I. Profile
       The Department now has 36 researchers (16 of senior researchers and 12 intermediate researchers) and is constituted by 6 research groups involving multiple disciplines such as chemical synthesis, pharmaceutical preparation, analytical chemistry, reproductive pharmacology, pharmacokinetics and molecular biology, etc.. As the key laboratory of contraceptives and Devices of the National Population and Family Planning Commission of China and a main competent research division ofShanghai Engineering Research Center of Reproductive Health Drugs and Devices., the Laboratory is principally occupied in applied studies on new contraceptive/reproductive health medicine. Moreover, it is also a characteristic discipline of the Shanghai Institute of Planned Parenthood Research (SIPPR) with powerful strengths and rich experience in the field of contraceptive medicine investigations. In the period from “7th Five Year Plan” to “12th Five Year Plan”, it has undertaken many research subjects in this sector and accomplished its missions outstandingly. In addition to an Award of Outstanding Team Executing the National Science and Technology Program during the “11th Five Year Plan”, Research Chen Hailin has obtained the Outstanding Contribution Award for executing such a Program. Subdermal implants successfully prepared by the Laboratory have been industrialized, including mifepristone, misoprostol, gestodene and levonorgestrel, etc.. In addition, one single rod subcutaneous implant containing gestodene and pessulum containing natural progesterone, etc. under preparation, both of which have acquired clinical research approvals of new drugs, are clinically studied. Meanwhile, the Laboratory possesses more than 20 China’s patents for invention in this field. Moreover, it is also equipped with advanced instruments and devices for investigations on sustained-release preparations, reproductive pharmacology, molecular biology and molecular oncology and an experienced and professional talented team with a reasonable age structure occupied in contraceptive medicine research. In a word, the Laboratory now has become a major research and development base of new birth control/reproductive health medicine in China.
       II. Main Research Orientations
       Focusing on long-acting controlled release drug delivery system and intelligent targeted nano-drug delivery system studies, the Laboratory utilizes modern medicinal chemistry, pharmacology and toxicology research methods to develop birth control/reproductive health drugs and appliances with a stronger specificity to target organs starting from the realization of objectives covering safety, validity and acceptability improvement.
       Here, animal and cell model evaluation platforms for reproductive diseases such as dysmenorrheal, abortion, endometriosis, hysteromyoma, endometrial cancer, ovarian cancer and testicular infertility, etc. have been constructed to assess pharmacological functions of drugs (appliances) against reproductive system diseases and probe into their mechanisms of actions, so as to provide instrumental and service platforms for new reproductive health and birth control medicine preparation. Moreover, a pharmacokinetic testing platform has been also established for low-dosage contraceptives to conduct pre-clinical and clinical pharmacokinetic studies on contraceptives.
       Modern biological research means are adopted to perform molecular pharmacology research and explore new treatment and prevention approaches and methods for reproductive diseases, which can provide technical reserves for new reproductive health and birth control medicine technology R & D.
       III. Research Staff
       Director of the Laboratory: Researcher Chen Jianxing
       PI: Chen Jianxing, Shao Haihai, Yang Jun, Zhu Yan, Ni Xiaohua, Zheng Huajun
       The number of senior researchers is 16.
       The number of intermediate researchers is 12.
       The number of junior researchers is 8.
       IV. Contact Information
       Contact Person: Huang Ting
       Tel: 13918074025
       E-mail: ting-lemon@163.com

       V. Laboratory Composition

       Drug and Preparation Research Group
       i.Research Orientations
       Biodegradable long-acting controlled release drug delivery system and intelligent targeted nano-drug delivery system studies; new oral contraceptive studies;  transdermal drug delivery system studies; studies on original new drugs against Alzheimer's disease; and, studies on pharmacokinetics  evaluation systems for early in vitro absorption, distribution and metabolism and excretion (ADME) of drugs.
       ii.Main Research Achievements
       Products prepared by the Laboratory have been smoothly industrialized, including mifepristone, misoprostol and gestodene, etc.. In addition, one single rod subcutaneous implant containing gestodene and pessulum containing natural progesterone, etc. under preparation, both of which have acquired clinical research approval of new drugs, are clinically studied. Meanwhile, preparation and clinical studies on pessulum containing natural progesterone used in the suckling period have obtained the third prize of National Science and Technology Achievement Award for Women and Children Health. Moreover, a subject (project number: 2016YFC1000902) named as the Research and Development of Biodegradable Long-term Controlled Release of New Type Contraceptive and Treatment Device, successfully applied for and funded by the National Key Research and Development Program. The first-phase R & D work of biodegradable subcutaneous contraceptive implants has been entirely fulfilled. Among 4 projects funded by the Bill & Melinda Gates Foundation, it is the only project that has accomplished all technological and economic indexes. In addition, it has acquired the second phase funding provided by this Foundation exclusively. Additionally, the Group also takes multiple national, ministerial and internationally cooperated research tasks in this domain.
       iii.Personnel Structure of the Research Group
       PI: Researchers Chen Jianxing and Feng Linglin; and, professor-level senior engineer Chen Liangkang
       The number of senior researchers is 8.
       The number of intermediate researchers is 4.
       The number of junior researchers is 1.

       Long-acting Sustained Release Drug Research Group                                                                                   i.Research Orientations
       Study non-biodegradable long-acting controlled release drug delivery systems
       ii.Main Research Achievements
       A subject (project number: 2016YFC1000904) named as The research on new vaginal ring for contraception and therapy.has successfully applied for and funded by the National Key Research and Development Program. Two rod subdermal implants containing levonorgestrel have been also smoothly industrialized in China and Indonesia and registered in 25 countries (funded by the Bill & Melinda Gates Foundation). From 2012 to 2014, 1.8 million sets of such implants have been exported, which generates a sales amount of USD 15.3 million. They have an absolute right of speech of the corresponding price on the international market (USD 8.5/Set) and have been referred to as one of the most successful cooperation achievements of the Bill & Melinda Gates Foundation in China. Both preparation and clinical studies on vaginal ring containing natural progesterone used in the suckling period and studies on single rod female subdermal implants have obtained the third prize of the National Science and Technology Achievement Award for Women and Children Health. Now, they are under clinical research.
       iii.Personnel Structure of the Research Group
       PI: Professor-level senior engineer Shao Haihao
       The number of senior researchers is 1.
       The number of intermediate researchers is 1.
       The number of junior researchers is 1.

       Foods for Special Medical Purpose Research Group
       i.Research Orientations
       With an aim to develop foods for special medical purpose, it relies on classical microbiology technologies, molecular biological techniques, the latest high-throughput sequencing technologies and bioinformatics techniques, utilizes clinical specimens together with cell and animal models, and regards health of women at gestational age and fine rearing of newborns as two major research objects to study foods for special medical purposes suitable for patients with gestational diabetes, probiotics and newborn health, and genes related to breast cancer among Chinese populations, etc..
       ii.Main Research Achievements
       Based on a gene trapping method, it has been found that a helicase family gene helG is related to the occurrence of gastrulae. Through in vitro experiment, HelG protein is proven to have a uncoiling activity effect on DNA. Genomics and transcriptomics methods are utilized to construct a nitrogen source utilization model for lactobacillus bulgaricus, interpreting the reason why bacterial strains cannot grow on synthetic media as well as the mechanism based on which utilization efficiency of lactoalbumin is higher than that of casein. According to molecular ecological studies, inherent relations between intestinal flora and eczema risks of infants are revealed to demonstrate that bacterial genus and microbial strain differences lie in intestinal flora enrichment between infants in eczema and healthy babies. Moreover, it has been also found that bacteria associated with inflammation (e.g., clostridium leptum group and active ruminococcus) are enriched in intestinal tracts of infants in eczema. Furthermore, akkermansia muciniphila that have been enriched in their intestinal tracts may lower integrity of the intestinal barrier function, so as to increase the risk of eczema occurrence. In this situations, bacteria with anti-inflammatory properties, such as bacteroides fragilis and streptococcus salivarius, etc., is very poor in intestinal tracts of infants with eczema. Corresponding clinical tests have confirmed that total nutrient enteral nutrition agents intaken have the capability to reduce postprandial peak glucose and improve insulin secretion index.
       iii.Personnel Structure of the Research Group
       PI: Researchers Ji Zaisi and Zheng Huajun
       The number of senior researchers is 3.
       The number of intermediate researchers is 1.
       The number of junior researchers is 1.

       Reproductive Pharmacology Research Group
       i.Research Orientations
       Study drug efficacy and pharmacology of contraceptive and birth control medicine (appliances); and, establish preclinical evaluation methodology for drug efficacy and pharmacology of contraceptive medicine (devices); perform pre-clinical and clinical pharmacokinetic studies on contraceptives and a pharmacokinetic detecting platform of low-dosage contraceptives is under construction; and, utilize cell and animal models for reproductive diseases including dysmenorrhea, abortion, endometriosis, hysteromyoma, endometrial cancer, ovarian cancer and epididymal infertility, etc. to carry out R & D of new drugs against reproductive health and tumors in combination with molecular biology.
       ii.Main Research Achievements
       Participate in developing new drugs including Levonorgestrel Ethinyloestradiol Contraceptive Patch and Gestodene-compound Patch, etc., that have acquired 2 clinical research approvals, 4 drug registration approval and 2 third prizes of the National Excellent Science and Technology Achievement Award of Population and Birth Control during the “11th Five Year Plan”. In addition to more than 80 papers published, it has won 4 patents for invention. The Group also takes part in compiling some monographs such as Experimental Methodology of Pharmocology (4th Edition) and Report on Advances in Pharmacy (2010-2011), etc.. Besides, it has participated in and undertaken over ten fund programs, namely, the National Science and Technology Support Program of “11th Five Year Plan” and “12th Five Year Plan”, Key Research and Development Program of “13th Five Year Plan” as well as other subjects supported by the Natural Science Foundation of China, the Natural Science Foundation of Shanghai and the National Health and Family Planning Commission of PRC, etc.. Through drug research and development cooperation with domestically well-known pharmaceutical enterprises and research institutes such as Beijing Zizhu Pharmaceuticals, Runbio Biotech Co., Ltd., Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Second Military Medical University and Shanghai Institute of Pharmaceutical Industry, etc., it has mastered ultra-low-dosage steroid hormone detection technology. In addition, the Group also cooperates with clinical pharmacology bases such as Zhongshan Hospital, Fudan University to complete multiple clinical bioequivalence evaluations on contraceptives and realize industrialization of research results.
       iii.Personnel Structure of the Research Group
       PI: Researcher Zhu Yan
       The number of senior researchers is 2.
       The number of intermediate researchers is 2.
       The number of junior researchers is 4.

       Molecular Oncology Research Group
       i.Research Orientations
       It is mainly engaged in studies on oncomolecularbiology, especially reproductive tumors, covering siRNA and miRNA targeted agents of tumors, tumor markers and DNA methylation mechanisms, devoting itself to developing new diagnostic approaches and RNA based therapeutic methods.
       ii.Main Research Achievements
       Gene therapy that utilizes cationic liposome-siRNA compounds. To be specific, the liposome combines with siRNA via negative and positive ions and specific targets are also designed, so that the liposome and target cell membranes are fused and then take along siRNA entering the target cell. In this way, the objective of targeted therapy can be realized. 17β-HSD5siRNA is designed and chemically synthesized to inhibit 17β-HSD5 expression in breast cancer cells.
       Relevant research findings have been published in some well-known SCI journals of biomedical science such as Journal of Clinical Investigation, Molecular Cancer Therapeutics, Nucleic Acids Research, Current Medicinal Chemistry, Cancer Research, Current Drug Targets, Nature Communication, Cell Discovery and Journal of Biochemistry.
       iii.Personnel Structure of the Research Group
       PI: Researcher Ni Xiaohua
       The number of senior researchers is 3.
       The number of intermediate researchers is 2.

       Molecular Pharmacology Research Group
       i.Research Orientations
       Protein bridge theory and protein model have been constructed and improved for calcium ions in transduction events of IP3R calcium ion. On this basis, molecular mechanisms of matter transport, cell apoptosis and migration and gene expression regulation involved in by IP3R that participates in the reproductive development process are explored. Furthermore, the protein model is also adopted to design, synthesize and screen direct or indirect antagonism or agonist compound probe by using calcium signals as biomarkers, so as to determine physiological functions of the corresponding signal transduction pathway. Probe disturbance and tools indicated by calcium signature tag are employed to investigate physiological functions of IP3R and its binding proteins and define clinical application values of probe compounds simultaneously.
       ii.Personnel Structure of the Research Group
       PI: Researcher Yang Jun
       The number of senior researcher is 1.
       The number of junior researcher is 1.