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Ambrisentan Localized: China Approves First-to-market Ambrisentan Generic (Punuoan) of Hansoh Pharma

2018.08.27 Size

The first Ambrisentan Generic (trade name: Punuoan) produced by Jiangsu Hansoh Pharma received approval, which means Ambrisentan, the drug targeting pulmonary arterial hypertension, was officially localized. As a Category 4 drug, the approval for launch of Punuoan is deemed the same as passing the consistency evaluation.

  

“Blue lips”: Look nice, or do they?

There are a group of people who seem normal, but it’s fatal for them to overwork or engage in heavy labor jobs. Simply climbing up a few stairs may cause them difficult breathing and blue lips. You might have crossed paths with them many times without giving them a second look. They sometimes get cold shoulder for being mistakenly judged as “pretentious”. They are patients suffering from pulmonary arterial hypertension, which is more commonly known as “blue lips”.

Pulmonary hypertension, a fatal cardiovascular disease characterized by elevated pulmonary artery pressure and progressive development, can affect males and females of any age. Usually more than 70% of patients are young people, and women are about twice as likely as men to have the disease. Despite its low incidence rate, the disability and fatality rate of pulmonary hypertension is quite high. After diagnosis, the patient usually live for about 2.8 years. Therefore the earlier the treatment, the greater the benefits to the patient.

 

Intellectual Property, Not Intellectual Monopoly

Ambrisentan is a new type of highly selective endothelin receptor antagonist. It’s mainly used for treating pulmonary hypertension by acting on the endothelin and associated receptors that affect the patients’ pulmonary function. It can mediate vasoconstriction, thus alleviate symptoms and improve patients’ quality of life and survival rate.

As a renowned innovative drug company and a multiple-time winner of the top 3 most innovative pharmaceutical companies in China, Hansoh Pharma has been committed to providing patients with efficient, safe and economical drugs. In order to break the monopoly of the original drug and increase the supply, Hansoh Pharma finally commercialized the China-version first-to-market Ambrisentan generic after years of scientific researches and multiple technical breakthroughs thanks to our outstanding R&D platform and research team.

 

Ambrisentan is a first-line drug, patent of which is expected to expire in 1 year.  This is one of the main drivers for Punuoan’s rapid approval and the reason why its NDA review was prioritized.

 

Punuoan – High-quality Ambrisentan Tablets

Punuoan is a quality China-version Ambrisentan which takes the dosage form of tablets. It has passed the consistency evaluation, proven to be consistent with the original drug in the aspects of production process route and crystal form. Control of genotoxic impurities is implemented. Consistency from lots to lots is improved by the strict control of the preparation process. Bioequivalence tests also showed that Punuoan has equivalent efficacy with the original drug, offering patients with an alternative option.  

 

Punuoan is one of the most important cardiovascular products of Hansoh Pharma, and clinical trials showed that the drug has significant advantages in the treatment of pulmonary hypertension:  

 

1.Highly selective for the type-A endothelin receptor

 

2. Better safety and tolerability, lower rate of hepatotoxicity, no need to monitor liver function on a monthly basis

 

3. No obvious interaction with other drugs usually used to treat pulmonary hypertension, which makes it more suitable to be combined with other types of targeted drugs

 

4. Demonstrated efficacy in pulmonary hypertension treatment, patients’ exercise capacity improvement, reduced dyspnea, cardiac function and hemodynamic indicators improvement, etc.

 

5. Once-a-day dosing, which is convenient and conducive to increase medication adherence

 

Disease-induced poverty is very common among families with patients suffering from pulmonary hypertension. High drug prices create an unbearable financial burden for patients. Giving Hansoh Pharma’s Punuoan (first-to-market Ambrisentan generic) the green light to enter the market enables Chinese patients with pulmonary hypertension to access quality drugs that are equivalent in efficacy, but more cost-effective than original drugs, thus making them feel more comfortable about their health status.

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