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    Home > Active Ingredient News > Endocrine System > Inventory: 9 innovative drugs developed by Chinese companies have been declared for listing in the United States

    Inventory: 9 innovative drugs developed by Chinese companies have been declared for listing in the United States

    • Last Update: 2021-05-02
    • Source: Internet
    • Author: User
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    The internationalization of Chinese pharmaceutical companies started with intermediates and APIs, and their capabilities and levels continued to improve.
    After nearly 30 years of accumulation and development, it has been a routine operation for Chinese pharmaceutical companies to obtain ANDA approvals for generic drugs in the United States, and more and more innovative drug development explorations have gradually come to fruition.
    At present, nine innovative drugs developed by Chinese companies have been declared for listing in the United States, and three of them have been approved.

    Innovative drugs developed by Chinese companies and declared for listing in the United States

    1.
    Ibalizumab (Ibalizumab)

    1.
    Ibalizumab (Ibalizumab)

    Company: Taiwan Zhongyu Pharmaceutical

    Indications: Used in combination with other antiretroviral drugs for adult patients with multi-drug resistant HIV-1 infection that have failed existing treatment regimens

    Ibalizumab was originally developed by Biogen.
    In the late 1990s, Tanox obtained the exclusive global development rights for lbalizumab.
    In January 2007, Tanox was acquired by Genentech, but the lbalizumab project did not receive Genentech's attention.
    On the recommendation of Dr.
    He Dayi, the inventor of HIV "cocktail therapy", Zhongyu Pharmaceuticals obtained the exclusive global market authorization of lbalizumab from Genentech.

    In August 2017, the cGMP production base of WuXi Biologics for the production of lbalizumab's stock solution and sterile preparations successfully passed the pre-approval review of the U.
    S.
    FDA.
    Ibalizumab was approved by the FDA in March 2018, making it the first sterile biological product produced in China and approved by the FDA to enter the United States.

    Ibalizumab is the first anti-HIV drug with a new mechanism of action in the past ten years, the first long-acting new HIV drug, the first monoclonal antibody to treat HIV, and the first biological drug manufactured by a Chinese company and approved by the FDA.
    A monoclonal antibody drug developed based on the CD4 target and approved for marketing.

    2.
    Zebutinib

    2.
    Zebutinib

    Company: BeiGene

    Indications: Adult mantle cell lymphoma who has received at least one therapy in the past

    Zebutinib is a BTK inhibitor independently developed by BeiGene.
    In November 2019, Zebutinib was approved by the FDA for accelerated listing based on the data of two key clinical studies, becoming the successor to Ibrutinib and Acatinib.
    The third BTK inhibitor approved for marketing in the world.
    Zebutinib is the first innovative oncology drug independently developed by a Chinese company and approved by the US FDA for marketing.

    In June 2020, Zebutinib was approved for marketing in China through priority review and special approval, for the treatment of adult mantle cell lymphoma (MCL) that has received at least one therapy in the past, and has received at least one therapy in the past.
    Adult Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) is the second BTK inhibitor approved in China.

    In addition, Zebutinib was approved in the United Arab Emirates in February 2021 for the treatment of patients with relapsed or refractory MCL, and was approved for marketing in Canada in March 2021 for the treatment of Waldenstrom's macroglobulinemia (WM) Adult patients.

    On February 17, 2021, BeiGene submitted the second sNDA application for Zebutinib to the FDA for the treatment of Waldenstrom's macroglobulinemia (WM).

    3.
    L-Amlodipine Maleate Tablets

    3.
    L-Amlodipine Maleate Tablets

    Company: CSPC

    Indications: Hypertension

    On December 20, 2019, CSPC announced that the FDA approved the marketing application of Conjupri (levamlodipine maleate) tablets for the treatment of hypertension.
    Conjupri is the first Chinese local modified new drug approved by the FDA.
    Levoamlodipine is a purified (S)-amlodipine, that is, a pharmacologically active enantiomer in a racemic mixture of amlodipine ((R)- and (S)-amlodipine.

    CSPC held a pre-marketing application meeting with the US FDA in October 2018, completed key clinical studies in December 2018, and then completed the submission of the new drug application materials for the product in March 2019.

    CSPC has promoted the sale of L-Amlodipine Maleate Tablets (trade name: Xuan Ning) in China since 2003.
    The clinical development of L-Amlodipine Maleate Tablets in the United States is based on China's safety and efficacy data, as well as data showing that L-Amlodipine has fewer adverse effects than amlodipine.

    4.
    Risperidone Microspheres for Injection II

    4.
    Risperidone Microspheres for Injection II

    Company: Luye Pharmaceutical

    Indications: Schizophrenia

    Risperidone Microspheres II for Injection (trade name: Recinto) is a sustained-release preparation of risperidone developed by Luye Pharma based on its microsphere technology platform.
    It is an improved new drug and is administered by intramuscular injection every two weeks.
    once.
    Compared with products already on the market, Recinto does not need to take oral preparations 3 weeks after the first injection, and can reach steady-state blood drug concentration faster, providing patients with new treatment options.
    Rexinto is the first domestic innovative microsphere preparation with independent intellectual property rights and global registration, and it is also the first domestically developed second-generation long-acting antipsychotic injection.

    Luye Pharmaceuticals submitted a marketing application to the U.
    S.
    FDA in May 2019.
    During this period, Luye received a complete response letter (CRL) from the FDA regarding the product.
    In the letter, the FDA requested Luye to provide more information and solve the inspection problem of the raw material drug production site.
    , The US approval of Risperidone Microspheres II for injection will be delayed.

    Risperidone Microspheres II for injection has passed the priority review and approval method and was approved by the National Food and Drug Administration on January 14 this year.
    Its patents have been authorized in China (including mainland China and Hong Kong), the United States, Europe, Japan, South Korea, Russia, Canada, and Australia, and the patent period is up to 2032.

    5.
    Cidacchi Oron (cilta-cel)

    5.
    Cidacchi Oron (cilta-cel)

    Company: Legendary Bio

    Indications: Treatment of relapsed and/or refractory multiple myeloma (MM) in adults

    cilta-cel is a CAR-T therapy targeting B cell maturation antigen (BCMA) independently developed by Legend Bio, and it is also the first variety to be included in CDE as a breakthrough therapy.
    In December 2017, Yang Sen (a Johnson & Johnson company) and Nanjing Legend (a subsidiary of KingScript Biotechnology) reached a license agreement.
    Nanjing Legend granted Yang Sen the right to jointly develop and promote cilta-cel globally.

    On December 21st, Janssen/Legendary Bio announced that it has begun rolling submission of cilta-cel's Biologics License Application (BLA) to the FDA for the treatment of relapsed and/or refractory multiple myeloma in adults.
    The application materials have been submitted recently.

    cilta-cel is expected to become the first cell therapy approved by a Chinese company in the United States, and it is also expected to become the world's second BCMA CAR-T cell immunotherapy approved for marketing after Bristol-Myers Squibb Abecma.

    6.
    Surufatinib

    6.
    Surufatinib

    Company: Hutchison Pharmaceutical

    Indications: Pancreatic and non-pancreatic neuroendocrine tumors

    Sofatinib is a new oral tyrosine kinase inhibitor independently developed by Hutchison Medicine.
    Based on two phase III neuroendocrine tumor clinical studies in China and data support in the treatment of patients with non-pancreatic and pancreatic neuroendocrine tumors in the United States, Hutchison Medicine submitted a rolling submission of Sofantinib for the treatment of pancreas to the U.
    S.
    FDA on December 28, 2020 A new drug application for non-pancreatic neuroendocrine tumors (NETs), this is Hutchison’s first US NDA.
    If approved, Sofatinib will be the first local innovative drug to be simultaneously marketed globally using Chinese clinical research data, or it will create a record for the approval of Chinese drugs in the European and American markets.

    Sofatinib was approved for listing in China on December 30 last year under the trade name Sutaida.
    For the treatment of non-pancreatic neuroendocrine tumors (NET), it is the only VEGFR-TKI drug approved for the treatment of non-pancreatic NET in the world.
    The marketing application of Sofatinib for the treatment of pancreatic NET indications is under review by the State Food and Drug Administration.

    7.
    Teriprolizumab

    7.
    Teriprolizumab

    Company: Junshi Bio

    Indications: recurrent or metastatic nasopharyngeal carcinoma

    On March 3, Junshi Biotech announced that it had begun rolling submission of teriprizumab to the US FDA for the treatment of BLA for recurrent or metastatic nasopharyngeal carcinoma.
    Since this indication was approved as a breakthrough therapy by the FDA in September last year, it can be submitted to the FDA on a rolling basis and obtained rolling review.
    Teriplizumab is the first domestic anti-PD-1 monoclonal antibody to submit BLA to the FDA.

    Teriplizumab is also China’s first anti-PD-1 domestic monoclonal antibody drug approved for marketing.
    Since its first approval for marketing in December 2018, two indications have been conditionally approved for marketing by NMPA.
    Unresectable or metastatic melanoma that has previously failed systemic treatment and recurrent/metastatic nasopharyngeal carcinoma that has failed second-line or above systemic treatment.
    In addition, the indications for the treatment of locally advanced or metastatic urothelial cancer that have been treated in the past will soon be approved; the first-line treatment of nasopharyngeal carcinoma indications are in the approval stage.
    According to the financial report, the sales of Teriplimumab in 2020 will be 1.
    003 billion yuan.

    8.
    Recombinant human granulocyte colony stimulating factor-Fc fusion protein (Ryzneuta™, F-627)

    8.
    Recombinant human granulocyte colony stimulating factor-Fc fusion protein (Ryzneuta™, F-627)

    Company: Yiyi Bio

    Indications: Prevention and treatment of neutropenia caused by cancer patients during chemotherapy

    F-627 is an innovative biopharmaceutical developed by Yiyi Biologics (formerly known as Jiannenglong), a subsidiary of Efan Pharmaceuticals, based on the proprietary and independent intellectual property rights Di-Kine bimolecular technology platform.
    The type of drug belongs to the Fc fusion protein and is expressed by CHO cells.
    Recombinant human granulocyte colony stimulating factor (rhG-CSF) dimer, with long-acting and potent biological characteristics, is used to prevent and treat neutropenia caused by cancer patients during chemotherapy.

    On March 31 this year, Yiyi Biotech submitted a BLA application for F-627 to the US FDA.
    EiBio is the first biopharmaceutical company to complete Phase I, Phase II and Phase III clinical trials at home and abroad and declare BLA to the US FDA.

    9.
    Punabulin

    9.
    Punabulin

    Company: Wanchun Pharmaceutical

    Indications: In combination with G-CSF, it is suitable for severe neutropenia (CIN) caused by myelosuppressive anticancer drugs in patients with non-myeloid malignant tumors

    Pranabrin is a First-In-Class new drug independently researched and developed by Wanchun Pharmaceutical.
    It is a new small molecule drug optimized with natural seaweed active ingredients.
    The breakthrough features of Pranabrin include: ①75% of clinical adverse events occurred during the first 8 days, and the current standard therapy G-CSF cannot take effect in the first 8 days.
    Pranabrin can quickly take effect in the first 8 days to protect neutrophils; ② When combined with G-CSF, it forms a complement, significantly reducing the incidence of severe CIN in patients with non-medullary cancer due to chemotherapy.

    In the second half of 2020, the National Food and Drug Administration of China and the U.
    S.
    FDA respectively granted pranablin breakthrough therapy designation for the treatment of CIN.
    On March 31, Wanchun Pharmaceutical submitted a marketing application to NMPA and FDA at the same time, becoming the first product of Wanchun Pharmaceutical to declare for marketing.

    In addition to the above nine innovative drugs, HLX02 (trastuzumab) developed by Henlius was approved by EMA in July 2020; Biotech also announced that it had submitted BAT1706 to EMA and the US FDA at the end of November last year.
    (Bevacizumab) application for marketing of biological products.
    This is the first time Biotech has submitted a marketing authorization application outside of China, and it is also the first domestic bevacizumab biosimilar to be marketed in the United States.

    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.
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