On June 17, according to the latest announcement on the CDE official website: Huayi Pharmaceutical's application for the listing of the Class 3 generic drug acetylcysteine tablets was accepted, making it the eighth Chinese pharmaceutical company to enter this dosage form. This move has caused new waves in the acetylcysteine market.

from Tidu , the sales of acetylcysteine tablets in all terminals have been growing in recent years. In 2024, the sales of all terminals exceeded 389 million yuan, a year-on-year increase of more than 13%. In the entire expectorant market, acetylcysteine has topped the list for four consecutive years with a share of over 50%.

Acetylcysteine tablets are a commonly used expectorant in clinical practice. By decomposing the disulfide bonds of mucin in sputum, it effectively reduces the viscosity of sputum and promotes the discharge of sputum. In clinical practice, it is mainly used to treat symptoms such as thick sputum and difficulty in expectoration caused by respiratory diseases such as acute and chronic bronchitis, emphysema, and bronchiectasis.

At present, the notable feature of the acetylcysteine market is the coexistence of multiple dosage forms and uneven development. Different dosage forms perform differently:

inhalation solutions dominate, and in 2024, the sales of acetylcysteine solutions for inhalation in public hospitals will reach 2.306 billion yuan, accounting for more than 60% of the entire acetylcysteine market. The advantage of this dosage form stems from its direct action on the respiratory tract, which is particularly suitable for acute and critically ill patients and children.

Oral dosage forms are clearly differentiated, with tablets showing strong growth momentum:

Effervescent tablets: sales of 280 million yuan in 2023, falling back to 236 million yuan in 2024

Granules: soared to 398 million yuan in 2023 due to pre-centralized procurement stocking, and plummeted to 121 million yuan after centralized procurement in 2024

Tablets: from 159 million yuan in 2021 to 321 million yuan in 2024, doubling in four years

The growth of tablets mainly comes from their differentiated advantages: compared with inhalation solutions that require professional atomization equipment, tablets are easy to carry and take; compared with effervescent tablets that need to be dissolved and taken, ordinary tablets can be taken anytime and anywhere; compared with granules that have a special smell, tablets have less odor problems.

With the entry of Huayi Pharmaceutical, the competition landscape of the acetylcysteine tablet track has gradually become clear. Compared with the situation where 28 companies compete on the same stage for inhalation solutions, the tablet field is still in a state of limited competition.
China in May 2025 , the application boundaries of acetylcysteine in the field of acute and critical diseases are being broadened. As a differentiated product among oral dosage forms, the value of tablets lies not only in chronic disease management, but also in the incremental space brought by the expansion of new indications.

The entry of Huayi Pharmaceutical has accelerated the differentiation of the acetylcysteine tablet market. Whether Huayi Pharmaceutical can seize market opportunities when it is approved at the end of 2026 depends on its industrialization speed and commercialization capabilities. By then, Huayi Pharmaceutical will face a market environment where the overall demand for respiratory system drugs is still growing, but the pattern of oral dosage forms (especially granules that have undergone centralized procurement) has been reshaped. Whether it can stand out among the limited tablet competitors and establish its own positioning in the competition with inhalation solutions and other oral dosage forms will be a key test for Huayi Pharmaceutical.

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