Hengrui, Huahai, humanwell, etc. entered the United States, and 77 products were approved! Dig gold overseas, or save the country by curve?

In 2018, Chinese pharmaceutical companies obtained the largest harvest of generic applications in the United States According to the statistics of e drug managers, as of December 24, 2018, the Chinese pharmaceutical enterprises represented by Renfu, Huahai, dongyangyao, Hengrui, Nantong Lianya, etc have obtained 77 anda approvals in the United States, involving 19 enterprises in total Note that these 77 document numbers are all official anda applications, excluding Provisional approvals If we compare this year's "achievements" with those of previous years, we can easily find the difference In the whole year of 2017, there were 31 official anda approvals successfully applied by Chinese pharmaceutical companies in the United States, involving 8 companies in total; in 2016, there were only 22 official anda approvals, and the number of companies was also 8 In the years from 2012 to 2015, China's pharmaceutical companies have won 11 to 13 andas each year, only 5 or 6 companies are involved, and they are familiar faces every year The emergence of new players and the explosion of the number of approved anda numbers are the biggest differences between the Chinese pharmaceutical products going to sea in 2018 and the past few years Behind it, on the one hand, of course, the enthusiasm of local enterprises for exploring foreign markets is growing, but on the other hand, we can not exclude the idea of saving the country by a curve, especially the recognition of the consistency evaluation for the common products in Europe and the United States, so that the effect of this approach has been officially demonstrated All in all, 2018 is the harvest year for Chinese pharmaceutical companies to approve generic drugs in the United States, and this trend will continue However, for each enterprise, the significance of Anda in the United States and the reason why they have to spend a lot of energy to do this work may not be the same Data source: FDA official website, statistics date as of December 24, 2018 not affected by Sino US trade war, anda approval burst out In 2018, the Sino US trade war was regarded as the biggest "black swan incident" in the whole year, including a "301 report" near the end of the year, which pointed out that China's venture capital seriously affected the safety of us biomedical assets, and all kinds of tense atmosphere made people in China's pharmaceutical industry panic However, from the figures of the past year, Chinese pharmaceutical companies' anda declaration in the United States has not been greatly affected In terms of the total number, the total number of all the official anda numbers declared is 77 As of December 24, 2018, FDA approved 790 anda numbers This means that nearly 10% of the newly approved anda varieties in the United States this year are from Chinese pharmaceutical companies From the perspective of declaration enterprises, this year is also quite lively On the one hand, the old players still exist, and the representative ones are still the backbone of Renfu pharmaceutical, Huahai pharmaceutical, Ouyi, Hengrui pharmaceutical, Nantong Lianya, etc In recent years, these companies have basically achieved continuous anda file stream, and the number of each year is basically stable The only small outbreak this year is humanwell medicine In 2017, there were three varieties approved by humanwell, and this year, 13 varieties were approved to rank first among all companies In addition to the five varieties declared by the subsidiary Yichang humanwell, the rest of the products are completed by the two subsidiaries of epic and puracap which humanwell pharmaceutical acquired overseas On the other hand, the performance of new entrants is also quite impressive For example, east sun medicine In fact, it seems inappropriate to define dongyangyao as a new entrant After all, dongyangyao submitted the Anda application for prasugrel's first generic drug in the U.S market in 2014 This is the first anda imitated by dongyangyao in the U.S and the first anda imitated by the U.S in China However, the east sun medicine, which has always been quite low-key, doesn't make too much noise In 2018, dongyangyao suddenly broke out, and from May to December, it successively obtained 12 anda numbers Some enterprises, for example, Hainan Puli Pharmaceutical Co., Ltd., are the first anda in their enterprise history in 2018 In March 2018, it was approved the generic application of levetiracetam injection, which is an antiepileptic drug At present, the sales scale of the product in the U.S market has been maintained at about $50 million in the past three years, and there are 10 companies selling the product According to the calculation, if the market share is 10%, the product will bring 16 million yuan of net profit to Puli pharmaceutical in the future At present, there is only one original research product on sale in China, and the market competition pattern is more favorable for it A little surprising is Yiling pharmaceutical As an enterprise mainly engaged in traditional Chinese medicine, Yiling pharmaceutical won five anda numbers in the United States in 2018 Obviously, the internationalization route of Yiling pharmaceutical industry is still trying to open up with chemical drugs, and its advantage lies in the field of traditional Chinese medicine According to the data, Yiling pharmaceutical has formulated a three-step chemical development strategy of "transfer processing - generic drugs - patented new drugs", and established an international production, quality, marketing and management team Another point worthy of attention in 2018 is the reappearance and feeding back of the first generic drugs of Anda, which has not appeared for several years The main character of this time is Hengrui From the perspective of generic drug declaration, the significance of first copy is undoubtedly very important On the one hand, because FDA believes that the first generic drugs are of great significance to public health, it will generally give priority to the evaluation of the first generic drugs; on the other hand, the famous hatch Waxman Act stipulates that the first generic drugs with successful patent challenge will have a 180 day market monopoly period and can be sold at a price of about 50% - 80% of the new drugs According to the official FDA website, on February 26, 2018, the Anda of Hengrui medicine "desflurane for inhalation" was approved It is also the second and the first generic drug of Hengrui medicine since 2018, which has been listed in the United States since cyclophosphamide As of August, the FDA approved only 36 first generic drugs Although there will be many benefits after winning the first imitation, it is not easy to win the first imitation It not only requires planning in advance, but also more investment than general generic drugs, and there will be litigation risk of original research drugs at any time For enterprises, it is also required to fully plan and investigate the market scale, competitive situation and market feasibility after listing As for the first imitated product of Hengrui, desflurane belongs to inhalation preparation, which requires binding application of raw materials and devices, so it is very difficult to develop In the U.S market, only Baite's original research products were approved for marketing in 1992, with few imitators Hengrui pharmaceutical announced that it has invested about 30.2 million yuan in the research and development of desflurane Hengrui is one of the representatives of all enterprises applying for anda That is to say, the ability to establish a sales network in the United States, or to ensure that the products can generate actual sales, has a substantial impact on the company's expansion of overseas markets In the layout of varieties, they often choose high-quality varieties with high development difficulty and large market space In recent years, the trend of its application varieties gradually changing to high barrier and high income is very obvious But at the same time, not all enterprises apply for anda in order to open up the international market It is a more realistic and common way for them to obtain FDA's "certification" by virtue of the advantages of policies and turn to feed the domestic market Representative is the consistency evaluation policy which has been paid close attention to in recent two years in China On September 14, 2016, the former CFDA issued "interpretation of policies related to the consistency evaluation of quality and efficacy of generic drugs", which specifically explained the two situations of "deemed" passing the consistency evaluation One is the drugs listed on the same production line in China and approved to be listed in the European Union, the United States or Japan; the other is the generic drugs that the domestic drug manufacturers have been approved to be listed in the European Union and the United States This makes it a practical path for domestic enterprises to apply for anda in the United States and then report the domestic consistency evaluation, and indeed more and more enterprises begin to pay practical actions along such a path Huahai pharmaceutical industry is one of the typical representatives As a company that has established a mature and stable product flow in the overseas market, Huahai Pharmaceutical Co., Ltd has been approved by anda in recent years, and has become one of the important suppliers in the U.S generic drug market However, returning to the domestic market through the priority review channel is also a path that Huahai has successfully opened up Six varieties have entered the domestic priority review The list of drugs can be regarded as passing the consistency evaluation after being approved However, it is worth noting that not all varieties can obtain dividends in the domestic market through this way, especially some of the more competitive varieties, such as amlodipine This year's anda approved also has this variety, but the data shows that after 2016, more than 50 manufacturers started be research but did not apply for listing or consistency evaluation by new classification Currently, there are 5 manufacturers that have passed the consistency evaluation, and as many as 15 enterprises are applying for consistency evaluation Therefore, even through the consistency evaluation of the declaration of Anda, it is not necessarily able to achieve the desired results.