Practice Insights
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.
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.
2025/12/17
The new autoimmune drug “Picankibart Injection” from Innovent Biologics has been approved in China
On November 28, 2025, the official website of the National Medical Products Administration (NMPA) announced that the Class 1 new drug Picankibart Injection (brand name: Xinmeiyue®, research and development code: IBI112) developed by Innovent Biologics (Hangzhou) Co., Ltd. (hereinafter referred to as “Innovent Biologics”) has been approved for marketing, intended for the treatment of moderate to severe plaque psoriasis (acceptance number: CXSS2400103, approval number: NMPA S20250066). The launch of this domestically produced innovative biologic not only breaks the long-term dependence on imported IL-23p19 target drugs in the field of psoriasis treatment, but its once-every-12-weeks maintenance dosing regimen also marks the official entry of China’s psoriasis treatment into a new phase of long-term management with “quarterly dosing”, providing a new treatment option for over 7 million psoriasis patients in China.
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
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.
2025/11/21
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.