Wave of Generic Drug Approvals Hits China: Jingxin, Hannuo, and Jiudian Among Recent Filers

　　【Pharmaceutical Network - Industry Trends】 Since 2026, China has seen a surge in the approval of generic drugs, including numerous first-to-market generics. Industry experts attribute this trend to a strategic shift in pharmaceutical companies’ R&D focus, reflecting the rise of first-to-market approvals for novel dosage forms and differentiated manufacturing processes.
 

Recently, Jingxin Pharmaceutical announced that it had received the "Drug Registration Certificate" for Cariprazine Hydrochloride Capsules, approved and issued by the National Medical Products Administration. The specifications are 1.5mg and 3mg, intended for the treatment of adult schizophrenia. The original research drug has not yet entered the Chinese market, making this approval the first of its kind in China.
 

Cariprazine Hydrochloride is an atypical antipsychotic drug, classified as a partial agonist at dopamine D₂ and D₃ receptors, originally developed by Gedeon Richter of Hungary. In September 2015, the U.S. FDA approved it for the acute treatment of schizophrenia in adults and for manic or mixed episodes associated with bipolar I disorder. Data shows that global sales of Cariprazine Hydrochloride reached RMB 25.8 billion in 2025.
 

On July 1, the website of the National Medical Products Administration (NMPA) showed that Hybio Pharmaceutical’s Class 2.2 new drug, Liraglutide (H) Injection, had been approved for marketing, making it the first company in China to produce liraglutide via chemical synthesis. On the previous day, the Abbreviated New Drug Application (ANDA) for Tirzepatide Injection submitted by the company to the U.S. Food and Drug Administration (FDA) had also received a notice of acceptance for review.
 

It is understood that the original research product of liraglutide is Victoza from Novo Nordisk. Currently, four companies have entered the domestic market with generic liraglutide: United Laboratories Biopharmaceuticals, Huadong Medicine, Tonghua Dongbao Pharmaceutical, and Chia Tai Tianqing Pharmaceutical. Tirzepatide is a GLP-1R/GIPR dual-target agonist developed by Eli Lilly, with total sales of approximately $36.507 billion in 2025. Among this, the diabetes treatment version, Mounjaro, contributed $22.965 billion, while the weight loss version, Zepbound, contributed $13.542 billion.
 

July 1 News: Jiudian Pharmaceutical announced that it has recently received the "Drug Registration Certificate" issued by the National Medical Products Administration, obtaining drug registration certificates for Cilnidipine Tablets (specification: 10mg; registration category: Class 3 chemical drug) and Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution (specification: 100ml containing 150mg of ambroxol hydrochloride and 100μg of clenbuterol hydrochloride). Among them, Cilnidipine Tablets are indicated for the treatment of patients with hypertension, while Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution is used for symptoms such as cough and viscous sputum caused by acute and chronic respiratory diseases.
 

On July 2, CSPC announced that its developed Iron Sucrose Injection (5 ml: 100 mg iron and 1.6 g sucrose) has been approved for marketing by the National Medical Products Administration, becoming the first product in China to be deemed as having passed the Consistency Evaluation of Quality and Efficacy of Generic Drugs. This product is an intravenous polysaccharide-iron complex, indicated for patients with iron deficiency anemia who require intravenous iron supplementation due to poor absorption or intolerance to oral iron agents.
 

On July 3, Huahai Pharmaceutical announced that the company had recently received the "Drug Registration Certificate" for Metaraminol Bitartrate Injection, approved and issued by the National Medical Products Administration (NMPA). The drug is classified as Category 3, with a specification of 1 ml:10 mg. It is primarily indicated for the prevention and treatment of acute hypotension associated with intraspinal block anesthesia, as well as hypotension caused by cardiogenic shock or sepsis. To date, the company’s cumulative R&D investment in the Metaraminol Bitartrate Injection development project amounts to approximately RMB 5.98 million.
 

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Overall, the recent concentrated approvals of blockbuster generic drugs in therapeutic areas where original research has been weak—such as neuropsychiatry, antivirals, digestive endoscopy, and rare chronic diseases—indicate that domestic substitution is extending into high-barrier specialty medications. Industry experts predict that in 2026, driven by the synergistic effects of policy, industry dynamics, and corporate strategies, more blockbuster generic drugs will emerge, benefiting a broader patient population.
 

　　Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice for any person.