Xi'an Janssen: Bida quinoline tablets are approved by the State Food and Drug Administration (CFDA)
December 07, 2016 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Xi'an Janssen Pharmaceutical Co., Ltd. announced today that China's State Food and Drug Administration has approved the use of bedaquinol fumarate tablets as part of a combination therapy for the treatment of adult (≥18 years old) multidrug-resistant tuberculosis. As an important scientific research achievement of Janssen Pharmaceutica NV, betaxipin fumarate tablets is an innovative mechanism for treating tuberculosis, which is expected to significantly improve the therapeutic effect of multidrug-resistant tuberculosis. The patient's treatment needs.
Multidrug-resistant tuberculosis refers to a form of tuberculosis that is resistant to two of the most effective drugs in the first-line treatment of tuberculosis, isoniazid and rifampicin. Therefore, treatment options for patients with MDR-TB are more limited. Bida quinoline is an antibiotic with a novel mechanism of action that inhibits M. tuberculosis ATP (5'-adenosine triphosphate) synthetase, which is required for M. tuberculosis energy production.
"Multidrug-resistant tuberculosis occurs because the patient is infected with a drug-resistant strain of Mycobacterium tuberculosis, or because of a previously failed treatment plan," said Professor Chu Naihui, director of the tuberculosis department at Beijing Chest Hospital. "Multidrug-resistant tuberculosis is a heavy burden for patients. It is a more significant problem for China. The number of new MDR-TB patients in China accounts for about 15% of the number of new-onset patients worldwide. Daquinoline has an innovative mechanism of action that will bring good news to patients with multidrug-resistant tuberculosis in China."
Tuberculosis, especially MDR-TB, is one of the most significant public health problems in the world today. This disease has brought a heavy burden and a huge threat to China. According to the World Health Organization, the number of new tuberculosis patients in China is as high as 1 million per year, including 70,000 patients with multidrug-resistant tuberculosis.
In 2015 alone, there were approximately 10.4 million new tuberculosis patients worldwide, of which 1.4 million lost their lives as a result of the disease. It is expected that by 2050, MDR-TB will bring economic losses of up to US$16 trillion to governments around the world and become a major threat to the global public health sector.
Most of the drugs currently used for the treatment of tuberculosis have been approved before the 1960s, and the treatment options for MDR-TB are more limited.
"Betaquinoline in combination with a suitable background treatment regimen provides an innovative treatment option for addressing the serious public health problem of tuberculosis. Taking betaxazoline shortens MDR-TB compared with placebo controls The patient sputum cultured the yin time and increased the sputum culture rate." Dr. Avery Ince, Vice President of Medical Affairs, Xi'an Janssen Pharmaceutical Co., Ltd. said. "With the cooperation of colleagues from all walks of life, we are confident that we can ensure the reasonable application of betafin in China and help overcome this disease."
At the same time, bedaquinoline marked an important advance in the global public health issue of "solving bacteria against antibiotics." At the recent UN High-Level Meeting on Antibiotic Resistance, leaders of various countries called for multi-sectoral cooperation to address this dilemma. Xi'an Janssen has been committed to the development of public health, and the development of the innovative drug Betadaquino has once again confirmed Xi'an Yangsen's commitment to respond to major public health challenges by providing innovative drugs.
The rational use of bedaquinoline is essential for the fight against multidrug-resistant tuberculosis. To this end, Xi'an Yangsen is working with partners and frontline medical workers in the field of tuberculosis prevention to establish a comprehensive drug management and use mechanism to ensure that Chinese patients can correctly and reasonably use betaridine and reduce new resistance. The possibility of developing tuberculosis.
"Xi'an Yangsen understands China's medical needs and challenges in the field of multidrug-resistant tuberculosis treatment. We will continue to work with multi-partners to promote the introduction of betaxudal fumarate tablets and enhance this innovation. Accessibility of treatment options," said Asgar Rangoonwala, president of Xi'an Janssen Pharmaceutical Co., Ltd. "Ensuring the rational use of drugs is an indispensable part of the process of introducing new drugs and treatments. Xi'an Yangsen attaches great importance to this and will go all out to ensure that the fumaric acid fumarate tablets are used reasonably and effectively. Bringing good news and hope to patients with multidrug-resistant tuberculosis in China."
About fumaric acid fumarate tablets
As a major scientific research achievement of Janssen, the fumaric acid fumarate tablets are the first new anti-tuberculosis drugs with innovative mechanisms of action approved in recent decades. It has a unique mechanism of action that inhibits M. tuberculosis ATP (5'-adenosine triphosphate) synthetase, which is required for M. tuberculosis energy production.
In 2012, the US Food and Drug Administration (FDA) accelerated the approval of beta-quinoline, which was conditionally approved by the European Union. Through the Russian Federation and the partner of the CIS countries JSC Pharmstandard, the fumaric acid fumarate tablets were successfully registered in the Russian Federation. In addition, betaxazol fumarate tablets have been approved in China, Armenia, Hong Kong Special Administrative Region of China, India, New Zealand, Peru, Philippines, South Africa, South Korea, Taiwan, Turkmenistan, Uzbekistan, in Bangladesh, Burundi Colombia, Ghana, Indonesia, Kenya, Mexico, Rwanda, Tanzania, Thailand, Turkey, Uganda and Viet Nam submitted their applications for approval to the regulatory authorities and submitted additional applications to the regulatory authorities in Moldova through partner Pharmstandard.
About Xi'an Yangsen Pharmaceutical Co., Ltd.
Xi'an Yangsen Pharmaceutical Co., Ltd. is a pharmaceutical subsidiary of Johnson & Johnson in China. In Yangsen, Xi'an, we are committed to creating a world free of disease. The goal of preventing, blocking and treating diseases in a new and better way has always inspired us. We bring together advanced concepts and pursue scientific achievements with development prospects. We are Xi'an Janssen. We work together with the world to create health.
YT-H706
YT-H706
Shenzhen Sunshine Technology Co.,Ltd , https://www.yatwinsz.com