Qilu Pharmaceutical's Macitentan Tablets (Xinyitong®) Approved for Market Launch as a Rare Disease Treatment

Recently, according to the official website of the National Medical Products Administration, Qilu Pharmaceutical's rare disease treatment drug Macitentan Tablets (Xinyitong®) has been approved for marketing by the National Medical Products Administration.

Macitentan Tablets are suitable for patients with pulmonary arterial hypertension (PAH, WHO Group 1) to delay disease progression. The clinical manifestation of PAH involves abnormally elevated blood pressure within the pulmonary arteries, eventually leading to right heart failure and even life-threatening conditions. Therefore, the disease is also known as "cancer of the cardiopulmonary vascular system." It is reported that the average survival time for PAH patients is only 29 months, and currently, there are no drugs available to cure the condition. Before the application of targeted drugs, the efficacy of traditional medications such as calcium channel blockers and diuretics was very limited, indicating unmet clinical needs. The use of targeted drugs like macitentan has significantly improved this situation.

As a next-generation endothelin receptor antagonist (ERA), macitentan is the only targeted drug proven to reverse right ventricular remodeling, significantly delay disease progression, improve patients' quality of life, and reduce mortality. Additionally, macitentan has low hepatotoxicity, does not require routine liver function monitoring, and demonstrates an overall good safety profile. This product was first approved for marketing in the United States on October 18, 2013, and received approval for import and sale in China in September 2017. In 2019, macitentan was included in the first batch of rare disease medications listed in the "Notice on Value-Added Tax Policy for Rare Disease Medications."

In order to meet the clinical needs of patients, Qilu Pharmaceutical courageously assumed social responsibility and actively responded to policy requirements by immediately initiating the development of Macitentan Tablets in 2019. Throughout the R&D process, the researchers adhered to the concept of "quality by design," conducting scientific and meticulous studies on the product, tackling key problems, and optimizing critical processes layer by layer. Through repeated experiments, they successfully overcame multiple intellectual property barriers and quickly identified the optimal formulation process. At the same time, they strictly followed relevant guidelines both domestically and internationally, conducting comprehensive quality comparison studies and human bioequivalence research to ensure that the quality and efficacy of their self-produced products were consistent with the original drug, guaranteeing the safety and effectiveness of the product for clinical use. This time, Qilu Pharmaceutical's Xinyitong® has been approved for marketing and is considered to have passed the consistency evaluation. To date, Qilu Pharmaceutical has had 174 products pass the consistency evaluation.

Qilu Pharmaceutical Always Adheres to the Core Values of "Great Medical Integrity, Family and Country as One". Remembering the Original Intention of Patient-Centric Care, It Aims to Address Unmet Clinical Needs by Continuously Developing High-Quality, Affordable Medicines Produced in China That Are Accessible to the General Public. In the Future, Qilu Pharmaceutical Will Continue to Uphold Its Original Mission, Forge Ahead, and Persist in Innovation-Driven Development. With New Productive Forces, It Will Create More Effective and Innovative Medicines, Provide Patients with More Treatment Options, Enhance Accessibility, Improve Quality of Life, and Make Greater Contributions to the Construction of a Healthy China!

Editor: Mu Mian

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