Five magic weapons for generic companies to win! Hengrui, LVYE, xinlitai and other five enterprises play like this

On May 2, Guangdong Drug Trade Center released the list of goods not supplied according to the contract and not supplied in time on its official website, requiring the manufacturers to supply and distribute goods in time within ten days The reporter noted that the Guangdong Drug Trade Center announced that 1004 drug products were not supplied or not supplied in time, involving 135 drug companies and 68 drug dealers, with 335 new low-cost drugs, accounting for more than 30% of the total The source | section is selected from the author | smart bud | 2017 generic white paper | smart bud | in the six months after a large number of generic drugs go on the market, the price usually falls to about 20% of patent drugs, while the sales of patent drugs will fall by 70% This phenomenon is called "patent cliff" In recent years, a number of biological drugs with sales volume at the forefront of the world will face the problem of patent expiration As shown in the figure below, the top 10 U.S patents expired in 2017 The total sales of these 10 drugs in the U.S last year were more than 10 billion dollars The expiration of patent protection for large-scale drugs has ushered in the golden age of generic drugs, but at the same time, the strict control of consistency evaluation and other policies, as well as the fierce and changeable market competition environment, have caused many generic drug companies to fall into various puzzles How to take the road of winning? Generic companies can make some efforts from the following five aspects: reference article: Fan Ping, "six examples analysis of high-end generic drugs under the new drug price system" in the above five aspects, some companies have made good attempts and made some achievements, detailed cases are as follows: 1 Taijia: seize policy opportunities Taijia of Shenzhen xinlitai has won the first opportunity in China by taking advantage of imitation In 2012, the single product revenue was more than 1.2 billion yuan, which is one of the largest sales and the most profitable varieties of specialized prescription drug list in China Taijia was approved to be the first imitated listed in China in 2000 With the help of the "policy dividend" at that time, Taijia enjoyed a protection period of 8 years as a class II new drug The protection period plus the subsequent imitation and declaration time is more than 12 years, so Taijia has been the exclusive generic medicine for 12 years Taijia has made good use of the opportunity of being the first and only generic medicine to build its unshakable market position Yisaipu: challenge the high-tech threshold Compared with chemical generic drugs, bio generic drugs have higher requirements on the experience, technical strength and investment of enterprises, and the threshold to enter the bio generic drug market is higher At present, the examination and approval procedure of bio generic drugs is still in the stage of gradual improvement, which brings uncertainty to the examination and approval of bio generic drugs Yisaipu's imitated product is etanercept, which is jointly sold in the world by Amgen, Pfizer and Takeda In 2014, the total global sales reached 8.54 billion US dollars, ranking fifth among the world's best-selling drugs Considering the high cost of treatment, foreign pharmaceutical companies had little interest in introducing such drugs into China Except infliximab, other products entered China later, including etanercept Yisaipuk has overcome many technical obstacles, seized the market opportunity, and developed the domestic market at this stage According to the sample hospital sales database of Pharmaceutical Association, the sales volume of yisaipu in sample hospital in 2014 was 233 million yuan In 2010, etanercept (enri), the original research drug of ISEP, entered China Meanwhile, Shanghai SAIJIN's etanercept generic (qiangke) was also approved for listing in 2011 However, in terms of share, there is still a big gap between the two varieties and yisaipu AI Su: with the help of the market reputation, create the brand image The product name of docetaxel produced by Hengrui is AI Su, which was first imitated and listed in China in 2002 It is the best-selling anti-tumor drug of Hengrui at present It is mainly used for the treatment of advanced breast cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, small cell lung cancer, gastric cancer, pancreatic cancer, melanoma and so on At present, Hengrui Pharmaceutical Co., Ltd is one of the top pharmaceutical R & D companies in China Especially in recent years, it has made remarkable achievements in the field of new drug innovation At the same time, the company attaches great importance to market publicity and brand image construction Therefore, the generic drugs produced by it are easy to obtain high recognition and acceptance in doctors and patients As shown in the figure, among the docetaxels in the Chinese market, AI Su has become the best-selling anti-tumor drug In 2014, the sales volume of Exelon in the sample hospital was 414 million yuan, and its market share increased, accounting for 40.38% of the market share of docetaxel Lipitor: attach importance to scientific and technological innovation, and continue to upgrade Lipitor, which was developed and listed by Nanjing LVYE Cisco in 2003, was successfully upgraded through the optimization of preparations Paclitaxel is an alkaloid anti-tumor drug, which is one of the most commonly used anti-tumor drugs in clinic It was approved by FDA as early as 1992 The paclitaxel trade name of the original research party Bristol Myers Squibb is taxol Paclitaxel itself is difficult to dissolve in water In order to make an injection, the original drug and other conventional generic drugs have to add the surfactant polyoxyethylene castor oil into the drug, which will cause a variety of side effects Based on the original research of paclitaxel, the company developed a new liposome dosage form to solve the problem of paclitaxel solubility In the process of R & D, the Intellectual Property Department of LVYE pharmaceutical has provided special foreign patent personnel for relevant R & D projects, whose work focus is to study domestic and foreign patent laws and regulations and adjust patent strategies, so as to promote the timely and effective acquisition of patent applications in the world According to the target market, green leaf pharmaceutical has successively submitted and obtained patent applications for invention in 8 countries including the United States, Indonesia, Russia, India, etc Through scientific and technological innovation, Lipitor has been recognized by the market and its market share has been growing In 2014, the sales volume of liproxol in the sample hospital was 750 million yuan, far exceeding the share of the original research drug Oviga: marketing collaboration, expand market share Oviga, a generic drug of Lansoprazole for injection developed by Jiangsu aosaikang company, has successfully achieved a scale of 650 million in three years Because it is mainly aimed at the hospital market, aosaikang's popularity is not very high, but it has absolute leading advantages in the field of PPI injection Aosaikang has three PP injections, including omeprazole for injection, pantoprazole for injection and Lansoprazole for injection, of which omeprazole for injection is the first domestic imitated PPI injection From the perspective of oviga's market performance, the marketing coordination system built by the company plays a key role At present, the company has formed a three-level self built team marketing network with Nanjing, the location of Jiangsu aosaikang, as its marketing headquarters, covering the central, northern, southern, Eastern, Shanghai and other major regions of China In addition to the above strategies, generic companies can also stand firm in the volatile biomedical market through other ways For example, expanding the scale of enterprises by expanding the business layout in emerging markets, or establishing scale effect to maintain high profitability, or acquiring additional production capacity through mergers and acquisitions or alliances to enter the bio similar drug market, etc.