"Valsartan amlodipine tablets" of Baiao Pharmaceutical Co., Ltd. was approved for marketing

On February 6, the listing application of valsartan amlodipine tablets (I) (cyhs1800095) submitted by Beijing Baiao Pharmaceutical Co., Ltd according to the new 4 categories was approved by the State Drug Administration, which has arranged to issue drug approval documents Baiao Pharmaceutical Co., Ltd has become the first manufacturer of this classic compound antihypertensive drug in China Valsartan amlodipine tablet, developed by Novartis, is a single compound tablet composed of angiotension receptor antagonist (ARB) valsartan and calcium channel antagonist amlodipine It is suitable for patients who are not fully controlled by valsartan alone or amlodipine alone There are two specifications available: Valsartan 80mg / amlodipine 5mg and valsartan 160mg / amlodipine 5 mg, i.e valsartan amlodipine tablets (I) and valsartan amlodipine tablets (II) Valsartan amlodipine tablet was approved by the European Union as early as January 15, 2007 Its trade name is exforge (median trade name: beibote), with a peak sales value of US $1456 million In 2019, the global sales volume is still US $1 billion Source: nextpharma Baiao pharmaceutical was approved as Valsartan and Amlodipine Tablets (I), i.e the specification of 80mg/ amlodipine 5mg Since the application submitted by Baiao pharmaceutical is in accordance with the new 4 categories and has been approved, it is equivalent to directly passing the conformity assessment At present, there are six other generic pharmaceutical enterprises in China that have submitted listing applications, namely Hengrui, kunyao, Huayuan Pharmaceutical, alembic, Chengdu Beite and Huahai, all of which are in the stage of evaluation At present, the patent protection of Novartis' compound valsartan amlodipine tablets has expired, and Baiao pharmaceutical industry can be successfully listed and sold after being approved, breaking the monopoly situation of the original research drug beibote in China Source: nextpharma Hypertension is a common chronic disease According to the latest survey results of the National Cardiovascular Center, the prevalence of hypertension in adults in China is about 23.2%, and the number of patients is about 245 million In recent years, although some progress has been made in the prevention and control of hypertension, the overall disease control rate is only about 15.3%, and the current situation of prevention and control is still grim Hypertension is a chronic disease, patients need to take medicine on time for a long time Clinical studies have shown that more than 70% of patients with hypertension need to take more than two kinds of antihypertensive drugs at the same time to achieve blood pressure control standards However, the survey results of China's Cardiovascular Center show that the proportion of missing antihypertensive drugs in daily life reaches 40.4%, with poor compliance, while the emergence of single compound preparation can significantly improve the compliance of patients On the other hand, the clinical research also fully proves that the single drug compound preparation has obvious advantages over the single drug or the free combination drug in the antihypertensive effect, the prevention of cardiovascular and cerebrovascular complications, and the reduction of adverse reactions In recent years, Europe, the United States, Japan and other countries have successively updated the hypertension management guidelines, and single-chip compound preparations have been more and more recommended.