--- title: "Montelukast sodium warns of impact on the children's medication market, with CSPC PHARMA, Yangtze River Pharmaceutical, and other billion-level single products facing volatility risks" type: "News" locale: "en" url: "https://longbridge.com/en/news/270889101.md" description: "The National Medical Products Administration issued a notice requiring a unified revision of the instructions for Montelukast preparations, adding warning phrases mentioning \"depression and suicidal tendencies\" and other serious neuropsychiatric adverse reactions. This revision may affect patient compliance and physician prescribing decisions, thereby impacting manufacturers' sales and operating costs. Montelukast sodium was developed by Merck in the United States and is produced by several well-known pharmaceutical companies in China, with terminal sales in public medical institutions in China exceeding 1 billion yuan in 2023" datetime: "2025-12-27T09:04:13.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/270889101.md) - [en](https://longbridge.com/en/news/270889101.md) - [zh-HK](https://longbridge.com/zh-HK/news/270889101.md) --- > Supported Languages: [简体中文](https://longbridge.com/zh-CN/news/270889101.md) | [繁體中文](https://longbridge.com/zh-HK/news/270889101.md) # Montelukast sodium warns of impact on the children's medication market, with CSPC PHARMA, Yangtze River Pharmaceutical, and other billion-level single products facing volatility risks This report (chinatimes.net.cn) reporter Guo Yilin and Yu Na reported from Beijing A revised announcement from the National Medical Products Administration has put a cough medicine with annual sales exceeding 1 billion yuan in the spotlight. On December 22, the National Medical Products Administration issued an announcement requiring a unified revision of the instructions for Montelukast preparations. The new warning language explicitly mentions serious neuropsychiatric adverse reactions such as "depression and suicidal tendencies," and the revision covers all dosage forms including Montelukast sodium tablets, chewable tablets, granules, and orally dissolving films, with the latter three primarily for pediatric use. It is reported that Montelukast sodium, as a commonly used medication for the respiratory system, is particularly favored by pediatric patients. This drug was developed by the American company Merck, and domestic production units include several well-known domestic pharmaceutical companies such as Qilu Pharmaceutical, Huasan Pharmaceutical, Tianyu Pharmaceutical, CSPC PHARMA, Yangtze River Pharmaceutical, and Yabao Pharmaceutical. This revision stems from the evaluation results of adverse drug reactions and aims to further ensure the safety of public medication use. According to data from Minai Network, Montelukast's sales scale in public medical institutions in China exceeded 1 billion yuan in 2023. Another set of data shows that from 2020 to 2024, the cumulative sales of this drug in domestic hospital terminals reached 5.544 billion yuan, with an average annual sales also exceeding 1 billion yuan. In response, Shi Wankui, a partner at Hejun Consulting, told a reporter from the China Times, "The safety issues of Montelukast have been brought to the public's attention, which may have some impact on patient compliance and doctors' prescribing decisions, thereby affecting the sales and operating costs of the direct manufacturers. If Montelukast faces further restrictions due to safety issues in the future, related companies may face performance volatility risks." **New Warning Language** Montelukast sodium was developed by the American company Merck and was first approved for marketing in 1998. As a selective leukotriene receptor antagonist, it is primarily used to treat and prevent asthma symptoms and alleviate discomfort caused by allergic rhinitis. The psychiatric adverse reactions of this drug are not new findings; industry insiders have long been aware of the related impacts from the instructions and manufacturer promotions. A study in 2019 found that children with asthma who were diagnosed with newly occurring neuropsychiatric events were nearly twice as likely to have been prescribed Montelukast in the year prior to the event compared to children who did not use the drug. In March 2020, the U.S. Food and Drug Administration had already added a black box warning to the Montelukast sodium instructions, alerting to its serious psychiatric adverse reactions and restricting its use. In this regard, Ji Lianmei, founder of "Ask the Pharmacist," pointed out that Montelukast sodium is not the first-choice medication for allergic rhinitis or asthma treatment, and the proportion of children experiencing psychiatric side effects such as irritability and abnormal attention is higher. Regardless of whether in adults or children, if neuropsychiatric symptoms occur during medication, it is necessary to stop the medication and seek medical attention immediately, and a thorough assessment of benefits and risks must be conducted before use. According to information from the National Medical Products Administration's official website, there are over 60 approved numbers for this drug, and production units include several well-known pharmaceutical companies. Our reporter has sorted out that the main participants in the global and Chinese Montelukast sodium market include multinational pharmaceutical companies/generic drug companies: Merck (originating company), Mylan, and Teva Pharmaceuticals Sandoz, Aurobindo Pharma, Sun Pharmaceutical, etc. Domestic Chinese pharmaceutical companies include Yangtze River Pharmaceutical Group, CSPC PHARMA, Huasan Pharmaceutical, Qilu Pharmaceutical, Lunan Beite, Fuyuan Pharmaceutical, Haichen Pharmaceutical, Yabao Pharmaceutical, and Tianyu Pharmaceutical. Public sales data shows that from 2020 to 2024, the cumulative sales of montelukast sodium formulations in domestic hospital terminals reached 5.544 billion yuan, with an average annual sales exceeding 1 billion yuan. In the PDB database's classification of asthma medications, montelukast ranked third in total sales across all channels in the first three quarters of 2024, reaching 1.33 billion yuan. The announcement from the National Medical Products Administration requires that all marketing authorization holders of montelukast products must complete the revision of the product insert and file it by March 12, 2026. Within nine months after filing, the product inserts and labels of already manufactured drugs must be replaced or patients must be informed of the updated information. He Wanyi, a senior analyst in the medical industry at the Head Leopard Research Institute, stated in an interview with the China Times that "in recent years, the FDA's black box warnings and domestic insert revisions have compounded regulatory actions, which may lead to a decrease in doctors' willingness to prescribe and lower patient adherence to medication. Especially in the field of asthma treatment, as guidelines recommend downgrading montelukast from a first-line medication to a second-line option (only for alternative therapy or specific scenarios), the market share of this drug is likely to face further contraction in the future. Merck needs to rebuild trust through academic promotion and patient education, but the costs are high and the effects are limited, which may compress long-term profit margins. For domestic listed companies, they not only face a sharp decline in single product sales but also have to deal with the pressure of short-term benefits and long-term compliance. If montelukast is further restricted in use or withdrawn from certain markets due to safety issues in the future, generic drug companies need to accelerate product pipeline iterations to reduce reliance on a single variety, or they may face performance volatility risks." Meanwhile, this regulatory decision directly impacts related companies in the montelukast supply chain. Public information shows that Hubei Nengte Technology Co., Ltd.'s wholly-owned subsidiary, Nengte Company, has montelukast sodium intermediates as one of its leading products. The company stated in its 2024 annual report that it will continue to strengthen, supplement, and extend the montelukast sodium intermediate production chain to further improve the self-supporting nature of the supply chain to withstand fierce industry competition. It is noteworthy that Hubei Nengte Technology reported a net profit attributable to shareholders of the listed company of -588 million yuan in its consolidated financial statements for 2024, with a cumulative undistributed profit of -977 million yuan. The company's investor lawsuit involves a total of 1,075 investors, with a total compensation amount of 91.6652 million yuan. In addition, the listed company Lingrui Pharmaceutical mentioned in its 2025 semi-annual report that it is "accelerating the commercialization process of montelukast sodium chewable tablets and strengthening market coverage of drugs for pediatric asthma treatment." **The Tip of the Iceberg** In fact, montelukast sodium is not the only commonly used medication with neuropsychiatric risks. Academic research shows that over-the-counter anti-vertigo medication diphenidol, some antiepileptic drugs (such as carbamazepine and sodium valproate), and antihypertensive drugs (such as propranolol) have also drawn attention due to similar risks Difenidol is primarily used for vasodilation, improving blood supply to the vertebrobasilar artery, and inhibiting vestibular function. Clinically, it is mainly used to treat vertigo and motion sickness (such as car sickness and seasickness), and can be categorized into coated tablets and film-coated tablets. According to a study published in the Chinese Journal of Clinical Pharmacology in August 2024, from 2011 to 2022, the highest proportion of poisoning incidents involving difenidol occurred in the age group of 11 to 30 years, with a predominance of young females. The risk of death significantly increases for patients taking doses greater than 3000 mg or with blood drug concentrations exceeding 6 μg·mL. Meanwhile, this medication is also used in children, with the instructions indicating "for children aged 6 months to under 12 years, 0.9 mg/kg per dose, three times a day or as directed by a physician." Specific symptoms after taking the medication include dry mouth, irritability, hallucinations, headaches, euphoria, consciousness disorders, respiratory arrest, and even arrhythmia leading to death. Therefore, the aforementioned study recommends that drug regulatory authorities require the inclusion of information regarding the risk of poisoning and symptoms in the instructions, restrict individual consumers from purchasing large quantities in a short period, cancel the sale packaging of high-dose specifications, and even consider converting it to prescription drug management or canceling its registration certificate. These findings correspond with a forensic toxicology analysis study published in the Journal of Criminal Technology in 2025, which pointed out that difenidol poisoning is difficult to diagnose in forensic practice and can easily be confused with other diseases. Regarding the risk of drugs causing mental illnesses, a review in the Therapeutics journal in 2024 noted that many drugs are associated with mental disorders, but "confounding indications" is an important methodological limitation, as information about patients' mental status is not always available. Major companies in the domestic difenidol industry include Jiangsu Sihuan Biopharmaceutical Co., Ltd., Zhejiang Ruixin Pharmaceutical Co., Ltd., Ruiyang Pharmaceutical Co., Ltd., and Hebei Changtian Pharmaceutical Co., Ltd. According to industry reports, the global difenidol market revenue is expected to reach several billion yuan in 2024, with a stable compound annual growth rate projected during the forecast period. As awareness of the suicidal abuse risk of difenidol deepens, related regulatory measures may be further strengthened. Research clearly recommends restricting individual consumers from purchasing large quantities of difenidol tablets in a short period and canceling the sale packaging of high-dose specifications. In fact, these companies face challenges similar to those of manufacturers of montelukast sodium: how to effectively manage potential risks while ensuring drug accessibility. Shi Wankui stated, "For drugs with neuropsychiatric risks, a multi-layered and comprehensive control system needs to be established. The drug marketing authorization holder should conduct in-depth research on the mechanisms of newly reported adverse reactions and take effective measures to promote training on drug use and safety issues. At the regulatory level, consideration could be given to converting high-risk over-the-counter drugs to prescription management, setting purchase restrictions, modifying packaging specifications, and clearly warning of potential risks in the instructions." ### Related Stocks - [CSPC PHARMA (01093.HK)](https://longbridge.com/en/quote/01093.HK.md) - [Merck & Co., Inc. 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