| 深圳市天达康基因工程有限公司
简介
“深圳市天达康基因工程有限公司”是一家在深圳市高新区设立的留学生企业暨民营科技企业，成立于2001年，注册资本1000万元人民币。“重组腺病毒-胸苷激酶基因制剂”（缩写：ADV-TK），为本公司运用独有的药物发明专利，研制成功的一种目前世界上新一代的、具有自主知识产权的基因治疗抗肿瘤新药。
ADV-TK 以5型重组腺病毒为载体，属于肿瘤自杀基因治疗的范畴，为目前肿瘤基因治疗领域研发的主要抗肿瘤药物品种之一，获得2002年国家“十五”重大科技专项“创新药物品种研究”第一批课题资助。
ADV-TK 通过对人体肿瘤特别是局部实体瘤进行转染，在更昔洛韦的参与下，产生“自杀效应”和“旁观者效应”，能针对特异性杀灭肿瘤细胞，具有明确、高效的抗肿瘤活性，且安全性好，临床应用方便，可用于治疗肝癌、肺癌、胃癌、乳腺癌、前列腺癌等多种多发性肿瘤疾病。另外，可实现与传统治疗方法有机结合，如在治疗中辅以小剂量放疗或化疗，将产生良好的协同效应。特别是用于多种宿主肿瘤局部直接注射，对手术不能切除或切除不完全的局部病灶有独到的治疗效果。
国家新药（抗肿瘤药物）临床试验基地——中山大学附属肿瘤医院GCP中心承担并顺利完成了ADV-TK的I期临床试验。I期临床试验主要评价药物的安全性，入组病例为已接受放、化疗等多种抗肿瘤治疗且治疗失败的晚期肿瘤患者。试验结果表明：受试患者耐受良好，未出现剂量限制性毒性，对环境影响较小，在17例可评价疗效的肿瘤患者中已显示出初步疗效（有效率为38.8%，ADV-TK仅为单次使用）。
另外，经与北京市器官移植中心合作开展的中晚期肝癌肝移植加局部ADV-TK基因治疗的科研临床试验，结果显示：ADV-TK在治疗肝癌方面有着良好的临床预期效应。
与国外已进入临床试验的TK基因治疗方案相比，ADV-TK的药效学试验结果证明，其抗癌谱更广，同时，在公认安全的药物剂量范围内，杀灭肿瘤的效率与作为阳性对照的环磷酰胺、顺铂等经典化疗药物相当，且对泰素耐药的肺癌细胞系的杀灭率达80%左右，表明ADV-TK在克服肿瘤耐药性方面具有潜在的应用价值。
鉴于ADV-TK在治疗肝癌等难治性肿瘤疾病方面的良好应用前景。为此，该新药的临床主要适应症将首选肝癌。近些年来，我国肝癌发病人数始终居于世界首位，每年死亡人数约30万人，占全球肝癌死亡总数的一半以上。目前，该新药即将开展II期临床试验，因此，一旦完成临床试验后投产面市，可望为满足国内肝癌等肿瘤患者的治疗需求提供一种现实有效的治疗手段，将具有良好的医学、社会和市场价值，及取得显著的经济和社会效益。
公司地址：深圳市高新区生物孵化器大楼1-104室
负 责 人：武晓章
联系电话：86-755-26031003 25889512
电子邮箱：sztdk@163.com
邮政编码：518057
Shenzhen Tiandakang Gene Engineering Co., Ltd.
Profile
Shenzhen Tiandakang Gene Engineering Co., Ltd is a private enterprise established in Shenzhen in 2001 with a registered capital of RMB ￥10 million. Recombinant Adenovirus - Herpes Simplex Virus Thymidine Kinase（shortened as ADV-TK）is a new medication with gene-based anti-cancer effect. The medication has been successfully developed with our exclusive medicinal patent and is regarded as a new generation so far based on our own intellectual rights.
ADV-TK, belonging to tumor suicide gene treatment based on Type V Recombinant Adenovirus, is one of the major anti-tumor medications in gene-based research and development thus far. As the first batch of innovative new medication research, the project was funded by the State Tenth Five-Year Plan Key Science Special Project in 2002.
ADV-TK specifically aims at killing tumor cells through transfection of malignant tumors, especially the partial tumor, thus creating suicide effect and bystander effect with the participation of Ganciclovir. ADV-TK is highly effective in treating various cancers including liver cancer, lung cancer, breast cancer, gastric cancer, ovarian cancer and prostate cancer, and it takes effect rapidly, without visible toxic or adverse side effects, and is safe and convenient to use. Moreover, it can be combined with the traditional therapies, specifically adjuvant with the small dosage of radiotherapy and chemotherapy to generate synergistic effects. When injected into or near the tumor of multiple hosts that cannot be removed or excised completely by surgical operation, the drug has unique efficacy due to local, direct and more concentrated delivery of the medicine, thus resulting in faster and more visible efficiency in killing cancer cells.
As the clinical testing base for the State new medicine (anti-tumor medication), GCP at the Tumor Hospital affiliated to Sun Yat-Sen University has undertaken and successfully completed Phase I clinical testing for ADV-TK. The major purpose of Phase I testing is to evaluate the safety of the medication on some patients who experienced several anti-tumor treatments with radiotherapy and chemotherapy but failed. The testing results show that these patients felt good without any dosage limit toxicity. The medication has little effect on the environment. Preliminary medical effect can be seen from the seventeen evaluable cases (effective rate 38% with ADV-TK used on a single basis).
In addition, we worked with Beijing Organ Transplant Center for clinical tests on patients of intermediate and terminal stages for liver transplant and local ADV-TK gene therapy. The results demonstrate ADV-TK has excellent positive clinical effects in the treatment of liver cancer.
Compared with foreign TK gene therapies already in the clinical stage, ADV-TK proves a broader spectrum in cancer treatment based on pharmacodynamic test results. Meanwhile, in recognized safe dosage, the drug has an equal efficiency in killing tumor cells to chemotherapy medications such as cyclophosphane and DDP in positive contrast. And it can kill up to 80% of the lung cancer cells that have drug resistance to Taxol. This shows that ADV-TK has a potential application ＆#118alue in overcoming the drug resistance of tumors.
As is stated above, ADV-TK has a good prospect in treating hard-to-cure tumors such liver cancer. Therefore, we firstly chose liver cancer for the application of our new medication. In recent years, China is in the first place in terms of the number of patients with lung cancer in the world. Approximately 300,000 people died of lung caner in China each year, accounting for over half of the total number of patients who died of the disease globally. At present, the new medication is due to be put in its Phase II clinical testing. Thus upon completion of clinical testing and the start of production and sale of the medication, the needs will be met for patients with tumors like liver cancer in China. The medication can help to cure the disease in a practical and effective way. Excellent medical, social and market ＆#118alues can be seen with economic and social efficiency.
Address: 1-104室：Suite 104, Tower 1, Bio-Tech Industry Incubator, Hi-Tech Industrial Park Central, Shenzhen
Responsible person: Wu Xiaozhang
Tel: 86-755-26031003 25889512
E – mail ：sztdk @ 163.com
Post code: 518057 |
