IMPACT Therapeutics and Pharmanovia Announce Positive CHMP Opinion for Senaparib, as a Potential First-Line Maintenance Treatment of Advanced High-Grade Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

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Stephan Eder, CEO, Pharmanovia

IMPACT Therapeutics (07630.HK), a commercial-stage biotechnology company focused on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality mechanisms, together with global specialty pharmaceutical company Pharmanovia, today jointly announce that 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 advance epithelial ovarian, fallopian tube and primary peritoneal cancer.

Following the CHMP’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 (EEA) countries.

The positive opinion from CHMP is primarily based on the results of the pivotal Phase III FLAMES¹ 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) Ovarian Cancer (OC) 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.

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.

Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT, commented: "The positive opinion from EMA CHMP is a critical step towards market authorization by the EC, marking a significant milestone not only for senaparib and IMPACT Therapeutics, but also for the global footprint of innovative Chinese-originator biotech companies. We look forward to the final decision by the EC, and we will continue to work closely with our partner Pharmanovia to efficiently advance access to senaparib across the licensed territories in Europe, the Middle East, North Africa, Australia and New Zealand, accelerating the global reach of this innovative Chinese-originated drug to benefit more patients worldwide."

Dr. Stephan Eder, Chief Executive Officer, Pharmanovia, added: "Our partnership combines IMPACT’s scientific expertise with our launch and market expertise. The CHMP’s positive opinion marks an important next step in the regulatory process for this medicine. Our focus is now on using our market access, medical and launch capabilities to bring senaparib as a novel treatment option to patients in our territories.

References:

¹ Nature medicine - senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial - https://www.nature.com/articles/s41591-024-03003-9 - last accessed 16.09.26
² EMSO data- https://www.esmo.org/for-patients/patient-guides/ovarian-cancer - last accessed 16.09.26

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 7^th 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.

Forward-looking Statements

This press release contains forward-looking statements relating to the likely future developments in the business of IMPACT Therapeutics (The Company) and its subsidiaries, such as expected future events, business prospects or financial performance. The words “expect”, “anticipate”, “continue”, “estimate”, “objective”, “ongoing”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends”, “visions”, “schedule” and similar expressions are intended to identify such forward-looking statements. These statements are based on assumptions and analyses made by the Company at the time of this press release in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company currently believes are appropriate under the circumstances. However, whether actual results and developments will meet the current expectations and predictions of the Company is uncertain. Actual results, performance and financial condition may differ materially from the Company’s expectations.

All of the forward-looking statements made in this press release are qualified by these statements. Consequently, the inclusion of forward-looking statements in this press release should not be regarded as representations by the board of directors (the “Board”) or the Company that the plans and objectives will be achieved, and investors should not place undue reliance on such statements.

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