Ascentage Pharma, a China-based drug developer with international ambitions, now has $126.4 million from a U.S. IPO that may primarily help late-stage medical improvement of two medicines that might supply benefits over some at the moment obtainable most cancers therapies.
Ascentage has traded on The Inventory Change 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 underneath the inventory image “AAPG.”
The one commercialized Ascentage product is olverembatinib, a drug permitted in China as a therapy for sure sufferers with persistent myeloid leukemia (CML). This drug is a small molecule inhibitor of tyrosine kinases, enzymes that drive most cancers progress. 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 mentioned 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 fast 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 also be proof against first- and second-generation TKIs. The corporate factors to real-world information in China displaying 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 antagonistic occasions, or TRAEs, continued to lower over such interval,” Ascentage mentioned within the IPO submitting. “Subsequently, we consider that olverembatinib, with its real-world affected person information in China, the place it’s permitted, has the potential to be a world 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 examine is meant to help an FDA new drug utility, which Ascentage plans to file in 2026. Extra Part 3 assessments 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 fingers of an enormous pharmaceutical firm. Final June, Ascentage granted Takeda Prescribed drugs Worldwide an unique possibility to license olverembatinib for improvement and commercialization outdoors of higher China and Russia. Takeda paid $100 million for that possibility; the choice train charge 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 progress and drug resistance. Ascentage is creating lisaftoclax for varied sorts of blood cancers. A brand new drug utility for the molecule is underneath regulatory evaluation in China for the therapy of superior instances of persistent 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 international locations, in keeping with the submitting. Its important competitors could be Venclexta, a Bcl-2 inhibitor marketed by companions AbbVie and Genentech. Nevertheless. Venclexta will not be at the moment permitted in China for CLL or SLL. The Ascentage pipeline contains further 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 possibility 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 international locations, and to increase the drug’s label to earlier strains of CML therapy amongst different indications, in keeping with 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 might help approvals of this drug within the U.S. and different international locations. Between $10 million and $20 is put aside to fund R&D of different drug candidates.
Photograph: Angela Weiss/AFP, by way of Getty Photos
