—During the reporting period, Akeso's revenue was RMB3,676.9 million, an increase of 2,154.4% from 2022H1; Akeso recorded a profit of RMB2,489.5 million. —RMB2,915.2 million was recognized by Akeso as license fee income during the reporting period due to the receipt of an upfront payment equivalent to US$500 million for Akeso's PD-1/VEGF bispecific antibody (ivonescimab) out-licensing agreement with Summit Therapeutics Inc. —The total product sales were RMB794.7 million.
HONG KONG, Aug. 29, 2023 /PRNewswire/ -- Akeso (9926. HK) released its 2023 interim performance: the Company achieved financial profitability for the first time in the first half of 2023, reaping success in new drug development, commercialization and globalization.
Currently, Akeso has a total of 13 registrational Phase III clinical trials underway for 4 products, 3 drugs are approved. In addition, 40+ Investigator initiated trials (IITs) for cadonilimab are underway. Ivonescimab(PD-1/VEGF) is Akeso's another bispecific antibody. 1 NDA of ivonescimab has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). There are 4 Phase III clinical trials been initiated/are underway globally, of which 3 are Phase III clinical trials with PD-1 monoclonal antibody as the positive control drug, 2 are international multicenter Phase III clinical trials; 9 Phase II clinical trials for Ivonescimab have been conducted. Ivonescimab in combination with chemotherapy for patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC progressing on third-generation EGFR-TKI therapy (HARMONi / AK112-301) is enrolling patients; In December 2022, Akeso out-licensed Summit Therapeutics exclusive rights to ivonescimab (PD-1/VEGF) for the development and commercialization in the United States, Canada, Europe, and Japan in. Akeso is to receive a US$500 million upfront payment and the total potential deal value is up to US$5 billion including regulatory and commercial milestone payments. And Akeso will also receive a low double-digit percentage of royalties on net product sales of ivonescimab . The clinical development of CD47, IL-4R, IL-17, CD73, TIGIT and other phase II and III target products is also in orderly progress. "We are very encouraged to see that our team has continued to achieve excellent results.In the first half of 2023 we had our best results since the company's inception in terms of financial performance, commercialization of new drugs, clinical development, and operation."
Said Dr. Michelle Xia, founder, Chairwoman, CEO, and President of Akeso. "Such achievements do not come easily in a complex and difficult external situation. We would like to thank Akeso's team for their ten years of continual pursuit of excellence and improvement. We have put into practice the concept of new drug development driven by clinical value, maintain a forward-looking strategic layout and exceptional managerial efficiency, calmly respond to market changes, seize development opportunities, and grow on an ongoing basis. In the future, with successive approval of our innovative core products and their broad indications, and the further increase in our operational and managerial capabilities, Akeso will enter another period of rapid growth. We will continue to work diligently, professionally, and effectively to promote the more rapid, thorough, and wide-ranging translation of new drug innovations into global value, and we look forward to seeing the company enter a new stage of commercialization and sustained profitability in the coming years, to better deliver innovative clinical value to patients, and reward society and investors."Dr. Michelle Xia said.