Kelun-Biotech Receives IND Approval for SKB103, a Novel TAA-PD-L1 Bispecific ADC

On March 24, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that the Investigational New Drug (IND) application for SKB103, its self-developed novel bispecific antibody-drug conjugate with combined Tumor-Associated Antigen-targeting and Immuno-Oncology mechanisms (TAA-PD-L1 bsADC), has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of advanced solid tumors. The approval marks SKB103 as the Company’s first TAA-PD-L1 bsADC candidate and its second bsADC program for tumor therapy to enter the clinical stage, following SKB571.

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As one of the industry leaders in the ADC field, Kelun-Biotech has established a solid competitive advantage. Currently, the Company’s self-developed TROP2 ADC and HER2 ADC have been approved for marketing, demonstrating significant clinical efficacy and competitive differentiation. Focusing on advances in oncology therapeutics, Kelun-Biotech continues to expand its innovative layout by building a diversified pipeline covering cutting-edge therapies such as RDCs and bsADCs and fully driving breakthroughs and innovations in existing cancer treatment paradigms.

SKB103 is a potential best-in-class novel bsADC developed using Kelun-Biotech’s proprietary OptiDC platform. Designed as a single molecule, it is expected to realize targeted delivery of cytotoxic payloads to tumors and modulation of tumor immune microenvironment simultaneously. In preclinical studies, SKB103 demonstrated outstanding anti-tumor activity and a favorable safety profile. The therapeutic potential of SKB103 will support its subsequent clinical development.

"The IND approval for SKB103 represents another important milestone in our bsADCs pipeline and reflects the continued clinical translation of our novel DC strategy, further solidifying our core technical advantages in the ADC field," said Dr. Michael Ge, CEO of Kelun-Biotech. "Innovation in IO and ADC is currently reshaping the global cancer treatment landscape. Leveraging our systematic and platform-based R&D capabilities and extensive ADC development experience, we will advance the development of next-generation ADC drugs like SKB103, deeply explore the global clinical value of our portfolio, and fully promote innovation in cancer therapies, opening up broader prospects for the treatment of patients worldwide and the Company’s sustainable development."

(Press release, Kelun, MAR 24, 2026, View Source [SID1234663877])

Citius Oncology to Participate in USCLC Annual Workshop 2026, Highlighting LYMPHIR™ in Discussions with Leading Cutaneous Lymphoma Experts

On March 24, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported that members of its commercial and medical affairs teams will attend the USCLC Annual Workshop 2026. The meeting, titled "Frontiers in Cutaneous Lymphoma: New Technologies, Therapeutics, and Future Directions," will take place on March 26, 2026, at the Hyatt Regency Denver at Colorado Convention Center.

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The United States Cutaneous Lymphoma Consortium (USCLC) Annual Workshop is widely regarded as one of the most focused scientific gatherings dedicated to cutaneous lymphomas, including cutaneous T-cell lymphoma (CTCL). The meeting brings together leading dermatologists, hematologist-oncologists, translational researchers, and academic investigators from major U.S. cancer centers who specialize in diagnosing and treating CTCL and related diseases.

This year’s workshop is expected to convene dozens of key opinion leaders and clinical investigators from leading academic institutions, with program sessions covering:

Novel molecular diagnostics and biomarkers
Radiology and digital pathology advancements
Emerging therapies for CTCL
Future clinical and research directions in cutaneous lymphoma
The workshop format emphasizes small-group discussions and direct interaction among experts, creating an environment where physicians and researchers can exchange insights about evolving treatment paradigms and clinical experience.

Citius Oncology’s team will participate in the meeting to engage with clinicians and researchers regarding the treatment landscape for CTCL and discussions regarding clinical experience with LYMPHIR (denileukin diftitox-cxdl) which Citius Oncology recently launched in the U.S.

"Our participation in the USCLC Workshop reflects our commitment to engaging directly with the leading clinicians who treat patients with cutaneous lymphoma," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "The USCLC community represents many of the foremost experts and practitioners in CTCL care, and we look forward to productive scientific discussions regarding treatment experience, patient selection, and emerging opportunities to improve outcomes."

About the USCLC Annual Workshop

The USCLC Annual Workshop is organized by the United States Cutaneous Lymphoma Consortium, a collaborative network of leading U.S. academic centers dedicated to improving research, diagnosis, and treatment of cutaneous lymphomas. The workshop serves as a platform for leading specialists to discuss cutting-edge diagnostics, emerging therapeutics, and future research directions in CTCL and related diseases.

USCLC is the only organization in America where professionals from the collaborating disciplines of dermatology, medical oncology, radiation oncology and pathology can exchange ideas and practice tips, discuss, plan and execute scientific collaborations, develop new educational tools, and help shape the research agenda in cutaneous lymphomas. USCLC was created with the express purpose of breaking communication barriers, encouraging "outside-the-box" thinking, and fostering and supporting innovative ideas regarding the treatment and research relating to cutaneous lymphomas. The key initiatives of USCLC are a national registry, a virtual tissue repository, and a clinical trials network.

About LYMPHIR (denileukin diftitox‑cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, MAR 24, 2026, View Source [SID1234663876])

Aethlon Medical, Inc. Advances to Final Cohort in Oncology Clinical Trial Following Positive DSMB Review

On March 24, 2026 Aethlon Medical, Inc. (Nasdaq: AEMD), a clinical-stage biotechnology company developing the investigational Aethlon Hemopurifier, an extracorporeal device for oncology and other indications, reported that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing clinical trial AEMD-2022-06 has completed its scheduled safety review of the second cohort participant data and recommended advancing to the third and final cohort. They also stated that "no safety concerns were noted with Hemopurifier device/procedure".

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The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab", is being conducted to assess the Hemopurifier’s safety, feasibility, and optimal dosing.

The DSMB, comprised of independent medical experts in nephrology and oncology- reviewed data from participants enrolled in the second cohort, in which patients received two Hemopurifier treatments over a one-week period. Based on their evaluation, the DSMB found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier device or treatment have been reported.

"The DSMB’s continued positive recommendation supports the safety profile observed to date and allows us to advance into the third and final cohort of this study," said Steven LaRosa, M.D, Chief Medical Officer of Aethlon Medical. "We are encouraged by the gathering momentum of the trial and having a final data set and clinical study report to share with potential investors, partners and regulatory agencies".

Enrollment for Cohort 3 is now open. In this final cohort, participants will receive three Hemopurifier treatments over a one-week period further evaluating safety, feasibility and dosing parameters at the study’s three active clinical sites in Australia. This trial is designed to enroll approximately 9 to 18-patients with solid tumors who have stable or progressive disease, while receiving treatment that includes Pembrolizumab (Keytruda) or Nivolumab (Opdivo).

The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier- treated patients. In addition to safety monitoring, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of extracellular vesicles (EVs) and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These findings are expected to inform the design of a future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities.

Aethlon Medical, Inc. remains committed to advancing the Hemopurifier for use in oncology and will continue to provide updates as the clinical trial progresses.

About the Hemopurifier

The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived EVs from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects.

The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for:

The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and
The treatment of life-threatening viruses not addressed with approved therapies.
The Hemopurifier is being developed under an open Investigational Device Exemption (IDE) for both indications.

(Press release, Aethlon Medical, MAR 24, 2026, View Source [SID1234663875])

Fosun Pharma Announces 2025 Annual Results

On March 24, 2026 Fosun Pharma ("the company", stock code: 600196.SH; 02196.HK), an innovation-driven global pharmaceutical and healthcare group, reported its 2025 annual operating results (the reporting period).

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Powered by the dual engines of innovation and globalization, Fosun Pharma achieved total operating revenue of RMB 41.662 billion, up 1.45% year-on-year. Of this, revenue from innovative drugs reached RMB 9.893 billion, rising 29.59% year-on-year; overseas revenue amounted to RMB 12.977 billion, growing 14.87% year-on-year. Net profit attributable to shareholders of the parent company was RMB 3.371 billion, up 21.69% year-on-year; recurring net profit attributable to shareholders of the parent company amounted to RMB 2.34 billion, increasing 1.12% year-on-year; and net cash flow generated from operating activities reached RMB 5.213 billion, up 16.45% year-on-year, further consolidating the foundation for high-quality development.

Innovative Drugs Emerge as Core Growth Engine

Revenue from innovative drugs hit RMB 9.893 billion, accounting for 33.16% of pharmaceutical business revenue, becoming the core engine of performance growth. Total R&D investment for the year amounted to RMB 5.913 billion, up 6.46% year-on-year, of which R&D investment related to innovative pharmaceuticals reached RMB 4.303 billion, a year-on-year increase of 15.98%, accounting for 80.26% of pharmaceutical business R&D investment.

High-intensity R&D investment has been translated into fruitful results. During the reporting period, 16 indications of 7 innovative drugs were approved for marketing in China and overseas markets; marketing applications for 6 innovative drug candidates were accepted, and nearly 40 innovative drug clinical trials received approval from China and overseas regulatory authorities; and multiple core products entered key clinical phases, laying a solid pipeline foundation for subsequent commercial growth. Additionally, 5 new innovative drugs were included in the 2025 National Reimbursement Drug List (NRDL), and the CAR-T therapy Yikaida (axicabtagene ciloleucel injection) was successfully listed in the first edition of the Commercial Insurance Innovative Drug Catalog. This not only improves patient access to innovative drugs but also further unlocks the volume potential of commercialization.

Building Differentiated Clinical Pipeline Advantages

Fosun Pharma focuses on innovative drugs as its development priority. Centering on the three core therapeutic areas of oncology (solid tumors, hematologic tumors), immune inflammation and neurodegenerative diseases, the Company continuously strengthens its pipeline construction through in-house R&D, collaborative development and licensing-in.

Oncology: In 2025, Fosun Pharma further strengthened the layout of its innovative pipeline around key indications such as breast cancer and lung cancer. The company’s self-developed small-molecule innovative drug Fumaining (luvometinib Tablet) received approval for two indications, filling the gap in the treatment of rare tumors in China; the innovative small-molecule CDK4/6 inhibitor Futuoning (fovinaciclib citrate capsules) was launched for two indications in China, bringing a brand-new treatment option for breast cancer patients; the anti-PD-1 monoclonal antibody Serplulimab Injection was approved in Europe and multiple emerging markets for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), becoming the first anti-PD-1 monoclonal antibody to receive such approval in the EU and accelerating the company’s globalization pace; antibody and ADC drugs such as HLX43 and HLX22 entered key clinical phases, continuously improving the echelon of the oncology pipeline. The marketing application for the second CAR-T product Brexucabtagene Autoleucel was accepted.

Immune Inflammation and Chronic Diseases: The licensed-in first-in-class innovative drug Wantile (Tenapanor Hydrochloride Tablets) was successfully approved, providing a new treatment option for chronic kidney disease patients on dialysis in China. Steady clinical progress was made for core products such as FXS7553.

Neurodegenerative diseases: Opicapone Capsules, a treatment for Parkinson’s disease, was launched in the Boao Pilot Zone for innovative drugs. Fosun Insightech accelerated product upgrading and indication expansion for its Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system. Sodium Oligomannate Capsule was incorporated into the Company’s Alzheimer’s disease innovative drug pipeline, with post-marketing confirmatory clinical trials underway. AR1001, an in-licensed asset, has advanced into global multi-center Phase 3 clinical trials. These initiatives further enriched the Company’s product pipeline in the neurodegenerative disease sector.

Breakthroughs in Cutting-Edge Technologies and Two-way Licensing

On the basis of consolidating core technology platforms including antibodies, ADCs, small molecules, and cell therapy, Fosun Pharma is strategically investing in advanced fields such as radiopharmaceuticals and small interfering RNA (siRNA). The radiopharmaceutical project SRT-007 successfully initiated Phase I clinical trials, establishing a preliminary "imaging diagnosis – targeted therapy" integrated R&D pathway; in cell therapy, the autologous dual-target CAR-T product FKC289 had its clinical trial application accepted by the NMPA, continuously empowering the reserve of follow-on innovative products.

In 2025, Fosun Pharma’s global resource integration capability has been significantly enhanced. The total upfront payment from out-licensing reached over US$260 million in the whole year, with potential milestone payments exceeding US$ 3.8 billion. Among them, the global licensing project of the GLP-1 target YP05002 garnered an upfront payment of US$150 million and potential total payments of US$2.085 billion, fully confirming the global competitiveness of the company’s innovative R&D. In terms of collaborative development, Fosun Pharma entered into a joint development agreement with Teva for FXB0871 and established original innovation cooperation with a fund under Aditum Bio. Meanwhile, Fosun Pharma introduced multiple overseas original drugs, including Akynzeo (netupitant and palonosetron hydrochloride capsules), Pu Rui Ni (pretomanid tablets) , and Daxxify (botulinum toxin type A for injection), through licensing-in, achieving marketing approval for them in China.

Globalization Moves Towards "System-centric Globalization"

In 2025, Fosun Pharma’s international development achieved a strategic upgrade from "product-centric going global" to "system-centric globalization", making comprehensive breakthroughs in innovative R&D, production quality, registration and access, commercialization and academic influence, and building a global operation network covering markets such as China, the United States, Europe, Africa, India and Southeast Asia. In 2025, the company’s overseas revenue reached RMB 12.977 billion, accounting for 31.15% of the total revenue, increased by 3.64 percentage points year-on-year.

Fosun Pharma has built a global R&D and production synergy registration capability featuring "leading breakthroughs in Europe and the US, and in-depth cultivation in emerging markets". The core innovative drug Serplulimab Injection has been approved for marketing in more than 40 countries and regions worldwide. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026. Biosimilars such as Denosumab have successively obtained approvals from the FDA and the EU, marking that the quality system and registration capability of the biologic drug platform have been certified to international standards; the small-molecule innovative drug Fumaining received Priority Review status from the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, becoming an important fulcrum to leverage the Middle East and global markets.

Seventeen of Fosun Pharma’s workshops/production lines in China have passed GMP certifications of mainstream regulatory markets such as the US, the EU and the WHO. The relevant biologic drug production lines have realized regular supply to the global market, covering China, Europe, Latin America, Southeast Asia, India and other markets. Multiple injection production lines of India’s Gland Pharma have passed certifications in Europe, the US, Japan and Australia, providing a solid guarantee for the stability and quality controllability of the global supply chain.

Fosun Pharma has formed a mature overseas go-global model of "independent operation + licensing authorization" running in parallel, with over 6,000 commercial personnel worldwide and established a marketing network covering over 40 countries and regions in Africa; the controlling subsidiary Sisram’s marketing network covers over 110 countries and regions, while Breas covers over 50 countries and regions.

ESG Governance Recognized by Global Authorities

While achieving high-quality development of its core business, in 2025, Fosun Pharma’s MSCI ESG rates were upgraded to "AA", retained its Hang Seng ESG rating of "A-" and was selected into the 2025 Fortune China ESG Influence List, being the only Chinese pharmaceutical enterprise on the list.

"In 2025, Fosun Pharma firmly implemented its corporate strategy of Innovation Driven, Deep Globalization and AI Embracement, achieving high-quality growth powered by innovative drugs and globalization." Chen Yuqing, Chairman of Fosun Pharma said, "Looking ahead, Fosun Pharma will always focus on unmet clinical needs, continue to innovate, and further deepen its layout in core therapeutic areas such as oncology, immune inflammation and neurodegenerative diseases. It will integrate innovative resources from a global perspective, drive operational upgrading with digital intelligence, and strive to become a world-leading integrator of medical innovation, creating long-term value for shareholders and providing more high-quality and accessible medicines and healthcare solutions for patients."

(Press release, Fosun Pharma, MAR 24, 2026, View Source [SID1234663874])

Myosin Therapeutics Awarded Florida Cancer Innovation Fund Grant to Support STAR-GBM Clinical Trial

On March 24, 2026 Myosin Therapeutics reported that it has been awarded $2 million in funding from the Florida Department of Health through the Casey DeSantis Florida Cancer Innovation Fund (FCIF) to support the company’s STAR-GBM Phase 1/2 clinical trial evaluating MT-125 in patients newly diagnosed with glioblastoma (GBM).

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FCIF is a statewide initiative designed to accelerate the development of innovative cancer therapies and strengthen the life sciences ecosystem in Florida by supporting promising research programs and emerging biotechnology companies. Myosin Therapeutics was selected for funding based on the scientific innovation and clinical potential of MT-125, the company’s lead oncology therapeutic candidate. The award will specifically support clinical trial activities being conducted at the Mayo Clinic campus in Jacksonville, FL.

The Phase 1/2 STAR-GBM clinical trial represents the first clinical evaluation of MT-125 and is being conducted in collaboration with Mayo Clinic, with all three Mayo Clinic clinical research units in the U.S. participating in the study. The Phase 1 portion of the trial will evaluate safety, tolerability, and pharmacokinetics, while generating early clinical data to inform the Phase 2 dose expansion portion of the study.

"We are honored to receive support from the Casey DeSantis Florida Cancer Innovation Fund as we bring MT-125 to patients," said Dr. Courtney Miller, Co-Founder and CEO of Myosin Therapeutics. "This funding helps support the continued progress of our Phase 1/2 STAR-GBM trial and reflects the growing strength of Florida’s life sciences community in advancing innovative cancer therapies."

Mayo Clinic’s Florida campus is a leading academic medical center in the region and plays an important role in advancing new therapies through early-stage clinical trials. Participation of the Florida site in the STAR-GBM trial brings together specialized neuro-oncology expertise and clinical trial infrastructure to evaluate MT-125 in patients with newly diagnosed GBM.

"This support from the Florida Department of Health will help accelerate the clinical development of MT-125 and strengthen Florida’s role as a growing hub for biotechnology innovation," said Dr. Patrick Griffin, Co-founder and Chief Scientific Officer of Myosin Therapeutics. "Programs like FCIF play an important role in enabling emerging biotechs to translate promising scientific discoveries into clinical programs that can ultimately benefit patients."

MT-125 is being developed for several treatment-resistant cancers, including acute myeloid leukemia and pancreatic cancer. And it has received Orphan Drug Designation for malignant gliomas and Fast Track Designation for glioblastoma, supporting an accelerated regulatory pathway for therapies addressing serious diseases with significant unmet medical need.

(Press release, Myosin Therapeutics, MAR 24, 2026, View Source [SID1234663873])