On March 15, 2023 Akeso Inc. (HKEX Code: 9926.HK, "Akeso", or the "Company") reported its 2022 annual report (Press release, Akeso Biopharma, MAR 15, 2023, View Source [SID1234628836]). During the reporting period, the company enjoyed booming business development and made breakthrough progress in drug innovation and development, commercialization and internationalization.
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开坦尼（cadonilimab, PD-1/CTLA-4 bispecific antibody）saw a strong start
With excellent safety and efficacy profile, a well-established commercialization platform and great efforts by the highly productive sales force, 开坦尼 recorded strong sales of RMB546.3 million for the financial year ended December 31, 2022.
On June 29, 2022, 开坦尼 , the first-in-class PD-1/CTLA-4 bi-specific antibody independently developed by the company, has been granted marketing approval by the NMPA for the treatment of recurrent or metastatic cervical cancer (R/M CC) patients who have progressed on or after platinum-based chemotherapy. 开坦尼 is the first approved dual immune checkpoint inhibitor bispecific antibody globally, addressing a huge unmet medical need for immunotherapy for advanced cervical cancer in China, and is also pioneering the development of bispecific antibodies in China.
安尼可(penpulimab injection, PD-1), jointly developed by Akeso and Sino Biopharmaceutical Limited (stock code: 1177.HK), recorded product sales of RMB558.1 million in 2022, increasing 164%. In April 2022, three indications were included in the 2022 CSCO Guideline, which are penpulimab for treatment of refractory/relapsed classic Hodgkin Lymphoma (r/r cHL), penpulimab in combination with chemotherapy as first-line treatment of squamous NSCLC, penpulimab as secondline treatment or salvage treatment of recurrent/metastatic nasopharyngeal carcinoma (r/m NPC). In January 2023, 安尼可 in combination with chemotherapy as first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer was approved by NMPA.
Expediting global collaboration and development signified by landmark outlicensing transaction of ivonescimab (PD-1/VEGF, AK112）
Another breakthrough development was overseas licensing which set a new record for the transaction amount of a single innovative drug in China. In December 2022, exclusive development licensing rights were granted to Summit Therapeutics in the United States, Canada, Europe and Japan for ivonescimab, a breakthrough PD-1/VEGF bispecific antibody independently developed by Akeso. Akeso has received an upfront payment equivalent to US$500 million and the total potential deal value is up to US$5 billion, including regulatory and commercial milestone payments. Akeso will also receive a low double-digit percentage of royalties on net product sales.
Currently, the cooperation between the two sides has been deeply and completely carried out, which fully demonstrates the huge global commercialization potential of ivonescimab and paves a fast track for its globalization and commercialization.
Strong R&D efficiency contributed to six products in 14 Pivotal/Phase III studies
During the reporting period, Akeso’s new drug development entered the advanced stage in batches, and a total of 14 clinical studies were in the Pivotal/Phase III stage, six of which have completed enrollment and will soon submit marketing applications.
The Phase III clinical studies on 开坦尼 for major indications including first-line cervical cancer, first-line gastric cancer and hepatocellular cancer were advanced efficiently, while those for first-line cervical cancer and first-line gastric cancer were enrolled.
The patient enrollment of Phase III clinical trial of ivonescimab plus chemotherapy versus chemotherapy in EGFR mutated advanced non-squamous NSCLC that failed in prior EGFR-TKI therapy, has been completed. Ivonescimab monotherapy versus pembrolizumab monotherapy as the first-line treatment for NSCLC patients with positive PD-L1 expression is going well, and the Phase III trial of ivonescimab plus chemotherapy versus PD-1 inhibitor plus chemotherapy for advanced squamous NSCLC was approved. Ivonescimab has received Breakthrough Therapy Designation Status in China for three indications in lung cancer.
In the field of autoimmunity and metabolism, the first applications for new drug marketing are expected to be submitted in 2023 for two Phase III studies on ebdarokimab (IL-12/IL-23, AK101) for the treatment of moderate to severe psoriasis and ebronucimab (PCSK9, AK102) for the treatment of hypercholesterolemia.
"We are pleased to see our best performance since the company’s establishment, particularly the strong growth in sales of our two new drugs, as well as the record licensing agreements for our self-developed drug, which reflect the tremendous clinical and commercial value of our innovative drugs and demonstrate our robust commercialization capability in the first place. These achievements are mainly due to our strategic vision and R&D layout ability, its drug innovation R&D system at the forefront of science, a high standard and demanding production system, and our professional management and execution. These provide a solid foundation for us to fulfill our mission and embark on a new journey in biopharma," said Dr. Michelle Xia, co-founder, Chairwoman, CEO, and President of Akeso.
"Over the next five years, we will be launching more than six independently developed new drug varieties, covering a broad range of areas including cancer, autoimmunity and metabolism." Dr. Michelle Xia said.