Qilu Pharmaceutical Secures First-to-File Generic Approval for Belumosudil Mesylate Tablets, a Product with 483% Sales Surge Potential

Recently, the official website of the National Medical Products Administration showed that two generic drugs of Qilu Pharmaceutical were approved for production on the same day and considered to have passed the consistency evaluation. Among them, the Formoterol Fumarate Inhalation Solution is the first inhalant approved by the company; the Berzosertib Mesylate Tablets is the first generic drug in China to pass the evaluation. The sales growth rate of the original product in China's three major terminals and six major markets (the statistical scope is detailed at the end of this article) is approximately 483% by 2025.

Belumosudil mesylate tablets are a Rho-associated protein kinase 2 (ROCK2) inhibitor used to treat chronic graft-versus-host disease patients aged 12 years and older who have had an inadequate response to glucocorticoids or other systemic therapies. The original product was first approved for entry into the Chinese market in August 2023 and has now been included in the National Reimbursement Drug List (Class B) through negotiation.

Data from Menet shows that in 2024, the sales revenue of Berotralstat Mesylate Tablets in China's three major terminals and six major markets exceeded 20 million yuan, with urban physical pharmacies as the main sales channel; in 2025, its sales revenue will exceed 100 million yuan, increasing by approximately 483% year-on-year, with urban public hospitals as the main sales channel.

In terms of generic drug applications, currently, only two companies in China have submitted production applications for Berdofel Mesylate Tablets under the new registration classification. Qilu Pharmaceutical's product has recently been successfully approved, securing the first domestic generic approval and the first to pass the evaluation; Zhejiang Huayi Pharmaceutical's product is still under review.

Formoterol Fumarate Inhalation Solution is a long-acting selective β2-adrenergic receptor agonist used for the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD). In recent years, the drug has rapidly increased in sales volume across the three major terminals and six key markets in China. In 2024, its sales exceeded 400 million yuan, representing a year-on-year growth of approximately 344%; in 2025, sales surpassed 600 million yuan, marking a year-on-year increase of about 56%.

Currently, more than 20 companies in China have received approval for the production of Formoterol Fumarate Inhalation Solution, including Qilu Pharmaceutical, Shijiazhuang Fourth Pharmaceutical, Changfeng Pharmaceuticals, Renhe Yikang, and Bet Pharmaceutical.Kelon Pharmaceuticaletc.; In addition, Lunan Pharmaceutical, Huluwa Pharmaceutical,Fosun PharmaProducts of companies such as Qilu Pharmaceutical Co., Ltd. are under review for production approval.

Formoterol Fumarate Inhalation Solution is the first inhalation product approved for Qilu Pharmaceutical. In this formulation, the company has seven products under review with new registration classifications, all of which are respiratory medications. Among them, Fluticasone Furoate Nasal Spray, Tiotropium Bromide and Olodaterol Inhalation Spray, Revefenacin Inhalation Solution, Tiotropium Bromide Inhalation Spray, Indacaterol and Glycopyrronium Bromide Inhalation Powder, and Indacaterol and Glycopyrronium Inhalation Powder (Ⅱ) currently have no generic versions approved.

Since the beginning of this year, Qilu Pharmaceutical has received approvals for six new products, among which Brexpiprazole Orally Disintegrating Film is a Class 2.2 new drug and the company's seventh approved orally disintegrating film product; Mesylate Befusartan Tablets, Formoterol Fumarate Inhalation Solution, Oxybuprocaine Hydrochloride Eye Drops, Brexpiprazole Orally Disintegrating Tablets, and Lusutrombopag Tablets have been approved for production and are considered to have passed the evaluation.