Ascentage Pharma launches new groundbreaking drug for CML

Olverembatinib, a new drug by Ascentage Pharma that can treat adult patients suffering from chronic or accelerated chronic myeloid leukemia (CML), was launched in China on Dec 18.

Based in Suzhou, Jiangsu province, Ascentage Pharma said that Olverembatinib is the first of its kind in China. The drug was approved by the National Medical Products Administration in late November.

Manufactured by Guangzhou HealthQuest Pharma Co Ltd Inc, a wholly-owned subsidiary of Ascentage Pharma, the drug will be especially useful for those with drug-resistant CML, which affects an estimated 10,000 patients in the country each year, according to the company.

Huang Xiaojun, a principal investigator of the drug's clinical trials in the country, said that data proving the therapy's effectiveness and safety indicates that the drug is likely to become a best-in-class treatment in the field of drug-resistant CML with unmet clinical need.

"The launch of the new drug, a novel milestone therapy, means that the original drug resistance difficulty of China's CML treatment is broken, which is of great significance to clinicians and patients," said Huang, who is also director of the Institute of Hematology at Peking University and director of hematology department at Peking University People's Hospital.

Chen Kaixian, an academician with the Chinese Academy of Sciences who specializes in new drug research, said that Olverembatinib is a new drug supported by the National Major New Drug Discovery and Manufacturing program.

"The launch of the therapy fully demonstrates the innovative level of local pharmaceutical companies and will encourage more fellows to devote themselves to the research and development of innovative drugs," he said.

Senior executives of Ascentage said that the oral drug has been granted orphan drug and fast track designation by the United States Food and Drug Administration.

"We anticipate that this innovative drug from China can benefit more patients from all over the world in the near future," said Zhai Yifan, chief medical officer of Ascentage and chairman and CEO of HealthQuest.

Ascentage also held an inauguration ceremony of its global headquarters and R&D center in Suzhou on the same day.

During the ceremony, the Ascentage Institute of the National Center for Clinical Medicine of Hematological Diseases was unveiled. The company also signed two agreements with the China Pharmaceutical University and Suzhou Oriza Holdings Corporation to construct an institute of innovation and industrialization and a platform to incubate programs by local startups respectively.