The leading breed of hypertension, valsartan, has ushered in a consistent evaluation product.

Medical Network June 5, June 4, Huahai Pharmaceutical announced that the company's valsartan tablets (40mg, 80mg, 160mg) recently obtained the drug registration approval from the State Food and Drug Administration. As a treatment for mild to moderate essential hypertension, valsartan tablets were developed by Novartis Pharmaceuticals and approved for marketing in the United States in 2001. At present, the main domestic manufacturers are Beijing Novartis Pharmaceutical Co., Ltd. and Changzhou Sifang Pharmaceutical Co., Ltd. According to IMS data, the sales of 缬沙坦片 in the US market was approximately US$61 million in 2017, and the sales volume of valsartan in the domestic market was approximately US$1.717 billion. It is reported that Huahai Pharmaceutical's approved valsartan film is an oral preparation that has been listed in Europe and the United States but has not been listed in China, using overseas data declaration, and accepting conformity evaluation according to the approval of new four types of generic drugs.

The reporter learned from the public information of Huahai Pharmaceutical that in June 2015, the company had received a notice from the US FDA, and its application for a new drug for valsartan tablets filed with the US FDA was approved. In May 2016, the application for registration of valsartan tablets was submitted to the Zhejiang Provincial Drug Administration for the first time and accepted, and in December of the same year, it entered the priority review catalogue.

As stated by Yu Mingde, honorary president of China Pharmaceutical Enterprise Management Association, “Huhai Pharmaceutical is the biggest gainer of the consistency evaluation of generic drugs. The main strategy is to first approve the US ANDA and then take the priority review channel. Entering the domestic market, other products are expected to accelerate the listing in China through this development path and ideas, and pass the consistency evaluation."

　　 "Double Report" Strategy Helps Consistency Evaluation

In the follow-up products of the president, the reporter noticed that in addition to valsartan, Huahai Pharmaceutical also has 10 new products such as duloxetine enteric-coated capsules and voriconazole tablets, which are declared according to the same route and strategy. They are all in different stages of review.

The reporter noted that at present, there are more sales potentials in the domestic and ANDA “Double Report” products, and the products that have been listed in China have been reported to ANDA. Most of the "double-reported" oral preparations are in the state of declaration. According to the policy, the generic drug manufacturers that have been approved for listing in the European Union, the United States or Japan will apply for the registration of generic drugs in accordance with the relevant requirements of the “Notice on the Issuance of the Chemical Drug Registration Classification Reform Work Plan”, which will be reviewed by the Drug Testing Center. After approval of the listing, it is considered to pass the consistency evaluation.

In fact, in the oral preparations, the slow-release preparations are also actively conducting research. At present, there are six slow-release preparations in the declaration of consistency evaluation, but only the varieties that have not passed the consistency evaluation, and now there are 14 The controlled release preparations were approved by the US FDA.

Zhang Zhengzan, deputy general manager of Guangzhou Xinji Pharmaceutical Technology Co., Ltd., told reporters recently that "orally controlled release preparations have the advantages of reducing drug side effects and improving patient compliance, and are one of the important directions for the upgrading of innovative medicine products. After the expiration of the patent for new drug compounds, it is also an important technical means for improved new drugs." He believes that the innovation and design of slow-release preparations should be based on clinical needs, evaluate the feasibility of the drug according to the nature of the drug, and design a reasonable dosage form and technology. Path to achieve clinical needs. Due to the long release and absorption process of the slow-release preparation in vivo, whether it is the development of innovative preparations or generic preparations, it has relatively high technical difficulty and needs to be controlled from raw materials, auxiliary materials , processes and equipment.

It can be seen that for manufacturers listed at home and abroad, “double report” is regarded as the drug variety that is evaluated through the consistency of generic drugs, and the social security department will provide appropriate support in the payment of medical insurance. Medical institutions should give priority to procurement and give priority in clinical practice. Selection, policy dividends can be expected.

Valsartan leads the hypertension market

It is understood that according to population size and structure estimates, there are currently about 330 million hypertensive patients in China, accounting for about one-third of the total number of hypertension in the world. However, the control rate of 5.7% of hypertension in China has a very large gap with European and American countries. Relevant research institutions surveyed 1.6 million people from 31 provinces (autonomous regions and municipalities) from November 2016 to May 2017. The survey included 203 community health centers, 401 community health stations, 284 township health centers and 2474. A rural clinic with a total of 3,362 primary health service stations. 11.3% of them did not have antihypertensive drugs. Experts pointed out that "the most important thing is to standardize the training of community doctors, carry out community-based prevention and treatment of hypertension and chronic diseases. Conduct offline training, online consultation, cloud management, and improve patient compliance."

It can be seen that there is still a lot of room for the cardiovascular drug market to be explored.

According to the data of HDM system, in 2016, the market for hypertension drugs in public hospitals in 16 key cities in China reached 4.955 billion yuan, of which the sultan drugs ranked first, accounting for 38.25%. Among the sartans, the TOP 3 varieties are valsartan, irbesartan, and losartan potassium, which are currently a new class of highly competitive treatments for hypertension.

It is reported that the domestic market of 缬沙坦片 and capsules is estimated to be nearly 3 billion yuan. The sales of public medical institutions in the intranet statistics reached 1.88 billion yuan, of which the original research Novartis accounted for about 74% of the market share, Changzhou four drugs, Lunan Bate, China Resources SEC each has a market share of approximately 6%, 5% and 5%. There are many approvals for valsartan capsules in China, and there are 9 enterprises with production approvals; while valsartan tablets only have 80mg and 160mg approvals for the original research, and 40mg approval for Changzhou four drugs, while Huahai is the only one with three specifications of valsartan. Film business. At present, only the Lepu Hengjiu Pharmaceutical Co., Ltd., which has a BE test for domestic manufacturers, will have a larger market share.

In addition, the new edition of the National Basic Medical Insurance Catalogue contains 271 cardiovascular drugs, including 144 western medicines and 127 Chinese patent medicines. It is worth mentioning that in the second batch of 36 drugs that entered the medical insurance catalog in 2017, 6 of them were cardiovascular drugs. The data show that in 2016, China's hypertension medication has exceeded the market size of 80 billion yuan, an increase of 13% over the previous year. With the improvement of the medical security system, urban public hospitals, county-level public hospitals, urban communities, and township health centers have become the main market for blood pressure lowering drugs, calcium antagonists, angiotensin receptor antagonists and compound antihypertensive drugs. Sub-categories have formed a full potential.