Qilu Pharmaceutical Secures First-to-File Generic Approval for Rasagiline Mesylate Tablets and Levosimendan Injection, Two High-Growth CNS and Cardiovascular Blockbusters

On June 21, the official website of the National Medical Products Administration (NMPA) indicated that Qilu Pharmaceutical's Levosimendan Injection and Rasagiline Mesylate Tablets have been approved for production and are deemed to have passed the consistency evaluation. Data from Menet shows that Qilu's Rasagiline Mesylate Tablets are the first domestic generic version in China, with sales of the originator product in the Chinese market surging by over 300% in 2020; terminal sales of Levosimendan Injection at China's public medical institutions reached nearly 600 million RMB in 2020, and Qilu's product is the first to pass the consistency evaluation.

Rasagiline is an irreversible selective MAO-B inhibitor that increases extracellular dopamine levels in the striatum. Clinically, it is indicated as monotherapy (without levodopa) for patients with idiopathic Parkinson's disease, and as an adjunct to levodopa for patients with Parkinson's disease experiencing end-of-dose wearing-off fluctuations.

The originator product was approved for market entry in China in June 2017, and to date, no generic versions have been approved for marketing. According to Menet data, the product's combined sales in 2020 across urban public hospitals, county-level public hospitals, urban community health centers, and township health centers in China (collectively referred to as China's public medical institutions), as well as physical retail pharmacy terminals in urban China, reached nearly RMB 50 million, representing a year-on-year increase of 328.72%.

Sales Overview of Rasagiline Mesylate Tablets in China's Urban Physical Pharmacy Channel (Unit: RMB 10,000)

Source: MENET Competitive Landscape of China's Urban Retail Pharmacy Market

Currently, three companies have submitted marketing authorization applications for rasagiline mesylate tablets under the new registration classification. Qilu Pharmaceutical was the first to submit its product for approval, successfully securing the first generic approval.

Production Application Status of Rasagiline Mesylate Tablets Under New Classification

Source: Menet One-Click Search

Levosimendan Injection is a calcium sensitizer indicated for the short-term treatment of acute decompensated heart failure when conventional therapy (diuretics, angiotensin-converting enzyme inhibitors, and digitalis) is ineffective and there is a need to increase myocardial contractility.

Currently, two domestic enterprises and one multinational company in China hold production approvals for Levosimendan Injection. According to Menet data, sales of this product in China's public medical institution terminal market reached nearly RMB 600 million in 2020, representing a year-on-year increase of 13.58%.

Qilu Pharmaceutical (Hainan) and Yangzijiang Pharmaceutical submitted marketing authorization applications for Levosimendan Injection under the new registration classification. Among them, Qilu Pharmaceutical (Hainan)'s product was approved for production and deemed to have passed the consistency evaluation, making it the first in China.

Source: MENET Database, Official Website of the National Medical Products Administration (NMPA)