Qilu Pharmaceutical's Warfarin Sodium Tablets First in China to Pass Consistency Evaluation

On September 17, Qilu Pharmaceutical received the approval for the consistency evaluation of Warfarin Sodium Tablets issued by the National Medical Products Administration, marking the company as the first domestic pharmaceutical enterprise to pass the consistency evaluation for this product. To date, the company has a total of 17 products that have passed the consistency evaluation, among which 12 are the first in China, and 6 products are currently the only ones to have passed the consistency evaluation.

Warfarin Sodium Tablets, an intermediate-acting anticoagulant of the coumarin class, were first launched in the United States in 1954. They are indicated for patients requiring long-term continuous anticoagulation to prevent the formation and progression of thrombi. The Warfarin Sodium Tablets developed by Qilu Pharmaceutical were launched in China in 1995. In the decades since its market introduction, warfarin sodium has maintained enduring clinical application and has gained consistent recognition from healthcare institutions and patients alike.

In recent years, several new oral anticoagulants have been successively launched in foreign markets. These agents offer advantages such as rapid onset of action and no requirement for routine monitoring of coagulation parameters. For certain indications, such as the prevention of thromboembolism in patients with non-valvular atrial fibrillation, these novel drugs have been recommended by European and American clinical guidelines. However, for anticoagulation therapy in patients with valvular heart disease (such as those with valvular atrial fibrillation, prosthetic valve replacement, or valve repair), dose-adjusted warfarin remains the agent of choice. Given the substantial number of patients with valvular heart disease in China, warfarin continues to hold significant clinical importance and broad application value.

In 2016, warfarin sodium tablets were included in the "Catalog of Generic Drugs Required to Complete Consistency Evaluation by the End of 2018," published by the state, commonly known as the "289 Catalog" varieties. However, evaluating the in vitro and in vivo equivalence of this drug presents significant challenges.

According to Insight data, there are currently five domestic manufacturers of this drug in China. It is understood that some manufacturers have already abandoned the consistency evaluation for this product. This means that if no company overcomes all difficulties to carry out the consistency evaluation work for Warfarin Sodium Tablets, this important clinical drug may face shortages in the future.

Qilu Pharmaceutical was among the first to initiate the consistency evaluation for this project in March 2016. The R&D team promptly conducted systematic development in accordance with relevant guidelines and performed comprehensive quality comparative studies against the originator drug. The final results demonstrated that the pharmaceutical quality of Qilu Pharmaceutical’s warfarin sodium tablets was equivalent to that of the originator drug, and in vivo studies confirmed bioequivalence with the originator drug, thereby fully ensuring the safety and efficacy of the product in clinical use.

After more than two years of pharmaceutical and clinical research, the project was ultimately submitted as the first application to the National Medical Products Administration in September 2018, and successfully received approval for consistency evaluation as the first applicant one year later.

Note: The original text has been abridged.