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

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)
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• 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
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  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
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• The company presents preliminary clinical data at SITC 2020
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  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
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• In December 2020, the SEARCH-01 phase II clinical trial of Jiangsu Kangning Jereh KN026 combined with KN046 completed the first patient's administration
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  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
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• 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)
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  This is the third orphan drug designation granted to the company by the FDA
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• 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
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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
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• 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
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• 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
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• 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
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• 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
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• 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
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• 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
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• Dr.
  Xu was awarded the 6th "Suzhou Outstanding Talent Award" by the Suzhou Municipal Government
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• Corning Jereh Biopharmaceuticals (9966.
  HK) was included in the Hang Seng Composite Index
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• 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
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• 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
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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
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• Corning Jerry's management team has further expanded, including the appointment of Dr.
  Johannes Nippgen as Chief Medical Officer
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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
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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
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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
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• 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)
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  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)
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• 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)
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  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
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• 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)
  .