At the beginning of 2025, the CNS track continues to be highly active.First, the multinational pharmaceutical company Johnson & Johnson invested tens of billions of dollars to strengthen its CNS pipeline and brought the new antipsychotic drug Caplyta under its wing. Subsequently, Luye Pharma, a leading CNS company in China, announced that its new antipsychotic drug TAAR1/5-HT received approval in the United States.2CClinical Trials of R Dual-Target Agonist Continue to Explore Next-Generation Antipsychotic Drugs.Looking back over the past two years, there have been several deals worth tens of billions in the CNS field, including those targeting schizophrenia. For instance, AbbVie acquired Cerevel Therapeutics, a CNS biotech company, for a total of $8.7 billion, while Bristol-Myers Squibb (BMS) purchased Karuna Therapeutics for $14 billion, gaining access to the star schizophrenia drug KarXT, among others.What kind of market is schizophrenia, attracting both MNCs and local pharmaceutical companies to place their bets? What is the current treatment landscape, and which companies in China have made strategic moves? As pharmaceutical companies shift their focus from the fiercely competitive oncology field to CNS (Central Nervous System) to open new battlegrounds, what new stories can we expect?
A Billion-Dollar Acquisition Sparked by an Antipsychotic Drug1Month13Johnson & Johnson announced that it would acquire at $ per share132Cash Acquisition in USDIntra-Cellular TherapiesAll outstanding shares,The latterIs a company focused onCNSCompany for disease treatment, with a total market capitalization of approximately146Billion US dollars.
Behind the heavy investment is Johnson & Johnson'sCaplytaThis new antipsychotic drug has a promising market potential. Public information shows,CaplytaIn2019Year obtainedFDAApproved for schizophrenia, and in2021Year extended toTreatmentBipolar DisorderRelevant depressive episodes。The Product2024Q3 Sales Revenue Increased Year-over-Year39%To1.75billion dollars, with this year's sales expected to be in6.65-6.85Between hundreds of millions of US dollars, and the recent sales forecast has been raised.Not coincidentally, this is not the first large-scale acquisition triggered by a new antipsychotic drug. BMS once acquired Karuna Therapeutics for a total price of $14 billion, gaining access to the star antipsychotic drug KarXT. As KarXT advanced in clinical trials, positive data emerged, and it was eventually approved for marketing, causing Karuna's market value to soar from $700 million at its IPO to over $10 billion.
Why Has the Anti-Schizophrenia Market Become a Goldmine?Schizophrenia is a chronic, recurrent, and protracted disease.Globally, there are approximately240010,000 Patients with SchizophreniaAntipsychotic drugs are the main treatment for schizophrenia, including first-generation antipsychotics such as perphenazine and second-generation antipsychotics such as risperidone and paliperidone. Among them, second-generation antipsychotics are currently the mainstream clinical medications.It is estimated that the global market value of schizophrenia drugs in 2023 was $8.18 billion. The existing market is already large enough, and antipsychotic drugs have proven the attractiveness of this market – the global sales of just the paliperidone palmitate extended-release injectable suspension category reached $5 billion in 2023.However, due to factors such as low consultation rates, limitations of existing drugs, and long medication cycles for patients, the "cake" of antipsychotic treatments will continue to expand: it is expected that by 2032, the market size will reach 12.97 billion US dollars, with an annual compound growth rate of 5.26%.Data shows that the medical consultation rate for schizophrenia is only 33% globally. Among patients receiving treatment, there are still significant unmet clinical needs, primarily in two aspects: efficacy and safety remain flawed, including the inability to improve cognitive function and negative symptoms, as well as a high risk of extrapyramidal side effects (EPS). Additionally, the relapse rate within five years for first-episode patients exceeds 80%, with multiple relapses leading to prolonged illness duration and increased treatment difficulty.The large-scale patient population, the allure of existing molecules with long life cycles, combined with unmet clinical needs, naturally attracts many pharmaceutical companies to explore and compete for the next "billion-dollar molecule."
Contest"Billion-Dollar Molecule"From the iteration of antipsychotic drugs, most first-generation antipsychotics are specific dopamine 2 (D2) receptor antagonists, while the advantage of second-generation antipsychotics lies in their multi-target pharmacological characteristics, which have an effect onD2Receptors have antagonistic or partial agonistic functions, while blocking 5-hydroxytryptamine 2A (5-HT2A) receptor, for D2The receptor has high affinity. Meanwhile, many pharmaceutical companies have quietly started to develop new mechanism antipsychotics. Here we list a few antipsychotic drugs and related companies that are worth paying attention to:1. Johnson & Johnson/Intra-Cellular Therapies: CaplytaCaplyta (lumateperone) is uniquely characterized by its effect on serotonin 5-HT at therapeutic doses.2AHigh receptor occupancy, dopamineD2Low receptor occupancy. In all three short-term clinical studies of approved indications, Caplyta was similar to placebo in terms of weight change, metabolic effects, and EPS, which are commonly considered reasons for discontinuation of treatment.Before Johnson & Johnson announced the acquisition of Intra-Cellular Therapies, Intra-Cellular had just reached a settlement agreement with Sandoz to resolve patent litigation related to its core product, Caplyta. The settlement allows Sandoz to begin selling generic versions of Caplyta on July 1, 2040.2. BMS/Karuna/Zai Lab: Cobenfy (xanomeline and trospium chloride combination, KarXT)Different from the mechanisms of action of first- and second-generation antipsychotics,KarXTIt is a compound oral muscarinic antipsychotic drug. Based on the positive results of three clinical studies (Phase II EMERGENT-1 study, Phase III EMERGENT-2 study, and Phase III EMERGENT-3 study) evaluating the efficacy and safety of KarXT versus placebo in treating patients with schizophrenia, Karuna submitted its first New Drug Application (NDA) for KarXT to the FDA in November 2023. Less than a month later, BMS announced the acquisition of Karuna for $14 billion.In September last year, the drug received FDA approval for marketing. This is the first drug with a completely new mechanism for treating schizophrenia to be approved in 60 years. The rights to the drug in Greater China belong to Zai Lab.3. Luye Pharma: TAAR1/5-HT2CR Dual-Target Agonist (LY03020)Due to the high difficulty in developing new drugs for schizophrenia, pharmaceutical companies in China have less presence in this field, with most focusing on generic drugs. For instance, companies like Hisun and Haisco have developed generic versions of Lurasidone Hydrochloride, while Kanghong Pharmaceutical, Enhua Pharmaceutical, and Huahai Pharmaceutical have focused on Aripiprazole generics.Luye Pharma is an exception. The company's newly approved dual-target antipsychotic drug targeting TAAR1 and 5-HT has recently entered clinical trials in the United States.2CR acts on dual targets. Among them, TAAR1 is mainly expressed on the presynaptic membrane, and its activation can lead to a reduction in the release of monoamine neurotransmitters such as dopamine (DA) and serotonin (5-HT) into the synaptic cleft.5-HT2CRExpressed in both presynaptic and postsynaptic membranes, activation of presynaptic receptors can further reduce the release of neurotransmitters such as 5-HT, enhancing the efficacy in controlling negative symptoms; activation of postsynaptic receptors can help manage metabolic syndrome-related adverse reactions such as weight gain and abnormal glucose and lipid metabolism. LY03020 is considered a new generation of antipsychotic drug that distinguishes itself from first- and second-generation antipsychotics, and it is currently in the clinical stage in China.In addition to being the first to lay out the next generation of new antipsychotic drugs, Luye Pharma is also the first Chinese pharmaceutical company to launch a CNS new drug in the U.S. market, where it has already established a strong position with Erzofri, a mainstream second-generation long-acting injectable antipsychotic.Looking forward to more pharmaceutical companies entering the market, investing in research and development, and contributing to breakthroughs in the CNS treatment field, including schizophrenia.Copyright © 2025 PHARMCUBE. All Rights Reserved.
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