Practice Insights
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.
2025/12/17
Daiichi Sankyo wins appeal, avoids paying $41.8 million in damages
In 2020, Pfizer’s Seagen accused Japanese rival Daiichi Sankyo of infringing its patent with the cancer drug Enhertu, which Daiichi jointly developed with AstraZeneca. In 2022, a jury found Daiichi liable for patent infringement and awarded Seagen $41.8 million in damages.
2025/11/21
On November 10, 2025, according to the official website of the National Medical Products Administration (NMPA), the generic drug of Class 3, Enzalutamide Tablets, submitted by Kelun Pharmaceutical, was approved for marketing and deemed to have passed the consistency evaluation, making it the first generic drug enterprise in China to receive approval for Enzalutamide Tablets.
2025/11/21
China Approves Domestic Innovative EGFR Inhibitor Mefatinib
The National Medical Products Administration (NMPA) has recently approved the launch of Mefatinib Maleate tablets in China for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) exon 21 L858R substitution. Developed by Huadong Medicine’s wholly owned subsidiary, Zhongmei Huadong, Mefatinib is a Category 1 innovative drug with independent intellectual property rights, representing a new domestic targeted therapy option for this mutation subtype.
2025/11/21
Samsung Electronics Ordered to Pay $191 Million for Patent Infringement
In 2023, Pictiva Displays filed a lawsuit against Samsung Electronics, alleging that Samsung’s Galaxy smartphones, televisions, computers, wearables, and other products incorporate Pictiva’s patents for improving the resolution, brightness, and energy efficiency of OLED displays.
2025/10/21
Understanding Your Labor Rights in Taiwan as a Foreign Employee
Foreign professionals working in Taiwan should be aware of their basic labor rights. A written employment contract is essential — it should clearly state your job duties, working hours, salary, leave entitlements, and termination conditions. If your contract is only in Chinese, consider getting a professional translation.
2025/10/21
AT&T and Nokia Win Patent Infringement Lawsuit
In August 2021, Finesse Wireless LLC filed a lawsuit against AT&T Mobility in the U.S. District Court for the Eastern District of Texas, alleging that AT&T had infringed two patents related to reducing wireless signal interference. Nokia, which designed and manufactured the base stations used in AT&T’s network, intervened in the case and contested Finesse’s claims, arguing that its equipment did not infringe the asserted patents.
2025/10/21
UCB’s “Zilucoplan” has been approved for marketing in China
On October 11, 2025, UCB S.A. (hereinafter referred to as UCB) announced that the NMPA had approved the marketing authorization for Zilucoplan (brand name: ZHUOBEIKE®), which is used in combination with conventional therapeutic drugs for the treatment of adult generalized myasthenia gravis (gMG) patients with positive anti-acetylcholine receptor (AChR) antibodies.
2025/10/21
FDA Approves the World’s First PDE4B Inhibitor Nerandomilast for Idiopathic Pulmonary Fibrosis
On October 7, 2025, the U.S. Food and Drug Administration (FDA) officially approved Boehringer Ingelheim’s oral tablet nerandomilast (brand name Jascayd) for the treatment of adult patients with Idiopathic Pulmonary Fibrosis (IPF). This marks the first FDA approval of a new IPF therapy since nintedanib (Ofev) and pirfenidone (Esbriet) were approved in 2014, representing a major breakthrough after more than a decade of stagnation in this therapeutic field.
2025/09/29
xAI Wins Court Order Blocking Former Engineer from Sharing AI Technology with OpenAI
Elon Musk’s artificial intelligence startup xAI has filed a lawsuit against a former engineer, accusing him of misappropriating “cutting-edge AI technologies with features superior to those offered by ChatGPT” and using them in his new role at OpenAI. The engineer began working at xAI last year, where he helped train and develop the company’s chatbot, Grok.