Statins are in competition! The first domestic imitation "A Le" to grab the 20 billion market

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In the past two years, the country has frequently introduced new policies on drug supervision. CFDA's heavy hammer on the consistency evaluation of generic drug quality and efficacy has become a top priority for pharmaceutical companies. Consistency evaluation is the process of phoenix nirvana and rebirth.

13 varieties of about 9 pharmaceutical companies in the first batch of 6 provinces on-site inspection are currently in the state of application and approval. The enterprises involved include Beijing Jialin Pharmaceutical, Zhejiang Jingxin Pharmaceutical, Zhejiang Kangenbei, Jiangsu Haosen Pharmaceutical, Jiangsu Hengrui Pharmaceutical, Jiangxi Qingfeng, etc., while the first batch of 7 varieties to start on-site inspection are in the process of promotion. It is reported that in late November, the Food and Drug Audit and Inspection Center (CFDI) of the State Food and Drug Administration has launched the first batch of first-line inspections of generic drug consistency evaluation varieties.

DepletedDyslipidemia is not groundless

The "China Cardiovascular Disease Report 2016" shows that the mortality rate of cardiovascular disease in China still ranks first in the composition of disease deaths, higher than tumors and other diseases. Cardiovascular diseases account for 45.01 per cent of the population's disease mortality in rural areas and 42.61 per cent in urban areas. Dyslipidemia is a silent and frequently-occurring disease, which is the main factor leading to cardiovascular and cerebrovascular diseases, arteriosclerosis and embolism. With the change of China's lifestyle and the acceleration of the aging process, the high incidence of hyperlipidemia syndrome has further promoted the rapid growth of China's lipid regulation market.

The survey results show that the incidence of dyslipidemia in China has reached 40.4 per cent, of which the incidence of hyperlipidemia has exceeded 30 per cent. It is predicted that between 2020 and 2030, the increase in cardiovascular events caused by elevated lipid cholesterol alone will reach 9.2 million. This has become a serious social health problem, so it is extremely important to evaluate the consistency of lipid-regulating market varieties.

DepletedStatin market: The pack

At present, the statins in the blood lipid regulating market are mainly monopolized by atorvastatin, rosuvastatin, pitavastatin, simvastatin, pravastatin, fluvastatin and lovastatin. Atorvastatin is the first of the group.

Even in the world, the lipid-regulating drug market is second only to the anti-tumor chemical drug market, ranking second. Although alemtuzumab (Alirocumab) of Sanofi Aventis and Ivorocumab (Evolocumab) of Amjin have been launched in 2015, the global cholesterol-lowering market is still dominated by statins and their combination drugs.

In China's lipid-regulating prescription drug market, statins account for about 90% share. In the 10 years from 2006 to 2016, my country's blood lipid regulating market has increased by 5 times, becoming a class of drugs that have attracted much attention in China, and have played an inestimable role in cardiovascular clinical treatment.

DepletedFirst-hand data, ironclad evidence

According to data from the Intranet, in 2016, China's urban public hospitals, county-level public hospitals, urban community centers, township health centers, physical pharmacies, and online pharmacies showed that the overall market for blood lipid regulation exceeded 20 billion yuan. An increase of 9.24 percent over the previous year. Atorvastatin is already the leading variety in the domestic lipid-regulating drug market, with mainstream terminals such as urban and county-level public hospitals and retail pharmacies in China accounting for 36% of the lipid-regulating drug market.

DepletedAtorvastatin, Lipid-regulating Market Leading Variety

According to the data of Mi Neiwang, the leading variety of atorvastatin in China's lipid regulation market is showing a trend of rapid growth. In 2016, the sales volume of atorvastatin in China's urban public hospitals and county-level public hospitals was 6.075 billion yuan, and the atorvastatin market in China's retail pharmacies has reached 2.431 billion yuan. China's urban public hospitals, county-level public hospitals, urban community centers, township health centers, physical pharmacies, and online pharmacies have exceeded the market size of 13 billion yuan in atorvastatin sales. It is predicted that atorvastatin will be on the new platform of 15 billion yuan in 2017.

DepletedRefined atorvastatin market

Atorvastatin is a fully synthetic and selective HMG-C0A reductase inhibitor. It is the backbone of Pfizer in the United States, and its trade name is Lipitor. Since its listing in 1997, it has achieved a performance of more than 150 billion US dollars. Atorvastatin is used in the treatment of blood lipid disorders, and it is one of the essential drugs after interventional treatment of thrombosis. Its remarkable efficacy and fast-growing market have attracted wide attention from the global pharmaceutical industry. In 1999, the first imitation listing of domestic atorvastatin and Lipitor entered China, becoming one of the fastest growing cardiovascular drugs. In 2016, Pfizer's Lipitor sales in the domestic public medical institutions and retail terminal markets reached a market size of 8.488 billion yuan. It is expected that the overall domestic Lipitor market will be around 9.5 billion yuan in 2017.

According to data from the Mi Intranet, the sales of atorvastatin in public hospitals in key cities in 2016 was 1.283 billion billion yuan, an increase of 8.78 percent over the previous year. In the past two years, atorvastatin has rapidly expanded into retail channels. In 2016, China's retail drugstore terminal chemical drug market ranked 6th in the TOP100 sales list. China's retail drugstore atorvastatin market has reached 2.431 billion yuan, up 18.95 from the previous year. According to the sales data in the first half of 2017, the sales of atorvastatin in retail pharmacies in China will reach a market size of nearly 3 billion yuan this year.

DepletedThe first domestic imitation of A Le

As we all know, atorvastatin is a new drug variety advocated by China, and domestic drugs are developed successfully by Beijing Jialin Pharmaceutical. On September 29, 1999, he obtained the new drug certificate and production approval issued by the former State Food and Drug Administration, and the trade name was "A Le". Atorvastatin is a variety loaded into the 2004, 2009 and 2017 editions of the National Health Insurance Catalog, and its entry into the health insurance catalog has comprehensively promoted the company's performance upgrade. In 2016, the overall market of 10mg and 20mg tablets in China has exceeded 124.36 million boxes, with the sales amount reaching 3.9 billion yuan.

Beijing Jialin Pharmaceutical is the drafting unit of the quality standard for atorvastatin drugs. In order to improve product quality and enhance market competitiveness, Jialin Pharmaceutical voluntarily proposed to CFDA in 2009 to revise the quality standard for atorvastatin calcium and tablets, which was approved by CFDA. The improvement of quality standards has effectively raised the entry threshold for such products of Jialin Pharmaceutical to be imitated, avoiding the phenomenon of too many generic drugs.

According to reports, after the listing of Jialin Pharmaceutical, R & D investment has continued to increase. In 2016, the amount of R & D investment was 51.83 million yuan, an increase of 41.8 from 36.55 million yuan in 2015, accounting for 3.59 of operating income. The consistency evaluation of the company's core product, Ale, is progressing smoothly. In cooperation with Tsinghua University to develop anti-tumor drugs based on BRM inhibition, screening and optimization of candidate drugs are in progress.

DepletedGrowth in competition

There is an idiom in China that it is difficult to sing with a single hand. After the expiration of the domestic protection of the first generic drug, Ale, the state has approved the production of several enterprises. According to 2017 data on CFDA's official website, the domestic imported atorvastatin preparation market is mainly Pfizer's tablet Lipitor, Beijing Jialin's tablet Alle, Henan Tianfang's capsule Youjia, Slovenia's Laike's Shanle, Guangdong Encyclopedia's dispersible tablet Jingshu, and Zhejiang's Xindonggang's tablet Youliping. There are 17 atorvastatin bulk drugs approved and registered by CFDA, of which the importers are Pfizer (Pfizer) of the United States, Cadilla of India, Dr. Reddy and DSM of India. After 2015, Zhejiang Haisen Pharmaceutical, Changzhou Yabang Pharmaceutical and Hubei Yitai Pharmaceutical have been newly approved to produce atorvastatin bulk drugs in China. This constitutes a great potential, but objectively proves that each drug is also the top 3-5 that atorvastatin.

In 2016, in the atorvastatin market of public hospitals in key cities, Pfizer's Lipitor ranked first, occupying 76.09 percent of the market, Beijing Jialin occupying 18.59 percent of the market, Tianfang Pharmaceutical occupying 3.97 percent of the market, Xindonggang Pharmaceutical, Slovenia Leko and Guangdong Encyclopedia occupying 1.35 percent of the market. It is worth mentioning that Xindonggang Pharmaceutical, Slovenia Leko and Guangdong Encyclopedia have higher growth rates, 178.20 per cent, 65.95 per cent and 116.48 per cent, respectively.

In 2016, the TOP5 regions for atorvastatin use were Beijing, Guangzhou, Shanghai, Wuhan and Chongqing, accounting for 65.83 of the market share in 16 cities and still the main consumption area. From the perspective of growth rate, the top 5 regions with high growth rate are Tianjin, Jinan, Wuhan, Guangzhou and Shijiazhuang, which increased by 26.32, 22.92, 22.24, 21.42 and 18.02 respectively compared with 2015, which is the driving force for the growth of atorvastatin market.

DepletedSuccessful listing, increased productivity

In July 2016, with the approval of the CSRC, Jialin Pharmaceuticals to "major asset replacement issue shares transfer to raise supporting funds", successfully backdoor, transaction price 8.368 billion, to "Dezhan Health" landing on the main board. Thus becoming the largest backdoor listing case in the history of China's pharmaceutical industry, further promoting the company's rapid development process.

Jialin Pharmaceutical is mainly engaged in the research and development, production and sales of cardiovascular and cerebrovascular drugs. The drugs being produced and sold include atorvastatin calcium tablets (Alle), anti-angina drug trimetazidine capsules (Fengle), antiviral drug famciclovir tablets (Fanle), anti-arrhythmia drug amiodarone tablets, acute and chronic leukemia, chronic myeloid leukemia treatment drug azathioprine tablets, malignant melanoma, gastric cancer, colon cancer, breast cancer treatment drug hydroxyurea tablets. Anti-hyperuricemia, gouty arthritis drug Narcissus tablets. A Le is the company's fist variety. Under the excellent operation of the company, the accumulated profit in the first three quarters of 2017 was 0.634 billion yuan. Under the research and development of the first imitation drug atorvastatin calcium tablets, the improvement of quality standards, industrial production and innovative management, the realization of the promised profit of 0.779 billion yuan in 2017 has been a sure victory.