IMPACT Therapeutics’ Senaparib Receives Positive EMA CHMP Opinion for Ovarian Cancer Maintenance Treatment
IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on developing targeted anti-cancer therapies based on synthetic lethality mechanisms, and global specialty pharmaceutical company Pharmanovia have announced a major regulatory milestone for senaparib. 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 Sepalna® (senaparib) as a maintenance treatment for patients with advanced epithelial ovarian, fallopian tube and primary peritoneal cancer.
The positive CHMP opinion represents an important step in the European regulatory pathway for senaparib and moves the medicine closer to potential commercialization across the European Union and associated markets. Following the recommendation, the application will be submitted to the European Commission (EC), which is responsible for issuing the final Marketing Authorisation decision.
If the European Commission grants approval, senaparib will be authorized for marketing across all EU Member States and European Economic Area (EEA) countries, subject to the applicable regulatory framework.
The recommendation is primarily supported by data from the pivotal Phase III FLAMES1 clinical study, which evaluated the efficacy and safety of senaparib as first-line maintenance therapy in patients with advanced ovarian cancer who had responded to initial platinum-based chemotherapy.
Phase III FLAMES Study Supports Senaparib’s Regulatory Application
The FLAMES trial was designed as a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study. It evaluated senaparib against placebo as maintenance treatment for patients with advanced ovarian cancer classified as FIGO Stage III-IV.
Eligible participants had achieved either a complete or partial response following first-line platinum-based chemotherapy. The study was designed to assess whether continued treatment with senaparib could delay disease progression or death following initial chemotherapy.
According to the results supporting the regulatory application, senaparib demonstrated a significant improvement in progression-free survival (PFS) compared with placebo in a broad population of patients with advanced ovarian cancer.
At the prespecified interim analysis, the median PFS had not yet been reached (NR) in the senaparib treatment group, compared with 13.6 months for patients receiving placebo. The hazard ratio was 0.43, with a 95% confidence interval of 0.32-0.58 and a p-value of less than 0.0001.
These findings corresponded to a 57% reduction in the risk of disease progression or death for patients treated with senaparib compared with placebo.
An important aspect of the FLAMES findings was the breadth of the patient population in which the treatment effect was observed. The company reported that the PFS benefit was demonstrated regardless of BRCA mutation status, while consistent benefits were also observed across homologous recombination subgroups.
This broad activity is particularly relevant in ovarian cancer, where molecular characteristics such as BRCA mutation status and homologous recombination deficiency can influence treatment strategies and the selection of targeted therapies.
Potential Maintenance Option Following First-Line Chemotherapy
Maintenance therapy has become an important component of the treatment strategy for advanced ovarian cancer. While platinum-based chemotherapy can produce responses in many patients, advanced disease remains associated with a significant risk of recurrence or progression.
The FLAMES results position senaparib as a potential maintenance treatment following first-line platinum-based chemotherapy for patients who have achieved a complete or partial response.
Rather than being administered as the initial chemotherapy regimen, maintenance therapy is intended to continue disease control after the patient has completed first-line treatment and responded to it. The objective is to extend the period before the cancer progresses.
The positive CHMP opinion therefore represents a significant development for IMPACT Therapeutics and Pharmanovia as the companies prepare for the next stage of the European regulatory process.
If the European Commission grants the requested authorization, Sepalna® could become available as a maintenance treatment for eligible patients with advanced epithelial ovarian, fallopian tube and primary peritoneal cancers across the EU and EEA.
Regulatory Review Moves to European Commission
The CHMP is responsible for conducting the scientific assessment of medicines seeking centralized authorization in the European Union. A positive opinion from the committee is an important regulatory milestone, although it does not itself constitute the final marketing authorization.
The next step will be consideration of the CHMP recommendation by the European Commission. A final approval would provide centralized authorization across EU Member States, while the applicable arrangements would also support availability within the EEA.
IMPACT Therapeutics and Pharmanovia are now expected to continue working together as the application progresses toward the EC’s final decision.
The companies have also established a broader commercial partnership designed to support the potential international launch of senaparib.
Pharmanovia Partnership Covers 66 Countries
In July 2026, IMPACT Therapeutics entered into an exclusive partnership with Pharmanovia covering the development, manufacturing and commercialization of senaparib as maintenance monotherapy.
Under the terms of the licensing agreement, Pharmanovia received exclusive rights across 66 countries. The territory includes all 27 European Union member states, as well as the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and countries across the Middle East and North Africa.
The partnership brings together IMPACT Therapeutics’ drug discovery and development capabilities with Pharmanovia’s experience in commercialization, market access and product launches.
For IMPACT, the agreement provides a pathway to expand senaparib beyond its existing development activities and establish a broader international presence for the company’s oncology portfolio. For Pharmanovia, the collaboration adds a potentially differentiated oncology medicine to its commercial pipeline.
The companies said the partnership will support efforts to make senaparib available to patients across the licensed territories following the necessary regulatory approvals.
IMPACT Highlights Global Potential of Chinese-Originated Drug
Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT Therapeutics, described the positive CHMP opinion as an important milestone for both senaparib and the company.
Cai said the recommendation brings senaparib closer to potential European market authorization and highlighted its significance for IMPACT’s international expansion. The company also views the regulatory progress as an example of the increasing global reach of innovative therapies originating from Chinese biotechnology companies.
The IMPACT chief executive said the company will continue working with Pharmanovia as the regulatory process advances and as preparations move toward potential access across Europe, the Middle East, North Africa, Australia and New Zealand.
The companies’ stated objective is to accelerate the international availability of senaparib and potentially expand treatment options for patients with advanced ovarian cancer.
Pharmanovia Prepares for Market Access and Launch Activities
Dr. Stephan Eder, Chief Executive Officer of Pharmanovia, said the partnership combines IMPACT Therapeutics’ scientific capabilities with Pharmanovia’s expertise in market development and product launches.
According to Eder, the positive CHMP opinion represents another significant stage in the regulatory pathway for senaparib. Pharmanovia will now focus on its market access, medical and commercial capabilities as the medicine moves closer to potential availability in its licensed markets.
The company’s responsibilities will include supporting preparations required for a potential launch and helping establish access to the medicine within the relevant healthcare systems, subject to final regulatory approval and local requirements.
Senaparib Advances Toward Potential European Availability
The CHMP recommendation marks the latest step in the development of senaparib and follows the positive results generated in the Phase III FLAMES study.
The study’s findings showed that first-line maintenance treatment with senaparib reduced the risk of progression or death compared with placebo in patients with advanced ovarian cancer who had responded to platinum-based chemotherapy. The reported hazard ratio of 0.43 and 57% reduction in risk provide the principal clinical evidence supporting the current European regulatory application.
The reported benefit was observed across a broad patient population, including patients irrespective of BRCA mutation status, with consistent effects across homologous recombination subgroups.
The next key milestone will be the European Commission’s final decision on the Marketing Authorisation application. Until that decision is issued, senaparib remains subject to the European regulatory process and is not yet authorized for marketing in the EU on the basis of the CHMP opinion alone.
If approved, the authorization would expand access to senaparib across a large geographic territory through IMPACT Therapeutics and Pharmanovia’s partnership. The companies are also expected to continue regulatory, market access and commercial preparations across the other countries covered by their agreement.
For IMPACT Therapeutics, the potential European authorization would represent an important step in transforming senaparib from a clinical-stage oncology asset into a commercially available medicine across international markets. For Pharmanovia, the program provides an opportunity to apply its commercialization and market-access infrastructure to a targeted oncology therapy supported by Phase III clinical data.
With the CHMP now recommending approval, attention turns to the European Commission’s final decision and the subsequent preparations required to bring Sepalna® to eligible patients across the company’s licensed territories.
About Senaparib (IMP4297)
The active substance senaparib is a novel, inhibitor of poly (ADP-ribose) polymerase (PARP) (ATC code: L01XK07) that blocks the repair of damaged DNA in cancer cells and causes the cancer cells to die. Sepalna® (senaparib) will be available as 20 mg hard capsules.
Senaparib capsules received National Medical Products Administration of China (NMPA) approval in January 2025 as a first-line maintenance therapy for adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer achieving complete or partial response to platinum-based chemotherapy and has been subsequently included in the National Reimbursement Drug List (NRDL) in December 2025.
About Ovarian Cancer (OC)
OC is one of the most lethal malignancies affecting women, with a mortality rate that ranks among the highest for female cancers. OC patients typically receive first line (1L) systemic therapy upon diagnosis. Following completion of initial treatment, patients who achieve complete or partial response generally enter the 1L maintenance phase as part of the standard treatment paradigm. As such, 1L maintenance therapy represents the largest and most broadly applicable treated population within the overall OC patient pool.
Ovarian cancer forms in ovarian tissues. The ovaries are the female reproductive organs in which the egg cells are formed and female hormones are produced. It arises from a thin layer of cells in the surface of the ovary or from the fallopian tube epithelium – a form called epithelial ovarian cancer, which is also the most frequent type of ovarian cancers, or from other tissues within the ovary (non-epithelial ovarian cancer).2 According to ESMO it is the 7th most common cancer in women worldwide2.
About Pharmanovia
Pharmanovia is a global specialty pharmaceutical company. We partner with innovative biotech and large pharma to bring innovative specialty medicines to patients, while supporting trusted established brands across more than 160 markets.
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.
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.