绥美凯获批适应症

On January 20, 2019, the State Food and Drug Administration (CFDA) approved the new AIDS treatment compound preparation Suimeikai (chemical name: doptabalamid tablets) to enter China. As an innovative single-pill compound preparation with obvious clinical therapeutic advantages, it can provide great convenience for the treatment of AIDS patients and has been granted priority review and approval by the State Food and Drug Administration.

It is understood that Suimeike is an innovative HIV treatment drug for ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK). It is currently the only three-in-one compound drug containing dolutegravir (DTG). It has the characteristics of good tolerability, high resistance barrier and few drug interactions. It can be taken once a day, one tablet at a time, significantly reducing the medication burden of AIDS patients, thereby increasing patients' medication compliance and significantly improving their quality of life.

Thirty years ago, AIDS was almost equivalent to a terminal illness. Through the joint efforts of doctors and scientists, significant progress has been made in AIDS treatment. Currently, AIDS is becoming a controllable chronic disease. As of June 30, 2016, there were more than 620,000 living HIV/AIDS patients reported across the country, more than 190,000 reported deaths, and more than 420,000 patients currently receiving antiretroviral treatment.

Dr. Wim Swyzen, MD, head of medical affairs and vice president of GSK China/Hong Kong, said, "Through effective HIV drug treatment, the life spans of HIV patients and healthy people are getting closer and closer. Drug compliance and convenience of medication play an increasingly important role in further improving the quality of life of patients. Currently, there is no drug that can be taken once a day, one tablet at a time. The approval of Suimeikan fills this gap and meets the urgent need for convenient medication use by doctors and patients."

Wim Swyzen said that the CFDA has recently taken positive actions in the review and approval of new drugs. GSK will continue to strengthen R&D activities in China and strive to introduce more new AIDS drugs, such as two-in-one compound preparations, long-acting preparations, etc.

It is reported that Suimeikai has been approved in more than 100 countries and recommended by many authoritative academic institutions in Europe and the United States as a first-line treatment drug for newly treated AIDS patients. Following the launch of the new AIDS drug Tevicay last year, this is another new drug from GSK approved for the treatment of AIDS in China. GSK has been bringing AIDS drugs to Chinese patients since 1999. Shuangtaizhi is GSK's first approved AIDS antiviral treatment drug in China.