the U.S. Food and Drug Administration (FDA). This milestone marks a critical step forward in the product’s regulatory progress across major global markets and creates new international momentum for the treatment of this rare disease.
2026/01/26
Disney and James Cameron Accused of Copyright Infringement Over “Avatar: The Way of Water”
On December 15, 2025, 3-D animator and independent creator Eric Ryder filed a copyright infringement lawsuit in the U.S. District Court for the Central District of California against James Cameron, his production company Lightstorm Entertainment, The Walt Disney Company, and Disney subsidiaries.
2025/12/17
Baxdrostat Granted FDA Priority Review
AstraZeneca recently announced that its New Drug Application for Baxdrostat (No. 1428652-17-8) has been accepted for priority review by the U.S. Food and Drug Administration. The PDUFA target action date is expected in the second quarter of 2026. Baxdrostat is an oral small-molecule, first-in-class, highly selective aldosterone synthase inhibitor (ASI) designed to complement existing therapies and provide a new treatment option for patients with resistant hypertension who remain uncontrolled despite multiple antihypertensive agents.