First-Generation Generic Drugs Gain Momentum in Q1 2026, Spanning Multiple Therapeutic Areas

　　【Pharmaceutical Network Product InformationIn recent years, against the backdrop of the generic drug industry transitioning from "scale expansion" to "quality enhancement," first-to-market generic drugs have become a core breakthrough for many companies to capture market share and demonstrate technical strength due to their "first-mover advantage." Based on this, an increasing number of new achievements are continuously emerging. As of early April 2026, more than ten first-to-market generic drugs have been approved for marketing in China, covering multiple therapeutic areas including anti-infection, nervous system, respiratory system, and cardiovascular.
 

Recently, ST Renfu announced that its subsidiary, Yichang Renfu, has received the "Drug Registration Certificate" for Fentanyl Citrate Buccal Tablets issued by the National Medical Products Administration. This product is used to treat cancer breakthrough pain, and there are currently no similar products approved for marketing in China. It is reported that Fentanyl is a potent synthetic opioid analgesic. Previously, the buccal tablet form of this drug had long relied on imports. By 2025, the total sales of all terminal hospital markets for Fentanyl-related dosage forms will exceed 9.3 billion yuan.
 

On March 27, Qilu Pharmaceutical's Belumosudil Mesylate Tablets were approved for marketing in China. This ROCK2 inhibitor is indicated for chronic graft-versus-host disease (cGVHD) patients aged 12 years and above who have an inadequate response to corticosteroid treatment. The product was launched in the United States in 2021, approved in China by Kadmon, a wholly-owned subsidiary of Sanofi, in August 2023, and successfully included in the National Reimbursement Drug List (NRDL) in 2024.
 

On March 27, Shijiazhuang No.4 Pharmaceutical Co.,Ltd. announced that two generic drugs of Category 3, Sodium Lactate Ringer's Irrigation (3000ml) and Bumetanide Injection (2ml:1mg), were approved for marketing on the same day and deemed to have passed the consistency evaluation. Among them, Sodium Lactate Ringer's Irrigation (3000ml) is the first generic drug in China. This medicine is suitable for general irrigation needs where sterile electrolyte solutions are permitted. It was declared through the Category 3 generic drug pathway and deemed to have passed the consistency evaluation upon approval.
 

On March 30, ProPharmaceuticals announced that its controlling subsidiary, Zhejiang ProCon Pharmaceuticals Co., Ltd., had recently received the "Drug Registration Certificate" for Ephedrine Sulfate Injection and Ephedrine Sulfate issued by the National Medical Products Administration.Active Pharmaceutical Ingredients"Approval Notice for the Marketing Application of Chemical Active Pharmaceutical Ingredients." This injection is the first domestically approved product in China, considered to have passed the generic drug consistency evaluation, and is suitable for treating clinically significant hypotension under anesthesia.
 

On March 21, Kelun disclosed that the company's chemical drug "Brexpiprazole Oral Soluble Film" and its subsidiary Hunan Kelun Pharmaceutical Co., Ltd.'s chemical drug "Aripiprazole Injection" have recently received drug registration approval from the National Medical Products Administration. Among them, Aripiprazole Injection is the first domestically produced generic drug to be approved in China. This drug was developed by Otsuka Pharmaceutical and is a second-generation atypical antipsychotic. It was first approved in the United States in 2013; in 2023, China approved its import for use in adult schizophrenia. By 2025, global sales are expected to reach approximately 22 billion US dollars.
 

On March 13, CMS announced that the marketing authorization application for Desidustat Tablets (formerly known as Daprodustat Tablets), a novel drug for renal anemia, was approved by the National Medical Products Administration (NMPA) of China on March 13, 2026. This product is an innovative oral hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) indicated for the treatment of anemia in adult patients with non-dialysis-dependent chronic kidney disease (CKD).
 

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Overall, the continuous approval of domestically first-generic drugs in China indicates that under the dual pressures of normalized bulk procurement and the transition to innovative drugs, the "tough battle" for the generic drug industry has begun. Companies are accelerating their shift away from "speed competition" to focus on technological innovation and differentiated strategies. In the future, companies that can concentrate on difficult-to-copy drugs and complex formulations, build technical barriers and product portfolios, and achieve a dual enhancement of "technical depth" and "clinical value" are expected to stand out in the fierce competition.
 

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