The return of the king of generic drugs in China

On May 18, duloxetine hydrochloride enteric coated capsules (20mg, 30mg, 60mg) of Prinston, a US subsidiary of Huahai pharmaceutical, were approved by FDA According to Huahai pharmaceutical's annual report, in 2016, Huahai pharmaceutical has invested 360 million yuan in R & D, a year-on-year increase of 33.49%, accounting for 8.89% of operating revenue According to the proportion of R & D, Huahai has ranked among the top 20 pharmaceutical R & D investment in China Before 1999, Huahai was a chemical enterprise mainly engaged in manufacturing and exporting pharmaceutical intermediates In 1999, with the approval of the State Drug Administration at that time, the company was renamed Zhejiang Huahai Pharmaceutical Co., Ltd and its business scope was expanded to drugs, preparations and APIs, thus becoming a pharmaceutical enterprise In 2003, Huahai pharmaceutical entered A-share market, with bulk drugs and intermediates contributing most of its profits Its main products are captopril, enalapril, lisinopril, ketotifen fumarate, etc At that time, the development strategy of Huahai closely focused on cardiovascular drugs, antidepressants, diabetes drugs and anti AIDS drugs, with pharmaceutical preparations as the guide and raw materials as the pillar At that time, it was a slogan that preparations were the forerunner 96% of the revenue of Huahai pharmaceutical industry came from APIs and intermediates According to CPM, the first approved API product of Huahai is irbesartan (gyzz h2000505) About approval No.: letter "H" stands for For chemical drugs, the first and second digits are the source codes of the original approval number, among which "10" represents the drugs approved by the original Ministry of health, the third and fourth digits are the last two digits of the original approval number year, and the last four digits of the serial number are rearranged; for example, "19" and "20" represent the drugs approved by the former State Drug Administration on January 1, 2002, and the original years are "1998" and "1999", which are replaced The first and second digits are "19"; if the original year is "2000" and "2001", the first and second digits are "20", and the third and fourth digits are still the last two digits of the original approval number year Other drugs that use the first two administrative division codes of each province are those approved by the original provincial health administrative departments There are six main API products before Huahai goes on the market With strong advantages in production cost and process development, the Puli products of Huahai also occupy a large market share in the international market Data source: CPM, China new drug research and development monitoring database of China Pharmaceutical Industry Information Center, hit the world economy hard in 2008 The prices of APIs and intermediates fell into a downturn Huahai, which mainly exports raw materials, encountered an unprecedented crisis At the same time, the domestic market-oriented enterprises still maintain a large growth Since 2009, the reform of the medical system has been continuously promoted, and the trend of integration and concentration of the pharmaceutical industry has become increasingly obvious Driven by the increase of national investment and residents' payment level, the income and profits of the domestic pharmaceutical industry have been increasing Hua Hai accelerated his return to China and the transformation of preparations From 2003 to 2016, Huahai had 27 APIs and 17 preparations with approval numbers Data source: CPM of China new drug research and development monitoring database of China Pharmaceutical Industry Information Center is affected by serious backlog of generic drug review After 2010, a large number of varieties of Huahai pharmaceutical industry have obtained clinical approval documents for more than three years, the most serious situation in 2011 In 2014, the situation improved significantly, but the most important reason was the withdrawal of "7.22" clinical self examination storm There are also some generic products that have been listed in the United States, such as Telmisartan Tablets, escitalopram, lamotrigine and so on Data source: at present, China Pharmaceutical Industry Information Center's CPM database of new drug research and development currently has 18 varieties in the review process of Huahai, two of which have entered the priority review and approval, namely, valsartan tablets listed in the United States and efaviron APIs for AIDS treatment According to the opinions of the general office of the State Council on the evaluation of the consistency of quality and efficacy of generic drugs, if Huahai valsartan tablets can pass the following data review and on-site verification after being put on the market, it will be regarded as passing the evaluation of the consistency of generic drugs Data source: in addition to continuing to strengthen the advantages in chemical generic drugs, CPM, China Pharmaceutical Industry Information Center, China new drug research and development monitoring database, is also actively distributing biological drugs In recent years, with the revolution of biotechnology, the research and development of all kinds of biomacromolecule drugs, especially antibody drugs, has become the hotspot of new drug research and development in the world, and new antibody drugs, such as antibody conjugates, bispecific antibodies, nano antibodies, tumor immunotherapy, have become the new trend of antibody drug research and development From 2010 to 2015, China's monoclonal antibody industry (gagr) was nearly 50%, with rapid development The main reasons for the rapid development of China's monoclonal antibody industry were the technical advantages of monoclonal antibodies, the huge market of tumor treatment, favorable policies and expiration of foreign heavy-duty monoclonal antibody patents Data source: CPM of China new drug research and development monitoring database of China Pharmaceutical Industry Information Center Nowadays, with the introduction and preparation of policies such as generic consistency evaluation, limited review and approval, clinical trial organization filing system, and allowing social capital to establish clinical trial organization, domestic excellent enterprises are facing a more benign development environment, and generic enterprises such as Huahai, which have been recognized by European and American markets, are facing historic development opportunities.