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    Home > Medical News > Latest Medical News > The CAR-T River and Lake undercurrents behind kingsley at the top of the wind surge.

    The CAR-T River and Lake undercurrents behind kingsley at the top of the wind surge.

    • Last Update: 2020-09-30
    • Source: Internet
    • Author: User
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    On September 22nd the biotech company Kingsley Biotech Co., Ltd. ("Kingsley Bio") caused a stir when news of a customs anti-smuggling inspection caused a stir, sending its shares soaring, down more than 25 per cent and losing about HK$5.3 billion in market value.
    (previous article view: "Kingsley under customs investigation, or suspected human genetic irregularities out of the country, today's share price plummeted!) Legendary Bio's share price plunged 14.06% as a result of Zhang Fangliang's role as chief executive officer of its subsidiary Nanjing Legendary Biotech Co., Ltd. ("Nanjing Legend").
    known as the "King of Global Gene Synthesis," Legendary Creatures is a multinational subsidiary of Kingsley that specializes in CAR-T cell immunotherapy, founded in 2014.
    data show that gene synthesis services are a foundry service, instruments and technologies, although complex, but low profits, early Kingsley biogenics business is not attractive to investors.
    and its real high-gloss moment was in 2016, when Legendary Bio's CAR-T therapy achieved a 100% effective rate in eight multiple myeloma patients, and this result made Legendary Bio famous at the American Society of Clinical Oncology (ASCO) annual meeting in 2017 and won the country's first CAR-T clinical approval in 2018.
    Legendary Bio's breakthrough in the CAR-T field has also won the favor of Johnson and Johnson Group's Janssen, the two sides reached a global partnership to jointly develop and promote the drug to treat multiple myeloma patients.
    5, 2020 U.S. time, Legendary Bio was listed on NASDAQ.
    jumped as much as $37, or 60.87 per cent, at the start of the day and was hotly sought after by capital.
    legendary creatures have also made rapid progress in recent years.
    August 5, CDE's official website showed that legendary creature's LCAR-B38M CAR-T cell self-retranssigent appeared in the breakthrough treatment drug bulletin board, becoming the first variety in China to be included in the breakthrough treatment drug program, and its JNJ-4528/LCAR-B38M, developed jointly by Johnson and Johnson, is expected to apply to the FDA for a biologics license by the end of this year and to the European Medicines Agency (EMA) in early 2021.
    at the recent 2020 China Pharmaceutical Industry Information Annual Meeting, Fan Xiaohu, co-founder of Nanjing Legends, said in a public statement: "Some segments of China's CAR-T therapeutic field have become world-leading, to achieve best-in-class."
    " So what exactly is CAR-T therapy? What is the pattern of research and development progress in China at present? CAR-T therapy's predecessor, CAR-T, is a revolutionary treatment for cancer.
    principle, the therapy is genetically modified to ethloy "embedded antigens" (CAR) on T cells to identify antigen molecules on the surface of cancer cells, which in turn attacks cancer cells.
    , CAR-T cells targeting CD19 molecules on the surface of B cells can effectively treat a variety of B-cell malignancies (e.g. acute lymphoblastic leukemia, lymphoma).
    data show that CAR-T therapy was first proposed by Gross in the late 1980s, and has been developing for more than 30 years.
    the immunotherapy, where the therapy is located, is the third revolutionary breakthrough after chemotherapy and targeted therapy.
    CAR-T therapy is now becoming the focus of attention in our country.
    , car-T therapy has not been a smooth road in China over the past few years.
    in China, cancer immunocell therapy has been declared as a fourth type of treatment technology in addition to surgery, chemotherapy, radiotherapy, year-round in the gray area outside of regulation.
    2009, the Ministry of Health has included it in the third category of priority supervision of medical technology;
    May 2015, a paper order cancelled the approval of a third type of medical technology, cell therapy continued to wander into the gray area, a period of unbridled abuse of cell therapy by medical institutions, the market chaos.
    2016, the "Wei Ghasi incident" broke out, and the "lid" of abuse of cell therapy by medical institutions for profit was lifted.
    health planning committee explicitly prohibits hospitals from charging fees for cell therapy, while the Food and Drug Administration explicitly includes cell products in drug evaluation.
    2017, CAR-T Therapy is in its most landmark year, with the FDA's approval of NOVAR and Kate's CAR-T products on the international market, stimulating the enthusiasm of investors and researchers around the world.
    same year, at the ASCO conference, Legendary Creatures announced a stunning breakthrough in the 100% effectiveness of CAR-T therapy in eight patients with multiple myeloma.
    car-T therapy in China according to statistics, in China's layout of CAR-T therapy enterprises now have hundreds.
    , as of May 31, 2020, a total of 41 IND declarations of such drugs had been accepted by CDE, and the declaration of adaptive disorders and targets, according to Kozhikang Pharmaceuticals.
    images from: Ko Zhikang Pharmaceuticals (as of May 31, 2020) can be seen that the current clinical trials of Car-T cell therapy in China are mainly concentrated in CD19, BCMA and other targets.
    legendary creatures took the lead in the BCMA target to make a breakthrough, drug Ming Juno, Fosun Kate, Novarma, Koji Pharmaceuticals, Galaxy Biology, Hua dao Biological and other enterprises main layout CD19.
    , the Journal of Nature Reviews Drug Discovery, a global in-depth inventory of cell therapies, said CD19 was at the top of the list of the most popular TOP10 targets.
    images are from: Ko Zhikang Pharmaceuticals (as of May 31, 2020) and from the research and development process, most of the declared varieties are still in the clinical phase I. stage, and even clinical trials have not yet started.
    the rapid progress of legendary organisms, August 5, CDE official website shows that legendary organisms LCAR-B38M CAR-T cell self-retranscission preparations appear in the breakthrough treatment drug publicity column, becoming the first to be included in the breakthrough treatment drug procedures varieties.
    followed by Koji Creatures, Shanghai Hengrun Dasheng and Chongqing Precision Creatures, as well as Shanghai Fosun Kate and Novarma (China).
    From the listing step, in June 2020, Legendary Bio became China's first CAR-T cell therapy listed company (NASDAQ), July 10, 2020, Yongtai Bio followed closely behind, listed on the Hong Kong Stock Exchange.
    August 14, 2020, JW Therapeutics filed an IPO application with the Hong Kong Stock Exchange, which is expected to become the third CAR-T company to list in China this year.
    part of China's layout CAR-T therapy enterprises - Reference source: Ko Zhikang Pharmaceutical "most full CAR-T drug market approval summary"
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