iNtRON Bio, files Two Patent Applications for IMPA™ Platform-Based Gene Editing Technology

On August 26, 2025 iNtRON Bio reported, following its recent U.S. patent application related to colorectal cancer using the IMPA phage engineering technology, it has now completed the filing of two patents for a new IMPA gene editing technology utilizing CRISPR-Cas9 and recombination-based improvement methods targeting Pasteurella bacteriophages (Press release, iNtRON Biotechnology, AUG 26, 2025, View Source [SID1234655493]).

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The newly developed IMPA gene editing technology targets the capsid of bacteriophages infecting Pasteurella bacteria to produce modular phages and improve them so that multiple payloads can be loaded. It is a fundamental technology patent for various genetic engineering techniques, including gene editing, foreign protein labeling, and the introduction of novel capsids.

iNtRON Bio explained that, based on AI-driven analysis and multi-omics data, it utilized its integrated database (IDB), which consists of the ‘ip-Virtual BR Bank’ containing over 11,000 bacteriophage records and more than 600 whole genome sequences (WGS) of bacteriophages isolated and secured by the company. By selecting useful genetic resources applicable to novel CRISPR-Cas9 systems and recombination technologies and implementing them in bacteriophage gene editing technologies, it is expected that the technology will be used as a core platform for the development of anticancer drugs and vaccines in the future.

In particular, the newly filed patents present a method to precisely manipulate the genes of bacteriophages infecting Pasteurella strains using the CRISPR-Cas9 system. This involves developing and applying a plasmid capable of specific genetic manipulation at target sites while maintaining the original infectivity, thereby maximizing editing efficiency. Additionally, a dedicated plasmid capable of implementing a recombination system was also developed, enabling genetic modifications to be performed in a shorter period of time. Furthermore, the fact that gene editing of Pasteurella bacteriophages has become possible using these two improvement techniques is of great significance as it is the first case ever reported worldwide.

Jisu Son, Head of the BD Division of the Company, stated, "With the securing of the IMPA gene editing technology through this patent filing, we can now go beyond simply using bacteriophages as antibiotic alternatives for bacterial control, and expand the scope of application to a platform technology for developing targeted therapeutics or vaccines that label peptides or proteins selectively acting on specific diseases. This technology has enormous potential for broad use across the entire pharmaceutical industry, and we plan to apply it to gene editing of bacteriophages infecting bacteria other than Pasteurella in order to discover and select more effective drug candidates."

YOON, Kyung Won, the CEO of the Company, stated, "Following our recent U.S. patent application, these additional two patent filings not only strengthen our existing IMPA platform technology but also expand its technical differentiation and application areas. On the premise of filing for PCT, we have submitted the two applications in Korea first to proceed rapidly to patent registration. By further focusing on the development of the IMPA phage engineering technology linked to this invention, we are enhancing the completeness of the technology, which will serve as the foundation for iNtRON Bio to develop various new drug candidates, including ADC drugs, anticancer agents, and vaccines."

Genmab to Participate in a Fireside Chat at the Morgan Stanley 23rd Annual Global Healthcare Conference

On August 26, 2025 Genmab A/S (Nasdaq: GMAB) reported that its Chief Executive Officer Jan Van de Winkel and Chief Financial Officer Anthony Pagano will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference in New York City, NY at 7:45 AM EDT (1:45 PM CEST) on September 9, 2025 (Press release, Genmab, AUG 26, 2025, View Source [SID1234655478]). A webcast of the fireside chat will be available on Genmab’s website at View Source

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Fosun Pharma Announces 2025 Interim Results

On August 26, 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 operating performance for the first half of 2025 ("the Reporting Period") (Press release, Fosun Pharma, AUG 26, 2025, View Source [SID1234655494]).

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During the Reporting Period, Fosun Pharma continued to push forward its innovation transformation and the development and commercialization of innovative products, enhance global operations, and further strengthened its global commercialization capacity and infrastructure. Fosun Pharma also deepened its digitalization and AI strategy, progressively building a digital and intelligent system covering R&D, operation, and product application.

In the first half of 2025, Fosun Pharma achieved operating revenue of RMB 19,514 million, net profit attributable to shareholders amounted to RMB1,702 million. The revenue from innovative drugs grew steadily, exceeding RMB 4,300 million, representing an increase of 14.26% as compared to the same period last year. The operating cash flow amounted to RMB 2,134 million, representing a period-on-period increase of 11.90%. Meanwhile, the Group continued to divest and integrate non-strategic and non-core assets, and gathered resources on core businesses so as to optimize asset structure, improve asset efficiency and accelerate cash return. Since 2025, the cash inflow from asset disposals from contracts signed of the Group have exceeded RMB 2,000 million in aggregate.

Building a High-value Innovative Pipeline with Breakthroughs in Core Therapeutic Areas

Fosun Pharma always takes innovation as a core driving force in its development. Fosun Pharma has established a diversified and multi-level innovative model that integrates independent R&D, co-development, licensing, fund incubation, and industrial investment. the Company continuously enhances its capabilities across four key technology platforms: antibodies, ADCs, cell therapy, and small molecules, accelerating the translation of innovative technologies and products.

During the Reporting Period, Fosun Pharma’s total R&D expenditure amounted to RMB 2,584 million, of which R&D expenses amounted to RMB 1,717 million. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB 2,295 million, accounting for 16.51 % of pharmaceutical business revenue. In particular, the R&D expenses amounted to RMB 1,469 million, accounting for 10.57% of the segment’s revenue. Focusing on core therapeutic areas including solid tumors, hematologic malignancies and Immune-inflammatory disorders, Fosun Pharma has gradually built a high-value pipeline portfolio and is actively expanding into chronic diseases (cardiovascular, renal, and metabolic) and the neurological field.

In the field of solid tumors, Fosun Pharma has established a robust innovative product portfolio, represented by Serplulimab injection and Trastuzumab Injection to deal with lung cancer and breast cancer. During the Reporting Period, the approval of the innovative small molecule CDK4/6 inhibitor Fovinaciclib Citrate Capsules, of which Fosun Pharma owns independent intellectual property rights, further enriched the breast cancer treatment portfolio; the first independently developed innovative small molecule drug Luvometinib Tablets was approved for two indications, addressing unmet needs in rare oncological diseases; and Serplulimab Injection was approved in the EU, UK, India, and other regions. Fosun Pharma continuously advanced international multi-center clinical trials of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) and HLX43 for injection (PD-L1-targeted antibody-drug conjugate), while introducing HLX701 (SIRPα-Fc fusion protein) and FXB0871 (PD-1-targeted IL-2 fusion protein) to further enrich the pipeline.

In the hematologic tumor area, Fosun Pharma continued to expand access and affordability for its CAR-T therapy product Yi Kai Da (Ejilunsai injection). As at the end of the Reporting Period, Yi Kai Da was included in over 110 urban customized commercial health insurances and over 90 commercial insurances, while the number of treatment centers on record exceeded 200, covering more than 28 provinces and municipalities across China. In the immune inflammation area, the dipeptidyl peptidase 1 (DPP-1) inhibitor XH-S004 achieved overseas licensing in all regions globally except Chinese Mainland, Hong Kong SAR and Macau SAR, demonstrating international recognition of its clinical value.

In the chronic disease area, products such as Yi Xin Tan (sacubitril valsartan sodium tablets), Pang Bi Fu (etelcalcetide hydrochloride injection), Bei Wen (keverprazan hydrochloride tablets) and Wan Ti Le (Tenapanor Hydrochloride Tablets) were launched, further strengthening Fosun Pharma’s presence in cardiovascular, renal, and metabolic disorders. In the neurological area, Fosun Pharma licensed in AR1001, a small molecule oral therapy designed to slow disease progression in Alzheimer’s disease, leveraging synergies with Fosun Pharma’s medical device and diagnostics businesses to explore integrated solutions for neurodegenerative diseases.

During the Reporting Period, Fosun Pharma also advanced the R&D and launch of its vaccine pipeline, with its self-developed quadrivalent influenza virus split vaccine approved in Chinese Mainland for individuals aged three and above, enriching its vaccine portfolio.

In 2025H1, a total of 4 innovative drugs (either self-developed or licensed-in) gained approval for 5 indications, and a total of 57 generic drug varieties were approved for launch; a total of 4 innovative drugs with a total of 22 generic drug varieties were applied for launch. In addition, nearly 20 clinical trials of innovative drugs (calculated by approval) were approved to be conducted by domestic and overseas regulatory institutions during the Reporting Period. During the Reporting Period, a total of 142 patents had been applied for in the pharmaceutical manufacturing segment of the Group, including 3 U.S. patent applications and 3 PCT applications 27 licensed invention patent authorization were obtained.

Additionally, in the professional medical device sector, the Ion Bronchial Navigation Operation Control System ("Ion System") successfully achieved commercial launch. Together with innovative devices represented by the Da Vinci Surgical Robot, it has jointly improved medical accessibility in tumor surgeries. As of the end of the Reporting Period, the "Da Vinci Surgical Robot" had been installed in over 370 hospitals in Chinese Mainland, Hong Kong SAR and Macau SAR, with a cumulative installation volume exceeding 450 units, serving more than 760,000 patients. Among them, the Da Vinci Xi Surgical System achieved the highest bid-winning rate and maintained the leading market share in the industry.

Strengthening Global Operation Capabilities and Continuously Enhancing Global Market Presence

Guided by the 4IN strategy (Innovation, Internationalization, Integration, and Intelligentization), Fosun Pharma continues to enhance operational efficiency, strengthen global market presence, and promote the building of production system with international quality standards, thus laying a solid foundation for the overseas distribution of preparations. Fosun Pharma’s businesses primarily cover major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia. In the first half of 2025, Fosun Pharma’s overseas revenue reached RMB 5,478 million, accounting for 28.07% of total revenue.

Since 2025, the global academic influence of Fosun Pharma’s pipeline and marketed innovative products continued to grow. Notably, Luvometinib Tablets gained recognition from the internationally authoritative academic journal Drugs, which published a report in its August 2025 issue systematically outlining the drug’s development process and key clinical data. In July 2025, Luvometinib Tablets have entered Phase 3 clinical trial for the treatment of pediatric low-grade glioma (pLGG) in Chinese Mainland, marking the first MEK-targeted drug in Chinese Mainland to enter Phase 3 clinical trial for this therapeautic area. With the increasing quality of its innovation pipeline, Fosun Pharma achieved breakthroughs in global business development (BD) for innovative drugs, strengthening global two-way license cooperation during the Reporting Period. Focusing on unmet clinical needs and core therapeutic areas, the Group enhanced its innovation pipeline through licensing and co-development while also securing multiple out-licensing agreements through Fosun Pharma and its subsidiary Henlius, accelerating product entry into markets in Europe, the United States, and Asia-Pacific.

Fosun Pharma has established a mature commercialization system covering pharmaceutical and medical device businesses, including an overseas commercial team of over 1,000 people. The pharmaceutical manufacturing segment covered markets such as the United States and Africa, while steadily expanding into emerging markets, including ASEAN and the Middle East. In the U.S. market, Fosun Pharma has established the U.S. innovative drug team, and initiated the commercialization preparations before the launch of serplulimab injection and the preliminary preparations for the license-in projects of innovative drugs. Meanwhile, the Group has also built a clinical operations team, advancing a U.S. bridging trial for serplulimab injection in combination with chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), with over 100 trial centers activated. In emerging markets such as Africa, the Group has set up 6 regional drug distribution centers to provide one-stop services consisting of registration, circulation, academic promotion and post-launch safety alert and other services for customers. The medical devices segment has continued expanding its global marketing network. Sisram Medical, Fosun Pharma’s holding subsidiary, has set up12 direct-sales offices to globally, with marketing network now covering over 110 countries and regions worldwide. Meanwhile, Breas continued to deepen its presence in key markets such as Europe, the U.S., China, Japan, India, and Australia, steadily strengthening its global business layout.

With years of profound cultivation, Fosun Health, Fosun Pharma’s holding subsidiary, has formed a healthcare services platform centered on the Greater Bay Area, with the provision of general and specialized medical disciplines and the integration of online and offline services. The medical institutions controlled by Fosun Health had a total of 6,600 authorized beds, and held 9 internet hospital licenses. In terms of international and consumer-driven healthcare, Fosun Health is actively expanding into markets such as Indonesia, Hong Kong SAR, and Macau SAR, with four of its Greater Bay Area hospitals establishing international medical centers to form a high-quality medical hub with global reach. Among them, Foshan Fosun Chancheng Hospital and Heng Seng Hospital, as designated institutions under the "Hong Kong and Macau Medicine and Equipment Connect" program, introduced 15 new drugs and devices from the program’s catalogue.

ESG Rating Upgraded to AA and Sustainability Achievements Widely Recognized

While maintaining steady operations, Fosun Pharma prioritizes sustainable development, enhancing the global accessibility and affordability of innovative products. In the latest MSCI ESG rating, Fosun Pharma ascended to an ‘AA’ rating, reflecting its leadership position within the domestic pharmaceutical industry and its progress in sustainability management and performance. Fosun Pharma has been recognized in multiple prestigious lists, including the 2024 China ESG 50 List (Forbes), the China ESG Listed Company Pioneers 100 (CMG), and the China Best Managed Companies (Deloitte). Fosun Pharma was also listed on the 2025 Fortune China ESG Impact List, becoming the only Chinese pharmaceutical company featured, demonstrating broad societal recognition.

"In the second half of 2025, Fosun Pharma will continue to implement the 4IN strategy, enhance innovation capabilities and R&D efficiency, actively lay out products in core therapeutic areas with significant unmet needs, and focus on the internal development and external introduction of high-value pipelines." Chen Yuqing, Chairman of Fosun Pharma, said. "We will vigorously develop strategic products, seize global market opportunities, optimize asset allocation, and further improve internal operational quality and efficiency to optimize the financial structure and solidify the foundation for the Company’s long-term stable development."

Genmab Receives FDA Breakthrough Therapy Designation for Rinatabart Sesutecan (Rina-S®) in Advanced Endometrial Cancer (EC)

On August 26, 2025 Genmab A/S (Nasdaq: GMAB) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRα)-directed, TOPO1-inhibitor antibody-drug conjugate (ADC), for the treatment of adult patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy (Press release, Genmab, AUG 26, 2025, View Source [SID1234655479]). BTD aims to expedite the development and review of investigational medicines by the U.S. FDA for serious or life-threatening diseases in cases where preliminary clinical evidence shows that a therapy may provide substantial improvements over available therapies.

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The designation was supported by previously published results from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part, Phase 1/2 RAINFOL-01 trial (NCT05579366), evaluating the safety and efficacy of Rina-S in solid tumors. In the B2 cohort, 64 patients with heavily pretreated advanced or recurrent EC whose disease had progressed on or after an anti-PD-(L)1 and platinum-based chemotherapy were enrolled and treated with Rina-S. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"This Breakthrough Therapy Designation underscores the future potential of Rina-S as a treatment option for women diagnosed with advanced endometrial cancer, who face a poor prognosis after progressing on standard of care treatment," said Judith Klimovsky, M.D., Executive Vice President and Chief Development Officer of Genmab. "Rina-S reinforces Genmab’s determination to advance wholly owned antibody medicines in areas long overdue for innovation and our commitment to driving a strong clinical development program to help redefine what’s possible to treat gynecologic cancers."

Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial, the ongoing Phase 3 RAINFOL-02 trial (NCT06619236) in ovarian cancer, and several planned trials to evaluate Rina-S as a potential treatment option for a variety of tumor types, including a Phase 3 trial in endometrial cancer.

About the RAINFOLTM -01 Trial
RAINFOL-01 (NCT05579366) is an open-label, multicenter Phase 1/2 study, designed to evaluate the safety and efficacy of rinatabart sesutecan (Rina-S) Q3W at various doses in solid tumors that are known to express FRα. The study consists of multiple parts including Part A dose escalation; Part B tumor-specific monotherapy dose-expansion cohorts; Part C platinum-resistant ovarian cancer (PROC) cohort; Part D combination therapy cohorts; Part F a monotherapy endometrial cancer (EC) cohort; and Part K monotherapy QTc cohort in high-grade ovarian cancer.

About Endometrial Cancer
Endometrial cancer (EC) starts in the lining of the uterus, known as the endometriumii and ranks as the second most prevalent gynecologic cancer globally, with increasing incidence and mortality ratesiii,iv. Patients with advanced or recurrent EC have a relatively poor prognosis and treatment options are limited for those patients who have progressed following treatment with chemotherapy and immune checkpoint inhibitor. FRα is overexpressed on multiple tumors, including EC, making it a promising therapeutic target. Anti-tumor activity with Rina-S was observed across a broad range of FRα expression, and there are currently no approved FRα-directed therapies approved for the treatment of endometrial cancer.

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rinatabart sesutecan (Rina-S; GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at folate receptor α (FRα), a novel hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical trial program for Rina-S continues to expand including ovarian, endometrial and other cancers of unmet need.

The safety and efficacy of rinatabart sesutecan has not been established. Please visit www.clinicaltrials.gov for more information.

Curasight announces acceptance of clinical trial application (CTA) for phase 1 trial with uTREAT® in brain cancer patients

On August 26, 2025 Curasight A/S ("Curasight" or "the Company") (CPH: CURAS), a clinical stage radiopharmaceuticals company, reported the European Medicines Agency (EMA) has approved the company’s clinical trial application (CTA) for the investigation of uTREAT in a phase 1 trial (Press release, Curasight, AUG 26, 2025, View Source [SID1234655495]).

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The phase 1 trial is part of Curasight’s theranostic strategy developing more gentle and targeted diagnosis and treatment of certain types of cancer. Dosing the first patient in the trial is expected to occur before the end of the year.

Today’s news means Curasight is now in clinical development with both its diagnostic (uTRACE) and therapeutic (uTREAT) platforms.

"The approval of the CTA underlines the strong progress being made in developing uTREAT as a potential more targeted therapeutic solution for patients with aggressive brain cancer, where there is a strong unmet medical need," said Curasight’s CEO Ulrich Krasilnikoff and continues, "There has been little progress in treating glioblastoma over the last decades but recently published data from an investigator-initiated Phase II study highlighted the potential of both uTRACE and uTREAT in diagnosing and treating brain cancer where 94% of Grade 4 gliomas -including glioblastomas – were uPAR-positive.".

About the Phase 1 trial with uTREAT in brain cancer

The trial aims to investigate Curasight’s uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE and uTREAT both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight’s ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.