Over RMB 200 Billion Digestive & Metabolic Drug Market Sees New Disruption as Qilu Pharma Secures First-to-File Generic of Amisulpride Injection

　　【Pharmaceutical Network Industry DynamicsRecently, the website of the National Medical Products Administration showed that the Amisulpride Injection, a Category 3 generic drug applied for by Qilu Pharmaceutical, has been approved for production. This not only makes it the first domestically produced generic version in China but also secures the first qualification for passing the evaluation. Against the backdrop of the market size of digestive system and metabolic drugs in China exceeding 200 billion yuan, this breakthrough not only adds another key product to Qilu Pharmaceutical’s portfolio but also indicates that the market landscape in niche areas is set for a new round of changes.
 

Data show that amisulpride is a selective dopamine D2 and D3 receptor antagonist, widely recognized in the field of psychiatric treatment. According to the data from the National Medical Products Administration, currently marketed formulations of amisulpride in China include tablets, solutions, and injections. Among them, oral formulations are mainly used for the treatment of schizophrenia, while the antiemetic indication for postoperative use of injectable formulations has opened up a completely new market space.
 

Qilu Pharmaceutical's recently approved Amisulpride Injection took only 7 months from submission to approval — the marketing application was submitted in November 2023, and it successfully broke through in June 2024. Following the Amisulpride Tablets, Qilu Pharmaceutical once again secured the "first generic + first to pass the evaluation" for this product, demonstrating the company’s strong R&D capabilities. Currently, seven companies in China, including Enhua Pharmaceuticals and Nanjing Zhengke Pharmaceutical, have filed applications for this product under the new registration classification, all of which are still under review or in clinical stages. Qilu Pharmaceutical’s first-mover advantage has already established a significant technical barrier.
 

Data shows that in 2024, the sales revenue of digestive system and metabolic drugs (excluding traditional Chinese medicine) in China's three major terminals and six major markets exceeded 210 billion yuan. Despite a decline in overall scale in recent years due to factors such as centralized procurement policies and adjustments in clinical medication structure, postoperative nausea and vomiting (PONV), as a highly prevalent complication, still supports a significant demand in niche markets. Statistics indicate that approximately 30%-70% of postoperative patients experience varying degrees of nausea and vomiting, especially in surgical fields such as gynecology, orthopedics, and oncology. Effective preventive medication has become a crucial component of perioperative management.
 

The approval of Amisulpride Injection precisely meets the demand for highly effective drugs in this indication area in China. Compared with traditional antiemetic drugs, it exerts effects through a dual mechanism in the central and peripheral systems by selectively antagonizing dopamine receptors, offering advantages such as rapid onset, long half-life, and low extrapyramidal reactions, making it particularly suitable for the prevention of moderate to high-risk PONV patients. From the perspective of market competition, the current postoperative antiemetic drugs in China are mainly dominated by 5-HT3 receptor antagonists (such as Ondansetron) and glucocorticoids. The entry of Amisulpride, with its differentiated mechanism, will serve as a competitive complement and is expected to stand out in the perioperative medication market.
 

According to incomplete statistics, since the beginning of this year, Qilu Pharmaceutical has received production approval for 12 varieties, which are also considered to have passed the evaluation. These products cover multiple therapeutic areas including digestive metabolism, anti-infection, and anti-tumor treatments. Among them, Ibrutinib Tablets, Ixazomib Citrate Capsules, and Amisulpride Injection are all "first generics + first to pass the evaluation," while Isavuconazole Sulfate for Injection has become the second domestically approved variety in China. This demonstrates the company's full-chain R&D capabilities in first generics and complex formulations.
 

In the field of digestive metabolism, Qilu Pharmaceutical has built a complete product matrix ranging from gastrointestinal motility drugs, liver disease medications to antiemetics. The launch of Amisulpride Injection not only creates synergies with existing products in treatment scenarios but also allows rapid entry into the perioperative medication market through the first-to-market generic advantage. The approval of a first-to-market generic drug means that the company can first enjoy policy benefits such as medical insurance access and hospital procurement — under the normalization of national bulk procurement, products that are first generics and first to pass quality evaluations often secure better reporting ratios and price margins in volume-based procurement, which is crucial for consolidating market position.
 

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