Tadalafil,Sildenafil potential competitor——the prospect of Avanafil’s API market is divergent


Tadalafil,Sildenafil potential competitor——the prospect of Avanafil’s API market is divergent

The 100 billion Viagra market has attracted domestic companies to enter this market, and Kunming Pharmaceutical (600422.SH) has also joined the battle group. The company announced that it plans to purchase technical cooperation and clinical approvals for aravana raw materials and preparations for 5.38 million yuan. However, there is a clear divergence in the prospects for this variety of Avanafil in the industry.

According to public information, avermectin is an orally available, highly selective phosphodiesterase-5 (PDE-5) inhibitor for the treatment of male erectile dysfunction. The original research was developed by Mitsubishi Pharmaceuticals of Japan, authorized by the US Vivus (NASDAQ: VVUS). In April 2012, Avatar was approved for listing in the United States. At present, there is no clinical approval for the use of aravana in China. The fastest progress in research and development is Tianjin Hankang, which was just approved for approval in October this year. According to industry insiders, there are many companies that research Avatara in China. The contract of Kunming Pharmaceuticals is a clinical approval. It is very likely that the cooperation unit will take effect after obtaining the clinical approval. But it is still too early to get a real listing from this drug.

There is a clear divergence in the prospects for anafaviral in the industry. This disagreement stems from the current sales of the original drug. Those who look down on their prospects say that the original research drugs of this variety are currently not promoted, and the competitive varieties have occupied most of the market share; those who are optimistic think that Avatar is more effective than competing products and has obvious advantages. Once promoted smoothly, it will reverse the current bleak sales.

Since 2004, the male erectile dysfunction (ED) treatment drug market has been dominated by three major foreign brands, namely, the United States Pfizer’s sildenafil (trade name Wan Aike), the United States ICOS and Lilly (Lilly) co-developed Vardenafil (trade name Elite), which was jointly developed by Naf (trade name Xiaili), Bayer (Germany) and GlaxoSmithKline (GSK).

In 2012, the sales of Viagra in China have already sprinted 1 billion yuan. With the expiration of its patents, nearly 10 companies have been robbed of Wan Aike, including Lianhuan Pharmaceutical Baiyun Mountain (600332.SH), (600513.SH) ) and Changshan Pharmaceutical (300255.SZ) and so on.

The original research drug promotion is wilting, due to the failure of production capacity

Avarnafil is a Japanese-made Mitsubishi Pharmaceutical authorized by the US Vivus (NASDAQ: VVUS) to treat ED drugs, and Vivus is authorized by the US and European markets. In April 2012, Afanafil was approved for marketing in the United States under the trade name Stendra.

According to conservative estimates, the market for ED therapeutic drugs is between 60 billion and 100 billion yuan. However, in 2012, Avanafil did not bring a huge profit return to Vivus. On the contrary, its income was lower than market expectations.

“The main advantage of avervavir compared to sildenafil (Viagra) is that it works quickly, but the potential market for this drug cannot compete with Viagra and Cialis (Tadanafil). From ED treatments In terms of market rankings, sildenafil and tadalafil, Vardenafil dominates most markets. Avatar is more recognized as the largest annual sales of 300-400 million US dollars. An industry source revealed.

An investment banker also said that he was bearish. “This variety is not doing well in Japan, and it should not be good in China.”

However, a medical researcher said, “The original research manufacturers have not made efforts to promote in Japan, and American companies do not seem to do their best. Whether this product is effective or not is difficult to talk about.”

In fact, Vivus is not eager to promote the drug because it has not yet found a suitable company for its production, let alone promotion. A person who studies anafaxil said that the US drug listing is carried out by the drug listing permit holder (MAH) system, that is, the ownership and production rights of the listed drugs can be separated. Vivus got only a batch of approvals and was not capable of producing. Therefore, on the one hand, Vivus signed a promotion agreement with Italy’s Menarini to expand its sales, and on the other hand, it is urgently looking for a production company.

At present, Vivus has selected Chimie, a subsidiary of Sanofi, to be responsible for the synthesis of the main active ingredients of the drug. The above researchers further said that from the perspective of sales promotion capabilities, for Japanese companies, selling drugs is not their “specialization”, but American companies are still doing quite well. “I believe that Vivus has solved the production problem of the product. After no worries, the promotion of this product will be very good. After all, this variety has its own advantages. Once this product has a suitable sales strategy, it will be promoted domestically. The sales of generic drugs will also play an important role in the future.”

“From this point of view, Avadamine may not be a big breed,” he said.

Chinese compound patents are not authorized, R&D companies need to avoid preparation patents

The patent grant of aravana in the country has been rejected, and no further progress has been made in the review and division. A pharmaceutical company in Guangdong said that this means that there is no patent restriction on the domestic research and development of the drug, and there are many R&D companies. The competition after listing will become more intense in the future.

The source further stated that, as Viagra and Xi’ai patents are about to expire, generic drugs will have a significant impact on the ED therapeutics market, which will also threaten the market prospects of apafavir.

The aforementioned study of Avagina said that although Avataria has no compound patent, it has a patent for preparation, and this preparation patent is not easy to avoid, which also determines the threshold for the declaration of this variety. “Although there are many competitors, for domestic companies, the priority enterprises will still have a large first-mover advantage.”

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