Photocure ASA: Results for the third quarter of 2025

On October 29, 2025 Photocure ASA (OSE:PHO) reported Hexvix/Cysview revenues of NOK 134.1 million in the third quarter of 2025 (Q3 2024: NOK 120.1 million), and an EBITDA of NOK 10.2 million (Q3 2024: NOK 5.0 million) for the company. Looking ahead, Photocure expects product revenue growth in the range of 8% to 10% on a constant currency basis (compared to 7 to 11% previously) and an EBITDA improvement in 2025. While the company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant potential growth in milestones this year.

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"Photocure delivered another strong quarter, extending our track record of double-digit topline revenue growth with positive EBITDA. We continued to execute with discipline this quarter while in parallel advancing new growth initiatives that further amplify our central role in precision diagnostics for bladder cancer," said Dan Schneider, President & Chief Executive Officer of Photocure.

The company continued to execute on its plan to expand blue light cystoscopy (BLC) use in Q3 2025 with the installation of 14 new Saphira towers in the U.S. — 7 new accounts and 7 blue light tower upgrades. In addition, due to increasing demand, ForTec has acquired and deployed 6 additional BLC towers, bringing the total number of mobile BLC towers to 24. With the increasing momentum provided by ForTec’s mobile solution, Photocure had 373 active accounts in the U.S. at the end of the quarter, an increase of 23% versus the second quarter of 2024. Across Europe, a total of 49 Olympus Visera Elite III blue light cystoscopy (BLC) capable systems were installed since the launch in Q1 2025.

Total revenues ended at NOK 135.0 million in the third quarter of 2025, up from NOK 120.2 million, with an EBIT of NOK 2.9 million (-2.2). Cash and cash equivalents were NOK 247.8 million at the end of the period.

After the closing of the quarter, Photocure announced a partnership with Intelligent Scopes Corporation (ISC), a U.S. subsidiary of Claritas HealthTech, to develop AI software to support physicians in real-time during BLC, improving early-stage bladder cancer detection, diagnosis and resection completeness.

"Together, Photocure and ISC intend to pursue FDA clearance for the AI software compatible with any BLC system. Based on the terms of the agreement, Photocure will have exclusive, perpetual rights to commercialize the new solution via its direct sales force, distributors or partners, as well as license the software to device manufacturers in any given country upon regulatory clearance. Our partnership with ISC, along with other strategic initiatives underway, represents a step toward expanding clinical adoption, driving operating leverage, and building long-term intrinsic value for shareholders," Schneider added.

Photocure believes that the benefits of BLC with Hexvix/Cysview offer superior detection and management of bladder cancer..

"Looking ahead, we anticipate sustained revenue growth, fueled by rigid kit adoption, expansion of mobile BLC, and HD upgrades that enhance utilization and sales. The tailwinds from a wave of recently approved NMIBC therapeutics are raising awareness around early detection and personalized disease management, validating Photocure’s position at the center of this rapidly evolving ecosystem. In addition to our commercial progress, we are encouraged by potential catalysts that could further strengthen our growth trajectory. These include CMS reimbursement developments, reintroduction of flexible BLC solutions to the market, entrance of additional equipment manufacturers and a potential FDA reclassification in favor of BLC from a citizen’s petition — each representing an opportunity to broaden patient access and accelerate adoption. Lastly, our license agreement with Asieris for Cevira has potential to trigger a significant milestone payment when it receives regulatory approval in China," Schneider concluded.

(Press release, PhotoCure, OCT 29, 2025, View Source [SID1234657077])

Fosun Pharma Announces 2025Q3 Financial Results Innovative Achievements Continue to Come to Fruition, Revenue from Innovative Drugs Exceeding RMB6,700 Million in The First Three Quarters of 2025

On October 28, 2025, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; SSE: 600196, HKEX: 02196), a leading innovation-driven global healthcare company, reported its financial results for the first three quarters of 2025. In the first three quarters of 2025, Fosun Pharma achieved operating revenue of RMB29,393 million, net profit attributable to shareholders of RMB2,523 million. The revenue from Innovative Drugs grew steadily, exceeding RMB6,700 million in the first three quarters of 2025, up by 18.09% period-on-period, implying a continued optimization of revenue structure.

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Meanwhile, Fosun Pharma continued to deepen lean operations, drive cost reduction and efficiency enhancement, and advance asset-light strategies to optimize assets and financial structure, actively strengthen supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2025, the net cash flow from operating activities of Fosun Pharma amounted to RMB3,382 million, up by 13.23% period-on-period, representing a sustained improvement in operational quality.

Revenue from Innovative Products Maintains Steady Growth

Fosun Pharma’s innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors, and immune-inflammatory disorders, while emphasizing core technology platforms including antibodies/ADCs, cell therapy, and small molecules, building a synergistic, open, and global innovative R&D system.

In the third quarter of 2025, several self-developed Innovative Drugs from Fosun Pharma achieved key milestones in major markets. Notably, 1 additional indication for the innovative small molecule CDK4/6 inhibitor Fovinaciclib Citrate Capsules (Chinese trade name:复妥宁), of which Fosun Pharma owns independent intellectual property rights, was approved in Chinese Mainland. The inhibitor is for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative breast cancer, bringing more diverse treatment options to breast cancer patients in China.

In September 2025, the self-developed denosumab injection (project no.: HLX14), in both 60 mg/mL and 120 mg/1.7 mL presentations, was approved for launch successively in the United States and the European Union, becoming the first domestically developed denosumab to be approved overseas, covering all original indications. This provides additional therapeutic options in multiple areas related to bone loss, including osteoporosis.

In the hematology tumors field, the drug registration application of Brexucabtagene Autoleucel Injection (project code: FKC889) of Fosun Kairos was accepted by the National Medical Products Administration (NMPA) in September 2025. The declared indication for this application is for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Strengthening Original Innovation Capability, Building a High-Value Pipeline Portfolio

Fosun Pharma committed to innovation-driven sustainable growth, emphasizing the rational allocation of R&D resources and efficiency enhancement. The Group has gradually built a high-value pipeline portfolio and deployed radiopharmaceuticals, RNA, gene therapy, AI drug R&D and other cutting-edge technologies in order to facilitate the R&D process. Meanwhile, Fosun Pharma continuously strengthens its fundamental innovation capabilities and advances the deep integration of scientific and industrial innovation.

In terms of R&D investment, in the first three quarters of 2025, Fosun Pharma’s R&D investment amounted to RMB3,998 million in total, up by 2.12% period-on-period. In particular, R&D expenses amounted to RMB2,730 million. In the third quarter of 2025, R&D expenses amounted to RMB1,013 million, up by 28.81% period-on-period. The investment primarily focused on cutting-edge technology platforms such as radiopharmaceuticals and cell therapy, as well as global multicenter clinical trials of high-value pipelines, including HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) and HLX43 (PD-L1-targeted antibody-drug conjugate).

Fosun Pharma’s self-developed innovative anti-PD-1 monoclonal antibody (mAb) Han Si Zhuang (serplulimab injection) is making steady progress across multiple clinical studies. Among them, the phase 3 clinical study of Han Si Zhuang in combination with chemotherapy for the neo-/adjuvant treatment of gastric cancer has met the primary endpoint, supporting an early new drug application submission. Han Si Zhuang has become the world’s first perioperative (pre-/post-surgical) treatment regimen for gastric cancer in which an immunotherapy monotherapy replaces postoperative adjuvant chemotherapy, marking a major breakthrough in this field. In October, the U.S. bridging study of serplulimab injection in combination with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) has completed enrollment of all 200 patients, laying a solid foundation for the subsequent submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). As the world’s first anti-PD-1 mAb approved for 1L treatment of ES-SCLC, serplulimab has been approved in nearly 40 countries and regions including China, the U.K., Germany, Singapore and India, serving as a high-quality example of Chinese innovation drugs reaching global markets.

In October 2025, HLX43 (PD-L1-targetede antibody-drug conjugate) for injection was granted Orphan-Drug Designation (ODD) by the U.S. FDA for the treatment of thymic epithelial tumors (TETs). This designation will facilitate the subsequent R&D, registration, and commercialization of the product for the relevant indication in the United States.HLX43 is a potential best-in-class (BIC) broad-spectrum anti-tumor antibody-drug conjugate (ADC) that combines dual mechanisms of action—immune checkpoint blockade and payload-mediated cytotoxicity. As the world’s first PD-L1 ADC developed for TETs, HLX43 has demonstrated promising preliminary efficacy in the later-line treatment of patients with TC.It is positioned to address the unmet clinical need for ADC therapies in this rare and highly aggressive malignancy.Currently, Fosun Pharma’s subsidiary, Henlius, is advancing the clinical development of HLX43 at full speed, with over 400 patients enrolled globally.

In September 2025, Fosun Pharma established a radiotherapy business platform, Xingrui Jingxuan, which will deploy diagnosis-therapy integrated radiopharmaceuticals development in pan-tumor through both independent R&D and collaborative pathways, bringing more benefits to patients.

Launching Share Incentive Scheme, Successfully Issuing First Medium-to-Long Term Sci-Tech Innovation Bond in Private Pharmaceutical Industry

In addition, in the first three quarters of 2025, Fosun Pharma completed its A-share and H-share repurchase plans on schedule and proposed adoption of the 2025 A share option incentive scheme and the H share restricted share unit (RSU) scheme, further strengthening its long-term incentive mechanism. In August 2025, the Group successfully issued RMB 1 billion of medium-to-long-term Sci-Tech Innovation Bonds with a maturity of two years, becoming the first private pharmaceutical company to issue such bonds after the joint announcement of the People’s Bank of China and the China Securities Regulatory Commission in May 2025 regarding support for Sci-Tech Innovation Bonds. The bonds carry a coupon rate of 2.70% and will provide strong funding support for Fosun Pharma as it deploys in key scientific innovation areas, accelerating the transformation and commercialization of innovative products.

Looking forward, Fosun Pharma will continue to adhere to innovation-driven development, optimize R&D resource allocation, accelerate the clinical progress and commercialization of high-potential pipeline, and remain committed to delivering higher-quality and more accessible healthcare products and services to patients worldwide.

(Press release, Fosun, OCT 28, 2025, View Source [SID1234661789])

Quarterly Activities Report & Appendix 4C

On October 28, 2025 Starpharma reported Quarterly Activities Report and Appendix 4C for the quarter ended 30 September 2025 (Q1 FY26).

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(Press release, Starpharma, OCT 28, 2025, View Source,and%20executive%20directors%20of%20$355%2C000. [SID1234661699])

Orion Interim Report January-September 2025

On October 28, 2025 Orion reported Interim Report for the period of January to September 2025.

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(Presentation, Orion, OCT 28, 2025, View Source [SID1234661698])

Novartis Third Quarter and Nine Months 2025

On October 28, 2025 Novartis reported third Quarter and Nine Months 2025 Condensed Interim Financial Report (Presentation, Novartis, OCT 28, 2025, View Source [SID1234659310]).

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