News Center

News Center

Shengshi Taikang: Tafamidis Marketing Application Accepted by NMPA

Release date:

2020-02-29

　　Every year, the last day of February marks "International Rare Disease Day." Today, more than 7,000 rare diseases are known worldwide, with 80% having a genetic origin. Yet, only a few dozen of these rare diseases can currently be effectively treated or managed with medication. Diagnosing rare diseases remains challenging, and the cost of life-saving treatments is often prohibitively high, leaving patients struggling to survive. In the field of rare disease treatment, Shengshi Taikang is dedicated to delivering cutting-edge therapies that offer new hope to those affected by these conditions. On this special day, Shengshi Taikang proudly announces that its pioneering oral drug, teriflunomide—developed specifically for treating multiple sclerosis (MS), a devastating rare disease—has officially had its marketing application accepted by China’s National Medical Products Administration.

　　Multiple sclerosis is a lifelong, chronic, and progressive disease affecting more than 2.3 million people worldwide, with an incidence rate of approximately 0.03%. In China, over 30,000 patients are living with the condition. The underlying cause stems from an autoimmune system malfunction, which leads to damage and detachment of the myelin sheath surrounding nerve fibers, ultimately impairing the function of the spinal cord, brain, and optic nerves. As a result, patients experience progressively worsening neurological disabilities, often losing their ability to care for themselves, facing vision loss, and even risking their lives. According to research from authoritative institutions, multiple sclerosis remains incurable, meaning patients must learn to live alongside the disease. Therefore, early intervention is crucial—it not only helps better manage disease activity but also reduces the risk of irreversible neurological damage.

　　Tecfidera, developed by Sanofi Aventis, was approved by the FDA on September 12, 2012, as a treatment for relapsing forms of multiple sclerosis. On July 23, 2018, Tecfidera tablets were approved for import and are now indicated for the treatment of relapsing multiple sclerosis. Notably, this medication is currently the first FDA-approved, oral, first-line disease-modifying therapy for multiple sclerosis available in China.

　　Shengshi Taikang began its research and development initiative as early as when the drug was approved by the FDA, driven by the goal of reducing disease relapses and slowing disability progression—aiming to ensure patients could access the latest, internationally advanced treatment options as soon as possible. In March 2016, the company secured clinical trial approval for teriflunomide as a Class 3 new drug. And following the inclusion of multiple sclerosis in China’s “First Batch of Rare Disease Catalog” in May 2018, Shengshi Taikang swiftly completed process validation and production of both the active pharmaceutical ingredient and the finished dosage form of teriflunomide.

　　Ding Juping, Chairman of the company, introduced: "In 2019, we successfully completed the fasting and postprandial bioequivalence (BE) studies for Teflunomide tablets. The results demonstrated that Shengshitaike's Teflunomide tablets exhibit excellent safety profiles and demonstrate identical efficacy to the original reference product. Recently, the company submitted a marketing application for Teflunomide tablets to the National Medical Products Administration, making us the first domestic organization to achieve first-to-market generic status for this drug. This breakthrough will effectively ease the financial burden on patients while significantly improving their survival rates and quality of life."

　　It is reported that Shengshi Taikang's teriflunomide marketing application has been accepted by the National Medical Products Administration, with acceptance number CYHS2000167 Guo. Everything is now in place—ready and waiting for positive news.

 

 

Introduction to Shanlan Capital

Shanlan Capital is a specialized fund focused on early-stage and growth-phase investments in the healthcare industry. With offices in Shanghai and Beijing, the firm targets high-growth sub-sectors such as biopharmaceuticals, medical devices (including in-vitro diagnostics, gene technology, minimally invasive interventions, implantable devices, minimally invasive surgical instruments, and medical robotics), as well as healthcare services. To date, Shanlan Capital has invested in over 20 leading healthcare companies, including Guoke Hengtai, OpBio, Deepwise Medical, Shengshi Taikang, Baichen Medical, Zhishan Medical, Jingyu Medical, HopeLabs, and Langhe Medical. The core team at Shanlan Capital comprises founders of publicly listed companies in the healthcare sector, along with seasoned professionals specializing in finance and strategic investment. These experts provide value-added services to portfolio companies across critical areas such as strategy development, talent acquisition, R&D innovation, marketing, regulatory compliance, M&A, IPO preparation, and industry association networking. Additionally, Shanlan Capital helps its portfolio firms integrate cutting-edge international technologies while fostering globally aligned operational philosophies and standards, empowering them to drive continuous innovation and growth.

 

 

Prev：

Shengshi Taikang: The Molecular Designer and Their Business Vision

Next：

[Ranking] Cyzone 2019 Top 50 Innovative Healthcare and Wellness Companies in China Unveiled—Growing and Innovating Against the Grain Amidst the Capital Winter

中企跨境-全域组件 制作前进入CSS配置样式

在线客服添加返回顶部

页面顺滑的滚动

屏蔽页面上图片的alt/title提示

右侧在线客服样式 1,2,3 2

图片alt标题设置： Fland Environmental

表单验证提示文本： The content cannot be empty!

循环体没有内容时： Content is being organized—please wait!

CSS / JS 文件放置地