Casi (yingchuangyuanda) company is transforming, focusing on Asia Pacific, and looking forward to becoming China's celgene

Source: Shannon Ellis 2015-03-05 Shanghai - CASI pharmaceuticals Inc., a NASDAQ listed company, is transforming into a new enterprise focusing on the Chinese tumor drug market based on its US foundation In 2012, with the joining of new investors, entremed Inc, an American biotechnology company with a history of more than 20 years, changed its name to CASI (meaning China, the United States, collaboration, integration) to highlight its key eastward migration strategy Cynthia Wu, the company's chief operating officer, told BioWorld Asia, "write off your previous understanding of entremed." At present, idg-accel China fund has become the largest shareholder of CASI -- IDG has invested in Baidu (similar to Google in China) in its initial stage with the same shrewdness As you can imagine, IDG expects to see CASI become a leading enterprise in China Other investors on the company's board of directors are Kleiner Perkins Caufield Byers China Fund Casi, headquartered in Maryland, USA, has a wholly-owned subsidiary in Beijing, i.e yingchuangyuanda (Beijing) Biomedical Technology Co., Ltd and product R & D center Mr Ken K Ren, CEO of CASI, said, "the company's vision is that in the next 10 years, China is expected to become the world's largest cancer drug market, with many unmet medical gaps and development space Casi aims to become a large pharmaceutical enterprise integrating product introduction, development and industrialization Rich product line and high efficiency product development ability will be our company's core competitiveness In 2012, we only had one product and only one phase 2 clinical study in the world At present, we have 7 products, and 4 phase 2 clinical studies are in progress in the United States and Canada "In addition to being enthusiastic about the Chinese market, CASI has implemented a new drug development strategy that can not only save costs, but also provide development efficiency and avoid risks in order to achieve its development goals "Our product sources include three aspects: innovative drugs from our US companies, new preparations from our Beijing R & D center, and patented products from other companies "In order to expand the product line, the company obtained an exclusive license six months ago to develop and sell three antitumor drugs of spectrum pharmaceuticals Inc in Greater China, two of which have been approved by the FDA, namely, Zevalin for non Hodgkin's lymphoma and marqibo for acute lymphoblastic leukemia (vincristine sulfate liposome injection) As with other drugs applying for import drug registration, the above drugs must also be subject to confirmatory clinical trials in China "In Hong Kong, Zevalin has been approved for listing Although the market is relatively small, it is of strategic significance for our development in China "Mr Ren told BioWorld Asia," the sales and use in Hong Kong will help to accumulate the clinical application data of the drug in Chinese patients We plan to launch sales in Hong Kong in the second quarter of this year He added: "at the same time, we hope to build a Chinese cancer network system and build a bridge between Hong Kong, Taiwan and Mainland China on the application of new cancer treatment technologies "Marquibo has been approved as a second-line treatment in the United States as an orphan drug for rare leukemia According to Mr Ren, sales of the drug in China are expected to reach up to $50 million Enmd-2076, the leading candidate drug of CASI, is an oral targeted therapeutic drug with multiple mechanisms of action, which can selectively inhibit Aurora a laser kinase, angiogenic kinase and tumor growth factor At present, four phase 2 clinical trials are being carried out in the United States and Canada, of which 2 Project has been approved by the State Food and Drug Administration of China to carry out international multi center clinical research The inventor of enmd-2076 is Professor Tak Mak, a highly respected immunologist At present, he is the director of the Campbell family Breast Cancer Research Institute of the University of Toronto and Margaret Hospital, and the chairman and board director of CASI Scientific Advisory Committee The company has carried out a number of phase I clinical studies on this product, including ovarian cancer, breast cancer, liver cancer, renal cancer and sarcoma, as well as leukemia and multiple myeloma A phase II clinical trial for advanced ovarian cancer has been completed At present, three negative breast cancer (TNBC), advanced / metastatic soft tissue sarcoma, advanced ovarian clear cell carcinoma and fiberboard type liver cancer are being studied in two phases The company plans to expand the above trials to China as part of the global trials and carry out the trials in accordance with the US FDA ind (clinical application for new drug research) China has approved the international multicenter clinical study of the drug for two indications (Sanyin breast cancer and soft tissue sarcoma) The cost of conducting clinical research and development in North America is very high, but Mr Ren said that CASI, in cooperation with North American universities and clinical research institutions, uses corporate funding in combination with government funding to carry out this series of clinical research Clinical research focuses on finding tumor biomarkers of sensitive patient subsets and related indications Once such individualized targeted treatment data are verified, the company will accelerate to more advanced clinical research The company will establish cooperative relationship with other companies outside China to develop the European and American market, but will retain the exclusive right to operate the Chinese market In addition, the product may also be suitable for other types of cancer After years of research, it has been found that enmd-2076 may have a potential therapeutic effect on a rare liver cancer, fibrolamellar carcinoma (FLC), which is undoubtedly the most exciting progress in many years According to Mr Ren, enmd-2076 has a significant effect on a FLC patient The patient had received multiple local chemotherapy, doxyfenib, Amgen Inc and Bayer AG, and even liver transplantation, but the cancer continued to recur after treatment However, after treatment with enmd-2076 for 2 months, the disease began to stabilize After 12 months, the tumor shrank and reached partial remission, and the disease remained stable for 17 months At the beginning of February this year, CASI and FDA reached a consensus on the clinical research and approval of enmd-2076, and explored the therapeutic potential of enmd-2076 for the first-line treatment of FLC The company will conduct a phase 2 clinical study in two phases In the first stage, 16 patients are expected to be enrolled After treatment, the total remission rate of enmd-2076 is evaluated If no patients get remission, the study will be terminated; if one or more patients have remission (according to the criteria of RECIST 1.1), the study will enter the second stage, and more patients will participate in the trial Enmd-2076 has been approved by FDA as an orphan drug for the treatment of HCC When the clinical data meet the corresponding standards, the company said it plans to apply to the European Union for FLC orphan drug certification for enmd-2076 and to the FDA for breakthrough treatment certification At the end of the new drug delivery system development platform, another way for the company to diversify its product development strategy is to develop new product preparations through the new drug delivery system, including the development of new preparations for its 2-me2 (2-methoxyestradiol) products with independent intellectual property rights It is an obstacle for clinical research and development to determine the bioavailability of the drug after several phase II clinical trials (see biological world today, March 14, 2008) "we solved the solubility and bioavailability of 2-me2 by using new drug delivery technology "Mr Ren explained," at the same time, we used this platform technology to screen a variety of other anti-tumor drugs, and so far we have identified two candidate drugs, but considering the competition factors, we have not disclosed the drug name One of the patents for one drug has expired, and the global patent protection for the other will expire soon Our company's new preparation products are different from the products sold in the current market, so we can apply for global preparation patent protection "At present, the global sales of two products are more than US $1 billion "If our product has a competitive advantage over the products currently sold in the market, such as changing from injection to oral agent, which is more convenient to use, has less side effects, and has patent protection, we believe that it will have a broad market prospect in the world These products will come from China and will be made in China and will be available to the global market Low development cost, high success rate and low investment risk That's what Mr Ren said "Because low bioavailability is a common problem of most antitumor drugs and many other chemicals, our platform technology can be applied to the development of many other new preparations