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TOT BIOPHARM and Jun shi biological agreement

发布时间:2019-06-19

Recently, TOT BIOPHARM(hereinafter referred to as "TOT BIOPHARM") and Shanghai junshi biomedical technology co., LTD. (hereinafter referred to as "junshi biological") signed a cooperation agreement. According to the agreement, TAB008 (bevacizumab, an anti-vegf monoclonal antibody similar to bevacizumab) independently developed by TOT BIOPHARM and JS001 (recombinant human anti-pd-1 monoclonal antibody triprizumab, trade name: tuoyi) independently developed by junshishi biological will conduct joint drug research cooperation for advanced hepatocellular carcinoma.

Pd-1 / pd-l1 antibody has made breakthroughs in recent years, showing therapeutic effects in melanoma, lung cancer, liver cancer, nasopharyngeal cancer, urinary tract epithelial cancer, esophageal cancer, triple-negative breast cancer, Hodgkin's lymphoma and other cancers. A number of recent studies have shown that on the basis of pd-1 / pd-l1 inhibitors, the combination of other anti-angiogenic drugs, targeted therapy, chemotherapy, IO or radiotherapy may produce anti-tumor synergistic effect, thus leading to better therapeutic effect and, more importantly, prolonged patient survival time.

As a broad-spectrum anti-tumor monoclonal antibody, bevacizumab has unique advantages in the field of combination therapy. In addition to its specific anti-angiogenic effect in combination with VEGF, bevacizumab has been shown to initiate a T cell response to tumor antigens and reverse myeloid immunosuppression by increasing tumor t-cell infiltration. At present, bevacizumab has been used in combination with several chemical or biological drugs in the treatment of colorectal cancer, non-small cell lung cancer and other indications, and has shown good clinical efficacy data in the case of controllable safety. Bevacizumab significantly strengthens the treatment regimen of pd-l1 inhibitor plus chemotherapy, thus obtaining the indications for first-line treatment of advanced non-small cell lung cancer (NSCLC) and achieving significant initial efficacy in renal cancer and liver cancer. It can be predicted that bevacizumab will play an important role in the combined drug system of tumor therapy in the future.

Currently, liver cancer is one of the top five cancers with the highest mortality rate in China. However, there are only a limited number of drug treatments available in China. Therefore, liver cancer is a field that needs to be explored and overcome actively in the treatment of tumor in China. This cooperation will be conducive to promoting the development cooperation between TAB008, the developed product of TOT BIOPHARM, and JS001 developed by junshi biology in the combination of drugs for advanced hepatocellular carcinoma, and promoting the development of related combination drug therapy.

About TOT BIOPHARM

Focusing on the development and commercialization of innovative anti-tumor drugs and therapies, TOT BIOPHARM strives to build itself into a leading brand of tumor therapy worthy of the trust of medical professionals, patients and their families.

At present, TOT BIOPHARM has established three comprehensive technology platforms, including:

• therapeutic monoclonal antibody and ADC drug technology platform: integrating the r&d and production capacity of antibody drugs and ADC, the designed capacity of the commercial production base of biological drugs reaches 16,000 liters, which can realize the high quality commercial production of drugs under development;

• treatment technology platform based on genetic engineering: integrated anti-tumor immunotherapy, gene therapy and viral therapy, developed and produced oncolytic virus products against tumor targets;

• innovative delivery technology platform: developed advanced delivery systems for targeted liposomes and built facilities for commercial production of liposomes.

With the above platform, TOT BIOPHARM has developed several series and varieties of anti-tumor drugs, forming a complete and high-quality drug product chain. At present, the company has 12 drugs in the research and development stage, among which 4 biological drugs and 3 chemical drugs have submitted the application for clinical trials, and all of them have been approved for clinical trials. One variety of biological drug products has entered the phase III clinical study, and three varieties are in the phase I clinical study.

At the same time of independent innovation and development of drugs, TOT BIOPHARM relies on its entire industrial value chain to build a whole industrial chain platform from research and development, clinical, production to marketing, and adopts an open platform business model to carry out strategic cooperation with biomedical enterprises and third parties at different stages of the industrial value chain.

About TAB008

TAB008 is a biosimilar bevacizumab independently developed by TOT BIOPHARM. Beacizumab bead sheet resistance is a kind of humanized anti - VEGF monoclonal antibody, as early as 2004 by the us food and drug administration approved, commodity called Avastin ®, at present in domestic approved two indications (mCRC and nsNSCLC first-line treatment), approved in the United States or the European Union's other indications, including glioblastoma, renal cell carcinoma, cervical cancer, ovarian cancer and breast cancer. The results of the phase I clinical trial of TAB008 of TOT BIOPHARM showed that TAB008 was highly similar to Avastin® in pharmacokinetics and safety indicators. A phase III trial of TAB008 is currently under way.

About junshi creatures

NEEQ (NEEQ: 833330, HKEX: 01877) was founded in December 2012 by a number of teams who graduated from well-known universities in China and the United States and have rich experience in the transformation of transnational scientific and technological achievements and industries.

Junshi biological mainly develops therapeutic antibodies, focusing on the innovation of monoclonal antibody drugs and other therapeutic protein drugs research and development and industrialization. Currently has the rich in the research product line, including 16 innovation medicine, a biological analogue, is the first access to PD - 1 monoclonal antibody NMPA listed Chinese companies approved, the first made the first fight BTLA monoclonal antibodies in the United States FDA IND application approved by the company, is also the first domestic PCSK9 monoclonal antibody resistance and anti BLyS monoclonal antibody NMPA IND application approved by the Chinese company. We have more than 900 employees in San Francisco and Maryland, Shanghai, suzhou, Beijing and guangzhou.

About tuoyi (triprizumab injection)

Tuoyi (triprizumab injection), as the first domestic monoclonal antibody targeting pd-1 approved for market in China, was supported by major national science and technology projects. Since the beginning of 2016, the clinical research and development of this product has carried out more than 30 clinical studies covering 14 tumor species in China, the United States and other countries. In March 2018, the National Medical Products Administration officially accepted the application for market registration of this product, and included it in the priority category for review and approval to accelerate the review and approval. The clinical trial results of this product showed that the objective remission rate, disease control rate and 1-year survival rate of patients with unretractable or metastatic melanoma who had received systemic treatment failure were 17.3%, 57.5% and 69.3% respectively. The approval of this product on the market is of positive significance for the selection of clinical drugs for cancer patients in China.