Behind Men'S Secret Pain: Fierce Competition In The Male Drug Market With 10 Billion Ed

On October 25, Pfizer Prozac Viagra orally disintegrating tablets was officially launched. Not long ago, vardenafil hydrochloride tablets, a blockbuster product of Kelun Pharmaceutical Co., Ltd., became the first high selective type 5 phosphodiesterase inhibitor (PDE5I) for the treatment of erectile dysfunction (ED) in men, which was approved by the State Food and Drug Administration and listed on the market.

How many ED patients do Chinese men have? There are no published exact data. However, from the announcement and Research Report of some listed companies, the number of people is not large. According to the national health and health survey, the overall prevalence of ED in Chinese men is 40.5%. Among them, oral PDE5I drug is one of the main ways to treat ed. three PDE5I drug products approved for marketing in China: sildenafil (original research drug Pfizer Viagra), vardenafil (original research drug Bayer Elida), tadalafil (original research drug lillixieli).

According to toubao Research Report, from 2015 to 2019, sildenafil's generic drug was rapidly released, driving the market size of China's anti ed drug industry to rise from 2.43 billion yuan to 4.28 billion yuan. In 2020, the scale of China's anti ed drug industry will grow rapidly and will approach the level of 10 billion in 2024.

In fact, as the field of male health medication, the market competition of anti ed drugs has never been "gentle". Since Pfizer vanico has not launched the Chinese market, various trademark grabbing patent lawsuits have been on the rise; Beijing kangyeyuan, the partner of Guangzhou Pharmaceutical Group, has also "torn" with Guangzhou Pharmaceutical Group for the interests of Jinge, a generic drug of Baiyun Shanxi; in the recent national procurement with volume, Qilu pharmaceutical "killed" all competitors with the floor price of 2.08 yuan.

Xu Jiawei, head of Eli Lilly's xiaili and retail business department, told 21st century economic reporter that with more and more domestic generic drugs joining, China's anti ed drugs will inevitably compete, but on the whole, each company's share is growing, and the whole Chinese Anti ed drug market is in a growth trend. "For example, in the past 3-5 years, our sales in hospitals have increased by 15% - 20% every year, but the growth in retail pharmacies will be faster, more than 40% per year, and the Internet growth actually exceeds 60% growth."

ED has never been a "gentle drug market" for men. Visual China

10 billion market

How many patients with ED in China?

On November 14, 2016, guangshengtang also pointed out in a notice that it obtained the clinical approval of sildenafil citrate tablets. According to a conservative estimate, the number of ED patients in the world is about 100 million, and the number of patients in China is about 20 million.

In May 2018, Changshan pharmaceutical put forward the statement that "140 million Chinese people suffer from ED, and the product market is broad", which caused the company to fall into a whirlpool of public opinion. At that time, Changshan pharmaceutical announced that if 30% of them (140 million people) received treatment, and the number would reach 42 million, assuming that the treated ED patients could use drugs many times a year, the potential market size in China was expected to reach 10 billion yuan level in the future.

According to the data from Changshan securities in May 2014. Subsequently, Changshan pharmaceutical was investigated by the CSRC.

At present, it seems difficult to determine how many ED patients there are. According to the national health and health survey, the overall prevalence of ED in Chinese men is 40.5%. Zhou Yan et al. Published the article "progress in epidemiology and treatment of benign prostatic hyperplasia and erectile dysfunction" published in the Chinese Journal of new drugs. According to the article, the prevalence of ED in men over 40 years old in China is about 40%.

From the above data, there is a large market space for anti ed drugs in China.

In the 1990s, Pfizer researchers found that sildenafil was a better treatment for ED. After several clinical trials, in 1998, the US FDA approved the clinical use of Viagra, Pfizer launched Viagra into the market, and after 2000 entered the Chinese market; in 2004, Bayer Elida entered China; in 2005, Eli Lilly entered China.

In China, prescription drugs are not allowed to be advertised, and the competition among the three pharmaceutical companies is subdivided from the drug itself. For a long time, it monopolized the anti ED market in China. According to the data released by IMS Health in 2013, at that time, the domestic anti ed (erectile dysfunction) market completely showed the pattern of "three parts of the world" of Viagra (Pfizer), sielli (Lilly) and Alda (Bayer), with market share of 58.8%, 34.6% and 6.6% respectively.

According to toubao Research Report, from 2015 to 2019, sildenafil's generic drug was rapidly released, driving the market size of China's anti ed drug industry to rise from 2.43 billion yuan to 4.28 billion yuan. The outbreak of new crown pneumonia at the beginning of 2020 makes medical takeout usher in development opportunities. Medical takeout has the advantages of fast speed and good privacy, which is conducive to the rapid growth of China's anti ed drug industry. After that, the non generic drug market will be further increased rapidly with the expiration of 10 billion patents in China in 2020.

Original research and imitation war

There is no shortage of stories and "wars" in this 10 billion level field.

Before Viagra entered the Chinese market, it began to encounter a trademark battle.

In 1998, Pfizer developed and produced a special drug "Viagra" for the treatment of ED, and the name "Viagra" was also widely used by domestic media as the Chinese translation name of "Viagra". However, in May of that year, Guangzhou Wilman Pharmaceutical Co., Ltd. first registered the trademark in China, making Pfizer's "Viagra" only registered as "Viagra" when entering the Chinese market.

At the end of 1999, 17 domestic pharmaceutical enterprises applied to the State Food and Drug Administration for the production of Viagra. However, at the end of that year, the regulatory department issued a document demanding that the development, research, production and sales of Viagra should be managed according to narcotic drugs, and new applications should be stopped.

After entering 2000, Pfizer's Viagra was approved to be listed in China. However, domestic pharmaceutical enterprises are "in a hurry" and put forward demands that the State Drug Administration approve the listing of domestic drugs as soon as possible, and do not approve Viagra to apply for a patent in China. Then, domestic pharmaceutical companies began to invest a lot of money in clinical trials.

In September 2002, Pfizer and the "Viagra alliance" went to court directly in the reexamination board of the State Intellectual Property Office. On May 2004, the Patent Office of the State Council of Viagra decided that the patent was invalid. But Pfizer did not give up, and then filed a lawsuit to the Beijing first intermediate people's court. In June 2006, Pfizer won the lawsuit after five years of gaming with domestic pharmaceutical companies. Due to patent reasons, the listing of "domestic Viagra" was delayed, and Pfizer took more than half of China's Viagra market with Viagra.

But in July 2014, Pfizer's Viagra patent protection expired. In this year, Baiyunshan quickly launched Jinge, obtained the production approval of sildenafil citrate API and tablet approved by CFDA in September 2014, and officially launched on October 28, 2015.

According to media reports, the first anniversary of the listing of Jinge has achieved a sales performance of more than 700 million yuan (based on the retail price of the market). In 2015, the market share has reached 13.6%, ranking the third in the market. In 2016, the sales volume of Jinge was close to 400 million, with a year-on-year increase of more than 70%. In 2019, according to the annual report of Baiyunshan, the sales volume of Jinge is 6175935. In five years, the sales of chingo have increased nearly 4.1 times.

The popularity of Jinge has also aroused the dissatisfaction of Kang Yeyuan in Beijing. On July 18, 2019, Beijing kangyeyuan's wechat public account released a real name open letter entitled "against Li Chuyuan, the chairman of Guangzhou Pharmaceutical Group, who violated laws and regulations", pointing out that Jinge has huge profits, but Kang Yeyuan, as a shareholder, has yet to obtain any profit. According to industrial and commercial information, Beijing kangyeyuan is one of the shareholders of Guangzhou Baiyunshan Pharmaceutical Technology Development Co., Ltd., with a shareholding of about 49%.

At the first shareholders' meeting of Baiyunshan Technology Co., Ltd. in 2015, Beijing kangyeyuan proposed that in order not to affect the market promotion of the products, Baiyunshan Pharmaceutical General Factory would temporarily sell the products. Finally, the rights and interests of Baiyunshan Pharmaceutical Company and its shareholders need to be determined.

However, Beijing kangyeyuan didn't get a share of the interests of Jingge, so there was the above-mentioned bombardment. On October 14, 2019, Guangzhou Baiyunshan Pharmaceutical Group filed a lawsuit against Beijing kangyeyuan Investment Consulting Co., Ltd. for internet infringement of reputation right, involving a sum of 10.1357 million yuan.

In August 2020, Guangzhou Internet court ruled publicly in accordance with the law that Beijing kangyeyuan issued a public apology statement on its microblog and wechat public accounts to eliminate the influence of the plaintiff and restore its reputation, and compensate Guangzhou Baiyunshan Pharmaceutical Group for economic losses including reasonable expenses of 150000 yuan.

His dalafi field is not peaceful either.

Tadalafil, once regarded as the first generic drug of "second generation Viagra", which is expected to copy the successful experience of Baiyunshan's domestic "Viagra" Jinge, failed to succeed but fell into dispute.

According to the announcement disclosed by Laimei pharmaceutical on May 11, its wholly-owned subsidiary, Laimei pharmaceutical, owns the exclusive sales agency right of Haiyue tadalafil tablets in China. However, there has been a big dispute between the two parties recently. Laimei pharmaceutical filed a lawsuit with Changchun intermediate court, requesting to terminate the agreement in accordance with the law and return 50 million yuan of sales right transfer money.

According to the announcement of Laimei pharmaceutical on February 19, 2019, Hyatt Pharmaceutical Co., Ltd. granted the exclusive sales agency right of the newly approved generic drug tadalafil tablets in China.

At that time, both parties agreed that Hyatt pharmaceutical agreed to grant the exclusive sales agency of the authorized products in China to Laimei pharmaceutical, and the annual sales volume was determined by both parties through negotiation. If each of the first three years of LeMay has reached the agreed sales target, then LeMay will obtain the permanent exclusive sales agency right of the authorized products in China.

But the cooperation between the two sides is not as good as expected. Laimei pharmaceutical announced on April 25 this year that recently, there has been a big dispute between Laimei pharmaceutical and Haiyue pharmaceutical in performing the exclusive sales agency right of tadalafil tablets. Hyatt plans to terminate the agreement and cancel the exclusive sales agency qualification of Laimei pharmaceutical in China.

According to the announcement, the focus of the dispute between the two parties is that Haiyue pharmaceutical intends to cancel the plaintiff's exclusive sales right in China on the ground that Laimei pharmaceutical has failed to meet the task target stipulated in the contract. However, Laimei pharmaceutical believes that Haiyue Pharmaceutical Co., Ltd. failed to meet the requirements of tadalafil tablets, and participated in the national drug centralized procurement bidding in January 2020, which violated the relevant provisions of the agreement.

"Barefoot battle"

The fierce competition in the anti ed drug market has also led to the development of the whole industry upstream and downstream. The toubao report points out that China's anti ed drug industry has formed a mature industrial chain, and the participation of Chinese enterprises in it has been increasing. For example, in terms of upstream API supply, sildenafil API is about 500 yuan / kg. In addition to foreign-funded enterprises, five local enterprises have been approved by the State Food and Drug Administration and have the supply capacity; however, for Tadanafil, about 300 yuan / kg, no local enterprises have been approved, and they still rely on imports.

A senior person in the industry who has been focusing on anti ed drugs for a long time pointed out to the reporter of 21st century economic report that the competition in sildenafil field is far more intense than that of Tadanafil. On the one hand, the supply of API is on the other hand. More importantly, the expiration date of sildenafil original research drug patent is much earlier than that of Tadanafil.

Since the launch of Baiyunshan Jinge in 2014, Jiangsu Yabang also launched wanfil (sildenafil) in 2015. Subsequently, more than a dozen local pharmaceutical enterprises, including Dior pharmaceutical, Tianfang pharmaceutical, Lianhuan pharmaceutical and Yuanji pharmaceutical, successively joined in and submitted approval documents for generic drugs. Many generic pharmaceutical enterprises followed up by Tadanafil, such as Hyatt pharmaceutical, tianshli, Renfu pharmaceutical and Zhengda Tianqing, and vardenafil also copied several dosage forms of Kelun pharmaceutical.

And generic companies are not slow. For example, Pfizer puqiang announced the listing of Viagra orally disintegrating tablets on October 25, 2020. On September 9, 2020, Kelun Pharmaceutical Co., Ltd. submitted the listing application of sildenafil citrate orally disintegrating tablets, which was the first reported product in China.

With the addition of generic drugs, the price of anti ed drugs becomes more and more "people-friendly", especially with the arrival of bulk purchase, which makes the price lower and lower.

Since the second round of national centralized drug procurement, attention has been paid to andrology drugs. Tadalafil tablets from Changchun Haiyue and tadalafil tablets from Jiangsu Tianshili entered the second round of national centralized procurement. Sildenafil citrate tablets of Qilu pharmaceutical also entered the third round of national centralized procurement, and three domestic anti ed generic drugs were selected.

Among them, Qilu pharmaceutical's "domestic Viagra" (sildenafil), which won the bid in the third batch of national drug centralized procurement, even saved the floor price, and quoted 24.98 yuan / box. Based on 12 tablets per box, the average price was 2.0817 yuan / tablet, a decrease of more than 90%. Qilu pharmaceutical's move is also known as barefoot battle in the market. Previously, Qilu pharmaceutical's domestic Viagra has little market share, so this time it won the bid or expanded its sales market.

According to the data of the National Bureau of statistics, online pharmacies and the Research Institute of cheetah, the price range of Viagra is 50-80 yuan / tablet, xiaili is 50-70 yuan / tablet, Jinge is 30-50 yuan / tablet, wanfeile is 30-50 yuan / tablet, and other products are about 50-80 yuan / tablet. During the double-11 period, some products have preferential prices.

In fact, both Pfizer, Lilly and even Baiyunshan can clearly feel the pressure from the "back wave", and they are constantly improving their competitiveness.

On October 25, Pfizer launched Viagra orally disintegrating tablets. Professor Zhou Huiliang, director of andrology of the First Affiliated Hospital of Fujian Medical University, said that the fastest onset time of Viagra orally disintegrating tablets is 12 minutes, and the median onset time is about 25 minutes. Most people can achieve this goal, and more than 70% of people can live a married life. "It can take effect quickly, achieve relatively improvisation, and change the treatment mode of previous drugs." At present, Viagra 50 mg * 4 tablets are sold at 298 yuan in Jingdong pharmacy.

According to the data of Rubik's cube, the total sales of three PDE-5 inhibitors in China exceeded 3.3 billion yuan in 2019, with a total growth rate of more than 8%. Among them, tadalafil market share has surpassed sildenafil in public medical institutions, and sildenafil is still the sales champion in retail pharmacies.

Ren Xiaoxiu, vice president of Pfizer puqiang's China retail business, said that men's products are not the same as other diseases, and the sales outside the hospital can be far higher than those in the hospital. In addition, even if suggestions and prescriptions are obtained in the hospital, or there are new Internet hospitals, such prescription suggestions on Internet hospitals may be relatively private when purchasing drugs , can not let him produce embarrassing scenes to buy. Therefore, this kind of product is very unique, which is different from other drugs in sales.

Although there is fierce competition in the field of anti ed drugs, the whole "cake" is still expanding. Many andrology experts say that due to the influence of some concepts, the treatment demand has not been met, and there is still a lot of room for the application of anti ed drugs. Professor Jiang Hui, President of China sexuality society and director of Andrology and human sperm bank of Peking University Third Hospital, pointed out to the 21st century economic reporter that the rate of male erectile dysfunction in China is still less than 20%, only 17%.

Xu Jiawei pointed out to the reporter of the 21st century economic report that the market of male therapeutic drugs is far from its due level, because there is a very special situation in China, that is, the market of Chinese patent medicine and health care products is very huge. "But in the past two years, with more and more people's understanding of this field, and some inherent prejudices or barriers to western medicine are gradually decreasing, anti ed drug products have continued to grow. I believe that it will have a very high growth in the future for a long time."

For example, with the continuous expansion of domestic pharmaceutical products in the urban area, many domestic pharmaceutical companies can not cover the second tier market Because of the limitation of manpower and resources, it may not be covered.

"With the launch of many domestic products, many low-end cities and even some rural markets, more and more patients begin to receive these treatments, which is a great benefit for patients." Xu Jiawei pointed out. (Editor: Cao Jinliang)

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