On March 28, 2023 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), reported its full-year 2022 financial results and provided updates on key events and achievements since the start of 2022 (Press release, Antengene, MAR 28, 2023, View Source [SID1234629463]).

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1. Sales Revenue Reached 5.6 Times Year-Over-Year while the Adjusted Loss Narrowed by 10.3%

– XPOVIO (selinexor), Antengene’s first commercialized product and the world’s first oral XPO1 inhibitor leveraging a novel mechanism of action, generated a total of RMB160 million in revenue in 2022, a sum amounted to 5.6 times of 2021 (the product was commercially launched in Mainland of China on May 13, 2022).

– As a result of the strong revenue growth, the adjusted loss for 2022 was narrowed by 10.3%.

2. First/Best-in-Class Potential Clinical Programs as Value Drivers for Future Growth of Antengene

– Antengene has built a pipeline of 9 oncology programs at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. Some of these assets, such as ATG-031 (anti-CD24 antibody), have first-in-class potentials; while others, such as ATG-008 (mTORC1/2 inhibitor), ATG-037 (CD73 inhibitor), ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-008 (ATR inhibitor), ATG-022 (Claudin 18.2 antibody-drug conjugate), and ATG-017 (ERK1/2 inhibitor), have best-in-class potentials. These assets are currently being evaluated in a total of 16 clinical trials around the world.

– Clinical achievements in 2022 and early 2023 include obtaining 7 IND approvals and an Orphan Drug Designation, as well as the dosing of the first patient in 5 studies.

– Released results from 16 preclinical and clinical studies at 7 renowned international congresses and medical journals including the AACR (Free AACR Whitepaper), ASCO (Free ASCO Whitepaper), SITC (Free SITC Whitepaper), CSCO, EHA (Free EHA Whitepaper), ASH (Free ASH Whitepaper) and BMC Medicine.

3. Fast-Growing Pan-APAC Commercialization of XPOVIO

– The commercialization network for XPOVIO in China now covers 600 hospitals and over 120 direct-to-patient (DTP) pharmacies in over 30 provinces and autonomous regions, and municipalities. XPOVIO attained 34 urban-customized commercial health insurance listings (Huiminbao).

– 6 XPOVIO regimens received a total of 27 inclusions or upgraded recommendations by 7 major clinical guidelines and evidence-based studies. In addition, XPOVIO was also included into 2 Guiding Principles for Clinical Applications and expert consensuses.

– In 2022, XPOVIO obtained NDA approvals in 3 markets including Australia, Singapore, and Taiwan, China. In addition, Antengene secured the first APAC reimbursement listing for XPOVIO by the Pharmaceutical Benefits Scheme (PBS) in Australia. NDAs for XPOVIO were submitted in 3 other countries and regions including Macau, China, Thailand, and Malaysia.

– In 2023, Antengene expects XPOVIO to be approved in Hong Kong, China and Macau, China and plans to submit an NDA for XPOVIO in Indonesia. Moreover, the company also plans to submit a supplementary New Drug Application (sNDA) for XPOVIO for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) in Mainland of China.

4. High Profile Clinical Trial Collaborations in 2022

– Entered into a clinical collaboration with BeiGene on a Phase I/II study evaluating XPOVIO in combination with tislelizumab in patients with T and NK-cell lymphoma.

– Entered into a clinical collaboration with MSD on the Phase I STAMINA-001 trial designed to evaluate ATG-037 in combination with pembrolizumab in patients with locally advanced or metastatic solid tumors.

5. A Strong Cash and Bank Balance to Provide Runway Beyond 2025

– As of December 31st, 2022, the company has a cash and bank balance of about RMB1.8 billion. This strong cash and bank balance, together with the strong near-term revenue growth potential of XPOVIO and careful spending, enables the continuous growth, development, and operation of Antengene beyond 2025.

"In 2022, we made notable strides on multiple fronts of our business. The revenue from our lead product, XPOVIO, reached RMB160 million in 2022, a sum amounted to 5.6 times year-over-year. Meanwhile, we delivered crucial milestones in drug discovery and development, with a number of our potential BIC/FIC programs already entered clinical studies in Australia, Mainland of China, and the U.S. We expect these clinical programs to begin yielding results sometime during 2023 and 2024," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "This impressive performance is a testament to the highly effective global collaboration by our commercial teams and the company’s strong capabilities in drug discovery and development. Moreover, we expect our cash and bank balances totalling about RMB1.8 billion to support Antengene’s planned operations and revenue growth beyond 2025. Moving forward, we will continuously strive to become a leading multinational biopharmaceutical company with a portfolio of commercialized products, committed to improving the quality of life for cancer patients and creating value for our shareholders and partners."