According to Lu Xianping, president and chief scientific officer of Chipscreen Biotechnology, chidamide's new mechanism is specifically aimed at metastasis, recurrence and immune escape, and will be used for many types of tumors. At present, the research on breast cancer and lung cancer has entered the third phase of clinical practice. In the future, chidamide will be an important means to effectively help patients overcome drug resistance, recurrence and metastasis.
Chidamide's application for new drugs (the first indication) for relapsed and refractory peripheral T-cell lymphoma has been approved by China Food and Drug Administration (CFDA) and has completed the certification of good manufacturing practices. The first batch of products will be listed in early March this year at the earliest. In addition, Chipscreen Biotechnology has authorized the United States, Japan, Taiwan Province Province, China and other countries and regions to simultaneously carry out clinical research on other solid tumors such as hematological tumors, non-small cell lung cancer, breast cancer and other anti-tumor drugs.
Lu Xianping said in an interview: "In recent years, only two or three new drugs have appeared in this field, and the treatment cost is equivalent to 280,000 yuan per month and 1.4 million yuan respectively. Chidamide is superior to other products in terms of clinical efficacy, safety and ease of use, and the price is only one tenth of that of related products. "
Mechanism of action of zidovudine
Peripheral T-cell lymphoma (PTCL) is a group of abnormal lymphoproliferative diseases with strong heterogeneity, including about 18 pathological subtypes. The annual incidence rate of PTCL in China is about 60,000, and the annual incidence rate is about 90/ million, which can be classified as a rare disease.
Histone deacetylase (HDAC) is an important enzyme family in epigenetic regulation. By developing HDAC inhibitors, it can play a therapeutic role on tumors at the level of chromatin structure. Chidamide is a new oral subtype selective HDAC inhibitor, which originated in China and has selective inhibitory effect on HDAC 1, 2, 3 and 10 subtypes.
Chidamide inhibits the cell cycle of lymphoid and hematological tumors and induces tumor cell apoptosis by inhibiting specific HDAC subtypes and chromatin remodeling and gene transcription regulation (that is, epigenetic regulation) caused by them. Inducing and enhancing the tumor killing effect mediated by natural killer cells (NK) and antigen-specific cytotoxic T cells (CTL) and inhibiting the inflammatory reaction of tumor pathological tissues can not only directly contribute to the therapeutic effect of circulating tumor cells and local lesions in T lymphoma, but also be used to induce and enhance the overall regulatory activity of anti-tumor cellular immunity on other types of tumors.
In 2009 and 20 1 1 year, respectively, FDA approved the marketing of two new drugs, pralatrexate and Istodax, which are indicated by PTCL. Although it has a certain curative effect, its safety and tolerance are still poor.
In addition, on July 3, 20 14, FDA approved Beleodaq (belinostat) for the treatment of PTCL patients. Beleodaq works by blocking enzymes that help T cells become cancerous. This drug is suitable for patients who relapse after treatment or who have failed to respond to previous treatment.
In a clinical study involving 129 relapsed or refractory PTCL subjects, the safety and efficacy of Beleodaq were evaluated. All subjects were treated with Beleodaq until their disease worsened or the side effects became unacceptable. The results showed that 25.8% of the subjects' cancer disappeared (complete remission) or shrank (partial remission) after treatment.
Beleodaq and Pratrasha are sold by Spectrum Pharmaceuticals. Istodax is sold by Searle Gene. However, all three products are intravenous injection, while Chidamei is oral, which makes clinical medication more convenient and more compliant.
New Hope for the Development of Original Drugs in China
Although China is the world's largest producer of pharmaceutical preparations and the second largest producer of APIs, 98% of its products are generic drugs with expired patents in developed countries. There are few innovative drugs with independent intellectual property rights. Ordinary people in China basically rely on imports to use innovative drugs with unexpired patents, but the price is too expensive for ordinary people to bear.
Chen Kaixian, deputy chief engineer of the National Science and Technology Project of "Creating Major New Drugs", said that Shenzhen is a very important city for the development of biomedicine in China. From the past, it followed foreign R&D prevention and control, followed runners, and gradually developed into parallel runners, reaching the international leading position in some aspects.