CFDA approved snerry ® for combination therapy of MDR-TB in adults

On December 1, 2016, Xi'an Janssen Pharmaceutical Co., Ltd announced that China's State Food and drug administration has approved snerry ® (betaquiline fumarate tablets) as a part of the combined treatment for adult (≥ 18 years old) MDR-TB As an important scientific research achievement of Janssen Pharmaceutical N.V., betaquiline fumarate is a drug with innovative mechanism and treatment of tuberculosis, which is expected to significantly improve the treatment effect of MDR-TB and meet the treatment needs of many patients Multidrug-resistant tuberculosis (MDR-TB) is a form of tuberculosis that is resistant to isoniazid and rifampin Therefore, the treatment options for MDR-TB patients are more limited Betaquiline is an antibiotic with a new mechanism of action It can inhibit the ATP (5 '- adenosine triphosphate) synthetase of Mycobacterium tuberculosis, which is necessary for the energy production of Mycobacterium tuberculosis "MDR-TB occurs because the patient is infected with a drug-resistant strain of Mycobacterium tuberculosis, or because of a previously failed treatment program," said Professor Chu Naihui, director of the tuberculosis Department of Beijing chest hospital "MDR-TB is a heavy burden for patients and a more significant problem for China The number of new MDR-TB patients in China accounts for about 15% of the global total Betaquiline has an innovative mechanism of action, which will bring good news to China's MDR-TB patients " Tuberculosis, especially MDR-TB, is one of the most important public health problems in the world This disease brings heavy burden and great threat to China According to the statistics of the World Health Organization, the number of new TB patients in China is up to 1 million every year, including 70000 MDR-TB patients In 2015 alone, there were about 10.4 million new TB patients worldwide, 1.4 million of whom lost their lives due to the disease It is predicted that MDR-TB will bring up to 16 trillion dollars of economic losses to governments around the world by 2050, and become a major threat in the field of global public health Currently, most of the drugs for TB treatment were approved before 1960s, and the treatment options for MDR-TB are more limited "Betaquiline combined with appropriate background treatment program provides an innovative treatment option to deal with tuberculosis, a serious public health problem Compared with the placebo group, betaquiline can shorten the time of sputum culture negative transformation and improve the rate of sputum culture negative transformation in MDR-TB patients Said avery Ince, vice president of Medical Affairs Department of Xi'an Janssen Pharmaceutical Co., Ltd "With the full cooperation of colleagues from all walks of life, we are confident to ensure the rational application of betaquiline in China and help overcome this disease." At the same time, beidaquinoline marks an important progress in solving the global public health issue of "bacterial resistance to antibiotics" At the recent United Nations High Level Conference on antibiotic resistance, leaders called for multisectoral cooperation to solve this problem Xi'an Janssen has always been committed to promoting the development of public health, and the research and development of betaquiline, an innovative drug, once again confirms the commitment of Xi'an Janssen to meet major public health challenges by providing innovative drugs The rational use of betaquinoline is very important to overcome MDR-TB For this reason, Xi'an Janssen is working with partners and first-line medical workers in the field of tuberculosis prevention and control to establish a set of perfect drug management and use mechanism, so as to ensure that Chinese patients can correctly and reasonably use betaquiline, and reduce the possibility of the emergence of new drug-resistant tuberculosis bacteria "Xi'an Janssen understands China's medical and health needs and challenges in the field of MDR-TB treatment We will continue to work with our partners to promote the introduction of snerry ® and improve the accessibility of this innovative treatment plan " Said Asgar rangoo nwala, President of Xi'an Janssen Pharmaceutical Co., Ltd "To ensure the rational use of drugs is an integral part of the introduction of new drugs and treatment programs, Xi'an Janssen attaches great importance to this, and will make every effort to ensure the reasonable and effective use of snerry ® to bring good news and hope to the MDR-TB patients in China." As a major scientific research achievement of Janssen company, betaquiline fumarate is the first new anti tuberculosis drug with innovative mechanism approved in recent decades It has a unique mechanism of action, which can inhibit ATP (5 '- adenosine triphosphate) synthetase of Mycobacterium tuberculosis, which is necessary for energy production of Mycobacterium tuberculosis In 2012, the US Food and Drug Administration (FDA) accelerated the approval of betaquiline, and the EU also approved the drug conditionally Betaquiline fumarate tablets were successfully registered in the Russian Federation through JSC pharmaceutical, a partner of the Russian Federation and CIS countries In addition, the beadarquinoline fumarate tablets were approved in China, Armenia, Hongkong, China, India, New Zealand, Peru, Philippines, South Africa, South Korea, Taiwan, Turkmenistan and Uzbekistan, and in Bangladesh, Burundi, Columbia, Garner, Indonesia, Columbia, Indonesia, Rwanda, China, Turkey, Uganda and Vietnam submitted approval applications to the regulatory authorities, and 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 Janssen, Xi'an, we are committed to creating a disease-free world The goal of preventing, blocking, and treating disease in new and better ways has always inspired us We gather advanced ideas and pursue promising scientific achievements We are Xi'an Janssen We join hands with the world to build health.