When did eprazole apply for a patent?

However, times have changed and times have changed. The previous explosions followed the times and entered "Lian Po is old, can you still eat?" In a dilemma Livzon medicine, which is located at the junction of green and yellow, has not yet appeared a new "shoulder handle" product.

For such a company in transition and with great uncertainty in the future, there are only two words in the capital market: I don't like it.

In the past 10 month, Livzon Pharmaceutical's share price has halved, with the largest drop of 62.3%, which is relatively large in the pharmaceutical industry.

Star products no longer shine

Every company has its own flagship products, and Livzon Medicine is no exception. For a long time in the past, Shenqi Fuzheng injection, as the exclusive product and fist product of the company, has an irreplaceable position in the company.

According to the company's financial data, Caihuashe listed the company's total operating income in recent years, the branch income of Shenqi Fuzheng injection and the proportional relationship between them.

In absolute terms, the revenue of Shenqi Fuzheng Injection in the first half of 20 18 reached 546 million yuan, which was 3.46 1% lower than that of 7140,000 yuan in 20 15. In terms of proportion, before 20 16, the income of single product of Shenqi Fuzheng injection accounted for 1/5, and after 20 17, the proportion gradually decreased, and it plummeted in the first half of this year, accounting for only 12%.

Not only Shenqi Fuzheng injection, but also the mouse nerve growth factor in the field of nutritional nerves has stopped the previous continuous skyrocketing, from the high-speed growth of about 70% in previous years to the year-on-year decline of nearly 20% in the first half of this year.

Why did the sales of these two main products drop so much? Tracing back to the source lies in the change of policy. Under the impetus of the medical insurance cost control policy, the large-scale use of auxiliary drugs in clinic has become an important goal to control the medical insurance cost. Shenqi Fuzheng injection and mouse nerve growth factor were shot because of their auxiliary properties, and the logic of further growth of their market space no longer exists.

Even the injection of urinary follicle-stimulating hormone, which was highly anticipated by investors, failed to achieve the expected surge in revenue. As a key variety in the field of promoting sex hormones and assisted reproduction, the market expects that with the liberalization of the second child policy, the whole market scale will continue to expand and the company will also enjoy the industry dividend. However, the fact before us is that even with the continuous liberalization of the national population policy, contemporary China people have lost the fertility enthusiasm of the previous generation. The so-called baby boom didn't come as scheduled. There are various indications that the new population in 20 18 will drop by about 20% year-on-year. Follicle stimulating hormone for injection, which is used to promote follicular development and maturation, also has a dim market prospect.

There is no doubt that the decline in the income of several major single products of the company has an impact on the company. According to the data of the semi-annual report, in the first half of 20 18, the company achieved revenue of 4.565 billion yuan, an increase of single digits to 6.78% compared with the same period of 20 17. If the data is further narrowed, the company's revenue in the first three quarters of 20 18 is 684 10 billion, which is further reduced to 4.9% compared with the growth rate of 6.522 billion in the same period of 20 17, and the slowdown is more obvious.

Of course, at this point, this is not a thing. After all, these projects have fallen for such a long time, and the marginal effect of the negative impact on the company will gradually weaken. What really scares investors is that looking to the future, the company's research and development progress of innovative drugs is too slow, and the new products launched later are far behind competitors, so the company's prospects are worrying.

The development of innovative drugs is too slow.

Biopharmaceutical is undoubtedly the most promising field in the pharmaceutical industry, and it is also the fastest growing sub-industry in the pharmaceutical industry. Monoclonal antibody is the main melody on the biopharmaceutical stage.

All pharmaceutical companies realize that those who get monoclonal antibodies win the world.

Livzon Pharmaceutical has also followed the forefront of the industry and made extensive arrangements in this field. According to the introduction of Cai Hua Institution, at present, the company mainly has seven products under research, with different progress.

After seeing this table, we have two intuitive feelings: 1, R&D pipeline layout is good, covering the current hot targets. 2. Compared with competitors, the research and development progress of Livzon Medicine is too slow.

Take the company's fastest development of recombinant humanized anti-human tumor necrosis factor-α (TNF-α) monoclonal antibody for injection as an example. Its original drug "adalimumab" is known as "the king of medicine" in the fields of medicine and biology. In 20 17, the global sales reached18.4 billion USD, making it the "sixth consecutive champion" of global drug sales. Although the 20 18 annual drug sales ranking list has not yet been released, it should be certain that it will continue to be the first. For such a drug that has passed the patent protection period in Europe and America, it is undoubtedly coveted by many pharmaceutical companies. At present, more than 20 pharmaceutical manufacturers in China are developing similar products. Among them, Baiaotai submitted the listing declaration of adalimumab Biomimetic Drug (BAT 1406) to the Drug Evaluation Center (CDE) of China Food and Drug Administration in August, 20 18, which won the top spot in China. Cinda Bio followed closely, and submitted the listing application of adalimumab Biomimetic Drug (IBI303) to CDE in June of the same year, becoming the second one in the industry. In the same month, Fu Honghanlin also entered the third clinical phase. Progress is much faster than Livzon Medicine.

Take the popular PD- 1 target as an example. In the past 20 18 years, four domestic companies have approved the listing of PD- 1 monoclonal antibody products. That is, Bristol-Myers Squibb's O drug, Merck's K drug, Cindilizumab injection of Cinda Bio, a domestic biomedical rookie, and Treprilmab injection of Junshi Bio. In addition, Hengrui Pharma and Baekje Shenzhou have also submitted listing applications to CDE for approval. It is estimated that in 20 19 years, there will be 6 players in the whole PD- 1 market. The competitive pressure can be seen.

However, the PD- 1 of Livzon Medicine has just completed the phase I clinical work in the United States, and the phase I clinical work is under way in China.

The market situation of other products under research is similar. Although popular, but the competition is fierce, the company lags behind in the R&D echelon and cannot show obvious competitiveness in the industry. It is also difficult to see explosive products and explosive markets in the later period.

Can still be maintained.

Although the company's prospects are not optimistic and investors can't get excess returns, as a member of the "second-line army" in the pharmaceutical industry, according to the current product structure, the company can still occupy a place in the huge pharmaceutical market.

1. There is a huge room for the growth of drugs in the field of digestion.

For patients with stomach problems, there are "Lazio" drugs at home at any time. Whether it is omeprazole, esomeprazole, rabeprazole or pantoprazole, the core function of these drugs, which are collectively called "proton pump inhibitors", is to inhibit gastric acid secretion.

Livzon Medicine started as a gastrointestinal medicine, and has accumulated rich research and development experience and strong sales channels in this digestive field. Besides rabeprazole products, the company also owns the second generation proton pump inhibitor products: rabeprazole enteric-coated tablets and rabeprazole sodium for injection. In the first half of 20 18, the sales revenue of eprazole enteric-coated tablets reached 28 10/00000 yuan, a substantial increase of 34.49% year-on-year. In the third quarter, with the approval of ilaprazole sodium for injection and finally facing the end consumers, the total income of ilaprazole enteric-coated tablets and ilaprazole sodium for injection reached 456.5438 billion yuan, up 35.8 1% year-on-year.

According to Mr. Yang Liang, the director of the company, the domestic market capacity of proton pump inhibitors in 20 18 is more than 20 billion RMB, of which the injection market accounts for 70%, which is about1500 million RMB. It can be predicted that relying on the strong terminal sales team of Livzon Pharmaceuticals, its newly launched iprazol for injection will maintain the high-speed growth trend of last year in 20 19.

2. Microspheres also have room for growth.

According to the company's official introduction, Livzon Medicine has four varieties in the field of sex hormones, namely leuprorelin acetate microspheres for injection, urinary follicle stimulating hormone, urinary gonadotropin and chorionic gonadotropin. Among them, leuprorelin microspheres for the treatment of endometriosis, hysteromyoma and prostate cancer grew strongly in the past year.

In the first half of 20 18, the sales revenue of leuprorelin microspheres reached 359 million yuan, up 27.43% year-on-year; In the first three quarters of 20 18, the single product revenue was 590 million yuan, and the year-on-year growth rate further increased to 35.38%, indicating that it made further efforts in the third quarter.

With the rapid growth of leuprorelin microsphere revenue, its proportion in the company's total revenue is also increasing.

It can be seen that the proportion of leuprorelin microspheres in the company's revenue increased from 6.35% in 20 17 to 8.62% in the third quarter of 20 18. The company has a tendency to replace Shenqi Fuzheng injection.

Considering that there are more and more cancer patients in China, the incremental market space is constantly opening. At the same time, the market penetration rate of leuprorelin microspheres will be further improved by replacing the original drugs developed in triptorelin and leuprorelin. It is expected that the current rapid growth trend will continue further.

Of course, it is the general trend of pharmaceutical industry that biological drugs replace small molecular drugs, especially in the field of anti-tumor. We can't predict how long it will take to realize such a historic process. However, we confirm that in the face of such a rolling historical trend, most pharmaceutical companies will be eliminated by history, and only a few head companies that occupy the dominant position in the track can "hit the water in the middle and stop the waves flying." From such a longer-term perspective, the prospect of Livzon Medicine is not clear. Its huge decline does not mean that there are more excess returns. To some extent, we can understand that its aura is no longer, it has fallen into the mortal world.

■ Author | Chen Yong

■ Edit | He