On June 10, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the Taiwan’s Ministry of Health and Welfare (MOHW) has approved ropeginterferon alfa-2b-njft (BESREMi) for the treatment of adult patients with essential thrombocythemia (ET). BESREMi is the first new therapy approved for ET in nearly 30 years.

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The approval represents the first global regulatory approval of BESREMi in ET and marks an important milestone in the strategy to expand BESREMi across myeloproliferative neoplasms (MPNs). With the first global approval in ET now secured in Taiwan, BESREMi is well-positioned to address a significant global market opportunity, including in the United States, where the U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) for ET with a Prescription Drug User Fee Act (PDUFA) target action date of August 30, 2026.

ET is a chronic MPN characterized by excessive platelet production and increased risk of thrombosis, hemorrhage. Based on data from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies, PharmaEssentia believes BESREMi has the potential to address a broad ET patient population regardless of underlying disease subtype, supporting a significant global expansion opportunity for the BESREMi franchise.

"This first global approval of BESREMi in ET represents an important strategic milestone for PharmaEssentia and further strengthens the Company’s leadership position in myeloproliferative neoplasms," said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. "We believe ET represents a major long-term growth opportunity for BESREMi and has the potential to significantly expand the reach of the Company’s hematology franchise globally. This approval also advances our broader strategy to expand the global BESREMi franchise as we continue preparations for a potential U.S. approval and commercial launch in ET later this year."

Dr. Lin continued, "Data generated across the Phase 3 SURPASS-ET study and the Phase 2b EXCEED-ET trial demonstrated the potential of ropeginterferon alfa-2b to achieve durable hematologic and molecular responses in ET patients, supporting the potential for durable hematologic and molecular responses consistent with disease-modifying activity in ET. We believe the differentiated profile and dosing schedule of BESREMi position BESREMi as a differentiated treatment option for a broad range of ET patients."

The TFDA approval was supported by data from the global Phase 3 SURPASS-ET study, which evaluated ropeginterferon alfa-2b in high-risk ET patients resistant or intolerant to hydroxyurea. Specifically, in the global Phase 3 trial SURPASS-ET, BESREMi demonstrated a superior durable clinical response rate compared to anagrelide (42.9% vs. 6.0%; p=0.0001). Across clinical studies, BESREMi demonstrated clinically meaningful hematologic responses, molecular responses, and a manageable safety profile.

In addition to the ongoing FDA review of the ET sBLA, ropeginterferon alfa-2b has been added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for the treatment of ET, further supporting increasing adoption of interferon-based treatment approaches in ET and other MPNs.

PharmaEssentia is the inventor and owner of BESREMi (ropeginterferon alfa-2b-njft) and maintains intellectual property rights for the product across all indications.

(Press release, PharmaEssentia, JUN 10, 2026, View Source [SID1234666546])

On June 10, 2026 Sumitomo Pharma America, Inc. (SMPA) reported that it has enrolled the required number of participants in its pivotal Phase 2 monotherapy trial for enzomenib, an investigational, oral selective menin inhibitor for the treatment of relapsed/refractory acute leukemia with KMT2A rearrangement, to allow for interim analysis. Achieving this milestone will enable SMPA to obtain results of the interim analysis by the end of calendar year 2026. These results will be promptly disclosed, with detailed data to be presented at an upcoming medical congress. If the primary endpoint is met, SMPA would then proceed with preparation for regulatory submission with the aim of obtaining approval in the US and Japan during FY2027.

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"Acute leukemias, especially at the relapsed/refractory stage, are profoundly difficult to treat, and are associated with very poor outcomes," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. "Achieving this enrollment milestone is an important step in our efforts to bring a new, differentiated therapeutic option to acute leukemia patients and their families. My sincere thanks to the patients who are taking part in this study to further our scientific understanding of leukemia treatment."

In addition to this study, SMPA continues to enroll patients in its pivotal Phase 2 monotherapy study of enzomenib in patients with relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutation.

About Leukemia

Leukemia is a type of cancer that forms in blood-forming tissue, characterized by the uncontrolled growth of blood cells, usually white blood cells, in the bone marrow. Acute leukemia, a form of leukemia, requires immediate treatment as blood cells multiply rapidly leading to a sudden onset of symptoms.1 Approximately 30% of patients with AML have NPM1 mutations,2 and 5%-10% of patients with AML have KMT2A rearrangements.3

About Enzomenib (DSP-5336)

Enzomenib is an investigational, oral, small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction, a key interaction in acute leukemia and other tumor cell proliferation and growth. Menin is a scaffold nuclear protein that plays key roles in gene expression and protein interactions involved in many biological pathways, including cell growth, cell cycle, genomic stability, and hematopoiesis.4,5 In preclinical studies, enzomenib has shown selective growth inhibition in human acute leukemia cell lines with KMT2A rearrangements or NPM1 mutations.4,6 Enzomenib reduced the expression of the leukemia-associated genes HOXA9 and MEIS1 and increased the expression of the differentiation gene CD11b in human acute leukemia cell lines with KMT2A rearrangements and NPM1 mutation.7,8 The safety and efficacy of enzomenib is currently being clinically evaluated in a Phase 1/2 dose-escalation/dose-expansion study in patients with relapsed or refractory acute leukemia (NCT04988555) and the registrational Phase 2 Horizen-1 R/R mono AML/ALL (KMT2Ar + NPM1m) study. The FDA granted Orphan Drug Designation for enzomenib for the indication of acute myeloid leukemia in June 2022. The FDA granted Fast Track Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in June 2024. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted Orphan Drug Designation for enzomenib for the indication of relapsed or refractory acute myeloid leukemia with KMT2Ar or NPM1m in September 2024.

(Press release, Sumitomo Dainippon Pharma, JUN 10, 2026, View Source [SID1234666545])

On June 10, 2026 Matter Bio, a biotechnology company developing next-generation immunotherapies for difficult-to-treat cancers, reported that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for LM-LLO-TT, its attenuated Listeria monocytogenes-based immunotherapy candidate for the treatment of pancreatic ductal adenocarcinoma.

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The FDA clearance allows Matter Bio to proceed with a first-in-human Phase 1/2a clinical trial designed to evaluate the safety, tolerability, dose optimization, and preliminary anti-tumor activity of LM-LLO-TT in patients with pancreatic ductal adenocarcinoma.

"This FDA clearance represents a major milestone for Matter Bio and marks our official transition into a clinical-stage company," said Christopher Bradley, CEO of Matter Bio. "Pancreatic ductal adenocarcinoma remains one of the most challenging cancers to treat, and we believe LM-LLO-TT has the potential to activate tumor-directed immune responses in a way that could meaningfully contribute to the next generation of cancer immunotherapy."

LM-LLO-TT is designed to leverage an attenuated Listeria monocytogenes platform to stimulate targeted immune activity against tumor-associated antigens. The upcoming Phase 1/2a study will assess LM-LLO-TT in patients with pancreatic ductal adenocarcinoma, with the goal of establishing an appropriate dose and generating early clinical evidence to support further development.

The IND clearance follows Matter Bio’s previously announced IND submission and reflects continued execution of the Company’s development strategy for LM-LLO-TT.

"This milestone is the result of significant work across our scientific, clinical, regulatory, and manufacturing teams," said Dr. Sam Sharifi, CSO of Matter Bio. "We are grateful to our collaborators and advisors who have helped advance LM-LLO-TT to this important stage, and we look forward to initiating clinical evaluation."

(Press release, Matter Bio, JUN 10, 2026, View Source [SID1234666544])

On June 10, 2026 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, reported that the National Medical Products Administration (NMPA) of China has accepted the Investigational New Drug (IND) application for HBM7004 for the treatment of advanced solid tumors.

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HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the Company’s HBICE platform. This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy with the potential to enhance both efficacy and safety. The development of HBM7004 further demonstrated the HBICE platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window.

"Following the recent FDA IND clearance for HBM7004, we are pleased that the NMPA has accepted the IND application for HBM7004 for the treatment of advanced solid tumors," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. "HBM7004 exemplifies our strategy of leveraging our proprietary technology platforms to develop differentiated next-generation immunotherapies that address significant unmet medical needs in oncology. Supported by encouraging preclinical data, we look forward to working closely with regulatory authorities and advancing this program toward clinical evaluation in China."

(Press release, Harbour BioMed, JUN 10, 2026, View Source [SID1234666543])

On June 10, 2026 ExCellThera Inc. ("ExCellThera"), a global leader in blood stem cell expansion and metabolic fitness technologies, together with its wholly owned subsidiary Cordex Biologics ("Cordex"), reported exclusive licensing and supply agreements granting Medexus the Canadian commercialization rights for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy.

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Zemcelpro is a novel personalized cryopreserved hematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit. The product is used to treat hematological malignancies (blood cancers), such as leukemias and myelodysplasias. Given the product’s current stage of development in Canada, Medexus does not expect to begin commercializing the product before calendar year 2028 (depending on available regulatory pathways). As part of the regulatory process, Medexus intends to seek Health Canada approval of the brand name Zemcelpro.

"These agreements with Medexus represent today an important milestone and reflect our continued commitment to advancing Zemcelpro for patients with significant unmet medical needs," said David Millette, CEO of Cordex. "In addition to the strong commercial opportunity this partnership creates, we believe it has the potential to meaningfully improve access to innovative therapies for Canadian patients with high-risk blood cancers requiring allogeneic stem cell transplantation, where new treatment options remain critically needed."

Medexus is a leading specialty pharmaceutical company with extensive experience in hematology and oncology, making it a strong strategic fit for the partnership with Cordex.

Importantly, this agreement also represents a broader step forward in Cordex’s global commercialization strategy for Zemcelpro. Cordex continues to actively pursue additional strategic partnerships to support and accelerate the commercialization of Zemcelpro across Europe and other international markets.

"We believe there is substantial global interest in innovative therapies that address persistent unmet needs in blood malignancies and conventional stem cell transplantation, and we remain focused on identifying partners with the expertise, infrastructure, and shared vision necessary to expand patient access worldwide," said David Millette. "As we advance these discussions, our priority remains clear: bringing innovative and potentially life-changing therapies to patients who urgently need new treatment options while creating long-term value for our stakeholders."

The transaction includes royalties on Canadian net sales and milestone payments, creating a shared economic interest in the product’s long-term commercial success. Cordex will continue to manage the clinical program and will be responsible for the manufacturing and supply of Zemcelpro to Medexus.

About Zemcelpro

Zemcelpro (dorocubicel), also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro has recently received conditional marketing authorization from the European Commission for the treatment of adults with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning, for whom no other suitable donor cells are available. For complete product information, including warnings and precautions for use and adverse reactions (and their appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) for Zemcelpro.

Additional regulatory filings are planned for Zemcelpro with other health authorities, including in the US, Canada, the UK, and Switzerland.

Zemcelpro has been evaluated in over 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.

Zemcelpro has been tested in Phase 2 trials in patients with high- and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.

The use of Zemcelpro in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being investigated.

The product safety and efficacy have not yet been established by other regulatory agencies, such as the U.S. FDA, the MHRA and Health Canada.

(Press release, ExCellThera, JUN 10, 2026, View Source [SID1234666542])