From December 8th to December 14th , a total of 65 varieties passed/were deemed to have passed the consistency evaluation. During the same period, 69 varieties applied for consistency evaluation. 01 Guilin Nanfang Pharmaceutical: Rivaroxaban Dry Suspension On December 9th, the official website of the National Medical Products Administration (NMPA) showed that Guilin Nanfang Pharmaceutical's rivaroxaban dry suspension was officially approved, becoming the first generic and the first product to pass the consistency evaluation in China for this dosage form. Image source: NMPA official website. Rivaroxaban was jointly developed by Bayer and Johnson & Johnson. Since entering China in 2009, it has become one of the oral anticoagulants for the prevention and treatment of venous thrombosis, stroke, and pulmonary embolism. Global sales in 2024 still exceeded RMB 43.8 billion. Intense competition. Currently, 58 companies in China hold approvals for rivaroxaban, expanding into four dosage forms: tablets, granules, dry suspensions, and orally disintegrating tablets. Among them, tablets dominate, accounting for over 90% of approvals. National centralized procurement in 2018. When rivaroxaban tablets were included in centralized procurement, the price war swept through, instantly reshaping the market landscape. Bayer's market share plummeted by over 30%. Sales of rivaroxaban tablets in China also fell from a peak of 5.3 billion yuan to 3.6 billion yuan. Tablets have become a quagmire of thin profits and fierce competition. ▲ Rivaroxaban tablets sales trend in China (Image source: Yaozhi Data - Pharmaceutical Terminal Sales Analysis System) Against this backdrop, dosage form innovation has become a small path for companies to seek differentiation. Dry suspensions are particularly suitable for patients with swallowing difficulties or requiring dose adjustments (such as children or the elderly), offering certain convenience in clinical use. However, this dosage form had previously been absent in China , and Guilin Nanfang Pharmaceutical's approval fills a market gap. More notably, the product is manufactured by Nanjing Haina Pharmaceutical, which already holds approval for rivaroxaban granules. This collaboration between Guilin Nanfang Pharmaceutical and Nanjing Haina is not merely a simple product approval, but a well-thought-out strategic positioning. In the already fiercely competitive rivaroxaban market, whether Guilin Pharmaceutical can successfully carve out a share with its niche dry suspension formulation, or merely add another option to its product portfolio, remains to be seen. However, one thing is certain: in today's environment of centralized procurement and intense competition driven by product homogeneity, any subtle innovation in dosage form or the first-to-market advantage can be a crucial factor for companies seeking growth.

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