SHANGHAI and HONG KONG, March 18, 2022 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced its financial results for the full year ended December 31, 2021 and provided corporate updates on key events and achievements since the start of 2021.
"The last 15 months have been a time of significant achievements for Antengene," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "The company was founded to develop innovative cancer medicines to treat patients beyond borders, worldwide. We have delivered on our vision this year and significantly de-risked the Company. We accomplished this by securing our first regulatory approvals for our lead first-in-class/only-in-class product, XPOVIO® (selinexor), across China and 3 Asia-Pacific countries, and making the transition to a commercial organization, and by significantly advancing our portfolio with potential first-in class/best-in-class clinical programs in China, Australia and the US."
Dr. Mei continued, "We also delivered on our mission of building a research-driven biopharmaceutical company that is developing transformational, best-in-class/first-in-class medicines for cancer, focusing on resistant or relapsing diseases with high unmet medical needs. Today, we have 8 programs in 18 clinical studies, including 5 registrational trials, utilizing our internal capabilities and platform and clinical development partnerships. We have built a team of over 350 employees across China, the US and APAC regions, and have built core capabilities in drug discovery, development, manufacturing and commercialization."
"Looking ahead," said Dr. Mei, "2022 is the fifth anniversary of Antengene's founding and we believe it will be a landmark year for the Company. We expect to have regulatory approvals for selinexor in all 6 markets in Greater China and Asia Pacific markets where we have submitted new drug applications (NDAs). We are optimistic about the first launch of selinexor in Q2:22 in China, based on strong participation in the Named Patient Program (NPP) as well as the inclusion of selinexor in several important practice treatment guidelines. In addition, we expect to report data on at least 5 clinical programs and file 2 new investigational new drug (INDs), from in-house development programs."
In conclusion, Dr. Mei said "Looking forward, we believe our strong cash, bank balances and cash management products of RMB 2.370 billion, and revenue growth will continue to fund advancement of our programs and continue to deliver additional value for investors. Since cancer are diseases that knows no borders, we are devoted and passionate in advancing our programs to treat cancer patients beyond borders, worldwide. Antengene is optimistic about this year and the future based on the excellent work of our team and collaborators, all around the world, and we look forward to updating you on our progress as the year unfolds."
Overview of Antengene's Products and Clinical Pipeline:
XPOVIO® (selinexor) Commercial Approvals, Bridging Studies and Inclusion in Practice Treatment Guidelines: Antengene is strategically investing in XPOVIO® (selinexor) and positioning the product for a successful commercial launch across the Asia-Pacific region based on solid registrational data and a growing body of studies to support product adoption and label expansions. In addition, Antengene has implemented a well-supported Named Patient Program, and built a highly experienced, well respected commercial team to position for market launch and revenue growth.
Business Development: focused on partnerships to facilitate clinical collaborations, in-license novel programs or enable access to novel platform/drug development technologies to complement and enrich our in-house capabilities.
Clinical Program Poised to Deliver Multiple Data Readouts in 2022 and 2023 (originated in-house/through partners): The Antengene pipeline has been developed with a special focus on key mechanisms linked to relapsing/resistant disease including metabolic changes, genetic alterations, the tumor microenvironment and immune suppression/down-regulation. With a robust R&D portfolio, Antengene is well-positioned to evaluate proprietary combinations, further differentiating its programs.
Mid to Late-Stage Programs: (Antengene has certain Asia-Pacific rights): Antengene is exploring two members of the novel XPO1 family plus a novel mTOR cell growth inhibitor.
Selinexor (ATG-010, first-in-class XPO1 inhibitor): Antengene has developed a robust program to maximize the clinical utility for selinexor and the XPO1 class. The drug is being evaluated for new cancer indications, including maintenance treatment of endometrial cancer, and in combination with standard therapy for MM and DLBCL. The objective of these programs is to potentially improve response rates, maintain disease control, and expand the clinical utility of the drug.
Selinexor Data Presentations:
Eltanexor (ATG-016, second generation XPO1 inhibitor): An expansive program to evaluate ATG-016 monotherapy in:
Eltanexor Data Presentations:
Onatasertib (ATG-008, dual mTORC1/2 inhibitor) targets multiple key mTOR cell growth pathways. Data from the TORCH-2 Phase 1/2 solid-tumor dose-finding study in combination with PD-1 antibody was reviewed at Antengene's 2021 R&D Day in November 2021. This promising signal warrants further exploration and Antengene will move rapidly to expand the study whilst exploring a potential accelerated regulatory path (sponsored by Antengene).
Early-Stage Clinical Programs (Antengene has global rights)
Planning 2 INDs per Year (Antengene has global rights): Antengene has developed a vibrant, productive R&D team.
Corporate Updates: Corporate milestones related to development of critical research and development and manufacturing infrastructure to support biological and small molecule programs highlight Antengene's transition to a fully-integrated biopharmaceutical company are exemplified by opening and development of two major manufacturing and R&D centers. These resources help Antengene stand out in the industry.
Antengene's selection as a constituent stock in highlights the Company's significant progress since its November, 2020 IPO.
Financial Results
Cash, bank balances and cash management products: Cash, bank balances and cash management products at December 31, 2021 were RMB2,370.5 million as compared to RMB3,109.8 million at December 31, 2020.
Research and development costs: Research and development costs for the year ended December 31, 2021 were RMB405.0 million as compared to RMB347.7 million for the comparable period in 2020.
The increase relates to increased drug development expenses and expansion of R&D personnel.
Selling and distribution expenses: Selling and distribution expenses for 2021 were RMB67.9 million compared to RMB0.5 million for 2020.
The increase is primarily attributable to increased employee head count and professional fees related to preparations for the planned launch of our lead product, XPOVIO® (selinexor) in 2022.
Administrative expenses: Administrative expenses for 2021 were RMB169.5 million compared to RMB154.2 million for 2020.
The increase is attributable to increased professional fees and headcount related to costs of operating as a public company and in support of commercial operations.
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for cancer and other life-threatening diseases. Driven by its vision of "Treating Patients Beyond Borders", Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has obtained 22 investigational new drug (IND) approvals in the US and in Asia, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor/ATG-010/XPOVIO® in China, South Korea, Singapore and Australia approved. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. Antengene has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.
Forward Looking Statement
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled "Risk Factors" in our periodic reports filed with the Hong Kong Stock Exchange and the other risks and uncertainties described in the Company's Annual Report for year-end December 31, 2020, and subsequent filings with the Hong Kong Stock Exchange.
For more information, please contact:
Investor Contacts:
Donald Lung
E-mail: Donald.Lung@antengene.com
Mobile: +86 18420672158
PR Contacts:
Peter Qian
E-mail: Peter.Qian@antengene.com
Mobile: +86 13062747000