For historical reasons, more than 90% of China's pharmaceutical products are generic drugs. However, with the advancement of medical reform in recent years and the state encouraging innovative research and development, some Chinese generic pharmaceutical companies are actively deploying R&D, such as Hengrui Pharmaceuticals, Chia Tai Tian Qing, Green Leaf Group, etc. 5. The generic pharmaceutical companies all gradually transitioned to creating generic drug companies through different paths.
Recently, Changshan Pharmaceuticals announced that it will exclusively import, manufacture and sell the ConsensiTM drug developed by Israel's Kitov Pharma Ltd. (hereinafter referred to as 'Kitov') for the treatment of osteoarthritis complicated hypertension. With a regulatory milestone payment of $3.5 million, the commercial milestone pays $6.5 million in progress and 12% of net sales.
In response, on May 15th, Dongfang Gaosheng Chief Financial Officer and Executive Secretary Yang Xiuren pointed out to reporters that many traditional pharmaceutical companies are hoping to introduce new biopharmaceuticals to innovate bend drugs to overcome overtaking, and there are certain risks, but there are risks. It also brings expectations and imagination to the capital market. 'At this stage overseas purchases of products are also mature, with a variety of synergies, such as the above milestone payment method is a mature model with the other party to share risks.'
At the same time, on May 15, Chang Shan Pharmaceutical announced that its quality management system for sildenafil citrate tablets complies with the "Quality Control Practices for Pharmaceutical Production" and can be formally put into production and put on the market.
Executives of the company told reporters, 'This is the generic drug of Pfizer Inc.'s Canaqe. The Jingo of Baiyun Mountain is the first imitation. From the market point of view, both Wyndham or Goldgo are in a growth trend, indicating that there is still a lot of room for development in this area. There are mature channels in Changshan Pharmaceuticals. We believe that the sales of our products can follow or even surpass Jingge.
The above executives pointed out to reporters that under the background of the state's encouragement of innovation and development, Changshan Pharmaceutical is now moving from the original generic medicine (innovative) to the path of creating a combination of imitations. A pharmaceutical company research and development director pointed out that based on history The reason is that more than 90% of China are generic drugs, but with the advancement of medical reform in recent years and the state encouraging innovative R&D, some Chinese generic pharmaceutical companies are actively deploying R&D, such as Hengrui Pharmaceuticals, Chia Tai Tian Qing, Greenleaf Group and other generic pharmaceutical companies. All of these are gradually passing through different paths to create generic drug companies.
Introducing Israeli biological drugs
It is understood that Kitov is an innovative biopharmaceutical company focused on the treatment of osteoarthritis complicated by hypertension. It has developed and possessed a new combination of patented and specialized ConsensiTM formulated to treat osteoarthritis at the same time. Pain and hypertension are applicable to patients who currently use non-steroidal anti-inflammatory drugs for the treatment of osteoarthritis and high blood pressure.
At present, the product tablet has been completed in the United States has completed all the clinical research required for the application, its safety and effectiveness have been confirmed by clinical trials. It is expected that Kitov will receive a FDA response on the product listing application by the end of May 2018. If the approval process is successful , Changshan Pharmaceutical is expected to be able to achieve the domestic market in 2019.
According to Changshan Pharmaceuticals, after listing in the domestic market, Kitov obtains commissions from sales in accordance with the agreed ratio, with a ratio ranging from 8% to 12% of net sales; when the accumulated net sales reach the corresponding amount within 10 years after the first commercial sale of the product. , Changshan Pharmaceuticals pays the corresponding fee to Kitov, and the cumulative total is no more than six million US dollars.
'By introducing new varieties of innovative drugs, we can effectively shorten the research and development cycle of new drugs, reduce research and development risks, and help the company to carry out more international intellectual property cooperation in the future. At the same time, it will help the company to enrich its R&D product line outside the heparin series, which will help improve its profitability structure. , Enhanced profitability. ' The above executives pointed out.
According to the epidemiological data released by the CHC (China Heart Association) in 2017, the prevalence of hypertension in adults aged 18 years and over in China was 23.0%, and the number of patients suffering from hypertension was 243.5 million. The prevalence of hypertension increased with age. In 2015, there were 120 million people with arthritis in China, and the incidence rate was about 13%. It is speculated that the population of hypertensive patients with arthritis in China is about 41 million people.
According to Changshan Pharmaceuticals, there is currently no compound preparation for the treatment of osteoarthritic pain and hypertension at the same time in the global market. According to Minet statistics, sales of amlodipine for the treatment of hypertension in China reached RMB 7.3 billion in 2016 According to the International Institute of Mathematical Statistics (IMS), the total non-steroidal anti-inflammatory drug market in China was estimated at US$1.3 billion in 2016.
Yang Xiuren analyzed with reporters that the traditional pharmaceutical companies are facing more and more competitive pressures and narrowing their profit margins; biopharmaceuticals are emerging areas, and traditional pharmaceutical companies expect to adopt bends in overtaking through the introduction of bio-innovative drug varieties.
At present, there are many domestic companies like Changshan Pharmaceutical Co., Ltd. through the cooperation with foreign biopharmaceutical companies to obtain the authorization and permission of product patents, and to carry out the registration process of domestic drugs, exclusive import, production and sales of innovative products.
Yang Xiuren pointed out that the current phase of overseas purchases is more mature than before, from valuations, to varieties, product lines, to team R&D capabilities, to synergies, domestic and foreign resource integration, outsourcing of the brain, basically have a set of hits Law and ideas.
For instance, Changshan Pharmaceuticals is paying for patents, professional knowledge, etc., according to the international milestone payment method.
It is also understood that the introduction of Israel's innovative drugs is another layout of innovative medicines in addition to the cooperation between Changshan Pharma and ConjuChem LLC, a Chinese company whose richest man Huang Xinxiang belongs to. The GLP-1 drug is an innovative drug of type 1.1. It has outstanding advantages such as long half-life, good clinical tolerance, and once-a-week injection. It is included in the National 13th Five-Year major special project.
Turn to create a combination of imitation
At the same time, Changshan Pharmaceuticals is actively deploying generic drugs, and its sildenafil citrate products will be marketed in May. It is understood that in 2017, Changshan Pharmaceutical Co., Ltd The non-source drug drug approval number and "Drug GMP Certificate", and the drug approval number of the drug tablet.
Sildenafil Citrate is suitable for the treatment of erectile dysfunction. The corresponding original research drug is Pfizer, and the patent has expired. Baiyunshan Jingo is the first imitation. In general, in generic medicine, the first copy has a certain degree of certainty. With regard to price and market advantages, the follow-up listed generic drugs may have unsatisfactory sales and market share. In response, the above executives believe that there is still much room for development of the sildenafil citrate in Changzhou Pharmaceutical. .
Although Viagra passed the patent period, its sales volume continued to grow. The sales of KingGold increased by more than 40% year-on-year, indicating that the drug has a lot of room for growth. The sales ability of Changshan Pharmaceutical is strong and currently the main product of low molecular weight heparin preparation market. The market share exceeds GSK's original research drug, and it has the largest market share for many years in a row. Although sildenafil's sales channels are different from low-molecular-weight heparin preparations, the company is confident that it can be replicated through sales force organization and sales channels. The results of sales of low-molecular-weight heparin preparations. 'The executives said to reporters.
According to another report, Changshan Pharmaceuticals also established the Sildenafil Sales Division, which is responsible for all sales before and after the listing of Sildenafil products; at the same time, it also signed an “Agent Cooperation Agreement” with Kyushu Express to authorize Exclusively sells new packaging of sildenafil citrate tablets throughout the country. 'Sildenafil citrate tablets are new products developed by the company outside the heparin series and will become the company's new profit growth point.'
In fact, companies including Hengrui Pharmaceuticals, Chia Tai Tian Qing, etc. started as generics and focused on generics. If there are professional statistics in the industry, as of the end of April, the number of BE clinical trial registrations is positive. Clearly ranked first in 61, Qilu Pharmaceutical 36, Jiangsu Haosen 20, Hengrui Medicine 14, Shijiazhuang 12 drugs.
From a strategic point of view, the above pharmaceutical companies still insist on innovation and at the same time pay close attention to the development of generic drugs, and in particular strive to be the first example. Due to continuous investment in research and development, the market has been labeled as 'innovative'.
For example, in the “Thirteenth Five-Year Plan”, Chia Tai Tianqing has established a strategic goal of combining imitation with transformation, creation, and integration. At present, Chia Tai Tianqing is also moving from imitation to innovation, and the original generic pharmaceutical research and development forces can support it. , To supplement the construction of the new system, so that the new system can grow organically.
