SUZHOU, China, and ROCKVILLE, MD, Nov. 30, 2021 — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, and Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, jointly announce that the novel drug candidate olverembatinib of Guangzhou HealthQuest Pharma Co., Ltd., Inc., a wholly-owned subsidiary of Ascentage Pharma, has been approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test (an indication that has not been approved in the US).
Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing program, olverembatinib is a potentially best-in-class drug that will be co-commercialized in China market by Innovent and Ascentage Pharma, for the benefit of more patients and their families. As China’s first third-generation BCL-ABL TKI developed for the treatment of TKI-resistant CML, this approval fills an important treatment gap in T315I-mutant CML, and marks a major milestone signifying that Ascentage Pharma has successfully entered the commercial-stage.
This approval for olverembatinib is based on the results from two pivotal Phase II studies – the HQP1351CC201 study and the HQP1351CC202 study. These results showed that olverembatinib is efficacious and well-tolerated in patients with CML-CP and CML-AP, and the probability and depth of clinical response is expected to increase with prolonged treatment period.
CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for an effective treatment.
Prof. Xiaojun Huang, MD, Director of the Institute of Hematology, Peking University, Director of the Hematology Department at Peking University People’s Hospital, and a principal investigator of olverembatinib in China, commented: “Efficacy and safety data from studies to date have consistently showed that olverembatinib has enormous potential in effectively addressing the unmet medical need in the treatment of chronic myeloid leukemia, and is a drug with true best-in-class potential. The clinical progress with this novel therapeutic has also received widespread interest from the global hematology community over the years. I am excited that olverembatinib is now approved in China, as it finally brings about a breakthrough to the clinical conundrum caused by drug-resistance and a milestone in the treatment of CML. In a broad sense, this approval also signifies that China is rapidly emerging as a world leader in hematology clinical development.”
Prof. Qian Jiang, MD, Deputy Director of the Hematology Department at Peking University People’s Hospital, and another principal investigator of olverembatinib in China, noted: “First- and second-generation TKIs are ineffective in patients with T315I-mutant CML-CP and CML-AP, and drug-resistant CML has long represented an urgent unmet clinical need. This approval for olverembatinib bears great significance for doctors and patients, as it offers a long-awaited change to the treatment landscape in CML. I am confident that the approval of olverembatinib will bring significant survival benefit and renewed hope to patients with CML.”
Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma, President and CEO of Healthquest Pharma commented: “We are grateful to all the regulators and agencies for their understanding of the urgent clinical needs of patients with CML, and their strong support to home-grown pharmaceutical innovation in China. I would also like to thank all the clinical experts for their trust and dedication to the clinical development program of olverembatinib. Last but not least, I would like to express my most heartfelt appreciation for the employees of Ascentage Pharma for their dedication and perseverance that allowed us to overcome the unprecedented challenges posed by the COVID-19 pandemic. This approval for olverembatinib, China’s first and the world’s second approved third-generation BCR-ABL inhibitor, not only brings hope to Chinese patients with T315I-mutant CML who would otherwise have no effective treatment, it also indicates the drug’s potential in addressing a major unmet need in the treatment of CML globally.”
Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said: “This approval for olverembatinib, Ascentage Pharma’s first product entering commercialization, marks a very encouraging milestone in our transition from a R&D-driven biotech into a full-fledged biopharmaceutical company with commercialized product. We will fully engage Innovent to expedite the buildout of the commercial infrastructure for olverembatinib. Meanwhile, we are partnering with stakeholders such as genetic testing companies, commercial insurance companies, and online pharmacies, in order to make this China-developed novel therapy accessible to more patients , honoring our commitment to global innovation and the mission of addressing unmet clinical needs in China and around the world. Moving forward, we will continue to explore additional indications of this drug, advance its clinical development overseas, and accelerate the global development of other drug candidates in our pipeline, to further solidify our global presence. “
Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics, said: “We are pleased about the NDA approval of olverembatinib in China, which further strengthens Innovent’s franchise in oncology and hematology area by adding a new generation anti-cancer therapy to our commercial portfolio. In oncology area, Innovent has a robust pipeline of up to 20 assets, an industry-leading product development team, and a broad channel coverage with a commercial team of nearly 3000 people. We look forward to collaborating with Ascentage Pharma for the co-commercialization of olverembatinib, in order to bring forth this novel drug to solve the unmet medical needs from Chinese TKI-resistant T315I-mutated CML patients as early as possible.”