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    Home > Biochemistry News > Biotechnology News > TOT BIOPHARM-B (1875.HK): A pioneer in the ADC track, the future of differentiated development can be expected

    TOT BIOPHARM-B (1875.HK): A pioneer in the ADC track, the future of differentiated development can be expected

    • Last Update: 2022-05-02
    • Source: Internet
    • Author: User
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    Original title: TOT BIOPHARM-B (1875.


    In recent years, the domestic pharmaceutical industry has undergone earth-shaking changes under the influence of various factors such as the introduction of policies and medical insurance negotiations


    The author noticed that on December 1, TOT BIOPHARM announced that its self-developed bevacizumab injection Puxinting® (proposed English name: Pusintin®) TAB008 has been approved by the NMPA for the treatment of advanced, metastatic recurrent or recurrent non-squamous non-small cell lung cancer and metastatic colorectal cancer


    It is reported that Park Xinting® is TOT BIOPHARM's first approved antibody drug, which officially started the company's commercialization process on the antibody drug track


    Then, since its establishment, TOT BIOHO has how to respond to market changes in its development process, so that it can become an innovative drug enterprise integrating product research and development, production and sales


    The first layout in the ADC field, with a high-capacity production base

    In recent years, with the release of various anti-tumor biological drug policies such as the "Technical Guidelines for Biosimilar Drug R&D and Evaluation" and "Clinical Value-Oriented Clinical Research and Development Guidelines for Anti-tumor Drugs", the field of innovative biological drugs has become a A track where biotech companies are scrambling to flock to


    Under market changes, ADC drugs have both the cytotoxicity of small molecules and the targeting properties of monoclonal antibodies.


    Therefore, TOT BIOPHARM did not choose to continue to develop other monoclonal antibody-like drugs, but made a differentiated layout, aiming at the ADC field with higher technical difficulty in R&D and higher threshold for commercial production, becoming the first batch of ADCs in China Innovative drug companies in the field of drug research and development


    In addition, in addition to the ADC field in product research and development, TOT has two high-capacity production bases in commercial production


    When TOT BIOPHARM was established in 2009, small molecule drugs still occupied a dominant position in China's pharmaceutical market


    Then, the development of biological drugs became a boom


    It is worth mentioning that the No.


    Seize market opportunities and vigorously expand CDMO business

    As more and more innovative drugs are approved for marketing in China, commercial production capacity has become one of the key factors for pharmaceutical companies to realize their innovative achievements


    As early as 2016, TOT BIOPHARM has entered the field of CDMO.


    In addition, due to the high threshold of ADC drug production, many domestic companies do not have enough technology to support their production of ADC drugs, and there are very few domestic CDMO companies that can satisfy ADC drugs, resulting in a serious shortage of production capacity


    Therefore, TOT BIOPHARM has officially entered the CDMO field of ADC drugs since the second half of 2020


    Figure: CDMO/CMO revenue of TOT BIOPHARM (RMB 10,000)

    Data source: company information, compiled by Gelonghui

    It is worth noting that in TOT BIOPHARM's CDMO/CMO business, the order value of ADC projects has expanded rapidly, accounting for nearly 40% in the first half of 2021
    .
    Moreover, its business covers preclinical, IND and all clinical stage projects, showing TOT BIOPHARM's strong strength in CDMO/CMO
    .

    Chart: Comparison of CDMO/CMO Business Volume and Phased Projects

    Data source: company information, compiled by Gelonghui

    In September this year, the CDMO service of commercial scale scale-up and production of the new coronavirus-specific neutralizing antibody injection (JMB2002) provided by TOT BIOPHARM for its partner Jimin Trust, was one and a half months ahead of the expected delivery time, which fully reflected the The company's strong commercial production capacity
    .

    In addition, the company has further expanded its CDMO business strength through cooperation
    .

    Specifically, in July this year, TOT BIOPHARM and Borui Pharmaceutical (30.
    780, 0.
    18, 0.
    59%) cooperated in the CDMO cooperation of ADC, and jointly provided customers with pre-process development of ADC products, scale-up of intermediates and GMP production services.
    Further strengthen the company's CDMO service capabilities
    .
    The cooperation between the two companies is expected to accelerate the development and commercialization of domestic innovative drugs through complementary technologies and resources
    .

    summary

    In general, the current competition in the research and development of innovative drugs is becoming more and more intense, and more emphasis is placed on product quality and research and development speed, so the demand for international and domestic CDMO markets has surged
    .
    TOT BIOPHARM not only has a rich product pipeline including monoclonal antibodies, small molecules, and oncolytic viruses, but also is one of the few companies in China that has a platform for the entire ADC industry chain, and can provide CDMO services for many domestic innovative pharmaceutical companies
    .

    In addition, TOT BIOPHARM has also made a strategic layout in commercial sales
    .
    On November 23, TOT announced that its direct wholly-owned subsidiaries Yaozhan Pharmaceutical, China Resources Pharmaceutical Trading and Suzhou Huayaoyuan (an employee shareholding platform) jointly established a joint venture company Huayao Pharmaceutical
    .
    The cooperation between the two parties is expected to produce synergies, promote the transformation of TOT's marketing strategy, and further expand the company's innovative anti-tumor drug sales and medical service market
    .

    From this point of view, TOT BIOPHARM, from the research and development of ADC drugs, to the construction of production bases and the transformation of commercial sales, is making strategic layouts in line with market trends, and has initially achieved good results
    .
    And this time TOT BIOPHARM's first antibody drug, Park Xinting® (TAB008), was approved for marketing.
    With the strong marketing network and rich promotion experience of Jimin Trust Group, it is expected to promote TOT BIOPHARM under the strong cooperation of both parties.
    The performance of the company has further increased, and its future development is worthy of attention
    .

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