Domestic First-to-File Generic Drugs See Rapid Progress in May, with Dosage Form Innovation Emerging as a New Competitive Focus

　　【Pharmaceutical Network Product InformationSince May 2026, the field of domestically first-generic drugs in China has seen密集new developments, with multiple重磅varieties successively申报and落地, demonstrating显著characteristics of "major varieties, high technological barriers, and dosage form extensions."
 

Recently, Yizi® Minodronic Acid Tablets (Specification: 50mg) from Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, have been approved for marketing by the National Medical Products Administration and are deemed to have passed the quality and efficacy consistency evaluation for generic drugs.
 

It is reported that this product specification is the first domestic generic drug in China, applicable for treating osteoporosis in postmenopausal women. This product specification is orally administered once every 4 weeks, offering good medication convenience and compliance.
 

On May 12, Zhejiang Nuode Pharmaceutical Co., Ltd.'s application for finerenone tablets has been accepted. The original research company of finerenone tablets is Bayer. In June 2022, the marketing application of finerenone tablets (trade name: Kerendia) was approved by the National Medical Products Administration in China. The first approved indication was for chronic kidney disease associated with type 2 diabetes. In the same year, the drug successfully entered the national medical insurance directory through medical insurance negotiations.
 

Data shows that in 2023, the sales of Kesenda in China's three major terminals and six major markets broke through 170 million yuan. In the first half of 2024, the sales reached 190 million yuan, a year-on-year increase of 319.99%. In the past two years, the competition for the first generic of this product has been fierce. Apart from Nuode Pharmaceutical, a large number of companies such as Hunan Mingrui, Shandong Langnuo Pharmaceutical, Tiandi Hengyi Pharmaceutical, Hunan Huize Biopharmaceutical, Chongqing Huabang Pharmaceutical, and North China Pharmaceutical have also successively declared their entry into the market, joining the competition.
 

On May 11, Baiyunshan announced that its subsidiary, Tianxin Pharmaceutical, had received the "Drug Supplemental Application Approval Notice" for Cefuroxime Sodium for Injection (0.5g) and Candesartan Cilexetil Tablets (4mg) issued by the National Medical Products Administration, approving theirActive Pharmaceutical Ingredients (API)Supplementary Application Content on the Study of β-Lactam Polymer Impurities and Mutagenic Impurities in Formulations.
 

The announcement shows that the Sodium Cefuroxime for Injection is the first domestically produced generic drug by Tianxin Pharmaceutical. The drug passed the consistency evaluation in October 2023, with projected sales of approximately 264 million yuan in 2025; Candesartan Cilexetil Tablets were launched in 2005, with projected sales of approximately 46.3676 million yuan in 2025.
 

On May 7, the NMPA announced that the pitavastatin calcium orally disintegrating tablet submitted by Guangdong Wantai Innovation Technology had been approved, becoming the first orally disintegrating tablet formulation of this lipid-lowering drug. Data shows that this product was jointly submitted by Guangdong Wantai Innovation Technology and Shenzhen Xinlitai, with three specifications—1mg, 2mg, and 4mg—approved simultaneously.
 

Pitavastatin Calcium, as a statin lipid-lowering drug, is mainly used to treat familial hypercholesterolemia and hypercholesterolemia. In 2025, the sales of this drug exceeded 600 million yuan, increasing by 19% year-on-year, showing a steady market demand.
 

On May 6, according to the announcement on the website of the National Medical Products Administration, two first-generic drugs developed by CorePharm, a subsidiary of Qingfeng Pharmaceutical Group, Abemaciclib Tablets and Brivaracetam Injection, have been approved for marketing.
 

Abemaciclib, an oral CDK4/6 inhibitor developed by Eli Lilly, entered the Chinese market in December 2020 and has become a core drug for treating HR+/HER2- advanced or metastatic breast cancer. Data shows that by 2025, the sales revenue of abemaciclib in China's all-terminal hospital market will exceed 800 million yuan, with a year-on-year increase of 11.80%. Brivaracetam, developed by UCB, is a new-generation antiepileptic drug known for its rapid onset and good tolerability. In 2024, global sales of UCB's brivaracetam will surpass 700 million US dollars; in the Chinese market, the all-terminal hospital sales revenue of this drug will exceed 30 million yuan in 2025.
 

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Reviewing the progress of China's first generic drug applications and approvals in May, it is clear that large varieties have become the main battleground for first generics, while innovative differentiation in dosage forms has emerged as a new breakthrough for generic drug companies to avoid homogenized competition. Industry insiders predict that in the future, whoever can achieve breakthroughs in large varieties, realize differentiation in dosage forms, and take the initiative in patent challenges will gain an edge in this "generic drug upgrade battle."
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.