On October 27, 2023, the website of the State Food and Drug Administration showed that Jiangsu Huahan Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Huahan Pharmaceutical") declared sacubitril valsartan sodium tablets (brand name: Yuexintuo^®)Officially approved by the State Drug Administration.

Source:

https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20231027160158106.html

Sakubitril valsartan sodium tablet is the world's first approved angiotensin receptor enkephalinase inhibitor (ARNI) drugs are effective and safe in the treatment of heart failure and hypertension. They have been recommend and used by many international authoritative guidelines, including the American College of Cardiology (ACC), the American Heart Association (AHA), the American Heart Failure Society (HFSA), the European Society of Cardiology (ESC) and the Cardiovascular Branch of the Chinese Medical Association (CSC).

FromSince its launch in 2015, global sales of sacubitril-valsartan sodium tablets have continued to grow rapidly. In 2022, global sales of sacubitril-valsartan sodium tablets were 4.644 billion US dollars, up 37% year on year. In the first half of 2023, global sales of sacubitril valsartan sodium tablets were $2.915 billion, up 31% year-on-year (source: Novartis Group 2022 and 2023H1 earnings).

Sakubitril valsartan sodium tablets were originally developed and declared by Novartis. The Chinese patent to which the variety is linked (patent number:ZL 200680001733.0 and ZL 201210191052.2) protection period until November 2026.Previously, Huahan Pharma obtained a full license to two Novartis patents in China, soDeveloped by Huahan MedicineClass 4 generic sacubitril valsartan sodium tablets (brand name: yuexintuo®) can be legally listed and sold in mainland China during the patent protection period.

Yue Xin®The crystal structure is consistent with the Novartis reference preparation. Its unique co-crystal design has been verified by many multinational clinical trials, and is widely praised by the medical community for the prevention and treatment of cardiovascular events.

As a supramolecular complex with specific chemical composition and stable crystal form, eutectic can not only ensure the storage stability of tablets, but also enhance the bioavailability of valsartan in human body.Gradually attach importance to API consistency in international pharmaceutical regulations(API sameness) Currently, select Yexintuo that is consistent with the crystal form of the reference preparation.®In order to bring peace of mind and help to the treatment communication between doctors and patients.

Yue Xin®Key to Success: Internationalization and Intellectual Property Protection

Sakubitril-valsartan sodium tablets have great drug value and become the focus of competition among many domestic pharmaceutical companies. As of now,Huahan Pharmaceuticals is a pharmaceutical company that has obtained the complete license of the original research and can be legally listed in advance during the protection period of the original research patent.
    The reason why Huahan Medicine has been able to achieve such success,Can not be separatedits international background, global vision and resources.
    Public information shows that Huahan Pharmaceutical was established inOn October 24, 2019, its major shareholder was Yiwei Shengyi Technology Co., Ltd., a listed company in Taiwan, China ("Yiwei Shengyi")andNanjing Huaxun Intellectual Property Consultants Co., Ltd..Yiwei Medical is a biotechnology company with a global layout.ECC's intellectual property management is a high-level intellectual property information and consultant, adhering to the bridge between China and the world, technology and capital.The U.S. subsidiary of Eway Medical completed Yuexin.®Research and development. Subsequently, Huahan Medicine in ChinaContinentTechnology transfer, production and commercialization were completed.In addition, Yue Xintuo®It can be legally listed in advance, which can be traced back to August 2018. Nanjing Huaxun Intellectual Property Consulting Co., Ltd. and Novartis reached a settlement agreement in the patent invalidation lawsuit, and obtained the license of "Shakubatril Valsartan Sodium Tablets" to be listed in advance in China, and the exclusive sublicense was granted to Huahan Medicine, making it a generic drug legally listed and sold in China with the original research license.
   WithOur countryThe legal system for the protection of intellectual property rights in the pharmaceutical market is becoming more and more perfect.®The listing has undoubtedly createdOur countryNew models of earlier access to innovative drugs for patients.

Huahan Medicine continues to uphold the social mission of loving patients and will be committed to improving Yuexinto.®Accessibility, providing consistent and more affordable drug options for patients with heart failure and hypertension, and fulfilling the commitment to patients and the responsibility to society..In the future, relying on the Group's abundant resources, it will continue to invest in research and development, and actively introduce more high-quality, high-tech pharmaceutical varieties from overseas to enter the Chinese market,ForPatientProvideMore quality treatment options.

Source | Huahan Medicine& Yaozhi Net