The first domestic new anti-T-cell lymphoma drug "xidaban" released by microchip biology

On the morning of January 27, Shenzhen released the first domestic new anti-T-cell lymphoma drug - "original new drug, National 863 and special achievement of major new drug creation xidaban amine" developed by Shenzhen micro core biotechnology company, which was held in the press release Hall of Shenzhen municipal government Chen Kaixian, academician of Chinese Academy of Sciences and deputy chief engineer of major special technology of national "major new drug creation", standing committee of Shenzhen Municipal People's Congress Jiang Yuyang, vice director and chairman of Shenzhen Association of science and technology, Ma Jun, chairman of Steering Committee of China Society of Clinical Oncology, Jiang Wenqi, director of internal medicine of affiliated oncology hospital of Sun Yat sen University, Lu Xian, President and chief scientific officer of microchip biology attended the meeting on an equal basis, and introduced the relevant information of xidaban The press conference filled in the blank of new T-cell lymphoma drugs in China The original drugs usually refer to the drugs with new molecular structure, novel mechanism of action, unique curative effect and new application prospect, which have not yet met the clinical needs Although China is the world's largest producer of pharmaceutical preparations and APIs, 98% of the products are generic drugs, and few enterprises focus on the research and development of original new drugs The first indication of sidabamide was recurrent and refractory peripheral T-cell lymphoma As an original new drug, National 863 and special achievement of "major new drug creation", sidabamide has been approved by the State Food and Drug Administration for listing, and the first batch of drugs will be put on the market next month Sang Guowei, chief technologist of national innovative drug science and technology, said in a letter that xidaban is the first subtype selective histone deacetylase oral inhibitor, and the first original small molecule drug developed synchronously in the world in China It will fill the gap of peripheral T-cell lymphoma drugs in foreign countries, provide effective and safe drugs for patients, and start the transformation and upgrading of China's biopharmaceutical industry To play a positive exemplary role According to Ma Jun, there are about 120000 patients with lymphoma every year in China, with a total of 500000 lymphoma patients T-cell lymphoma accounts for 23% of all lymphoma patients, and it is often of high malignancy and has no feasible drugs to treat At present, there is a lack of recommended treatment of standard drugs in clinical practice The response rate to conventional chemotherapy is low and easy to relapse The 5-year overall survival rate is only 25% - 30% "Xidaban is much cheaper than similar treatment products in foreign countries The average monthly cost of patients is 20000 yuan, which is about one tenth of that of similar products in foreign countries Some free treatment will be provided six months later At the same time, the company has also developed a charity drug donation program to help those patients who have clinical benefits but low family income continue to receive treatment " According to Lu Xianping, the clinical research results show that the clinical benefit rate of relapsed and refractory peripheral T-cell lymphoma patients is nearly 50% and the survival period is significantly prolonged after 6 weeks of continuous oral administration of cedarbamate "With this medicine, we can treat these patients and give them hope for long-term survival." Ma Jun said that sidabamide has brought significant benefits to patients with lymphoma in China and the world We can make patients survive for a long time, or even be cured Completely different from chemotherapy and targeted drug therapy, since the completion of human genome sequencing in 2007, scientists began to turn to the study of gene expression regulation beyond the gene sequence They found that a large amount of genetic information outside the genomic DNA regulates gene expression, and epigenetics, a new discipline, came into being Epigenetics refers to the heritability change of gene expression without DNA sequence change This rapidly developing field of science reveals complex biological phenomena from the molecular level, which brings new hope for solving the mystery of human and other biological life and benefiting human health, and raises a new round of research upsurge for epigenetics around the world Epigenetic regulators will bring new treatment means for cancer patients As early as 2002, more than 70 turtle scientists of Shenzhen micro core biotechnology company, with a keen frontier vision, carried out the exploration and Research on the regulation of epigenetic on complex tumor systems, the molecular design of new epigenetic regulators and the mechanism of antitumor action It is through epigenetic regulation that sidabamide plays its role, which is completely different from traditional chemotherapy and targeted drug therapy About 120000 patients in China have T-cell lymphoma, accounting for 23% of all lymphoma patients The average monthly cost of xidabamide patients is 20000 yuan, which is about one tenth of that of similar products in foreign countries The results show that after 6 weeks of continuous oral administration of xidabamide, the clinical benefit rate of recurrent and refractory peripheral T-cell lymphoma patients is nearly 50% Chidamide (trade name: epidaza) is a new mechanism of action of comprehensive targeting anti-tumor drugs Its first indication is relapsed and refractory peripheral T-cell lymphoma Early clinical results show that the clinical benefit rate of patients is nearly 50%, and the survival period is significantly prolonged According to Lu Xianping, President and chief scientific officer of microchip biology, the new mechanism of sidabamide is specially aimed at metastasis, recurrence and immune escape, and will be used in various types of tumors At present, breast cancer and lung cancer research have entered the third stage of clinical practice In the future, sildenaniline will be an important means to help patients overcome drug resistance, recurrence and metastasis The new drug application of xidaniline for the first indication of relapse and refractory peripheral T-cell lymphoma has been approved by the State Food and Drug Administration (CFDA), and has completed the quality management standard certification of drug production The first batch of products will be listed at the beginning of March this year as soon as possible In addition, micro core biology has authorized the United States, Japan, Taiwan and other countries and regions to simultaneously carry out single drug and other anti-tumor drugs for other blood tumors, non-small cell lung cancer, breast cancer and other solid tumors "In this field, only two or three new drugs have appeared in recent years, and the cost of treatment is equivalent to 280000 yuan and 140000 yuan per month respectively," Lu said in an interview Sidapaniline is superior to other products in clinical effectiveness, safety and ease of use, and its price is only one tenth of that of related products " Peripheral T cell lymphoma (PTCL) is a group of highly heterogeneous lymphoproliferative disorders, including about 18 pathological subtypes The annual incidence of PTCL in China is about 60000, and the annual prevalence rate is about 90 / million, which can be classified as rare diseases Histone deacetylase (HDAC) is an important enzyme family of epigenetic regulation Through the development of HDAC inhibitors, it can play a therapeutic role in the level of chromatin structure Sidabamide is a new oral subtype selective HDAC inhibitor, which has a selective inhibitory effect on HDAC1, 2, 3 and 10 subtypes     By inhibiting specific HDAC subtypes and the resulting chromatin remodeling and gene transcription regulation (epigenetic regulation), cedarbamine can inhibit the cell cycle of lymphoid and blood tumors and induce tumor cell apoptosis; induce and enhance the tumor killing effect mediated by natural killer cells (NK) and antigen specific cytotoxic T cells (CTL) and inhibit tumor pathological groups The inflammatory response of tissue can not only directly contribute to the therapeutic effect of circulating tumor cells and local lesions in T-lymphoma, but also can be used to induce and enhance the overall regulatory activity of anti-tumor cell immunity against other types of tumor The FDA approved three drugs, pralatrexate The FDA approved two new drugs with PTCL as indication in 2009 and 2011 Although pralatrexate and istodax have certain efficacy, their safety and tolerance are still poor In addition, on July 3, 2014, the US FDA approved beleodaq (belinostat) for the treatment of patients with PTCL Beleodaq works by blocking enzymes that help T cells develop cancer This drug is suitable for patients who have relapsed after treatment or have no effect on previous treatment Beleodaq's safety and efficacy were evaluated in a clinical study involving 129 patients with recurrent or refractory PTCL All subjects were treated with beleodaq until their disease worsened or side effects became unacceptable The results showed that 25.8% of the cancer disappeared (completely relieved) or shrunk (partially relieved) after treatment Beleodaq and pratraxar are marketed by spectrum pharma Istodax is marketed by Searle gene However, these three products are intravenous injection, xidaban for oral medication, with more convenient clinical medication and better compliance New hope for the development of original drugs in China Chen Kaixian, vice president of science and technology of national "major new drug creation", although China is the world's largest pharmaceutical preparation and the second largest producer of APIs, 98% of the products are generic drugs with expired patents in developed countries And there are only innovative drugs with independent intellectual property rights But the common people in our country need to use the innovative medicine with patent not expired, which basically depends on import, but the price is expensive, which is not affordable for ordinary people Chen Kaixian, deputy chief engineer of science and technology special project of "major new drug creation", said that Shenzhen is a very important city in the development of China's biomedical industry In the past, it has gradually developed into a parallel runner following the foreign R & D controllers and runners, and in some aspects, it has reached an international leading position About Shenzhen microchip, Shenzhen microchip biology was founded in 2001 by the returned doctor team in the United States, specializing in the research and development of original small molecule drugs We have established many original new drug product lines in the fields of tumor, diabetes / metabolic disease and immune disease from laboratory to clinical and industrial stage At present, 67 global invention patents have been applied for, of which 36 have been authorized [actual record of press conference] guest: Dr Lu Xianping, President and chief scientific officer of microchip biology host: the press conference is now starting Dear academician Chen Kaixian, deputy director Jiang Yuyang, distinguished guests, friends of the media, good morning Today, we are here to hold a press conference on the original new drugs, the national "863" and the special achievement of "major new drug creation" Thank you for your presence The original new drug xidaban is a major achievement made by Shenzhen micro core Biotechnology Co., Ltd by venture capital investment, returnees scientific team and domestic clinical experts over 13 years The success of this product not only makes a lot of original contributions to the global new drug research and development, especially the application of epigenetic regulators in the field of tumor treatment, but also for China's health The transformation and upgrading of the physical and pharmaceutical industry has played a positive exemplary role Today, we gather here to release the achievements, not only to adhere to the development path driven by innovation and promote the spirit of innovation and entrepreneurship, but also to hope that this major achievement can reflect the value in safeguarding human health and play a role in promoting the development of biomedicine in Shenzhen and even in the whole country Now I'd like to introduce to you the leaders and guests attending today's press conference They are: Chen Kaixian, deputy chief engineer of major special technology of "major new drug creation" of the state, and Chen Kaixian, Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences