Ascentage Pharma, a China-based drug developer with world ambitions, now has $126.4 million from a U.S. IPO that may primarily help late-stage scientific improvement of two medicines that might provide benefits over some at the moment 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 is predicated 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 below the inventory image “AAPG.”
The one commercialized Ascentage product is olverembatinib, a drug permitted in China as a remedy for sure sufferers with power 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 change into resistant to those therapies, Ascentage stated in its IPO submitting. Moreover, first- and second-generation TKIs haven’t been in a position to 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 immune to 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 remedy, response charges continued to extend and the prevalence of treatment-related antagonistic occasions, or TRAEs, continued to lower over such interval,” Ascentage stated within the IPO submitting. “Due to this fact, we imagine that olverembatinib, with its real-world affected person information in China, the place it’s permitted, has the potential to be a worldwide remedy for CML.”
An ongoing Section 3 scientific program for olverembatinib is enrolling sufferers within the U.S., Canada, Australia, and China. Considered one of these pivotal research is testing the drug as a monotherapy for CML. The design of this research is meant to help an FDA new drug utility, which Ascentage plans to file in 2026. Extra Section 3 checks are evaluating olverembatinib in newly recognized Philadelphia chromosome-positive acute lymphocytic leukemia and gastrointestinal stromal tumor.
Olverembatinib might obtain Ascentage’s world ambitions within the arms of a giant pharmaceutical firm. Final June, Ascentage granted Takeda Prescribed drugs Worldwide an unique choice to license olverembatinib for improvement and commercialization exterior of better China and Russia. Takeda paid $100 million for that choice; the choice train payment and milestone funds may deliver Ascentage as much as $1.2 billion extra, in keeping with 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 growing lisaftoclax for varied varieties of blood cancers. A brand new drug utility for the molecule is below regulatory assessment in China for the remedy of superior circumstances of power lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL).
If permitted, Ascentage plans to launch the lisaftoclax in China in 2025 after which pursue regulatory approvals in a number of nations, in keeping with the submitting. Its predominant competitors can be Venclexta, a Bcl-2 inhibitor marketed by companions AbbVie and Genentech. Nonetheless. Venclexta just isn’t at the moment permitted in China for CLL or SLL. The Ascentage pipeline consists of extra small molecules in earlier phases 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 keeping with 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 scientific improvement of olverembatinib within the U.S. and different nations, and to increase the drug’s label to earlier strains of CML remedy amongst different indications, in keeping with the prospectus. One other $50 million to $60 million is budgeted for the regulatory approval and potential business launch in China of lisaftoclax as a remedy for relapsed or refractory CLL. The corporate additionally plans to run scientific trials that might help 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.
Photograph: Angela Weiss/AFP, by way of Getty Photographs
