January 26, 2025 (U.S. Eastern Time) – Ascentage Pharma Group International (Nasdaq: AAPG, HKEX: 6855) (the “Company” or “Ascentage Pharma”) announced its official listing on the Nasdaq Global Market today, becoming the first 18A company to achieve a dual listing on the U.S. stock market. This milestone marks the beginning of a new global chapter for Ascentage Pharma. In this offering, Ascentage Pharma offered 7,325,000 American depositary shares (“ADS”), with an offering price of USD$17.25 per ADS. The gross proceeds from the offering before deducting underwriting discounts and commissions and other offering expenses payable by Ascentage Pharma, are expected to be approximately $126.4 million. The offering is expected to close on January 28, 2025, subject to customary closing conditions.
Ascentage Pharma is committed to developing innovative drugs in therapeutic areas such as oncology to address unmet clinical needs of patients. The Company consistently adheres to a global innovation strategy centered on patients. On October 28, 2019, the Company was listed on the Main Board of The Stock Exchange of Hong Kong Limited under Chapter 18A of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited. Since its establishment, the Company empowered by its technical expertise in structure-based drug design and its innovative drug discovery engine has worked to address unmet medical need by targeting key proteins in apoptotic pathways, including Bcl-2 and MDM2-p53, as well as new-generation inhibitors targeting kinase mutations arising in cancer treatment. Ascentage Pharma has eleven completed or ongoing U.S. and/or international registrational trials.
The Company’s core product, olverembatinib, is the first third generation BCR-ABL inhibitor approved for marketing in China for the treatment of patients with CML in chronic phase(CML-CP) with T315I mutations, CML in accelerated phase(CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. All of its approved indications have been included in the National Reimbursement Drug List, or the NRDL and any participants in the national medical insurance program are eligible for full or partial reimbursement of the costs of medicines included in the National Drug Catalog for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance.
Currently, olverembatinib is undergoing three registrational Phase III clinical trials targeting chronic myelogenous leukemia (CML), Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL), and SDH-deficient GIST, with the clinical trial in CML receiving approval from the U.S. Food and Drug Administration (U.S. FDA). In terms of business development, in June 2024, Ascentage Pharma entered into an exclusive option agreement with Takeda, a multinational pharmaceutical company, for olverembatinib. Once exercised, the Option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of, among others, the mainland China, Hong Kong China, Macau China, and Taiwan China.
Another major product, Lisaftoclax (APG-2575), is a novel selective Bcl-2 inhibitor. Its new drug application (NDA) was accepted by the National Medical Products Administration (NMPA) Center of Drug Evaluation (CDE) in November 2024 and has been granted priority review for the treatment of relapsed and/or refractory (r/r) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Currently, lisaftoclax is undergoing four registration Phase III clinical trials covering CLL/SLL, acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other indications, one of which clinical trial has been cleared by the U.S. FDA.
The proceeds raised in this offering will primarily be used for;
(i) approximately US$50.0-60.0 million to pursue NDA approval of lisaftoclax for r/r CLL in China and to prepare for commercial launch in China, advance the clinical development of lisaftoclax in the United States and other countries, including completing enrollment for GLORA and pursuing clearance with regulatory authorities to add new trial sites in multiple countries and to pursue additional indications for lisaftoclax;
(ii) approximately US$30.0-40.0 million to advance the clinical development of olverembatinib in the United States and other countries, including completing enrollment for POLARIS-2 and pursuing clearance with regulatory authorities to add new trial sites in multiple countries, and to expand the label of olverembatinib into earlier lines and other indications;
(iii) approximately US$10.0-20.0 million to fund the research and development of our other product candidates, including completing the Phase 1 clinical trial for APG-5918 in anemia and pursuing clearance to initiate a registrational trial for alrizomadlin;
(iv) the remainder for the development of our future pipeline programs and for working capital and general corporate purposes
Dr. Yang Dajun, Chairman and CEO of Ascentage Pharma, stated: “We are very pleased to see Ascentage Pharma’s successful listing on Nasdaq. We thank our investors for their support and recognition. Looking back at the past year, Ascentage Pharma has achieved numerous milestones and has become one of the most outstanding companies among 18A companies listed in Hong Kong. From the Hong Kong market to Nasdaq, Ascentage Pharma has embarked on a new journey. Looking ahead, we will continue to advance our patient-centered global innovation strategy and accelerate the global clinical development of our pipeline products, benefiting patients worldwide.”
About Ascentage Pharma
Ascentage Pharma is a global biopharmaceutical company committed to developing innovative drugs to address unmet clinical needs in oncology and other therapeutic areas. On October 28, 2019, the Company was listed on the Main Board of The Stock Exchange of Hong Kong Limited under the stock code: 6855.HK. On January 24, 2025, the Company was listed under the ticker “AAPGV” on a “when-issued” basis, and the Company expects to begin trading on January 27, 2025, under the ticker symbol “AAPG” for “regular-way” trading.
This press release is not an offer of securities for sale in the United States, the securities may not be offered or sold in the United States absent registration or an exemption from registration, any public offering of securities to be made in the United States will be made by means of a prospectus that may be obtained from the issuer or the selling security holder and that will contain detailed information about the company and management, as well as financial statements.
Forward-Looking Statements
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, Ascentage Pharma undertakes 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 and expectations or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions and expectations may alter in light of future development.