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    Home > Active Ingredient News > Drugs Articles > Simcere Pharmaceuticals (2096.HK): R&D investment continues to increase the concentration of multiple innovative drug INDs

    Simcere Pharmaceuticals (2096.HK): R&D investment continues to increase the concentration of multiple innovative drug INDs

    • Last Update: 2021-05-09
    • Source: Internet
    • Author: User
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    With the announcement of the Hong Kong stocks' 2020 results coming to an end, the R&D investment capacity of various pharmaceutical companies has also surfaced.
    As more and more innovative drug companies have landed on the Hong Kong Stock Exchange in recent years, the development of the domestic innovative drug market has become the focus of attention.
    What details are revealed behind the "transcript" under this special year?

    R&D investment continues to increase "Innovation" will continue to lead the development of the industry

    As medical improvement enters the deep water zone, pharmaceutical companies regard innovative R&D as their core development strategy.
    According to McKinsey's 2018 "Break the Cocoon and Become a Butterfly: Transformation of Chinese Pharmaceutical Companies", China's contribution to global pharmaceutical R&D has risen to 4-8%, entering the second echelon of global R&D.
    After two years, the contribution rate of R&D investment of Chinese pharmaceutical companies may continue to rise.

    Judging from the disclosed financial data for 2020, the R&D expenditures of various pharmaceutical companies are continuously increasing.
    According to statistics from WIND, in the pharmaceutical sector of the Hong Kong stock market, Corning Jerry, Simcere, Zai Lab, and BeiGene have achieved significant growth in R&D expenditures.

    Specifically, Corning Jereh will spend 331 million yuan in research and development in 2020, a significant increase of nearly 99% over 2019.
    As a pharmaceutical company listed on the Hong Kong Stock Exchange in the fourth quarter of 2020, Simcere Pharmaceuticals, with its R&D expenses of 1.
    142 billion yuan in 2020, increased by 59.
    4% year-on-year, it is among the TOP 20 list of R&D investment in the pharmaceutical sector of Hong Kong stocks.
    In addition, Zai Lab and BeiGene continue to invest heavily in R&D.
    In 2020, R&D investment will be 1.
    463 billion yuan and 8.
    509 billion yuan, representing a year-on-year increase of 57% and 38% respectively.

    The increase in R&D expenditures of these companies is mainly used for key clinical trials, R&D costs related to prepayments for authorized drug candidates, and development costs related to cooperation with other companies.

    Chart 1: 2020 Top 20 R&D Companies in the Pharmaceutical Sector of Hong Kong Stocks

    Data source: official website of each company, compiled by Gelonghui

    Simcere Pharmaceutical: Innovation-driven, clinical progress continues to advance

    As a result of increasing R&D investment, many innovative pharmaceutical companies have begun to taste the joy of post-marketing.

    As a result of increasing R&D investment, many innovative pharmaceutical companies have begun to taste the joy of post-marketing.

    According to Simcere's annual report, the proportion of its sales revenue from innovative drugs in its total revenue in the same period is increasing year by year, reaching 45.
    1% in 2020.
    In 2020, Simcere Pharmaceuticals had a total of 3 drugs approved for listing, of which Including: the first class of innovative drug, "Beijing" (edaravone dextrozol injection concentrated solution) was approved for marketing and entered the 2020 national new medical insurance catalog, and the imported innovative drug Enrexu (abatacept injection) was approved for marketing , And Aijiewei (tofacitib citrate tablets) were approved for marketing and entered the 2020 National New Medical Insurance Catalog.
    In addition, the company has obtained 5 clinical approvals/clinical implied licenses, 1 new indications for new indications for marketed innovative drugs, and 2 product approvals for consistency evaluation.

    After the announcement of the annual report, Simcere Pharmaceuticals successively announced the concentrated implementation of multiple innovative drug R&D projects in the focus area.
    This also means that the company’s differentiated R&D layout in the oncology and neurological fields will be more complete, and the future revenue of innovative drugs will account for Ratio will continue to improve.



    1.
    A global innovative drug for cerebral edema AQP4 obtained clinical tacit approval to solve high clinical unmet needs



    In the field of central nervous system therapy, Simcere already has a portfolio of innovative drugs and branded products occupying a leading position in the market.
    SIM-307 is a small molecule Aquaporin 4 inhibitor introduced by Simcere Pharmaceuticals from Aeromics.
    It has obtained positive results in Phase I clinical trials in the United States.
    In November 2019, Simcere Pharmaceuticals Cooperated with Aeromics to jointly develop and commercialize the drug in Greater China (including Mainland China, Hong Kong, Macau and Taiwan).
    It is worth noting that SIM-307 is a First-in-Class new drug approved by the United States Department of Health and Human Services under the personal leadership and participation of Nobel laureate Dr.
    Peter Argre.

    On April 14, Simcere Pharmaceuticals announced that the clinical trial application of the drug SIM-307 for the treatment of acute ischemic stroke complicated by cerebral edema was approved by the State Food and Drug Administration.
    Subsequently, Simcere Pharmaceuticals will rapidly advance the SIM-307 treatment of acute ischemia Phase I clinical study of cerebral edema due to sexual stroke.

    From the perspective of market space, this indication has a broad market space.
    According to statistics from Frost&Sullivan, stroke is the top ten cause of death in the world.
    There are about 20 million patients in China, and about 2.
    5 million new strokes occur each year.
    Among them, the number of patients with cerebral edema caused by new strokes reaches 30-40.
    Ten thousand people.
    However, in the market with a large number of patients, it has been facing the embarrassing situation of lack of new drugs.

    The current experimental research on AQP4 has fully confirmed its role in the formation and resolution of cerebral edema.
    If it is successfully verified, SIM-307 will become the first therapy in this field.
    This is also the company's important R&D product in the neurological field.

    2.
    Trilaciclib, a whole bone marrow cell protectant that supports therapy, was approved for the second indication of CRC in China

    2.
    Trilaciclib, a whole bone marrow cell protectant that supports therapy, was approved for the second indication of CRC in China

    Trilaciclib (trade name: COSELA) is a "First-in-Class" small molecule short-acting CDK4/6 inhibitor discovered and developed by G1 Therapeutics in the United States.
    It is the world's first and only prophylactic administration before the start of chemotherapy to protect Products of bone marrow and immune system function.

    Trilaciclib (trade name: COSELA) is a "First-in-Class" small molecule short-acting CDK4/6 inhibitor discovered and developed by G1 Therapeutics in the United States.
    It is the world's first and only prophylactic administration before the start of chemotherapy to protect Products of bone marrow and immune system function.

    On the CDK4/6 inhibitor track, most of the currently marketed CDK4/6 inhibitors are concentrated in the field of HR+/HER2- breast cancer, and bone marrow protection is a unique effect exclusive to Trilaciclib, which has been granted priority review by the FDA As well as the breakthrough therapy designation, it was approved for marketing in the United States in February this year for the prevention of myelosuppression caused by platinum/etoposide regimen or topotecan regimen in adult patients with diffuse small cell lung cancer.
    In August 2020, Simcere introduced all the indications and commercialization rights of Trilaciclib in Greater China.

    It is worth looking forward to, Trilaciclib is exploring other indications such as triple-negative breast cancer (TNBC), colorectal cancer (CRC), etc.
    , and the future market space is broad.

    Currently, Trilaciclib's two clinical trial applications for small cell lung cancer and colorectal cancer in China were approved in January and April this year, respectively.
    Simcere Pharmaceuticals will join G1's global multi-center clinical trial platform.

    summary

    According to public information, as of November 2020, domestic biopharmaceutical companies have conducted 133 rounds of financing, far exceeding the data of 81 rounds of financing for the entire year of 2019, and the total amount of financing has exceeded 80 billion yuan.
    With the intensification of competition in the domestic biopharmaceutical market, products with sufficient innovation strength can become a prominent encirclement of enterprises and become an important rule for occupying the market.

    In 2020, dozens of biotechnology companies will successively land on the Hong Kong Stock Exchange and the Science and Technology Innovation Edition, and the scenery is endless.
    But from a long-term perspective, not every company is singing all the way in the capital market.
    Only if you have the ability to innovate and have enough strength to commercialize it, can you have the last laugh and go further.

    Today, Simcere has continuously increased its investment in innovative R&D through "independent research and development + external cooperation".
    It has not only established a more comprehensive pipeline layout in the central nervous system, but also planned in the tumor and immune fields.
    In Hongda's territory, more than 50 products under research at different stages of research and development are gradually fulfilling the schedule as planned, waiting for the flowers to bloom.

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