Qilu Pharmaceutical Secures First-to-Pass Consistency Evaluation for Isosorbide Mononitrate Sustained-Release Tablets, Leading with 35 Approved Products and 26 Under Review

On July 13, the National Medical Products Administration (NMPA) website released the latest batch of drug approval information. Qilu Pharmaceutical’s Isosorbide Mononitrate Sustained-Release Tablets passed the consistency evaluation, making Qilu the first company to achieve this milestone for the product. According to data from Menet, as of now, Qilu Pharmaceutical has had 35 products (covering 60 approval numbers) pass the consistency evaluation, establishing itself as the leader in this initiative.

Figure 1: Approval Status of Qilu Pharmaceutical's Isosorbide Mononitrate Sustained-Release Tablets

Source: NMPA Official Website

Isosorbide Mononitrate Sustained-Release Tablets are indicated for the prevention and long-term treatment of angina pectoris (cardiac pain caused by coronary artery disease) and, in combination with digitalis and/or diuretics, for the treatment of chronic heart failure. In 2019, it ranked third among the top 20 chemical drug products for oral treatment of heart diseases at terminal sales channels in China’s public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers, with sales exceeding RMB 700 million. The leading enterprise, Lunan Better Pharmaceutical, held a market share of nearly 60%.

Table 1: Overview of Qilu Pharmaceutical’s Products That Have Passed the Consistency Evaluation

Source: Menet Database, Qilu Pharmaceutical Official WeChat Account

Data from Menet shows that as of July 14, 2020, Qilu Pharmaceutical and its subsidiaries had 35 products that passed the consistency evaluation. Among them, 21 were the first to pass the evaluation. Currently, the products exclusively passed by Qilu include Oxaliplatin Injection, Leflunomide Tablets, Exemestane Tablets, Cefprozil Granules, Amisulpride Tablets, Risperidone Orally Disintegrating Tablets, Pregabalin Capsules, Ondansetron Hydrochloride Tablets, Isosorbide Mononitrate Sustained-Release Tablets, Warfarin Sodium Tablets, and Bivalirudin for Injection.

Table 2: Status of Supplementary Applications for Consistency Evaluation Under Review by Qilu Pharmaceutical

Source: Menet MED China Drug Review Database 2.0

As of now, Qilu Pharmaceutical and its subsidiaries still have 26 supplementary applications for consistency evaluation under review, involving 46 acceptance numbers, among which 19 products are expected to compete for the first approval.