The stone drug Malay acid L-Achloride tablets are fully approved by the FDA

, which has been fully approved by the FDA, is the story of a new small molecule drug already on the market in china that has gone to the U.S. to apply for a listing.Xuanning, FDA approved the listingDecember 20, shi pharmaceutical Malay acid L-Achloride tablets (commodity name Xuanning) was fully approved by the FDA for listing - Shi Medicine said, Xuanning is China's first FDA fully approved new drug approved for listing.Cypress Blue learned from Stone Medicine that on December 20, Hyunning was approved by the FDA, becoming the first chinese company to receive full U.S. approval for innovative drugs.In the meantime, Shi medicine experienced a total of up to 5 years of clinical, 10 months of standard review time, and finally Xuanning's clinical data, fully recognized by the FDA, and no additional clinical trials are required.In the past, China's clinical data is difficult to be internationally recognized, in 2017, China officially joined ICH (i.e., the International Coordinating Committee for the Registration of Human Medicines Technology).Subsequently, the National Drug Audit Center also issued the "technical requirements for accepting overseas clinical trial data" for comments, accelerating the mutual recognition of clinical data at home and abroad, Shi said, this for China's innovative drugs "in and out" to provide great support.Typical cases of real-world researchin addition to China's accession to ICH, real-world data research has also laid the foundation for the successful approval of Xuanning. Yao Bing, vice president of Shi Pharmaceutical Group and president of the research and development division, told Saibailan that Xuanning is a typical case study in the real world.It is reported that Malay acid left-handed ammonia chlorpyrine as early as 2003, listed in China, and then accumulated a large number of clinical data.In 2013-2017, Shi medicine participated in the national 12th Five-Year Major New Drug Science and Technology Major Special LEADER Study - Studying the comparative effect of L-Achloride and Phenyl sulfonate chloride in the treatment of hypertension.It is reported that the project is led by Professor Ho Yong of Peking University First Hospital, the project sample size of more than 10,000 cases.For the official approval of Xuanning, Professor Ho Yong said, from 30 years of medicine, has never seen China's innovative drugs into the U.S. market, usually used in the United States to domestic products, especially for anti-depressant drugs, Xuanning is the first domestic innovative drugs in the United States through the FDA and enter the U.S. market, I feel very excited and proud.Real World Research/Study, RWR/RWS is an evidence-based medical research approach corresponding to randomized controlled clinical trials (RCT).Real World Research digs into real-world data (Real World Data, RWD) outside of traditional evidence-based clinical research, takes non-random, open, and placebo-free studies, and analyzes real-world evidence (RWE) to support medical product regulatory decisions.Hypertension drug market, $35 billion QYResearch data predict that by 2022, the global market for antihypertensive drugs will reach $35 billion.At present, the international commonly used hypertension drugs are CCCB (calcium channel antagonist), ACEI (angiotensin conversion enzyme inhibitor), ARB (angiotensin-stressor antagonist), diuretics, β-blockers.At present, the international antihypertensive drug market is still dominated by multinational pharmaceutical companies - take ammonia chloride class, in 2018 China's public medical institutions terminal ammonia chloride sales of 6.376 billion yuan, Pfizer's live market share accounted for more than half.On the marketing of Xuanning, a stone pharmaceutical group executive said to Seberan, the product is very confident, because it is safe and effective, and half of the dose can achieve the effect of ammonia chloride, the risk of adverse reactions is relatively low.The results of the above real-world studies show that half the dose of L-Chloride of Malay acid has the same blood-lowering effect as that of benzodiacycline, and in terms of adverse reactions, L-Chloride of Malay acid is significantly better than that of phenylalanine chloride (imported), especially in edema and headache.The above-mentioned person told Saibailan, Xuanning in the domestic retail channel prices - a single piece, less than a third of imported products. (Cypress Blue)