2 min read
Meet Veristat at BIOSPAIN 2026
Where Biotech Innovation Meets the Path Forward
BIOSPAIN 2026: September 29- October 1, 2026 – Bilbao, Spain
Veristat...
3 min read
Veristat Helps Impact Therapeutics Receive CHMP Marketing Authorization for Sepalna
On September 18, 2026, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a Marketing Authorisation (MA) for the medicinal product Sepalna® (Senaparib), intended for the maintenance treatment of advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Following the CMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will be authorized for marketing in all EU Member States and European Economic Area countries.
Sepalna® (Senaparib) is in-house discovered and developed by IMPACT Therapeutics (07630.HK), which is a commercial-stage biotechnology company focused on advancing synthetic lethality (SL)-based precision anti-cancer therapies globally , delivering innovative treatments to address the unmet medical needs of cancer patients.
The Market Authorization Application (MAA) was commissioned by IMPACT to Veristat, led by the Regulatory Project Lead and Regulatory PM, who together provided regulatory consulting services, EMA point of contact and principal negotiator, document review, internal team and vendor and contract management, deliverable management and oversight, coordinator and regulatory strategy advisor. The Veristat Regulatory team worked efficiently and collaborated effectively with the broader cross-functional team at Impact to achieve this important milestone.
The positive opinion from CHMP is primarily based on the results of the pivotal Phase III FLAMES 1 study. The FLAMES study is a Phase III, randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of senaparib versus placebo as the maintenance treatment for subjects with advanced (FIGO Stage III-IV) epithelial high-grade Ovarian Cancer (OC), fallopian tube, and primary peritoneal cancer who are in response (complete or partial) following first-line (1L) platinum-based chemotherapy. In the FLAMES study, senaparib as 1L maintenance monotherapy reduced the risk of progression or death versus placebo in a broad patient population with advanced OC, irrespective of BRCA mutation status and with consistent benefits observed between homologous recombination subgroups. Notably, at the prespecified interim analysis, the median PFS was NR with senaparib versus 13.6 months with placebo (HR = 0.43, 95% CI 0.32-0.58; p<0.0001). Senaparib was associated with a 57% reduction in the risk of progression or death compared with placebo. The above results of the FLAMES study were published in Nature Medicine in May 2024.
In July 2026, IMPACT entered into an exclusive partnership with Pharmanovia. Under the licensing agreement, IMPACT has granted Pharmanovia exclusive manufacturing, development and commercialisation rights for senaparib as maintenance monotherapy for advanced epithelial high-grade ovarian, fallopian tube and primary peritoneal cancer across 66 countries, including all 27 European Union member states, as well as the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and countries in the Middle East and North Africa.
IMPACT commissioned Veristat to prepare the Marketing Authorization Application (MAA), led by Veristat’s Regulatory Project Lead and Regulatory Project Manager (PM). Together, they provided regulatory consulting services; served as the point of contact and principal negotiator with the European Medicines Agency (EMA); conducted document review; managed the internal team, vendors, and contracts; oversaw deliverables; and served as coordinator and regulatory strategy advisor.
About Veristat
Veristat is a full-service CRO and consultancy that helps life sciences companies bring novel therapies to market fast. With 30 years of experience and support in more than 100 regulatory approvals and deep expertise in rare disease, neurological disease, oncology, and advanced therapies, Veristat integrates strategic planning, regulatory insight, and trial execution to overcome complex challenges and accelerate success. From early planning through approval, Veristat delivers tailored solutions that drive meaningful outcomes for patients worldwide.
About IMPACT Therapeutics (07630.HK)
Founded in 2009, we are a commercial-stage biotechnology company focused on advancing synthetic lethality (SL)-based precision anti-cancer therapies globally, delivering innovative treatments to address the unmet medical needs of cancer patients. IMPACT was successfully listed on the Main Board of The Stock Exchange of Hong Kong Limited on May 13, 2026 (Stock Code: 07630.HK). We have in-house discovered and developed one of the most comprehensive and advanced SL franchises and are one of only three companies with both commercial-stage PARP1/2 inhibitors and clinical-stage next-generation PARP1-selective inhibitors worldwide.
Our core product, senaparib (IMP4297), has already been commercialized, following its approval as 1L maintenance therapy for OC “all-comers” in China in January 2025, and is reimbursable for OC 1L “all-comers” since January 1, 2026. Senaparib also delivered the most favorable PFS outcome among PARP1/2 inhibitors (non head-to-head) for 1L maintenance therapy for OC “all-comers” in China, setting a new benchmark in this class.
Our major pipeline assets include the PARP1/2 inhibitor senaparib (IMP4297), PARP1-selective inhibitors (IMP1734 and IMP1707, co-developed with Eikon Therapeutics), ATR inhibitor (IMP9064), WEE1 inhibitor (IMP7068), and multiple other synthetic lethality target inhibitors.
Our continued growth is powered by an integrated R&D platform that enables innovation across both small molecules and emerging modalities, including ADCs and degraders, with the identification of PCC from each modality. Additionally, we have forged partnerships with leading global biotech and China pharmaceutical companies to date, as validation of our pipeline and R&D platform.
Please click here for the full news article from Impact Therapeutics.
Contact IMPACT Therapeutics
For additional information, please visit www.impacttherapeutics.com
IMPACT Therapeutics Contact: +86 21 6841 1121
Investor Relations: IR@impacttherapeutics.com
Public Relations: PR@impacttherapeutics.com