Yesterday (October 14), the official website of the National Medical Products Administration (NMPA) announced that the Sacubitril Valsartan Sodium Tablets submitted by Shandong New Era Pharmaceuticals were approved and passed the review. Sacubitril Valsartan Sodium Tablets is an antihypertensive drug used for adult patients with chronic heart failure with reduced ejection fraction. As the world's first breakthrough innovative drug in the field of heart failure treatment, Sacubitril Valsartan Sodium Tablets entered the Chinese market in 2017 for the treatment of heart failure, and was later included in the 2020 National Medical Insurance Catalogue. In June 2021, it was first approved in China for the treatment of essential hypertension. In 2021, in-hospital sales exceeded 2 billion yuan in one fell swoop, a year-on-year increase of 170%.

According to the Zhongkang Kaisi system, the sales of hypertension drugs in graded hospitals in 2023 will reach about 24.2 billion yuan. In the subdivided track of hypertension drugs, the sales of drugs that act on the renin-angiotensin system, which ranks first in market share, will be about 10.9 billion yuan in 2023, while Sacubitril Valsartan Sodium Tablets will exceed 3 billion yuan, firmly sitting on the throne of the first in this subdivided track.

In the first quarter of this year, the sales of Sacubitril Valsartan Sodium Tablets hit a new high again, increasing by 47.7% year-on-year to 1.198 billion yuan; in the second quarter, it increased by 30% year-on-year to 1.184 billion yuan. The total in the first half of the year was 2.382 billion yuan, and it may hit 4.7 billion yuan by the end of the year. According to the information retrieved by Xinkangjie from the National Center for Drug Evaluation (CDE), as of today (October 15), CDE has hosted 67 generic marketing applications for Sacubitril Valsartan Sodium Tablets, covering 35 pharmaceutical companies. In addition to Shandong New Era Pharmaceutical, which was approved this time, there are also star pharmaceutical companies such as China Resources Double Crane, Kelun, Beite, Zhengda Tianqing, and Qilu.

Previously, 14 domestic companies' Sacubitril Valsartan Sodium Tablets have been approved for listing, including Zhengda Tianqing Pharmaceutical, Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical, Sichuan Kelun Pharmaceutical, Qilu Pharmaceutical (Hainan), etc. This time, Shandong New Era Pharmaceutical's Sacubitril Valsartan Sodium Tablets were successfully approved for listing, becoming the 15th domestic company.

In August last year, Nanjing Fangshenghe Pharmaceutical's subsidiary Nanjing Yixinhe and Shijiazhuang Pharmaceutical Ouyi's Sacubitril Valsartan Sodium Tablets were approved for listing and deemed to have passed the consistency evaluation. So far, the first generic competition for this variety has come to an end. Sacubitril Valsartan Sodium Tablets were originally developed from Novartis. Novartis' 2023 financial report shows that the company's annual revenue is US$45.44 billion, a year-on-year increase of 10%. Among them, the star product Sacubitril Valsartan Sodium Tablets (Entresto) achieved revenue of US$6.035 billion, a year-on-year increase of 31%.

According to the Zhongkang Kaisi system, from 2021 to the first half of 2024, Novartis Pharmaceuticals has accumulated sales of 10.391 billion yuan in the domestic graded hospital market. If the tenth batch of national drug centralized procurement includes Sacubitril Valsartan Sodium Tablets, this stable market pattern is expected to change rapidly and significantly. In fact, the past nine national drug centralized procurements basically covered the commonly used major varieties in the field of chronic diseases such as hypertension, heart disease, and diabetes. Most of the chronic disease drugs that have not yet been centralized are drugs within the patent protection period. The Chinese patent of the original research Sacubitril Valsartan Sodium expires in November 2026.

Among the generic drug products that have been approved for listing, Yixinhe's Sacubitril Valsartan Sodium Tablets (Yixintan) were the first to enter the market to compete with the original research drugs for domestic market share. Because Yixintan contains a new crystal form with 3 crystal waters, it circumvents the patent barrier of the original crystal form containing 2.5 crystal waters, allowing this drug to be legally approved for marketing 3 years in advance.
According to the relevant announcement of Nanjing Fangshenghe Pharmaceutical, Yixintan will be sold nationwide through Fosun Pharma. This is the first generic drug of sacubitril valsartan sodium tablets applied for in my country, and it is also the first drug of this type in the global regulatory market to be successfully approved for marketing through independent innovation and breaking through the patent barriers of the original research.

As a category with strong demand for drugs and previously dominated by original research, hypertension drugs have been the focus of national volume procurement. With the implementation of centralized procurement, more than 30 varieties have been included in centralized procurement. However, the sales of most hypertension varieties have obviously "shrunk" after centralized procurement. According to the Zhongkang Kaisi system, the sales of hypertension drugs in graded hospitals in 2023 will reach about 24.2 billion yuan. Among the TOP10 products of hypertension chemical drugs in 2023, the former "king of medicine" nifedipine fell, with sales falling sharply to 1.396 billion yuan, retreating from the first place to fourth place, a year-on-year decrease of 60.1%. TOP10 sales of hypertension chemical drugs in national graded hospitals in 2023

Most of the varieties with positive sales growth are non-centrally purchased varieties, such as sacubitril valsartan sodium, esmolol, alisartan medoxomil, benidipine, etc., which increased by 70.6%, 18.3%, 15.5% and 31.5% respectively. Among them, sacubitril valsartan sodium surpassed nifedipine and metoprolol with sales of 3.65 billion yuan, climbing from third to first place. As the chronic medicine with the highest prevalence, hypertension drugs have always been the "highlight" in all previous centralized procurements. The range of products involved in centralized procurement has been continuously expanded, and the dosage forms have become more abundant. Five products were selected in the eighth batch of centralized procurement to be implemented in July 2023, and four products were included in the catalog in the ninth batch of centralized procurement. According to incomplete statistics, in addition to the products that have been included in the national centralized procurement, there are currently 7 varieties of hypertension chemical drugs that meet the centralized procurement threshold, and the number of companies eligible for application has reached 5 or more. There are a total of 5 oral immediate-release dosage forms, 1 injection, and 1 sustained-release controlled-release dosage form, including sacubitril valsartan sodium, esmolol, doxazosin, spironolactone, tolvaptan, telmisartan hydrochlorothiazide, and macitentan. From the perspective of product review, the number of companies (by company name) that have passed the review for 20 hypertension chemical drugs (by drug name) has reached 10 or more, among which amlodipine besylate, captopril, valsartan amlodipine, indapamide, and nifedipine controlled release have reached 20 or more.

From the perspective of company review (by group), 94 hypertension chemical drugs (80 generic drugs) have been reviewed by companies, involving more than 200 pharmaceutical companies. From the perspective of manufacturer sales, multinational pharmaceutical companies such as Novartis, Pfizer, and AstraZeneca are leading, and domestic pharmaceutical companies such as Qilu Pharmaceutical and Xinlitai are ranked high. Among them, Novartis, Nanjing Haichen Pharmaceutical, Guilin Nanyao and other companies have sales growth rates of more than 20%.

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