To The Moon

Ascentage Pharma (6855.HK) today announced that APG-2449, a FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI), has been cleared by the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA) to enter two registrational Phase III studies that will separately evaluate APG-2449 in patients with non-small cell lung cancer (NSCLC) who are resistant to or intolerant of second-generation anaplastic lymphoma kinase (ALK) TKIs; and treatment-naïve patients with ALK-positive advanced or locally advanced NSCLC. These two pivotal studies will be multicenter, open-label, randomized, registrational Phase III studies: first one is to evaluate the efficacy and safety of APG-2449 versus platinum-based chemotherapies in patients with NSCLC who are resistant to or intolerant of

Ascentage Pharma (6855.HK) today announced that it has released the clinical data of olverembatinib (HQP1351), the company’s novel drug candidate, in patients with succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST), in a Mini Oral at the 2024 European Society of Medical Oncology (ESMO) Congress. These data of olverembatinib, presented in the Mini Oral at ESMO 2024, showed sustained clinical benefit in patients with SDH-deficient GIST. As of March 12, 2024, six of the 26 patients with SDH-deficient GIST enrolled in the study achieved partial responses (PRs). The objective response rate (ORR) was 23.1%, and the median progression-free survival (PFS) was 22 months. Furthermore, studies on mechanism of action (MOA) revealed that olverembatinib exerts its antit

Ascentage Pharma (6855.HK) today announced that it will present the latest clinical data of olverembatinib (HQP1351), the company’s novel drug candidate, in patients with succinate dehydrogenase- (SDH-) deficient gastrointestinal stromal tumor (GIST), in a Mini Oral at the 2024 European Society of Medical Oncology (ESMO) Congress. As one of the world’s leading and most influential oncology congresses, the ESMO Congress showcases the latest results in some of the most cutting-edge cancer research from around the world. This year, the ESMO Congress will be held from September 13 to 17 in Barcelona, Spain. Dr. Yifan Zhai Chief Medical Officer of Ascentage Pharma We are pleased to have this opportunity to showcase olverembatinib’s therapeutic potential for the treatment of SDH-deficient GIST.&

Ascentage Pharma (6855.HK) today announced its 2024 interim results. During the reporting period, Ascentage Pharma continued to execute its global innovation strategy, having achieved breakthroughs across various aspects of its business including external collaborations, commercialization, and clinical development. In particular, the company has set a new record with its revenue for the first half of 2024 and reported profit for the first time. During the reporting period, Ascentage Pharma has set a new record for its revenue that grew by 477% from the same period last year to RMB824 million, with most of the revenue generated from sales of pharmaceutical products and license income. For the very first time in its history, Ascentage Pharma reached profitability, having reported a net

Ascentage Pharma (6855.HK) announced today that its novel BCR-ABL1 tyrosine kinase inhibitor (TKI), olverembatinib, has been approved by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region (SAR) of the People’s Republic of China for the treatment of adult patients with tyrosine kinase inhibitors (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs.  This approval marks another major milestone for olverembatinib following initial approvals granted to the drug in the Chinese mainland for the above indications. Olverembatinib, a novel drug developed by Ascentage Pharma with suppo

Ascentage Pharma (6855.HK) announced today that on July 2, 2024, in relation to the Exclusive Option Agreement with Takeda for the third-generation BCR-ABL inhibitor olverembatinib (HQP1351), Ascentage Pharma has received the US$100 million option payment called for by the Exclusive Option Agreement. On June 14, 2024, Ascentage Pharma and Takeda entered into an Exclusive Option Agreement that granted Takeda an exclusive option to enter into an exclusive license agreement for olverembatinib. The Exclusive Option Agreement calls for Ascentage Pharma to receive an option payment of US$100 million and provides for Ascentage Pharma to be eligible for an option exercise fee and additional potential milestone payments of up to approximately US$1.2 billion and double-digit royalties on annual sale

Ascentage Pharma (6855.HK) announced today that the agreed equity investment by Takeda has been closed on June 20, 2024, with all proceeds already received. Pursuant to the terms of the Agreement, Ascentage Pharma has allotted and issued an aggregate of 24,307,322 subscription shares to Takeda International at the share purchase price of HK$24.09850 (equivalent to approximately US$3.08549). About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protei

Ascentage Pharma (6855.HK) announced today that updated results from three studies of olverembatinib (HQP1351), the first China-approved third-generation BCR-ABL1 inhibitor, have been released in posters at the 2024 European Hematology Association Hybrid Congress (EHA 2024), taking place in Madrid, Spain. Building on the data reported at the 2023 American Society of Hematology Annual Meeting, Ascentage Pharma has released the updated median 1-year follow-up data of olverembatinib in patients with chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). In the results, olverembatinib showed excellent durable clinical benefits and favorable long-term tolerability in patients who had been treated with multiple TKIs (including those who were resistant to

Ascentage Pharma (6855.HK) announced today that it has released updated data of the Bcl-2 inhibitor lisaftoclax (APG-2575), one of the company’s key drug candidates, combined with novel therapeutic regimens in patients with relapsed/refractory (R/R) multiple myeloma (MM) or immunoglobulin light-chain (AL) amyloidosis, in a poster presentation at the 2024 European Hematology Association Hybrid Congress (EHA 2024), taking place in Madrid, Spain. Building on results from the study released for the first time at the 2023 American Society of Hematology Annual Meeting, the updated data presented at EHA 2024 continued to show impressive efficacy and favorable safety of lisaftoclax-based combinations, particularly the combination with pomalidomide and dexamethasone in R/R MM. Moreover, the study r

• Ascentage Pharma has executed an Exclusive Option to License Global Rights to Olverembatinib worldwide other than China and a few other areas • Ascentage Pharma to receive an option payment of 100 million USD upon closing and be eligible for an option exercise fee and additional potential milestones of up to approximately 1.2 billion USD, and double-digit royalties on annual sales • Additionally, Takeda will purchase a minority interest in Ascentage Pharma  Ascentage Pharma (6855 HK) announced today the signing of an option agreement with Takeda to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hema