echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical Research Articles > Biotech suspends ADC and PD-1 research projects for hundreds of millions of yuan, only one drug is used to generate revenue

    Biotech suspends ADC and PD-1 research projects for hundreds of millions of yuan, only one drug is used to generate revenue

    • Last Update: 2021-07-21
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com


    In only about three months in 2021, Biotech has announced the suspension of the development of three new drug projects

    .
    According to preliminary statistics, Biotech has invested about 336 million yuan in three projects

    .


    On March 4, 2021, Biotech announced the termination of BAT8003 (recombinant humanized anti-Trop2 monoclonal antibody-maytansine conjugate for injection) and BAT1306 (recombinant humanized anti-PD-1 monoclonal antibody injection) ) Clinical development

    .


    These two projects of Biotech are in clinical phase I and phase II respectively

    .
    The announcement shows that as of December 2020, Biotech has invested 61.
    565 million yuan in R&D in the BAT8003 project and 51.
    974 million yuan in the BAT1306 project

    .
    Regarding the suspension, Biotech stated that it was to rationally allocate the company's R&D resources and focus on advantageous projects in the R&D pipeline

    .


    Biotech's new ADC drugs have "broken down" one after another

    .
    On February 8 this year, Biotech also announced the termination of the ADC project BAT8001 (recombinant humanized anti-HER2 monoclonal antibody-maytansine conjugate for injection) that has invested 226 million yuan in research

    .
    And because of the termination of this project, the clinical trial of BAT8001 combined with BAT1306 for the second-line treatment of HER2-positive advanced solid tumors was also terminated

    .


    A drug may be difficult to hold up the "banner" of research and development


    At the moment when only one product is on the market, due to the consideration of reducing R&D investment and timely stop loss, it is understandable that Biotech suspends three drugs this year

    .
    Moreover, in the BAT1306 project, competition in the domestic market is fierce.
    There are currently 4 domestically produced PD-1 products in the medical insurance catalog.
    The annual treatment cost of the first echelon product medical insurance negotiation is about 70 to 50,000, which is left to the players behind.
    There is not much room for profit

    .


    Biotech itself also pointed out that from the clinical data of various PD-1 monoclonal antibodies, it is estimated that in the next 2-3 years, there will be more than 20 PD-1 products on the market globally, and the market competition will become increasingly fierce

    .
    China is the region with the most intense competition for PD-1.
    There are 154 PD-1s in the world, of which 85 are developed or jointly developed by Chinese companies, accounting for 55%

    .
    PD-1 The global and domestic PD-1 monoclonal antibody research and development track has become crowded, and a large number of research and development competing products have also intensified the competition with CRO companies, which further intensified the development cost

    .


    What is regrettable in the industry is that Biotech has entered phase III ADC project BAT8001, and the drug's research and development progress is in the first echelon in China

    .
    However, regarding the suspension, Biotech stated that after preliminary statistical analysis by the company, the drug’s main efficacy index Progression-Free Survival (PFS) did not reach the preset superiority target compared to the control group (lapatinib combined with capecitabine).
    Thus terminated

    .


    In addition, the BAT8003 project was suspended.
    Biotech stated that it is mainly taking into account the current market structure changes in the Trop 2 ADC field, and considering that BAT8003 and BAT8001 have similar technical characteristics (although 8003 fixed-point coupling, but also uses batansine technology) , There are high clinical development and market risks

    .


    Biotech, established in 2003, focuses on the development of a new generation of innovative drugs and biosimilar drugs

    .
    Only one drug is currently on the market, the first domestically produced adalimumab injection

    .
    Biotech's adalimumab was approved by the State Drug Administration in November 2019, and its trade name is Glaly

    .
    In January 2020, Glorious officially went on sale

    .
    As of December 31, 2020, Gladley has been approved for ankylosing spondylitis, rheumatoid arthritis, psoriasis, Crohn's disease and uveitis

    .


    On the evening of March 4, Biotech’s 2020 financial report showed that during the reporting period, the company achieved operating income of 185 million yuan, a year-on-year increase of 263.
    27 times; net loss attributable to shareholders of listed companies was 513 million yuan, a year-on-year reduction of 49.
    81%; attributable to The net loss of listed company shareholders after deducting non-recurring gains and losses was 562 million yuan, a year-on-year reduction of 17.
    98%; the basic loss per share was 1.
    27 yuan

    .
    The company's R&D expenses in 2020 will be 563 million yuan

    .


    From the perspective of business structure, Biotech’s adalimumab has an annual operating income of 180 million, accounting for 100% of the revenue, and a gross profit margin of 89.
    1%

    .
    Biotech’s current full-year revenue almost relies on this drug

    .


    Moreover, Biotech did not generate any revenue before Glaring was not marketed for sale

    .
    According to Biotech’s prospectus, the company’s net losses in 2016, 2017, 2018 and 2019 were approximately 137 million yuan, 236 million yuan, 553 million yuan and 1.
    023 billion yuan, respectively

    .
    Counting 2020, Biotech has suffered losses for 5 consecutive years

    .


    However, Biotech’s Gelli also faces considerable competition

    .
    At present, including the original researcher AbbVie, the number of domestic approved companies for adalimumab has reached 5, and there are more than a dozen companies whose drug candidates are in clinical trials and late-stage development

    .
    In 2019, the original AbbVie adalimumab (trade name: Xiu Mei Le) entered the Chinese medical insurance catalog, and the price dropped sharply, which was close to the price of Glaly

    .
    In the future, it will inevitably be a situation of being brought into purchase

    .
    For Biotech, there is still a long way to go

    .


    Performance under pressure, Biaotai Hong Kong stock IPO frustrated


    The research and development of new drugs continues to burn money, and it is necessary to seek listing and raise funds to move forward

    .


    On February 21, 2020, Biotech was listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange.
    The total amount of funds raised was 1.
    966 billion yuan.
    After deducting the issuance expenses, the net amount of funds raised was 1.
    876 billion yuan

    .
    The issue price was RMB 32.
    76 per share, and the stock price rose to RMB 78 on the day

    .


    Just 117 days after listing on the Science and Technology Innovation Board, Biotech also sought financing on the Hong Kong Stock Exchange

    .
    According to the plan, if successfully listed in the Hong Kong stock market, Biotech will become the third unprofitable biotechnology company with "A+H" shares after Junshi and Kangsino

    .


    However, on February 24, the Hong Kong Stock Exchange revealed that Biotech’s H-share prospectus submitted on August 24, 2020 was invalid, and it has not yet been inquired about the company’s re-submission of the form to the Hong Kong Stock Exchange

    .


    Although the Science and Technology Innovation Board is open to unprofitable companies for listing, it also imposes certain requirements on the time for companies to lose money

    .
    According to Article 12.
    4.
    2 of the "Shanghai Stock Exchange Science and Technology Innovation Board Stock Listing Rules", a listed company that chooses the fifth set of criteria will have an audited net profit before and after the deduction in the fourth full fiscal year from the date of listing ( (Including retrospective restatement) is negative and revenue (including retrospective restatement) is less than 100 million yuan

    .


    In addition, if the audited net assets (including retrospective restatement) are negative, the company will also trigger the delisting conditions.
    According to the “Measures for the Continuous Supervision of Listed Companies on the Science and Technology Innovation Board (Trial)”, the The stock will be directly terminated from listing, and the procedures for suspension of listing, resumption of listing, and relisting will no longer apply

    .


    In the 2020 financial report, Biotech also revealed the company's current concerns

    .
    Biotech bluntly stated that although the company is unlikely to remain unprofitable for the next four complete fiscal years, because many products are still in the drug development stage, the company's unprofitable state may continue to exist or the accumulated uncovered losses will continue to expand

    .
    Therefore, it cannot be fully guaranteed to achieve profitability in the next few years, and the company may also face the risk of delisting after listing

    .


    What other products of Biotech are worth looking forward to?


    On the day when it was officially announced that it was in phase III ADC drug development, Biotech’s share price plunged 18.
    73% against the market, the largest one-day drop since its listing

    .
    As of the close, it closed at 25.
    03 yuan/share, a 23.
    6% drop from the issue price (32.
    76 yuan/share)

    .
    On March 5, Biotech’s closing price was 26.
    2 yuan per share

    .


    It can be seen that the termination of research projects has a significant impact on the company's stock market

    .
    However, most of the industry's comments on Biotech are also positive

    .


    Although Biotech has only marketed one drug, it still has 20 products under development, of which 2 products have been submitted for marketing applications, 3 products are in phase III clinical research, and 2 products are in phase II clinical research.
    , 3 products are in phase I clinical research phase

    .


    According to Biotech’s financial report, the company’s fastest listed drugs may be the biosimilar drug BAT1706 and the innovative drug batifiban (BAT2094), which have already submitted a listing application

    .


    Among them, BAT1706 is a bevacizumab injection developed by Biotech in accordance with China's NMPA, US FDA, and EU EMA biosimilar guidelines.
    It is also the second biosimilar drug submitted for marketing

    .
    The original research drug of the drug is Roche's ace biologic Avastin

    .
    At the end of January this year, Biotech announced that the FDA has accepted a biological product marketing authorization application (BLA) for BAT1706 (bevacizumab) injection

    .
    The applied indications include metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent or metastatic cervical cancer

    .


    Biotech’s self-developed recombinant humanized anti-interleukin 6 receptor (IL-6) monoclonal antibody BAT1806 (tocilizumab) is currently undergoing an international multi-center phase III clinical study, and it is also a fast-moving trust in the world.
    Biologicalsimilar of Lizumab; the world's first biosimilar candidate for Simpuny, BAT2506 (golimumab) is currently in phase III clinical phase

    .


    From a current point of view, Biotech’s next R&D focus will be on the above-mentioned drugs, with a clear focus on the field of autoimmune diseases

    .


    In addition, there is a personnel adjustment announcement along with the termination of the R&D project and the 2020 financial report.
    Biotech announced on the evening of the 4th that after the board of directors reviewed, it agreed to hire Mr.
    JAN CHAO-HSIANG DAVID as the deputy general manager; hire HUANG Ms.
    WENRONG is the deputy general manager; Mr.
    Wang Chaohe is hired as the deputy general manager; Mr.
    Song Shuqiang is hired as the deputy general manager; Mr.
    Bao Cai is hired as the deputy general manager; Mr.
    Lin Jian is hired as the deputy general manager

    .

    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent Echemi's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.