Multinational Pharma Leads in Psychiatric Drug Arena as Domestic Players Accelerate Breakthroughs

　　【Pharmaceutical Network Industry DynamicsRecently, Vanda Pharmaceuticals announced that the U.S. FDA has approved its Bysanti (milsaperidone) tablets for marketing, indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults.
 

Public information shows that Milsaperidone is a prodrug of the marketed antipsychotic drug iloperidone. After oral administration, it is rapidly converted into iloperidone. The drug is expected to go on sale in the third quarter of this year, and its latest patent is valid until 2044. Notably, the drug is currently undergoing research as an adjunctive treatment for treatment-resistant major depressive disorder, with results expected by 2026.
 

Schizophrenia is a chronic and often disabling mental illness that affects the way patients think, feel, and behave. With increasing social pressure and rising diagnosis rates, the demand for schizophrenia treatment is continuously growing. Currently, to meet the ever-increasing treatment needs and address issues such as insufficient symptom improvement and intolerable side effects faced by many patients, numerous pharmaceutical companies both in China and internationally are accelerating innovation in this field. The recent approval and market launch of Milsaperidone represent a new breakthrough amidst the ongoing emergence of advancements.
 

Notably, in recent years, pharmaceutical companies in China have made significant strides in the field of antipsychotic drugs through continuous efforts. This has resulted in three major breakthroughs: the introduction of first-in-class innovative drugs with novel mechanisms, dual advancements in improved new drugs and long-acting formulations, and a robust layout of first generics and multiple dosage forms.
 

On February 12, 2026, Qilu Pharmaceutical's application for Brexpiprazole Orally Disintegrating Tablets was officially approved, making it the first company in China to pass (equivalent to) the evaluation for this product. The original research of Brexpiprazole was conducted by Otsuka Pharmaceutical. Since its launch, the global sales of this drug have maintained steady growth, surpassing 18 billion yuan in 2024.
 

On December 23, 2025, Zai Lab announced that the NMPA had approved the new drug application for TAK-071 (KarXT) capsules for the treatment of adult schizophrenia. KarXT is a combination of an oral M1/M4 muscarinic acetylcholine receptor agonist and a muscarinic receptor antagonist. Unlike the mechanism of traditional antipsychotic drugs targeting dopamine, KarXT selectively acts on the muscarinic acetylcholine M1 and M4 receptors in the brain to influence core disease pathways.
 

In June 2025, SPH's improved new drug for the treatment of schizophrenia, Amisulpride Orally Disintegrating Tablets (Aosian®), was approved for marketing in China and was included in the national medical insurance within less than half a year. It is reported that Amisulpride Orally Disintegrating Tablets is the first Amisulpride formulation approved by the National Medical Products Administration of China to adopt oral disintegration technology. It is particularly suitable for schizophrenia patients with dysphagia, drug concealment behavior, or acute agitation. At the same time, it is an achievement of dosage form improvement developed based on the actual needs of Chinese patients, filling a gap in clinical treatment.
 

In February 2025, JIUDIAN PHARMACEUTICAL's new antipsychotic drug, Ziprasidone Hydrochloride Capsules, was approved for marketing by the National Medical Products Administration, making it the first company in China to pass the product's consistency evaluation. Ziprasidone is suitable for treating acute and chronic schizophrenia, schizoaffective disorder, and various psychotic symptoms associated with other conditions.
 

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Overall, in the current global and Chinese antipsychotic drug field, under the background of multinational giants dominating and local innovation rising, there is an approval pattern of three-pronged approach with new mechanism innovative drugs, improved new drugs, and generic drug formulations. In the future, if Chinese innovative pharmaceutical companies want to compete with multinational giants in this field, they need to accelerate the layout in terms of new mechanisms, long-acting formulations, and medical insurance coverage.
 

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