On August 26, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported its 2025 interim results for the six month period ending June 30, 2025, highlighting record commercial sales in China and major global advances in its oncology and autoimmune pipelines (Press release, Akeso Biopharma, AUG 26, 2025, View Source [SID1234655492]). The company has strengthened its leadership in IO bispecific antibodies for first-line cancers, cold tumors, and IO-resistant indications, while rapidly progressing next-generation bispecific-ADC therapies. Its "IO 2.0 + ADC 2.0" strategy is accelerating changes in the global oncology treatment landscape. Outside of oncology, Akeso is set to launch its third and fourth commercial products, boosting both its commercial portfolio and market capabilities. Driven by breakthrough clinical value, Akeso continues to optimize its oncology strategies, demonstrating leadership to reshape global treatment standards and clearly outlining its international expansion.

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Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said: "I want to sincerely thank the members of the Akeso family for their hard work, and also to say a big ‘Thank You’ to our partners for their strong support. Akeso has achieved historic results during this period.

First of all, in the first half of this year, we reached record commercial performance. With expanded indications for ivonescimab and cadonilimab, coupled with accelerated market access following their inclusion in the National Reimbursement Drug List (NRDL), our innovation driven commercialization has gained significant momentum.

Secondly, our ‘IO 2.0 + ADC 2.0’ strategy is establishing a lasting competitive advantage. Our first-in-class bispecific antibodies, cadonilimab and ivonescimab, position Akeso as a global leader in immuno-oncology bispecifics, reinforcing our pivotal role in shaping the future of cancer treatment.

We are advancing the global development of both cadonilimab and ivonescimab in first-line cancers, cold tumors, and immuno-oncology resistant settings. Together, they are being evaluated in 23 registrational/Phase III trials and in over 20 Phase II studies worldwide, highlighting our strong commitment to research and development and providing a solid foundation for global growth. Notably, ivonescimab’s initial Phase III trial demonstrated a statistically significant overall survival (OS) benefit, affirming its value across multiple endpoints, including progression-free survival (PFS) and OS.

At the same time, our lead bispecific-ADC, AK146D1, and a next-generation ADC, AK138D1, have entered global early-stage clinical trials. Additional bispecific-ADC and ADC candidates are currently being developed.

Both ivonescimab and cadonilimab are first-in-class drugs that have achieved regulatory approvals. Backed by their breakthrough clinical profiles and broad indication coverage, along with our leadership in global commercialization and a robust ADC pipeline that includes bispecific and next-generation platforms, we are now fully deploying our IO2.0 + ADC2.0 strategy worldwide. This positions us to build a transformative, long-term competitive advantage across our portfolio.

Third, we are pioneering advancements in the field of autoimmune diseases and our non-oncology pipeline serves as a significant growth driver. With the recent launches of ebdarokimab (IL-12/IL-23) and ebronucimab (PCSK9), and upcoming launches of gumokimab (IL-17) and manfidokimab (IL-4Rα), alongside innovative candidates such as our IL-4R/ST2 bispecific and assets targeting neurological diseases, we are enhancing our non-oncology portfolio and broadening our competitive position globally.

Backed by progress in R&D, clinical development, commercialization, and global strategy, Akeso has entered a new stage of growth. We remain committed to pioneering innovation, delivering transformative therapies to patients, and creating shared value for healthcare providers, patient communities, investors, and our team as we become a fully integrated global biopharma."

Breakthrough IO Bispecific Antibodies Demonstrate Sustained Commercial Momentum with High-Quality Growth

In the first half of 2025, Akeso’s total commercial sales, net of distribution cost increased by 49.20% from RMB939.4 million for the six months ended June 30, 2024 to RMB1,401.6 million for the six months ended June 30, 2025. The growth underscores the company’s robust commercial execution and deepening market penetration.

Research and development expenses for the six months ended June 30, 2025 was RMB731.2 million. As of June 30, 2025, The company’s total balance of cash, cash equivalents, time deposits, and financial products were RMB7,138.4 million.

Key Growth Drivers Include:

First-line Indication Approvals with Superior Clinical Profiles
Cadonilimab in gastric and cervical cancers, and ivonescimab in NSCLC, are addressing critical unmet needs with clinically meaningful benefits, driving rapid adoption among physicians and patients.

Enhanced Market Access via NRDL Inclusion
Inclusion in China’s National Reimbursement Drug List (NRDL) for cadonilimab (recurrent/metastatic cervical cancer) and ivonescimab (EGFR-TKI resistant NSCLC) significantly expands patient access and reduces out-of-pocket burden. Focused commercial efforts and clinician education accelerated uptake across key treatment centers.

Diversified Growth from Non-Oncology Portfolio
As the approvals for ebdarokimab (IL-12/IL-23) and ebronucimab (PCSK9) have followed one after another, the company’s development efforts in non-oncology areas such as autoimmune diseases and metabolic diseases are beginning to significantly contribute to the growth of our commercial franchise.

Ivonescimab Meets OS Endpoint in HARMONi-A Final OS Analysis; Demonstrates Potential to Reshape Global Treatment Landscape Across 8 Lung Cancer and 5 Other Major Tumor Indications

Ivonescimab has consistently demonstrated superior efficacy compared to current IO 1.0 therapies, with an expanding number of global clinical program that includes multiple registrational and Phase III trials across a broad spectrum of tumors. With particular focus in first-line high-incidence cancers, cold tumors, and IO-resistant indications, ivonescimab further establishes its international leadership in cancer therapeutics.

In August, Akeso announced that the final OS analysis of this clinical trial showed that ivonescimab met the OS clinical endpoint, demonstrating a statistically significant and clinically meaningful OS benefit. As the first Phase III final analysis for ivonescimab, these results not only reinforce its breakthrough value in progression-free survival (PFS), but also highlight its ability to deliver significant OS improvement, a key endpoint in global oncology drug development.

During the reporting period, an interim analysis of the first global multicenter Phase III trial (HARMONi) also demonstrated strongly positive PFS outcomes. Although statistical significance for OS was not yet reached at the time of the announcement, a promising trend toward OS benefit was observed. With 38% of the patients enrolled from regions such as Europe and North America, the intent-to-treat (ITT) survival outcomes were highly consistent with those from the China-based HARMONi-A study, supporting ivonescimab’s cross-regional consistency in efficacy and safety and enhancing its global market potential.

Furthermore, following positive results from HARMONi-2—a randomized, double-blind, head-to-head Phase III trial against pembrolizumab monotherapy that led to its approval in first-line PD-L1-positive NSCLC (its second approved indication), ivonescimab plus chemotherapy has now also demonstrated significant positive outcomes in another head-to-head Phase III study against tislelizumab plus chemotherapy in first-line squamous NSCLC. This clinical outcome demonstrates that ivonescimab shows significant clinical breakthroughs, whether compared to PD-1 monotherapy, or compared to PD-1 in combination with chemotherapy (the optimal standard of care for many cancer treatments), or compared to VEGF-related therapies in the area of anti-angiogenesis. This highlights the remarkable capability of ivonescimab to make leapfrog advancements in cancer treatment.

Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings:

Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints):

First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial)
First-line squamous NSCLC (versus tislelizumab + chemotherapy)
NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies)
First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy)
First-line PD-L1-high expressing NSCLC (versus pembrolizumab)
IO-resistant NSCLC
Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT)
Phase III trials for core immuno-oncology indications (first-line therapy ):

First-line biliary tract cancer (versus durvalumab + chemotherapy)
First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab
Phase III trials for cold tumors and more：

First-line triple-negative breast cancer (TNBC)
First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases)
First-line pancreatic cancer
Additional global Phase III trials are in advanced stages of planning
An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data to enable rapid transition to further registrational studies worldwide.

Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy.

For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab world wide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics.

Cadonilimab Advances with Global Registrational Trial Launch Following Demonstration of Broad Efficacy Across 10 Major Tumor Types First-line Therapy and IO-Resistant Settings

Cadonilimab is currently approved for recurrent/metastatic cervical cancer, first-line cervical cancer, and first-line gastric cancer, addressing significant unmet needs across multiple oncology indications. As the world’s first approved immuno-oncology bispecific antibody, its breakthrough clinical value has been consistently demonstrated across numerous clinical studies and real-world applications.

Robust evidence-based medical data confirms that cadonilimab delivers clinical benefit across a broad spectrum of patient populations, showing superior efficacy regardless of PD-L1 expression status. Furthermore, cadonilimab has exhibited significant clinical advantages over current standard therapies in multiple IO-resistant tumors and cold tumors that respond poorly to existing PD-1/L1 inhibitors.

The benefits of cadonilimab stem from its unique ability to simultaneously target both PD-1 and CTLA-4, resulting in a synergistic anti-tumor effect. This innovative mechanism not only leverages the therapeutic advantages of both targets but also addresses the efficacy and safety limitations traditionally associated with them, culminating in significant clinical value. Notably, cadonilimab effectively overcomes the efficacy constraints often encountered with the toxicity of CTLA-4 monotherapies. These compelling advantages have been validated across multiple Phase III clinical trials and in real-world applications, positioning cadonilimab as a transformative advancement in the landscape of current immunotherapies.

Cadonilimab is currently being evaluated in 10 global registrational/Phase III trials spanning first-line indications in major tumors, cold tumors, and IO-resistant diseases. Beyond its already approved indications (recurrent/metastatic cervical cancer, first-line cervical cancer, first-line gastric cancer), ongoing studies include:

Combination therapy with pulocimab (anti-VEGFR-2) in PD-1-resistant gastric cancer (phase III)
Perioperative treatment for resectable gastric cancer (phase III)
First-line treatment of PD-L1-negative NSCLC (versus PD-1+ chemotherapy)(phase III)
Consolidation therapy after concurrent/sequential chemoradiation in NSCLC (versus PD-L1 inhibitor) (phase III)
Adjuvant therapy after hepatocellular carcinoma (HCC) resection (phase III)
Intermediate-stage HCC (phase III)
Global multicenter registrational Phase II trial is underway for the treatment of second-line HCC
Notably, the first global multicenter registrational study of cadonilimab in combination with lenvatinib for the treatment of second-line HCC has recently been initiated (COMPASSION-36). This represents a significant milestone in its international development and regulatory pathway. The study aims to further validate cadonilimab’s potential to overcome the limitations of single-target immunotherapies in global clinical practice, while also demonstrating the synergistic anti-tumor effect achieved through the dual targeting of PD-1 and CTLA-4. Additional multinational registrational and Phase III trials are currently in preparation.

While advancing cadonilimab’s global development independently, Akeso remains open to strategic collaborations to integrate worldwide resources and accelerate its international expansion, maximizing global patient reach and therapeutic value.

Global Clinical Development of Bispecific ADCs, Leading a Transformative "IO 2.0 + ADC 2.0" Strategy in Oncology

As IO-ADC combinations emerge as a pivotal direction in cancer therapy, Akeso as the only company globally with two approved immuno-oncology bispecific antibodies (cadonilimab and ivonescimab), is leveraging its strong leadership in the IO field to advance a next-generation pipeline of ADCs, bispecific ADCs, and dual-payload ADCs. Building on extensive international experience in bispecific/multispecific development, Akeso is combining its IO bispecifics with novel ADC platforms to create multidimensional, iterative treatment strategies aimed at redefining the global oncology landscape.

The company has advanced its novel bispecific ADC targeting Trop2/Nectin4 (AK146D1) , and its differentiated novel HER-3 ADC (AK138D1) into global clinical development. Studies evaluating AK138D1 and AK146D1 in combination with cadonilimab or ivonescimab are currently in preparation.

Additional next-generation internally developed ADCs, bispecific ADCs, and dual-payload ADCs are set to enter clinical trials in the future.

Furthermore, ivonescimab and cadonilimab are also being widely explored in combination studies with ADCs from industry partners.

Notably, Akeso’s proprietary differentiated PD-1 inhibitor, penpulimab, has received approval from the U.S. FDA, making it the company’s first internally developed innovative drug to be approved in the United States, and the first biologic entirely led (from R&D and clinical development to manufacturing and regulatory submission) by a Chinese company to achieve U.S. FDA approval.

During the reporting period, other oncology assets also achieved key milestones:

Akeso’s in-house developed next-generation anti-CD47 antibody, ligufalimab, is being evaluated in multiple Phase III trials alongside cadonilimab and ivonescimab across several tumor types. Global clinical development of ligufalimab in hematologic malignancies is also ongoing
The in-house developed pulocimab (VEGFR-2) is being evaluated in several Phase III trials in combination with cadonilimab and ivonescimab
Two Additional Phase III Successes in Autoimmune Therapies Accelerate Non-Oncology Commercial Growth

Beyond its oncology portfolio, Akeso has achieved significant milestones in autoimmune diseases with its in-house developed novel therapeutics:

Ebronucimab (anti-PCSK9) has been approved in China for hypercholesterolemia, which affects approximately 110 million patients in China
Ebdarokimab (anti-IL-12/IL-23) is approved in China for the treatment of psoriasis, a condition affecting around 6.7 million patients in China
Gumokimab (anti-IL-17) has had its New Drug Application (NDA) accepted by NMPA for moderate-to-severe plaque psoriasis
Additionally, gumokimab has achieved positive results in a Phase III trial for active ankylosing spondylitis, and manfidokimab (anti-IL-4Rα) has also reported Phase III success in atopic dermatitis. NDA submissions for these indications are currently underway
The successive approvals and advanced development of these four non-oncology drugs enable Akeso to address diverse treatment needs across chronic, autoimmune diseases with large patient populations, creating a synergistic product portfolio that significantly enhances the company’s competitiveness in the immunology sector.

With further global innovations such as the IL-4R/ST2 bispecific antibody (AK139) and candidates targeting neurological diseases advancing through multi-indication development, Akeso continues to strengthen its non-oncology pipeline with first-in-class innovation.

Moving forward, Akeso remains committed to pioneering novel therapeutics through original innovation. We will continue to develop medicines with global competitiveness, aiming to benefit patients worldwide and grow into a leading global biopharmaceutical company.

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."

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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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."

On August 25, 2025 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported corporate highlights and unaudited financial results for the first half of 2025 (Press release, Molecular Partners, AUG 25, 2025, View Source [SID1234655462]).

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"Molecular Partners continues to make good progress towards key development milestones, notably in our two clinical programs. Following the expansion of our strategic radiotherapy partnership with Orano Med in January, we are advancing our lead program MP0712 towards its first-in-human trial. With the data package complete, we anticipate the IND filing and Phase 1 initiation in 2025, and initial clinical data in H1 2026. Our multispecific T cell engager MP0533 is making progress in its Phase 1/2a trial for acute myeloid leukemia. Recently presented data show both increased response rates and greater depth of responses and we look forward to presenting the first data under the amended study protocol in Q4 2025. We also strengthened our leadership with the appointment of Martin Steegmaier, Ph.D., as CSO, further underlining our commitment to delivering improved treatment options for patients and significant value for our stakeholders. Our finances remain robust with funding projected into 2028," said Patrick Amstutz, Ph.D., CEO of Molecular Partners.

Research & Development Highlights

MP0533 (Multispecific T Cell Engager; CD33 x CD123 x CD70 x CD3)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)/AML (ClinicalTrials.gov: NCT05673057). Molecular Partners presented updated data from the study at the 30th Annual European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June, outlining the impact of accelerated step-up dosing regimen of MP0533 on exposure and clinical responses in cohort 8, providing the rationale for further optimization to the dosing regimen implemented in the ongoing cohort 9. Initial data from cohort 8 show promising antitumor activity: 3 of 8 (>30%) evaluable patients with relapsed/refractory disease achieved a clinical response after the first cycle, with one complete response and two complete responses with partial hematologic recovery. Notably, two patients maintained their responses for over three months, including one patient still responding after more than six months at data cutoff (14 April 2025) and still on treatment today. This cohort benefited from a higher starting dose and a faster step-up dosing schedule, leading to prolonged exposure within the predicted therapeutic range and notable blast reduction in most patients, with an acceptable safety profile after dose adjustments in cohort 8.

Encouraged by these results, Molecular Partners amended the study protocol for cohorts 9 and 10 by further accelerating the step-up dosing, increasing the dosing frequency and introducing anti-CD20 premedication for greater cumulative exposure. These changes aim to enhance both the depth and duration of patient responses. Cohort 9 is exploring a lower target dose than cohort 8 to assess the safety of up to daily dosing for the first 14 days of treatment, leading to significantly denser dosing; cohort 10 aims at reaching the same target dose as cohort 8 while exposing patients to more drug over time. Initiation of cohort 10 is anticipated to start in the coming weeks, pending appropriate approvals. Cohort 9 is now fully recruited, with initial data expected to be presented in Q4 2025.
MP0533 continues to show broad activity, with initial blast reductions in a majority of patients treated. The data continue to indicate that the patients more likely to see durable responses will be those who initiate therapy with a lower level of blasts at baseline. Looking forward, Molecular Partners plans to explore future cohorts of MP0533 in combination settings, both in relapsed/refractory as well as in front-line patients, should favorable antitumor activity continue to be observed. The company is engaging with regulators such as the U.S. Food and Drug Administration (FDA) to discuss next steps.

MP0712 (212Pb x DLL3), Radio-DARPin Pipeline and Global Partnership with Orano Med

The Phase 1 Investigational New Drug (IND) application for MP0712, a 212Pb-based Radio-DARPin therapy (RDT) candidate targeting the tumor-associated protein delta-like ligand 3 (DLL3), co-developed with Orano Med for the treatment of small cell lung cancer (SCLC), is in preparation. Molecular Partners presented preclinical data in April at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025, showing a high tumor uptake and a favorable safety profile for MP0712, with good efficacy in mouse models matching clinically relevant DLL3 expression levels. Dialogue with the FDA is ongoing and IND filing expected in Q3 2025. The first clinical sites in the U.S. are identified and, pending regulatory clearance, patient dosing is planned to initiate in 2025 with initial first-in-human clinical data expected in H1 2026.

In H1 2025, Molecular Partners accepted a request from Nuclear Medicine Research Infrastructure (NuMeRI) in South Africa to provide MP0712 for imaging use under the legal framework in South Africa for compassionate care (also referred to as Section 21 of the Medicines and Related Substances Act). This approach allows for the potential to generate initial images applying MP0712 labelled with 203Pb in patients with SCLC and other DLL3-expressing neuroendocrine cancers. While the decision of where and how to share data from the image work under Section 21 remains at the discretion of NuMeRI, the Company anticipates providing an update on MP0712 in H2 2025. 203Pb and 212Pb are an element-equivalent pair of lead (Pb) isotopes, with 203Pb primarily used for imaging and 212Pb for therapeutic applications (targeted alpha therapy, TAT). As a "matched pair", pre-treatment imaging with 203Pb will provide a prediction of treatment behavior with 212Pb.

The second RDT program co-developed with Orano Med is MP0726, targeting mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. The development of therapeutics against MSLN has been hampered by high levels of shed MSLN. Leveraging the unique properties of DARPins, Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN. The Company presented preclinical data on MP0726 at AACR (Free AACR Whitepaper) 2025 in April and at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in June. Initial clinical data are expected in 2026.

In January 2025, Molecular Partners and Orano Med further expanded their agreement to co-develop up to ten radiotherapy programs. In addition to its world class expertise and capabilities in the development of TAT with 212Pb, Orano Med will ensure the production of the 212Pb-based Radio-DARPins for clinical trials and commercialization. Orano Med possesses virtually unlimited source material for 212Pb production and has established robust and independent supply and manufacturing capabilities required for the seamless delivery of TAT to clinical sites internationally.
Switch-DARPins (Next-Generation Immune Cell Engagers)

By employing a multi-specific Switch-DARPin, Molecular Partners aims to increase the safety and potency of T cell engagers (TCEs). Preclinical proof-of-concept in a solid tumor model for a novel CD3 Switch-DARPin TCE with CD2 costimulation was presented at AACR (Free AACR Whitepaper) in April 2025. The data show the feasibility of conditional T cell activation with potent co-stimulation in solid tumors, but not in healthy tissues. In addition, data showed that the CD3 Switch-DARPin activates T cells specifically in the presence of cells co-expressing the tumor targets MSLN and EpCAM, increasing tumor specificity. The Company will present an update on the CD3 Switch-DARPin program at the Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Q4 2025.

MP0317 (tumor-localized CD40 agonist)

Molecular Partners presented comprehensive biomarker analyses from the completed Phase 1 dose escalation trial of the localized CD40 agonist MP0317 in solid tumors at SITC (Free SITC Whitepaper) in November 2024. MP0317 is designed to activate immune cells specifically within the tumor microenvironment by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors. The Company believes this tumor-localized approach has the potential to deliver greater efficacy with fewer side effects compared to systemic CD40-targeting therapies.

Molecular Partners has committed to supporting an investigator-initiated trial of MP0317. The study is being designed for the treatment of patients with advanced cholangiocarcinoma in combination with standard-of-care. A study protocol has been submitted; pending regulatory approval, the study could be initiated in 2025.

Corporate Governance Highlights

As announced on August 21, 2025, Molecular Partners appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO) and member of its Executive Committee, effective October 1, 2025. He brings a wealth of experience in oncology drug development, having previously contributed to the advancement of several innovative cancer therapies at major biotech and pharmaceutical companies.

In H1 2025, Molecular Partners undertook a strategic review of its operations and headcount, with the objectives of increased efficiency in the organization and to sharpen the focus on advancing its clinical assets. As a result of this review, the Company informed the Amt für Wirtschaft of Kanton Zürich (Office for Economic Affairs) in June 2025 of its intention to reduce its current workforce by no more than 40 positions, representing up to ~24% of all positions. All employees affected have been informed, and based upon these headcount reductions, the Company now anticipates its cash runway to extend into 2028, beyond its prior guidance of 2027.

All motions proposed by the Board of Directors at the Annual General Meeting, held in April 2025, were approved by the shareholders of the Company by a wide majority.

Financial and Business Outlook
For the full year 2025, at constant exchange rates, the Company expects total operating expenses of CHF 55-65 million of which around CHF 7 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.

The Company’s cash and cash equivalents and short-term time deposits were CHF 114 million as of June 30, 2025 and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements into 2028.