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CGeneTech: Teriflunomide marketing application accepted by the Drug Administration

  • Categories:Media
  • Author:山蓝Family
  • Origin:
  • Time of issue:2020-02-29
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(Summary description)International Rare Disease Day is celebrated on the last day of February every year. There are more than 7,000 known rare diseases worldwide, 80% of which are genetic in origin, but only a few dozen of them can be treated and controlled with medication. Rare diseases are difficult to diagnose, expensive to treat, and difficult for patients to survive. As a key developer in the field of rare disease treatment, CGeneTech is committed to bringing new hope to patients with rare diseases with cutting-edge treatment solutions. On today's special day, CGeneTech announced that its first-line oral drug, teriflunomide, for the treatment of multiple sclerosis (MS), a rare disease, has been accepted by the State Drug Administration.

CGeneTech: Teriflunomide marketing application accepted by the Drug Administration

(Summary description)International Rare Disease Day is celebrated on the last day of February every year. There are more than 7,000 known rare diseases worldwide, 80% of which are genetic in origin, but only a few dozen of them can be treated and controlled with medication. Rare diseases are difficult to diagnose, expensive to treat, and difficult for patients to survive. As a key developer in the field of rare disease treatment, CGeneTech is committed to bringing new hope to patients with rare diseases with cutting-edge treatment solutions. On today's special day, CGeneTech announced that its first-line oral drug, teriflunomide, for the treatment of multiple sclerosis (MS), a rare disease, has been accepted by the State Drug Administration.

  • Categories:Media
  • Author:山蓝Family
  • Origin:
  • Time of issue:2020-02-29
  • Views:0

  International Rare Disease Day is celebrated on the last day of February every year. There are more than 7,000 known rare diseases worldwide, 80% of which are genetic in origin, but only a few dozen of them can be treated and controlled with medication. Rare diseases are difficult to diagnose, expensive to treat, and difficult for patients to survive. As a key developer in the field of rare disease treatment, CGeneTech is committed to bringing new hope to patients with rare diseases with cutting-edge treatment solutions. On today's special day, CGeneTech announced that its first-line oral drug, teriflunomide, for the treatment of multiple sclerosis (MS), a rare disease, has been accepted by the State Drug Administration.
  MS is a lifelong, chronic, progressive disease that affects more than 2.3 million people worldwide, with a prevalence of approximately 0.03%, and more than 30,000 patients in China. The cause of the disease originates from the lesion of the autoimmune system, which causes the breakdown and denudation of the nerve myelin sheath, resulting in damage to the function of the spinal cord, brain and optic nerve, and gradually increasing the neurological disability of patients, resulting in loss of self-care, blindness and even loss of life. According to the research of authoritative institutions, MS is incurable and patients have to live with the disease. Therefore, the earlier the treatment, the better the patient can control the disease activity, while reducing the occurrence of irreversible neurological damage.

  Teriflunomide, developed by SanofiAventis, was approved by the FDA on September 12, 2012 for the treatment of relapsing multiple sclerosis drug.On July 23, 2018, Teriflunomide tablets were approved for import for the treatment of relapsing multiple sclerosis, which is currently the first oral type of disease first-line corrective therapy drug approved in China for the treatment of multiple sclerosis.

  As early as the FDA approved the drug, CGeneTech started the research and development project with the purpose of reducing the relapse of patients' disease and delaying the progression of disability, in order to make the latest international good drug available to patients as early as possible. in March 2016, the clinical trial approval of teriflunomide class 3 new drug was obtained, and in May 2018, after multiple sclerosis was included in the first batch of China's Rare Disease Catalogue, the process validation and formulation of teriflunomide was rapidly completed. process validation and production of APIs and formulations.

  We successfully completed the fasting and postprandial bioequivalence (BE) tests for teriflunomide tablets in 2019, and the results showed that CGeneTech's teriflunomide tablets have a good safety profile and the efficacy is fully consistent with the original reference formulation," said Ding Torping, chairman of the company. The company recently submitted a marketing application for teriflunomide tablets to the State Drug Administration, making it the first first generic organization for this drug in China, which can effectively reduce the economic burden of patients and improve their chances of survival and quality of life."

  It is reported that CGeneTech's Teriflunomide marketing application was hosted by the State Drug Administration, with the acceptance number CYHS2000167 State, and all things are ready and waiting for good news.


Mountain Blue Capital Introduction

     Mountain Blue Capital is a professional fund focusing on early and growth stage healthcare industry investments with offices in Shanghai and Beijing, focusing on high growth segments such as biopharmaceuticals, medical devices (in vitro diagnostics and genetic technologies, minimally invasive interventions, implantable devices, minimally invasive surgical devices and medical robotics), and healthcare services. We have invested in more than 20 medical star companies, such as Guoke Hengtai, Oppo Bio, ShenRui Medical, ShengShiTek, BaiChen Medical, ZhiShan Medical, JingYu Medical, Hepalos, LongHope Medical, etc. Our core team is composed of founders of listed companies in the medical industry, professional financial and strategic investment professionals, who help our portfolio companies in strategy formulation, talent introduction, technology development, marketing, laws and regulations, mergers and acquisitions, IPO, and industry association resources. We provide value-added services to our investee companies, including strategy development, talent acquisition, technology research and development, marketing, laws and regulations, M&A, IPO, industry association resources, and provide assistance to our investee companies in integrating international advanced technologies and forming international operating concepts and standards, so as to help them continue to innovate and develop.

 

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