The confluence of many trickles can become river and sea, the accumulation of small steps can go a thousand miles.

"Most hypertension requires long term treatment. The selection of suitable hypotensive drugs shall take the patient's affordability into accounts and in accordance with patient's condition, financial situation and wish. The limited medical resource can result in larger social benefit via the selection of cheap hypotensor that is proved effective by clinical trial.”

Amlozen™ is the domestic Amlodipine Besylate Tablets that was issued and marketed in 2002 by Dawnrays Pharma in China. From market research, R&D and production to marketing, Dawnrays Pharma always instructs the work with the determination to build a brand.

Chinese Hypertension Market Situation

According to the latest annual report of Chinese cardiovascular diseases, at present there are more than 0.33 billion hypertensives in China. The morbidity rate of adult hypertension is greater than 30%. It is easy to have irregular heartbeat condition of atrial fibrillation if hypertension is not controlled well and thus results in severe consequence, for instance, stroke, which has the risk of death or disability. There are millions of people who die of hypertension every year. It relates to the life style of sit for the most time. The death rate of cardiovascular and cerebrovascular diseases is obviously in the high end among the people in large cities of Shanghai, Beijing and Guangzhou , etc..

The status quo of treatment for hypertensives in China is not optimistic. There are lots of hypertensives who are not examined to be with hypertension. While the one with examination and diagnosis have no treatment and the one with treatment have not received the standardized therapy. The control rate of hypertension in China is reported to be less than 10%. Such a low control rate directly results in high death rate and high disability rate.

In case of hypertension, if the disease can not be controlled efficiently by on diet, losing weight, giving up smoking and alcohol and enhancing exercises, etc., then the medicine therapy will be necessary. At present, medicine is the most effective way to cure hypertension. The patients must take the drugs strictly following doctor’s advice.

At present, the imported hypotensor (original product researched in US) in China has good effect and high price, but was mainly sold in developed areas. The domestic drug has general effect and low price, which is mainly sold in rural areas and economically underdeveloped areas.

Product Research And Development Of Amlozen™

Before 2000, the market of antihypertensive drugs was still very little. Lots of patients did not realize the necessity of drug therapy, while most of Chinese patients who took drugs at that time only used the antihypertensive drugs with low price and general effect. Only a few people can afford the imported drug. Dawnrays Pharma officially began the research on antihypertensive drugs since 2000 with an aim to research and to develop the domestic Amlodipine Besylate Tablets with quality and effect equals to American original products but with the affordable price for Chinese ordinary people. Relying on the efforts of multiple-party, Dawnrays Pharma finally gained the national drug production approval document for Amlodipine Besylate Tablets 5mg in the beginning of 2002. At that time, there was still no brand of domestic Amlodipine Besylate Tablets.

Before long, in 2003, Dawnrays Pharma gained the production approval for two new strengths of amlodipine besylate tablets 2.5mg and 10mg relying on its powerful R&D and technical strength in antihypertensive drugs area. In particular, the specification of 2.5mg means not only one more specification than others (including original research manufacturer) in China, but also that Dawnrays Pharma can implement reasonable drug dosage development based on the physique of the Chinese. Later, the Amlozen™ with strengths of 2.5mg and 10mg does not exceed the sales volume of that of 5mg, they are very popular with many doctors and patients.

Product Features

Since its marketing in 2002, Amlozen™ has been awarded a good reputation by vast doctors and patients. One of the key reasons for that is certainly the excellent quality and curative effect.
1. Amlozen™ is a kind of peripheral arterial dilator which will directly influence the vascular smooth muscle and lower the peripheral vascular resistance so as to lower the blood pressure.
2. Amlozen™ is a kind of calcium antagonist which has the metabolism neutral and anti-atherosclerotic effects;
3. Amlozen™ has a long half-life time. It reaches to the peak concentration in about 6-12 hours with taken orally once daily;
4. The oral absorption of Amlozen™ is completely but slow, which can control the blood pressure smoothly within 24 hours and relieve the myocardial ischemia within 24 hours;
5. Amlozen™ has no effect on the concentration of plasma calcium;
6. Only 1.5% patients discontinue the Amlozen™ due to its adverse reaction. It has a high safety;
7. Amlozen™ is suitable for combined with other antihypertensive drugs and thus can gain a better antihypertensive effect;
8. Dawnrays Pharma purchases the imported raw material to produce Amlozen™, and the product quality can be guaranteed.
9. Advanced Production Technology: since 2014, Dawnrays Pharma totally transferred the Amlozen™ production to new type solid dosage form workshop that satisfies the requirements of new GMP certification in China. The equipment of that workshop is mainly purchased from Germany and Korea, which adopts advanced digitalization full automatic management mode and thus significantly improves the product quality and production scale.
10. Strict Quality Control: Dawnrays Pharma is one of the domestic pharmaceutical enterprises that passed three-system certification of American AQA at the earliest. The quality control centre is the quality supervision organization via which Dawnrays Pharma ensures that the product will satisfy the specification from raw materials purchase to after-sales service;
11. Patent Protection: In June 2008, Dawnrays Pharma gained the patent for invention of "a preparation method of Amlodipine Besylate Tablets”-the drug synthesis production technology of cardiovascular system special medicine.

Market Development

Support: Dawnrays Pharma allocates the antihypertensive series products to under the management and sales of new drug company. New Drug Company is a team built by Dawnrays Pharma alone and it has abundant hospital clinical and commercial terminal sales resources and experience. It set up nearly 40 offices nationwide, which covers 95% large and medium-sized cities in China so that it can quickly promote the product in market.

Market Promotion: Since 2002, Dawnrays Pharma directly invests more than RMB 5 million every year in the market promotion of company cardiovascular system products, including dozens of academic meetings every year, participation in national and regional hypertension meetings, publishing enterprise and product advertisements on important cardiovascular disease magazines, making brand reminder, developing membership pharmacies, building hypertension website, "Health” (magazine for popularization of hypertension knowledge), manual for self-management of patients (patients education) , etc..

Academic Construction: Dawnrays Pharma invites Professor LIU Lisheng (chairman of world hypertension league and chairman of Chinese hypertension league) to be the academic adviser of company senior medicine so that it can provide valuable suggestions on the company products development.

Scientific Research Projects: Dawnrays Pharma participated in National Key Technology Research and Development Program of China during the "11th Five-Year Plan "-"Chinese Hypertension Intervention Efficacy Study (CHIEF Study)” that started in 2007. The project is the globally first large scale hypertension intervention study which aims to evaluate the comprehensive intervention in combined blood pressure reduction, lipid-lowering and life style for hypertensives with cardiovascular risk factors.

1. The National Key Technology Research and Development Program of China during the "11th Five-Year Plan" supported particularly by National Health and Family Planning Commission of the People's Republic of China as well as Ministry of Science and Technology;

2. The largest medical project of hypertension intervention efficacy in China;

3. There are more than 150 domestic hospitals and nearly a thousand doctors participate in it;

4. It involves more than 12,000 patients and a period of more than 5 years.

Dawnrays Pharma is:

1. The sole study partner and designated supplier of drugs for study;

2. Whose drug effect and quality gains the consensus of vast medical experts at home and abroad after the strict examination and consideration of the study team;

3. That enjoys the transformation and development rights of study achievements.

Brand Achievements:

1. "Amlozen™" is the famous brand of Jiangsu province and also the high-new technical product in Jiangsu province;

2. Amlozen™ was ranked the leading position continuously for many years amongst the statistics of domestic market share of domestic Amlodipine products; (according to the annual report data of China medicine statistics)

3. Amlozen™ is the designated investigational medicinal product (IMP) in the National Key Technology Research and Development Program of China during the "11th Five-Year Plan "-"Chinese Hypertension Intervention Efficacy Study (CHIEF Study)”

4. Amlozen™ was awarded the title of "2014 Excellent product brand of antihypertensive drugs in China chemical Pharmaceutical industry".