Major Milestone Achieved: European Regulators Endorse Sepalna as Impact Therapeutics-B (07630) Surges 15.51% at Close

Stock News
Sep 18

Shares of innovative drugmaker Impact Therapeutics-B (07630) experienced a strong rally on September 18, closing at HK$13.03, a rise of HK$1.75 or 15.51% from the previous trading day.

The stock opened the session at HK$11.37 and touched an intraday high of HK$14.24. Total trading volume for the day reached 21.1574 million shares, with a turnover of HK$278 million. The company's market capitalization now stands at HK$3.68 billion.

In terms of news catalysts, a significant positive development materialized on September 18 when Impact Therapeutics and global specialty pharmaceutical firm Pharmanovia jointly announced 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 authorization (MA) for Sepalna (senaparib). The recommendation is for the maintenance treatment of advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers.

Following the CHMP's positive recommendation, the application for senaparib will now be submitted to the European Commission for a final decision. If approved by the European Commission, senaparib would be authorized for marketing across all EU member states and European Economic Area countries.

The collaboration between Impact Therapeutics and Pharmanovia was established under an exclusive agreement in July 2026. Under the terms, Impact Therapeutics granted Pharmanovia exclusive rights to manufacture, develop, and commercialize senaparib across 66 countries, including all 27 EU member states, as well as the UK, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand, and countries in the Middle East and North Africa. The indication covered by this agreement is maintenance monotherapy for advanced high-grade epithelial ovarian, fallopian tube, and primary peritoneal cancers.

Additionally, Impact Therapeutics was recently included in the Stock Connect eligible list, allowing southbound capital to trade the stock directly and raising its profile among investors.

Market analysts suggest that the sentiment recovery in the innovative drug sector, combined with this international regulatory milestone for senaparib, the Stock Connect inclusion, and the ongoing ramp-up of domestic product sales, are collectively driving active capital inflows into the stock.

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