Ascentage Pharma, a China-based drug developer with international ambitions, now has $126.4 million from a U.S. IPO that may primarily assist late-stage medical improvement of two medicines that would provide benefits over some at present obtainable most cancers therapies.
Ascentage has traded on The Inventory Trade of Hong Kong since 2019. In preliminary monetary phrases set earlier this week for its U.S. inventory market debut, the corporate deliberate to supply greater than 7.3 million American depositary shares (ADS) priced at $20.34 every. Late Thursday, Ascentage, which relies in Suzhou, China, and maintains U.S. operations in Rockville, Maryland, priced its providing at $17.25 per ADS. These shares will commerce on the Nasdaq underneath the inventory image “AAPG.”
The one commercialized Ascentage product is olverembatinib, a drug authorised in China as a therapy for sure sufferers with continual myeloid leukemia (CML). This drug is a small molecule inhibitor of tyrosine kinases, enzymes that drive most cancers development. Tyrosine kinase inhibitors (TKIs) are already obtainable, such because the Novartis medication Scemblix and Gleevec. However CML can turn into resistant to those therapies, Ascentage stated in its IPO submitting. Moreover, first- and second-generation TKIs haven’t been capable of deal with CML with T315I mutations, that are related to speedy illness development and restricted affected person survival.
Ascentage describes olverembatinib as a next-generation drug for CML that’s pushed by T315I mutations and can be proof against first- and second-generation TKIs. The corporate factors to real-world information in China exhibiting profit in sufferers whose cancers developed resistance to the Novartis medication.
“In a five-year follow-up of CML [in the chronic phase] sufferers handled with olverembatinib, 73% had remained on the therapy, response charges continued to extend and the prevalence of treatment-related opposed occasions, or TRAEs, continued to lower over such interval,” Ascentage stated within the IPO submitting. “Subsequently, we consider that olverembatinib, with its real-world affected person information in China, the place it’s authorised, has the potential to be a worldwide remedy for CML.”
An ongoing Part 3 medical program for olverembatinib is enrolling sufferers within the U.S., Canada, Australia, and China. Certainly one of these pivotal research is testing the drug as a monotherapy for CML. The design of this research is meant to assist an FDA new drug utility, which Ascentage plans to file in 2026. Extra Part 3 exams are evaluating olverembatinib in newly identified Philadelphia chromosome-positive acute lymphocytic leukemia and gastrointestinal stromal tumor.
Olverembatinib might obtain Ascentage’s international ambitions within the palms of an enormous pharmaceutical firm. Final June, Ascentage granted Takeda Prescribed drugs Worldwide an unique choice to license olverembatinib for improvement and commercialization exterior of higher China and Russia. Takeda paid $100 million for that choice; the choice train charge and milestone funds might carry Ascentage as much as $1.2 billion extra, in response to the IPO submitting.
The following drug in Ascentage’s pipeline is lisaftoclax, a small molecule inhibitor of Bcl-2. Overexpression of this protein can contribute to tumor development and drug resistance. Ascentage is creating lisaftoclax for numerous varieties of blood cancers. A brand new drug utility for the molecule is underneath regulatory overview in China for the therapy of superior circumstances of continual lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL).
If authorised, Ascentage plans to launch the lisaftoclax in China in 2025 after which pursue regulatory approvals in a number of nations, in response to the submitting. Its fundamental competitors can be Venclexta, a Bcl-2 inhibitor marketed by companions AbbVie and Genentech. Nevertheless. Venclexta shouldn’t be at present authorised in China for CLL or SLL. The Ascentage pipeline consists of extra small molecules in earlier levels of improvement, primarily for cancers.
Ascentage co-founder Edward Ming Guo is the corporate’s largest shareholder with a 17.5% post-IPO stake, in response to the prospectus. Takeda owns 7.1% of the corporate. Within the 9 months ended Sept. 30, 2024, Ascentage reported 876.8 million Chinese language yuan (about $124.9 million) in income, most of which got here from the Takeda choice deal. On the finish of the third quarter of 2024, Ascentage reported its money place was $210.8 million.
With the IPO proceeds, Ascentage plans to spend $30 million to $40 million for medical improvement of olverembatinib within the U.S. and different nations, and to develop the drug’s label to earlier traces of CML therapy amongst different indications, in response to the prospectus. One other $50 million to $60 million is budgeted for the regulatory approval and potential industrial launch in China of lisaftoclax as a therapy for relapsed or refractory CLL. The corporate additionally plans to run medical trials that would assist approvals of this drug within the U.S. and different nations. Between $10 million and $20 is put aside to fund R&D of different drug candidates.
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