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Flu Season Strikes: Shisi Pharmaceutical’s Arbidol Joins the Frontline of Flu Prevention

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发布时间：2019-12-06

【概要描述】 Recently, the Medical Administration and Management Bureau of the National Health Commission issued the “Notice on Ensuring Quality Medical Care for Influenza This Winter and Next Spring” (Document No. [2019]819 of the Office of the National Health Commission), which was accompanied by the “Influenza Diagnosis and Treatment Protocol (2019 Edition)” as an annex. Notably, in this new edition of the influenza diagnosis and treatment protocol, the hemagglutinin inhibitor arbidol has been included in the list of antiviral drugs recommended for clinical use against influenza.

Flu Season Strikes: Shisi Pharmaceutical’s Arbidol Joins the Frontline of Flu Prevention

Recently, the Medical Administration and Management Bureau of the National Health Commission issued the “Notice on Ensuring Quality Medical Care for Influenza This Winter and Next Spring” (Document No. [2019]819 of the Office of the National Health Commission), which was accompanied by the “Influenza Diagnosis and Treatment Protocol (2019 Edition)” as an annex. Notably, in this new edition of the influenza diagnosis and treatment protocol, the hemagglutinin inhibitor arbidol has been included in the list of antiviral drugs recommended for clinical use against influenza.

The current situation in prevention and control is severe; anti-epidemic drugs are the mainstay.

Influenza, or the flu, is an acute respiratory infectious disease caused by influenza viruses and affects all populations. Due to the virus’s propensity for rapid mutation and efficient transmission, it gives rise to seasonal epidemics each year. Although influenza is typically a self-limiting illness, it can be fatal in high-risk groups, including children, older adults, individuals with compromised immune function, and those with chronic underlying conditions. According to a report by the World Health Organization (WHO), seasonal influenza epidemics worldwide result in 3 million to 5 million severe cases and 290,000 to 650,000 deaths from influenza-related respiratory diseases annually.

The disease burden of influenza in China is equally substantial. According to data from the Chinese Center for Disease Control and Prevention, during the first five months of 2019, the number of reported influenza cases reached 1.77 million, surpassing the total number of reported cases over the previous four years combined. Additionally, statistics from the National Health Commission indicate that, in northern and southern Chinese cities, the annual excess mortality rates attributable to influenza-related respiratory and circulatory diseases were 12.4 per 100,000 and 8.8 per 100,000, respectively.

In fact, influenza vaccination is the most effective measure for preventing influenza and its severe complications. However, due to insufficient awareness among the general public and primary-care health professionals regarding the harms of influenza and its disease burden, China currently faces a low influenza vaccination rate, which hinders effective early identification of influenza and timely antiviral treatment. To reduce the disease burden of influenza, the National Health Commission, drawing on the latest domestic and international research findings as well as China’s past experience in the diagnosis and treatment of influenza, has updated the influenza diagnosis and treatment guidelines for two consecutive years, with the aim of further standardizing and strengthening clinical diagnosis and management of influenza, thereby reducing the incidence of severe cases and lowering the case-fatality rate. Consequently, antiviral drugs remain the mainstay of frontline clinical efforts to combat influenza at this stage.

Currently, China has approved three classes of anti-influenza drugs: neuraminidase inhibitors, hemagglutinin inhibitors, and M2 ion-channel blockers. Arbidol, recently included in the new influenza diagnosis and treatment guidelines, falls under the category of hemagglutinin inhibitors. Developed by the former Soviet Union’s Research Center for Pharmaceutical Chemistry, Arbidol was first launched in Russia in 1993 and is available in multiple dosage forms, including capsules, tablets, and oral suspensions. Its indications include the prevention and treatment of influenza A and B as well as other acute respiratory viral infections in children aged 2 years and older and adults; combination therapy for recurrent herpes infections; combination therapy for the etiological treatment of acute rotavirus gastroenteritis in children aged 2 years and older; and the prevention of postoperative complications. Following years of clinical validation, Arbidol has been shown to be both effective in preventing and treating influenza and well-tolerated, earning it recommendation from the Russian Pharmacopoeia Commission as an essential therapeutic and prophylactic agent for combating influenza A and B viruses in elderly patients and children. Moreover, the Federal Service for Supervision of Healthcare and the Ministry of Health of the Russian Federation have designated Arbidol as a prescription drug for free medical assistance provided by physicians and as an essential medication for emergency response agencies. In addition, Arbidol is also regarded as an important strategic reserve drug.

Shijiazhuang Sihua Pharmaceutical Co., Ltd. houses a National Enterprise Technology Center and has established multiple drug innovation research centers in collaboration with renowned domestic universities and research institutes. The company is among the earliest pharmaceutical enterprises in China to conduct research and development on arbidol as an anti-influenza virus agent. In 2004, Shijiazhuang Sihua was the first in China to obtain a production approval number for arbidol and to launch the first generic version of the drug on the market.

Unique pharmacological mechanism; unanimously recommended in consensus guidelines.

Pharmacologically, arbidol exerts its antiviral activity by specifically inhibiting the fusion of the viral envelope with the host cell membrane through activation of 2,5-oligoadenylate synthetase, thereby blocking the initial step of viral infection. In addition, arbidol can induce the production of endogenous interferon, which not only suppresses viral replication but also modulates the host immune response by enhancing macrophage phagocytic function and promoting the activation of natural killer cells. Medical experts have noted that arbidol’s multi-mechanism synergistic action against influenza viruses confers advantages that are not shared by other anti-influenza agents.

Studies have shown that arbidol is currently the only drug with potent antiviral activity against all influenza virus subtypes (A, B, and C), with the strongest efficacy against influenza A viruses (H1N1, H2N2, and H3N3)—comparable to or even superior to that of neuraminidase inhibitors such as oseltamivir and zanamivir. In addition to effectively alleviating influenza-like symptoms such as sore throat, myalgia, and fatigue, arbidol can also shorten the duration of these symptoms and the overall disease course, increase the viral clearance rate, and accelerate patient recovery.

For high-risk populations susceptible to influenza, arbidol can effectively shorten the duration of fever and significantly reduce the incidence of pneumonia and other complications. As a non-nucleoside broad-spectrum antiviral agent, arbidol not only inhibits influenza viruses but also exerts inhibitory effects on common respiratory pathogens such as respiratory syncytial virus, rhinovirus, adenovirus, and coronaviruses. Additionally, studies have shown that in patients with chronic obstructive pulmonary disease, prophylactic use of arbidol during seasons when influenza and acute respiratory viral infections are more prevalent can markedly reduce (by a factor of 2.6) the incidence of acute respiratory viral infections.

Thanks to its outstanding clinical data, arbidol has earned widespread recognition in the medical community. Even before being included in the latest influenza diagnosis and treatment guidelines, arbidol had already been listed in the “Diagnosis and Treatment Protocol for Influenza A (H1N1) (2010)” issued by the former Ministry of Health. Moreover, the Respiratory Disease Branch of the Chinese Medical Association and the Pediatrics Branch of the Chinese Medical Association both recommended arbidol as a commonly used antiviral agent for influenza in their jointly published “Chinese Expert Consensus on the Antiviral Treatment and Prophylactic Use of Antiviral Drugs for Influenza (2016)” and in the “Expert Consensus on the Rational Use of Anti-Influenza Viral Agents for the Treatment of Influenza” released by the Respiratory Physicians Branch of the Chinese Medical Doctor Association in 2016, respectively.

Coincidentally, Arbidol is also recommended in the “Interpretation of Clinical Pathways (2018 Edition)—Respiratory Diseases Volume: Interpretation of the Clinical Pathway for Community-Acquired Pneumonia,” and is further included in the “Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease (2019 Edition).” In August of this year, Arbidol was successfully added to the 2019 National Medical Insurance Catalog as a Class B drug, with its use restricted to antiviral treatment of severe influenza in high-risk populations and critically ill patients.

Therapeutic effect To be king, one must also prioritize cost-effectiveness.

As the annual number of influenza cases continues to rise, so too do the medical costs associated with treating influenza patients. Domestic studies have shown that the average per-visit cost for outpatients is RMB 1,052, while the average per-admission cost for inpatients reaches RMB 11,153; among these, patients aged 60 and above incur the highest average cost per episode, at RMB 18,818, placing a substantial financial burden on influenza patients.

Parallel to the soaring cost of treatment is the record-breaking market sales of antiviral drugs. According to data from MeneNet, sales of systemic antiviral medications at the end-user level in China’s public medical institutions have increased year after year in recent years, reaching RMB 19.089 billion in 2018—a year-on-year increase of 9.01%. Among the top 20 best-selling products, anti-influenza drugs rank among the leaders in terms of volume. This substantial and unmet clinical demand has created a broad market outlook for anti-influenza medications; according to authoritative statistics, the annual compound growth rate of China’s major anti-influenza drugs has reached as high as 45.3%.

The aforementioned statistics also show that, among the antiviral drugs currently in mainstream clinical use for influenza, oseltamivir leads the market with an 87.3% share. However, industry insiders point out that arbidol, the “newcomer” in influenza treatment recently included in the influenza diagnosis and treatment guidelines, may shake up the existing competitive landscape in the hospital setting, thanks to its inclusion in the latest national medical insurance reimbursement list.

A head-to-head study comparing arbidol and oseltamivir demonstrated that arbidol is equivalent to oseltamivir in shortening the duration of illness and reducing the severity of symptoms. In terms of resistance, no resistant viral strains have yet been identified for arbidol, whereas highly resistant strains to neuraminidase inhibitors have already emerged for oseltamivir. Moreover, from a mechanistic perspective, while arbidol functions both as a hemagglutinin inhibitor and as an inducer of endogenous interferon production, oseltamivir—a neuraminidase inhibitor—targets a relatively more limited mechanism. Given comparable efficacy, arbidol clearly offers greater cost-effectiveness due to its lower average daily treatment cost.

Currently, Arbidol is manufactured by several domestic pharmaceutical companies; however, among public medical institutions and urban retail pharmacies, only Shijiazhuang No. 4 Pharmaceutical stands out as a top-tier player in the brand competition landscape. Its exclusive product, Ainuoda® Arbidol Hydrochloride Capsules, has been on the Chinese market for many years and enjoys strong market recognition. In October 2019, Ainuoda® was awarded the title of “2019 China’s Most Innovative Pharmaceutical Formulation,” and in November of the same year, it was also recognized as a “Landmark Achievement in China’s Pharmaceutical Science and Technology Commemorating the 70th Anniversary of the Founding of the People’s Republic of China.”

(Originally published in the Pharmaceutical Economic Daily)

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