Hepalink's Enoxaparin Sodium Preparation Allowed Clinical Trial against Covid-19 in Italy

2020-04-16

Although Covid-19 has been effectively put under control in China, it is still rampant in the rest of the world. Faced with this global major public health emergency, all countries are taking actions to strengthen epidemic prevention and develop anti-epidemic drugs and reagents.

On April 14, 2020, La Repubblica reported that AIFA approved follow-up heparin researches and would test on more than 300 moderate or critical patients in 14 centers of Italy. The test will evaluate whether different doses of anticoagulants are safe and effective in controlling the disease.

It is worth mentioning that the drug at the clinical trial, Inhixa, will be offered to the 14 centers for free by Techdow Pharma, the Italian subsidiary of Shenzhen Hepalink Pharmaceutical Co., Ltd (Hepalink). The clinical trial will further test whether enoxaparin preparations are effective in preventing viruses from entering cells and blocking the pathway of inflammatory factors based on the traditional anticoagulant mechanism of enoxaparin preparations.

It is also reported that “treating Covid-19 with enoxaparin is on a firm scientific basis, which has been proved by pre-clinical trials and preliminary studies of the human body.”

Hepalink is a China-leading and the world’s fourth largest enoxaparin sodium preparation manufacturer and distributor. With 5.4% of the global market share, the company is the only Chinese pharmaceutical enterprise that has sold more than 100 million enoxaparin sodium preparation s in the European Union. Meanwhile, it is also the second largest supplier of enoxaparin sodium preparations in China, enjoying 11.3% of domestic market share.


Low Molecular Weight Heparin (LMWH) AnticoagulantsMight Bring Hopes to Covid-19 Patients


According to the Clinical Management of Severe Acute Respiratory Infection When Novel Coronavirus (nCoV) Infection is Suspected: Interim Guidance released by the WHO on January 28, enoxaparin preparations are a kind of superior LMWH preparations. If used for symptomatic treatment, they will lower the possibility of vein thrombosis complication for Covid-19 patients.


Several previous clinical researches have shown that critical Covid-19 patients might suffer disseminated intravascular coagulation. At present, LMWH is a relatively effective and safe drug for the prevention of thrombosis. Applying LMWH to patients can help prevent thrombosis and deterioration.

Enoxaparin sodium preparations, as the gold standard for anticoagulant and antithrombotic drugs, are globally approved and widely applied LMWH sodium preparations with many indications.

In addition to anticoagulant effects, enoxaparin preparations also bear anti-inflammatory functions. The non-anticoagulant component of enoxaparin shows its role in inhibiting BEAS-2B from releasing IL-6 and IL-8 in vitro. Moreover, in vitro and in vivo experiments have shown that human coronaviruses adhere to target cells through HSPG, indicating that heparin might be helpful to the treatment of Covid-19.

The Booming Preparation Business Might Create BetterPerformance

Since the Spring Festival of 2020, a “Black Swan” event, namely, the unexpected epidemic has hit many industries, including the heparin industry.

According to the performance estimation of the first quarter of 2020, several listed companies in the heparin industry have seen different degrees of decline in performance, especially the heparin preparation business.

However, it must be noticed that Hepalink reversed the trend and raked in huge profits in the first quarter of 2020. The first quarter performance estimation unveiled by the company on March 29 shows that it is expected to earn 250 to 300 million RMB. One of the key factors behind this is that the inhibitor business maintains fast sales growth.

Recently, on a certain investor interactive platform, Hepalink told investors that the company’s preparation export business was running smoothly amid the epidemic in China and abroad, and that overseas epidemic spread would not deal a huge blow to the market demand of the company’s enoxaparin sodium preparations because as essential drugs, they are in inelastic demand. As such, the company has seen continuously fast sales growth in the European Union market, with average weekly sales in the Italian market and the Spanish market achieving new high.

Seen from Hepalink’s revenue, over 90% of its heparin industrial chain business earning came from overseas market, including market approval in 36 countries and sales in 15 countries. The globalization strategy has won the company an extensive market.

Hepalink’s enoxaparin sodium preparations are on the rise after promotion in European hospitals thanks to the high quality and cost advantage. Quantitatively speaking, they rank only second to Sanofi in the world. Based on Hepalink’s development momentum, Pacific Securities in its recent research report predicted that the company’s compound growth rate in the next 3 years would exceed 40%.

In terms of the price, pharmacy products are generally 1.5 times as expensive as those in the hospital. At present, the share of Hepalink’s pharmacy sales is 30%, and it is expected to increase to 70% in the future. As the terminal price increases due to higher costs, coupled with the rise of the share of pharmacies, the company’s enoxaparin sodium preparations will see a huge profit growth.

What’s more, as prescription drugs begin to see spillover at the retail end, and its list price is set according to the price of original drugs in some countries, the average price of enoxaparin preparations in these markets will continue to rise. Meanwhile, thanks to the natural increase and the substitution of other LWMH drugs, enoxaparin sodium preparations will see stably growing market demands. It is learned that Hepalink is now entering the US market through self-declaration and cooperation with drugs already in the market. Besides, as consistency evaluation policies in China are further implemented, the company is expected to occupy a larger share of the domestic market.

Hepalink continues to expand its market in the European Union, US and China, which will bring benefits to more patients in the world and might promote the development of the company’s enoxaparin sodium preparation business.


This article is reprinted from National Business Daily

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