庆辰专栏

Practice Insights

2025/09/29

InnoCare’s “Orelabrutinib” has been approved in Singapore

On September 8, 2025, Beijing InnoCare Pharma Tech Co., Ltd. (hereinafter referred to as “InnoCare”) announced that Orelabrutinib (brand name: InnoKai®) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed/refractory marginal zone lymphoma (R/R MZL). This marks the second indication for Orelabrutinib approved in Singapore, representing a solid step forward for the company on its path to internationalization.

2025/09/29

Novartis Atrasentan Hydrochloride Tablets Approved in China

Recently, Novartis announced that its innovative product Atrasentan Hydrochloride Tablets (Proprietary Name: VANRAFIA) has been approved by the National Medical Products Administration (NMPA) for reducing proteinuria in adult patients with primary immunoglobulin A nephropathy (IgA nephropathy) who are at risk of rapid disease progression. This marks the first non-immunologic therapy for IgA nephropathy in China, and the only highly selective endothelin-A (ETA) receptor antagonist approved domestically, representing a milestone that may reshape the long-term management of the disease.

2025/09/16

NT$10,000 Cash Handouts: Are Foreigners Eligible?

On August 29, the Executive Yuan passed in third reading the Special Act for Strengthening Economic, Social and National Security Resilience in Response to International Circumstances (因應國際情勢強化經濟社會及國土安全韌性特別條例), set to counter the adverse economic impact of the U.S. President Donald Trump’s tariff plan on Taiwan.

2025/09/07

The world’s first generic Dulaglutide has been approved for marketing in China

On August 8, 2025, the official website of the National Medical Products Administration revealed that Dulaglutide Injection (Boyouping®), independently developed by Shandong Boan Biotechnology Co., Ltd. (hereinafter referred to as “Boan Biotech”), a holding subsidiary of Luye Pharma Group, was officially approved for marketing, intended for blood glucose control in adult patients with type 2 diabetes. This product marks the world’s first and currently only biosimilar of Trulicity® to receive marketing approval. To date, no other domestic dulaglutide injections have progressed to the Biologics License Application (BLA) stage in China.

2025/09/07

Lululemon Sues Costco Over Alleged Counterfeit Sales

In July 2025, Lululemon filed a lawsuit against Costco in the U.S. District Court for the Central District of California, alleging that Costco’s private label brand, Kirkland, is manufacturing and selling hoodies, jackets, and pants that closely resemble some of Lululemon’s popular products. The suit claims this causes consumer confusion, leading some to mistakenly believe that Kirkland products are made by the authentic supplier of the “original” products.

2025/09/07

SUN PHARMA LAUNCHES HAIR LOSS DRUG IN THE UNITED STATES AFTER PATENT DISPUTE SETTLEMENT WITH INCYTE

On July 14, 2025, Sun Pharmaceutical Industries Ltd. (“Sun Pharma”), a generic drug manufacturer based in Bombay, India, announced the settlement of a patent infringement lawsuit with US-based biopharmaceutical corporation Incyte Corporation (“Incyte”) related to its hair loss drug LEQSELVI and the subsequent launch of that drug in the United States for the treatment of adults with severe alopecia areata.

2025/06/25

June 2025 Newsletter - Novartis’ new ophthalmic drug “Busizumab Injection” has been approved for market in China

On May 28, 2025, Novartis announced that its new generation of anti vascular endothelial growth factor (anti-VEGF) monoclonal antibody, Brolucizumab (trade name: Beiyoushi®), was approved by the National Medical Products Administration of China, and its indication was diabetes macular edema (DME). The application for marketing license of Busizumab for the treatment of neovascular (wet) age-related macular degeneration (wAMD) and proliferative diabetes retinopathy (PDR) indications has been submitted to the National Medical Products Administration in October 2024 and December 2024 respectively.

2025/06/25

June 2025 Newsletter - Disney, Universal Sue AI Image Generator Midjourney for Copyright Infringement

On June 11, 2025, several animation and film studios — including Disney, Marvel, Lucasfilm, 20th Century Studios, Universal Pictures, and DreamWorks Animation — jointly filed a lawsuit accusing AI image generator company Midjourney of infringing on their character copyrights. The characters include Darth Vader from Star Wars, Elsa from Frozen, and the Minions from Despicable Me.

2025/06/25

June 2025 Newsletter - Halozyme Files Patent Infringement Lawsuit against Merck over Subcutaneous Keytruda Formulation

On April 24, 2025, Halozyme, Inc. (“Halozyme”), a biotechnology company notably developing innovative drug delivery technologies, filed a patent infringement lawsuit against pharmaceutical giant Merck Sharp & Dohme Corp. (“Merck”) in the U.S. District Court for the District of New Jersey.

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