China's first decline in Anda approved in the United States "main force" and "backbone" rise

Compared with previous years, the number of approved anda of Chinese generic drugs in the United States declined for the first time in 2019 According to incomplete statistics of e drug managers, as of the date of publication, in 2019, Chinese drug companies obtained 62 official anda approvals in the U.S FDA, while in 2018, the number was 80, which was the highest in history As for the decline, there is a clue in the data, which is mainly reflected in the decrease of the supply of the main force and the failure to keep up with the speed of new faces, leading to the situation of "out of touch" According to statistics, in 2018, the number of applications for approval of two pioneer enterprises, dongyangyao and humanwell pharmaceutical, was 13, falling to 3-4 in 2019; the backbone of Huahai pharmaceutical, Qilu pharmaceutical, Ouyi, Yiling pharmaceutical and other backbone enterprises also dropped significantly In terms of number, except for the slight growth of Fosun Pharmaceutical and Haizheng pharmaceutical, most enterprises fell significantly However, some regular customers continued to grow, such as Nantong Lianya and Haizheng pharmaceutical, which increased 4 drugs in 2019, and some black horses emerged, such as Nanjing Jianyou and Jingfeng pharmaceutical In recent years, no matter in the research and development of innovative drugs or the layout of generic drugs, the performance of Dongyang Guangyao is remarkable According to the publicly disclosed data, as of the end of 2018, dongyangyao has produced 33 pharmaceutical products, mainly involving the antivirus product corway, accounting for 89.5% of the turnover In 2018, dongyangyao was approved as many as 13 anda drugs in the United States, most of which are anti infective drugs, ranking first with humanwell medicine It is worth noting that by 2019, although only three drugs have been approved, prasugrel in the approved drugs is an oral antiplatelet heavy bomb drug, which is the first U.S generic anda of dongyangguang and the first U.S generic anda of China In the past, humanwell pharmaceutical has obtained a number of Anda approvals by purchasing epic pharma By 2019, there is only one approval from epic, and the rest three are from Yichang humanwell It should be noted that epic is a U.S company purchased by management at a high premium, with a gross profit rate of 80% before the merger and acquisition, and the gross profit rate of performance changed to 40% shortly, which has impaired the 2.8 billion goodwill of epic At that time, the focus of M & A was on its foreign anda, and now its performance is starting to be weak and not optimistic Prior to that, Huahai pharmaceutical had been in the top three positions in the list of Anda of Chinese generic drugs to the United States Since 2007, in addition to the gap in 2009, the company has received approval of corresponding varieties in the United States every year, and the number has basically increased year by year in recent years By 2017, it had reached a record high, with 10 andas, but by 2018, it was reduced to 6, and by 2019, it was reduced to 2 According to the past reports of e-drug managers, the reason for the fall of Huahai pharmaceutical industry may be related to a notice of EMA (European Drug Administration) On July 5, 2018, EMA released a notice announcing that NDMA was detected as impurity in valsartan API produced by Huahai pharmaceutical industry Then came the recall and warning information of EMA and FDA On September 28, 2018, FDA issued an import ban alert to Huahai pharmaceutical industry, covering all APIs and preparation products produced by Huahai pharmaceutical industry So in 2018, the Anda of Huahai pharmaceutical industry fell Previously, an expert interviewed the e-drug manager and said that the Valsartan incident was only a case and should not be over interpreted However, the two products approved by Huahai in 2019 are potassium chloride, so it seems that the sequelae has not been eliminated Abitrone acetate tablet is the 22nd anda drug of Qilu pharmaceutical, which is suitable for treating various types of mcrpc patients and prolonging the life of patients with advanced prostate cancer Qilu pharmaceutical has made continuous efforts in internationalization in recent years It is not only the first domestic enterprise that has passed the FDA, EU EDQM and NHRA sterile product certification in the United Kingdom, but also has built three R & D centers in Boston, Los Angeles and San Francisco in recent years, so as to accumulate strength for the process of internationalization Compared with the above-mentioned leaders, Haizheng pharmaceutical industry has always been the backbone of Anda to the United States In 2019, the approved anda of Haizheng pharmaceutical industry increased by 4 to 8, and the quality of drugs improved In 2019, two anti-tumor drugs and one leukemia drug were added Among them, dacarbazine is a very good anti-tumor drug, which has a good therapeutic effect on malignant melanoma, lung squamous cell carcinoma, sarcoma, brain tumor, leiomyosarcoma and fibrosarcoma, and is the first choice drug for treating melanoma In combination with doxorubicin hydrochloride, another approved drug, it is especially effective for Hodgkin's lymphoma After approval, access to the Chinese market can be quickly obtained Nantong Lianya is also a "frequent customer" in the sea, which is a multinational company operating in China and the United States Anda is more important for it In 2019, Nantong Lianya obtained 8 anda approvals, 4 more than last year Among them, there are more cardiovascular and cerebrovascular drugs to reduce hypertension, including 3 drugs, 2 drugs to treat diabetes insipidus and 1 anticancer drug The indications of vinorelbine tartrate injection are non-small cell lung cancer, metastatic breast cancer, advanced ovarian cancer and malignant lymphoma At present, Qilu pharmaceutical and hausen pharmaceutical are applying for conformity evaluation It is also worth mentioning that Baiyang Pharmaceutical Co., Ltd successfully used the system tool of "patent challenge" in 2018, making its metformin hydrochloride sustained-release tablets (Ⅲ) Neda obtain the batch number of Anda and become its first anda drug.