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    Home > Medical News > Medicines Company News > Corning Jereh announces 2020 full-year financial results and company progress

    Corning Jereh announces 2020 full-year financial results and company progress

    • Last Update: 2021-07-14
    • Source: Internet
    • Author: User
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    • The company announced at the 2020 ASCO annual meeting the clinical trial results of KN035 for patients with advanced tumors with mismatch repair defects and the combination of KN035 and chemotherapy for the treatment of advanced gastric or gastroesophageal junction tumors (GC/GEJ)


      • In January 2021, KN035 was granted priority review by the Center for Drug Evaluation of China National Medical Products Administration




        • On April 15, 2020, Jiangsu Corning Jerry received an approval notice from the FDA, approving KN046 to conduct Phase II clinical trials for NSCLC in the United States


          • In January 2021, the ENREACH-Thymic registered clinical trial completed the first patient administration




            Progress during the reporting period

            • On May 12, 2020, two IND applications for Jiangsu Corning Jerry were approved by the CDE, including: Phase Ib clinical study to evaluate the effectiveness, safety and tolerability of KN026 combined with KN046 in the treatment of HER2-positive or HER2-expressing solid tumors; evaluation; KN026 is a phase II clinical study on the effectiveness and safety of KN026 as a monotherapy or combination treatment of HER2 low expression or HER2 positive recurrent/metastatic breast cancer (mBC)
              .
            • The company announced the KN026 Phase I clinical trial data for patients with HER2-positive metastatic breast cancer (mBC) in China at the ASCO annual meeting in 2020
              .
              The results showed that KN026 was well tolerated and showed encouraging anti-tumor activity in HER2-positive breast cancer patients who failed standard anti-HER2 therapy
              .
            • The company presents preliminary clinical data at SITC 2020
              .
              The combination therapy of KN026 and KN046 has achieved preliminary positive results in a phase Ib clinical trial for patients with HER2-positive solid tumors who have failed standard treatments
              .
            • In December 2020, the SEARCH-01 phase II clinical trial of Jiangsu Kangning Jereh KN026 combined with KN046 completed the first patient's administration
              .
              SEARCH-01 is an open-label, phase II, multi-center clinical study designed to evaluate the effectiveness, safety and tolerability of KN026 combined with KN046 in the treatment of HER2-positive solid tumors
              .
            • In December 2020, the FDA granted KN026 and KN046 combination therapy orphan drug designation for the treatment of HER2-positive or low expression gastric cancer and gastroesophageal junction cancer (GC/GEJ)
              .
              This is the third orphan drug designation granted to the company by the FDA
              .
            • In December 2020, the company received the approval of the IND application for KN026 combined with Aiboxin® (pibecili) or KN026 and Aiboxin® (piperazil) and fulvestrant combination therapy from the China National Medical Products Administration.
              In the treatment of HER2-positive locally advanced unresectable and/or metastatic breast cancer that has failed the treatment of trastuzumab and taxanes
              .


            2.
            Business operations


            Dynamics during the reporting period

            • On May 22, 2020, Jiangsu Corning Jerry and InxMed entered into a partnership agreement to jointly develop KN046 and the focal adhesion kinase inhibitor IN10018 as a combination therapy to explore the synergistic effect of the combination of KN046 and IN10018
              .
            • On May 28, 2020, Jiangsu Corning Jerry and Guangdong Dongyang Sunshine entered into a new cooperation agreement to expand the original cooperation.
              The two parties agreed to jointly develop multi-target small molecule kinase inhibitor CT053 (Ningatinib p-toluenesulfonate) and KN046 Anti-tumor combination therapy used in the field of solid tumors
              .
            • On June 9, 2020, Jiangsu Corning Jerry and Sanofi entered into an exclusive option agreement for strategic cooperation to promote the joint clinical research of KN026 and Sanofi's product Taxotere® for HER2-positive breast cancer patients
              .
            • On June 10, 2020, Jiangsu Corning Jerry and Shanghai Pasteur Institute entered into a cooperative development agreement to cooperate on the joint development, production and commercialization of COVID-19 multispecific neutralizing antibodies
              .
            • On June 19, 2020, Jiangsu Corning Jereh and Sinoway signed a partnership agreement to promote the development of KN046 and the small molecule inhibitor XNW7201 as a combination therapy for tumor indications
              .
            • On July 30, 2020, Jiangsu Corning Jereh entered into a partnership agreement with Kaifeng Pharmaceutical to jointly develop a combination therapy of KN046 and GT90001 for the treatment of HCC
              .
            • In July 2020, the company was recognized as the first batch of high-tech enterprises in the Suzhou Free Trade Zone; it was recognized as the Jiangsu International R&D Center
              .
            • Dr.
              Xu was awarded the 6th "Suzhou Outstanding Talent Award" by the Suzhou Municipal Government
              .
            • Corning Jereh Biopharmaceuticals (9966.
              HK) was included in the Hang Seng Composite Index
              .
            • At the end of November 2020, the company was awarded the "Top 100 Chinese Pharmaceutical Innovative Enterprises" at the 2020 China Pharmaceutical Entrepreneur, Scientist and Investor Conference
              .
            • The company has been included in the list of Southbound Stock Connect stocks under Shenzhen-Hong Kong Stock Connect and will take effect on December 28, 2020
              .

            Dynamics after the reporting period

            • On January 6, 2021, the company was awarded the "Best Pharmaceutical and Medical Company" award at the Fifth Golden Hong Kong Stocks Annual Awards Ceremony held in Shenzhen
              .
            • Corning Jerry's management team has further expanded, including the appointment of Dr.
              Johannes Nippgen as Chief Medical Officer
              .


            3.
            Production base


            Jiangsu Corning Jerry's new production base phase I 2x2,000L production line (with a total designed capacity of more than 30,000L) has obtained a drug production license issued by the Jiangsu Provincial Drug Administration in July 2020
            .
            The production line is equipped with world-class equipment that complies with the relevant GMP regulations of China's National Food and Drug Administration, FDA and European Medicines Agency
            .


            2020 full year financial summary

            • For the year ended December 31, 2020, the Group recorded other income of RMB 111.
              1 million (compared to RMB 34.
              4 million for the year ended December 31, 2019), mainly including interest income, government grants and Other miscellaneous income
              .
            • For the year ended December 31, 2020, other losses of RMB 117.
              6 million were recorded (compared to RMB 0.
              3 million for the year ended December 31, 2019)
              .
              For the year ended December 31, 2020, the company’s total losses and overall expenses were RMB 427.
              8 million (compared to RMB 832.
              7 million for the year ended December 31, 2019)
              .
            • For the year ended December 31, 2020, research and development expenses were RMB 331.
              2 million (compared to RMB 166.
              7 million for the year ended December 31, 2019)
              .
              Mainly due to the increase in the number of ongoing clinical trials; the expansion of the scale of clinical research; the progress of the clinical trials of candidate drugs; the increase in R&D personnel resulted in increased staff costs and increased salaries
              .
            • Administrative expenses for the year ended December 31, 2020 were RMB 78.
              2 million (compared to RMB 117.
              7 million for the year ended December 31, 2019)
              .
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