Lenalidomide and dasatinib, the heavyweight new drugs of Shuanglu pharmaceutical industry, may be approved within this year

Since the beginning of the year, the stock price trend of Shuanglu Pharmaceutical Co., Ltd has been "bright in the sky" with a record high Before that, Shuanglu pharmaceutical's share price had been trading sideways for more than a year, and the market was pessimistic about the company's performance However, these lost emotions may gradually disappear, and the two heavyweight new drugs are expected to be approved for production within the year Their marketing can generate huge profits, which will promote the company's performance Liaoning medi biology, the company's holding subsidiary, also has deep work in the field of cellular immunotherapy Two big money making tools for Shuanglu pharmaceutical industry have been waiting for a long time, namely lenalidomide and dasatinib These two products come from the "patent challenge" of Shuanglu pharmaceutical industry to the original pharmaceutical manufacturers In recent years, there is no lack of precedent for generic pharmaceutical companies to gain huge profits due to the success of patent challenges, but all of these are very strange to Chinese pharmaceutical companies Therefore, both the capital market and the pharmaceutical industry place high expectations on Shuanglu pharmaceutical industry Naduramine is a new generation of antitumor drug developed by celgene, which is mainly used to treat myelodysplastic syndrome and multiple myeloma Multiple myeloma is a malignant plasma cell disease of B lymphocytes, mostly in the middle and old age group The incidence rate of /10 in China is 1-2, and it is more than second It is more than leukemia, and is the incidence rate of hematological malignancies Celgene's annual report shows that the sales revenue of lenalidomide in 2013 was US $4.28 billion, up 13.6% year on year, of which the sales in the United States accounted for about half According to the insiders, Cavendish, a subsidiary of Shuanglu pharmaceutical, has obtained the composition patent of lenalidomide The product company challenges the global patent and aims at the global market Another person familiar with the matter said that the variety had obtained clinical approval documents in the first half of 2012 and applied for production approval documents in November 2014 As a drug in short supply in China, lenalidomide has been listed in the green approval channel and is expected to be sold in 2015 as soon as possible At present, the second-line treatment drug for multiple myeloma in China is bortezomib, whose market scale in 2014 has exceeded 100 million yuan However, the drug has been cited by the drug regulatory agency by the health department of Canada about the risk of death caused by improper use of bortezomib, which led to a decline in sales of the product As a latecomer, celgene was licensed by the General Administration of food and drug in 2013 to enter the domestic market In the past two years, celgene has spent a lot of energy on market cultivation Once the lenalidomine of Shuanglu pharmaceutical industry is approved for marketing, it is expected to rapidly realize import substitution by virtue of price advantage This is also a major breakthrough for the company's product line, which is expected to replace Becco as a potential product to support the company's sustained and high growth In addition, dasatinib, another important product of the company, has entered the technical review stage of the drug review center of the State Food and drug administration Dasatinib is a specific drug for chronic myeloid leukemia It is an important new drug in Shuanglu pharmaceutical industry as well as lenalidomide In 2011, the global sales volume of Bristol Myers Squibb, the original manufacturer of dasatinib, was US $800 million Shuanglu pharmaceutical industry insiders believe that dasatinib is a large variety that can reach hundreds of millions or billions, and has great potential in the overseas market Cell immunotherapy luzhenrong Shuanglu pharmaceutical industry started from biological medicine, including lisein, hingil and other varieties However, the market competition of these drugs is fierce, and their profitability and growth are limited Insiders of the company said that many years ago, the company was no longer limited to biological medicine, but to biochemical and chemical medicine layout, covering tumor, cardio cerebrovascular, internal medicine, trauma, immunosuppression and other fields The cellular immunotherapy business is also the business sector of the company Insiders said that the company is relatively low-key to the cell therapy business Although it has great confidence in the business sector companies, in order to avoid excessive market speculation, the company's executives basically shut up on the business during the research of securities companies After science magazine rated tumor immunotherapy as the first of the top ten scientific breakthroughs in 2013, cellular immunotherapy once again became the front focus at two authoritative American Cancer academic conferences AACR and ASCO in 2014 Cellular immunotherapy is to achieve the purpose of cancer treatment by enhancing the killing and controlling effect of patients' autoimmune system on cancer cells At the beginning of 2009, Shuanglu Pharmaceutical Co., Ltd invested 10.2 million yuan to establish Liaoning mindI Biotechnology Co., Ltd., holding 51% of its equity Li Wenxin, chairman of Liaoning mindI, once participated in the research of peripheral blood stem cell transplantation in cooperation with Tokyo National Cancer Center After returning to China, he successively carried out CIK, DC immunotherapy, stem cell transplantation and other projects, and achieved good research results The in vitro diagnostic reagents developed by Liaoning mindI include immunoantibody, protein related reagents, rapid diagnostic reagents, nucleic acid diagnostic reagents and biochemical diagnostic reagents Among them, the TAFI in vitro diagnostic kit, the first in China to predict heart and brain infarction, has been approved Immunocell biotherapy technology has been patented, providing treatment for more than 16000 cancer patients, and effectively controlling the disease According to an analysis by Peking University Cancer Hospital to China Securities News, cellular immunotherapy is a very promising treatment method at present, which can avoid the double pain caused by the decline of immunity caused by drugs and radiation "I think the business model of Liaoning medi's treatment method combined with tumor treatment hospital is reproducible The company's TAFI in vitro diagnostic kit is oriented to the field of cardiovascular disease, which has a very large market space " The doctor told China Securities News As a leading enterprise in the field of genetic engineering drugs, many investors asked whether the company was involved in the gene testing business on the investor interaction platform of Shenzhen Stock Exchange In response, Shuanglu pharmaceutical said that the company has not directly involved in this field, but the company invested 30 million yuan in 2013 to participate in the establishment of the "Chongde Hongxin fund" to invest in anouta gene technology (Beijing) Co., Ltd and Beijing panshengzi Biotechnology Co., Ltd are involved in the field of gene testing According to the company, anouda gene technology (Beijing) Co., Ltd was established in 2012 It is one of the two leading enterprises licensed in the field of prenatal diagnosis gene testing in China, and also a well-known enterprise in the domestic genome industry Anouta mainly focuses on the industrialization application of new generation genomics technology in human medical health and life science research The company has independent research and development, leading genome sequencing and bioinformatics technology, established a leading high-throughput sequencing platform and high-performance computing platform, and formed the bio it foundation and industrial service capabilities According to Shuanglu pharmaceutical, Beijing panshengzi Biotechnology Co., Ltd was established in 2013, which is a high-end service-oriented technology enterprise mainly focusing on cancer genomics analysis and cancer individualized full cycle diagnosis and treatment services Pan Sheng Zi is the world's leading company in the field of gene diagnosis and individualized treatment of brain cancer, bladder cancer and liver cancer Yan Hai, the company's scientist, is the discoverer of brain cancer related genes, listed as the gold standard in the west, and the founder of gene diagnosis of brain cancer in the world.