Domestic Market Welcomes a New Antipsychotic: Jingxin Pharma Secures First-to-File Approval for Cariprazine Hydrochloride Capsules

　　【Pharmaceutical Network - Corporate News] Recently, Zhejiang Jingxin Pharmaceutical Co., Ltd. announced that it had received the "Drug Registration Certificate" for Cariprazine Hydrochloride Capsules, approved and issued by the National Medical Products Administration (NMPA). The capsules are available in strengths of 1.5 mg and 3 mg for the treatment of schizophrenia in adults. The original innovator product 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, as well as for acute manic or mixed episodes associated with bipolar I disorder. Data show that global sales of cariprazine hydrochloride reached RMB 25.8 billion in 2025.
 

Zhejiang Jingxin Pharmaceutical Co., Ltd. signed a patent license agreement for cariprazine hydrochloride with Jirui Pharmaceutical in 2025, granting it the rights to develop, manufacture, and commercialize cariprazine hydrochloride formulations in China using the patented technology, andActive Pharmaceutical Ingredient (API)This approval marks a significant achievement in its neuropsychiatric product portfolio, helping to expand the company’s product matrix.
 

It is understood that Zhejiang Jingxin Pharmaceutical Co., Ltd. has deeply cultivated the fields of psychiatry/neurology and cardiovascular/cerebrovascular diseases. In recent years, to accelerate its innovative transformation, the company has been fully transitioning into an innovative pharmaceutical enterprise by adhering to its foundational generic drug business, while continuously increasing R&D investment, focusing on high-value pipelines, and expanding capital and internationalization pathways. Currently, the company’s innovative drug R&D pipeline has entered a period of intensive harvest, with multiple products approaching key approval or clinical milestones. For instance, in March 2026, the improved new drug JX2404 (for treating agitation symptoms in schizophrenia) obtained clinical trial approval.
 

Colesevelam tablets for the treatment of hypercholesterolemia have had their New Drug Application (NDA) submitted. JX2201, a novel lipid-lowering drug targeting Lp(a), has completed Phase I clinical trials and is currently advancing through Phase II clinical trials in China. In addition, the modified traditional Chinese medicine Kangfuxin Enteric-coated Capsules (for the treatment of ulcerative colitis) have also entered Phase III clinical trials.
 

In addition to internal R&D, the company is also actively leveraging external resources to accelerate its transformation. In early 2026, Zhejiang Jingxin Pharmaceutical Co., Ltd. made a push for listing on the Hong Kong Stock Exchange, planning to use the funds raised to accelerate the R&D of its innovative pipeline and market expansion. Notably, on July 2, possibly influenced by breakthroughs in innovative drugs and product approvals, the company’s stock hit the daily upper limit, reaching a price of RMB 14.66, an increase of 9.98%.
 

Furthermore, as early as September 2021, Zhejiang Jingxin Pharmaceutical Co., Ltd. announced a project collaboration with XtalPi to jointly advance the research and development of small-molecule antidepressant drugs. Through XtalPi’s integrated AI-driven drug discovery platform, Zhejiang Jingxin Pharmaceutical will obtain novel-scaffold candidate molecules with outstanding properties, including potency, selectivity, druggability, and safety.
 

Overall, Zhejiang Jingxin Pharmaceutical Co., Ltd. is at a critical juncture in its transition from a traditional generic drug manufacturer to an innovative pharmaceutical enterprise. The approval of the first generic version of cariprazine hydrochloride capsules marks a significant milestone in its expansion within the neuropsychiatric sector and represents a key achievement in its transformation process during the first half of 2026. Looking ahead, the company is expected to continue strengthening its competitive moats in the two core therapeutic areas—neuropsychiatry and cardiovascular/cerebrovascular diseases—through breakthroughs in internal pipeline R&D, AI-enabled technologies, and strategic M&A expansions.
 

　　Disclaimer: Under no circumstances shall the information contained herein or the opinions expressed constitute investment advice to any person.