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    Home > Active Ingredient News > Drugs Articles > Under-skin injection PD-L1 single anti-KN035 listing application was accepted by CDE! Treatment of MSI-H/dMMR solid tumors

    Under-skin injection PD-L1 single anti-KN035 listing application was accepted by CDE! Treatment of MSI-H/dMMR solid tumors

    • Last Update: 2021-01-04
    • Source: Internet
    • Author: User
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    On December 22, Corning Jerry Biopharmaceuticals ("Corning Jerry") announced that it had reached a strategic partnership with Syndicate Pharmaceuticals Group Co., Ltd. ("First Sound Pharmaceuticals") to restructure the humanized PD-L1 mono-domain antibody Nvolly monoanti-anti-injection (research and development code: KN035) The application for a biological product listing license (BLA) was accepted by the State Drug Administration (NMPA) on December 17, and the relevant adaptations include standard treatment for failed microsatellite instability (MSI-H)/mismatch repair functional defects (dMMR) advanced colorectal cancer, stomach cancer and other advanced solid tumors.
    KN035 (Nwolly monoantigen injection) is CorningEry's first declared market product and is expected to become the world's first subscapeor injection PD-L1 inhibitor to address unsolved clinical needs.
    microsatellite unstable esophageal (MSI-H) is widely present in multiple solid tumors, with a relatively high incidence of MSI-H in solid tumors such as stomach cancer (GC), colorectal cancer (CRC), bile throid cancer, prostate cancer, endometrial cancer, etc.
    a large number of clinical studies have shown that microsatellial instability (MSI-H)/mismatch repair functional defects (dMMR) are important predictive biomarkers for tumor immunotherapy, and these patients are more likely to benefit from immuno-checkpoint inhibitor therapy such as PD-L1.
    KN035 (Nwolly monoantigen injection) is expected to become the first PD-(L)1 monoantigen approved by the National Drug Administration for MSI-H/dMMR pan-tumor solid tumor adaptation.
    KN035 (Nwolly monoantigen injection) was independently developed by Corning Jerry, and the results show good safety and effectiveness in clinical trials of multiple tumor indications.
    This BLA is based on a critical phase II clinical trial evaluating KN035 (Nwolly monoantigen injection) single-drug treatment of microsatellite instability (MSI-H)/mismatch repair functional defect (dMMR) advanced solid tumor, and includes a total of 103 first-line and above systematic treatment failures of Chinese MSI-In patients with advanced H/dMMR solid tumors, the objective remission rate (ORR) was 42.7%, 43.1%, 44.4% and 40.0%, respectively, in the general population, colorectal cancer (CRC), stomach cancer (GC) and other tumor patients assessed by the Independent Review Committee (BIRC).
    Professor Shen Lin of Peking University Cancer Hospital, lead researcher in the Nwolli monoanti-anti-clinical trial, said: "The Nwolly monoantigen with under-the-skin injections has demonstrated long-lasting efficacy and good safety in key clinical studies, providing new safe, effective and convenient treatment options for patients with MSI-H/dMMR advanced solid tumors who have failed at least the first-line standard in the past.
    we look forward to the launch of Nvolly monoanti and the clinical benefits for our patients.
    "KN035 is the world's first off-the-cul-de-cor injection PD-L1 inhibitor and will fill the gap in immunotherapy for relevant allergens in China when approved," said Dr. Xu Wei, founder, chairman and president of Corning Jerry.
    thanks to the support of the researchers and patients involved in the clinical trial, as well as the partners and all the staff, we look forward to the early approval of KN035 for the benefit of more patients and their families.
    Corninger will use this as a cornerstone to continue to pioneer cutting-edge oncology immunotherapy and use our innovations to light the lives of patients and their families around the world. "The application for the listing of a new drug with Nwolly monoanti-anti-injection fluid has been formally accepted by the State Drug Administration, which is a major stage achievement in the process of clinical development and commercialization of Yidi Pharmaceuticals," said Dr. Yu Zhaolong, Chairman and CEO of
    Idea Di Pharmaceuticals.
    , Wedi Pharmaceuticals will continue to work closely with partners to advance follow-up efforts to achieve the early launch of Nvolly monoantigen injections.
    we believe that Nwolli's differentiation benefits will provide better treatment options for cancer patients in China. Mr. Jinsheng Ren, Chairman and CEO of
    Synthesic Pharmaceuticals, said, "Synthesic Pharmaceuticals already has a number of innovative drugs and first-market portfolios in the field of oncology treatment, and we look forward to Nwari monoantitor with unique differentiation to bring better treatment options to both clinical and patients."
    At the same time, with the support of policies to accelerate review and approval, we are confident that we will work with strategic partners and clinical research institutions to accelerate the clinical development and commercialization of this innovative product and work together to enable patients to use more effective drugs at an early stage.
    " about KN035 KN035 (generic name: Nwolly monoantigen injection) is Corning Jerry's self-developed PD-L1 mono-domain antibody Fc fusion protein, based on its unique design, in terms of safety, convenience, compliance advantages, patients do not need intravenous drips, while having low medical costs.
    March 30, 2020, Corning Jerry, Thought Di Pharmaceuticals, Synth Pharmaceuticals reached a strategic cooperation, Corning Jerry as the original research party responsible for production and quality, Thought Dee Pharmaceuticals is responsible for clinical development in the field of oncology, Synth Pharmaceuticals is responsible for the exclusive commercial promotion of products in Chinese mainland.
    KN035 (Nvoli monoanti-injection) has been conducted in China, the United States and Japan for a number of tumor adaptations simultaneous clinical trials, multiple adaptations have entered the registered / III. phase of clinical.
    KN035 (Nwolli monoantigen injection) has been approved by the FDA as an orphan drug for advanced bile disease.
    December 17, 2020, the National Drug Administration (NMPA) officially accepted the application for a license (BLA) for the listing of KN035 (Nwolli monoanti-injection) biological products.
    about Corning Jerry Corning Jerry Biopharmaceuticals is a biopharmaceutical company focused on the development, production and commercialization of innovative anti-tumor biometric drugs.
    12, 2019, the Company is listed on the Main Board of the Stock Exchange of Hong Kong.
    Corning Jerry Biopharmaceuticals has a fully integrated discovery, development and manufacturing platform for dual-specific antibody and protein engineering.
    's product pipeline includes eight highly differentiated anti-tumor candidates with independent intellectual property rights and a Covid-19 multi-functional antibody, four of which are clinically available in Phase I.-III.
    has a number of technology platforms with independent intellectual property rights, such as isodes and mixed antibodies, and large-scale production capacity in line with China, the United States and the European Union cGMP standards, and through a complete quality system that has been audited several times, including by EU QPs.
    is committed to building an international leading, multi-dimensional drug development and industrialization platform, focusing on multi-functional bio-molecular new drugs for the benefit of patients in China and around the world.
    About Idea Di Pharmaceuticals Thought Di Pharmaceuticals is a biopharmaceutical company in the stage of late clinical development and early commercialization layout, adhering to the concept of "helping cancer patients live longer and better", focusing on the future trend of slow-pathogenic treatment of tumors, focusing on the development of differentiated new generation of cancer immunotherapy drugs for cancer patients worldwide, extending the survival time of cancer patients and improving the quality of life of patients.
    company's product line includes a new generation of biomolytic and small-molecule chemicals, and has a team with international capabilities for new drug development, registration and commercial operations.
    About Acoustic Pharmaceuticals Synth Pharmaceuticals is a research and development-driven, rapid transformation to innovation of China's top 100 pharmaceutical enterprises, approved by the Ministry of Science and Technology to build a "national key laboratory for translational medicine and innovative drugs."
    focuses on the three major diseases of cancer, central nervous system and autoimmune, and is committed to making more effective drugs possible for patients at an early time.
    with excellent research and development and commercialization capabilities, its main products in China to maintain a leading market share.
    Pioneer Pharmaceuticals adheres to an open and innovative research and development strategy, and has become a strategic partner with a number of multinational companies and biotechnology companies to promote the value realization of global life science achievements in China.
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