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Haisco Enters into Exclusive License Agreement with Nuvectis for Two Drug Candidates in Oncology and Complement Indications

On June 23, 2026 Haisco Pharmaceutical Group Co., Ltd. (Ticker Code: 002653) reported that it has entered into an exclusive licensing agreement with Nuvectis, a U.S. biotechnology company. Under the agreement, Haisco has granted Nuvectis the exclusive rights to develop, manufacture, and commercialize its independently developed innovative drug HSK42360 worldwide, excluding Greater China, as well as its independently developed innovative drug HSK39297 worldwide, excluding Greater China, India, and certain Southeast Asia territories.

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HSK42360 is a best-in-class BRAF paradoxical breaker inhibitor designed to overcome acquired resistance to current BRAF inhibitors. It demonstrates strong potential in primary brain tumors and brain metastases and is currently being evaluated in a Phase I clinical trial in China. HSK39297 is a best-in-class potential once-daily (QD) CFB inhibitor. Two NDA applications for PNH have been submitted in China, while several additional indications are advancing through Phase 2 and Phase 3 clinical development in China.

"This collaboration is highly aligned with our global development strategy and is expected to generate sustainable value and long-term returns," said Dr. Pangke Yan, Chief Executive Officer of Haisco. "By partnering with a U.S. biotechnology company such as Nuvectis, Haisco aims to accelerate the global development of innovative oncology and complement therapies and bring high-quality treatment options to patients worldwide."

The collaboration strengthens Haisco’s global presence and enhances the value of its pipeline by leveraging Nuvectis’ proven research and development capabilities, extensive industry experience, and established track record in oncology and kidney diseases.

Under the terms of the agreement, Haisco will receive an upfront and near-term payment of USD $40 million and is eligible to receive up to USD $1.421 billion in additional development, regulatory, and commercial milestone payments, as well as tiered royalties on future net sales. The first four milestones may be payable by Licensee in cash and/or common stock, provided that the equity consideration shall represent less than 40% of the total milestone value. If the Licensee sublicenses all or part of the rights to a third party, or if a Change of Control occurs during the restricted period, Haisco shall be entitled to share in the corresponding sublicense income and Change-of-Control payments. In addition, the effectiveness of the agreement is subject to certain financing conditions which Nuvectis is required to meet to ensure sufficient capital for the development of the licensed products.

(Press release, Haisco Pharmaceutical, JUN 23, 2026, View Source [SID1234668916])

Mabwell Receives IND Clearance from NMPA for LILRB4/CD3-targeting TCE Bispecific Antibody 6MW5311

On June 23, 2026 Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that the National Medical Products Administration (NMPA) of China has cleared the clinical trial application for its innovative LILRB4/CD3 targeting T Cell Engager (TCE) bispecific antibody (R&D code: 6MW5311), for the treatment of hematologic malignancies, including acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and multiple myeloma (MM).

6MW5311 is the first LILRB4/CD3 targeting TCE drug candidate globally to receive clinical trial approval. Previously, it received FDA clearance for the clinical trial application.

6MW5311 is developed based on Mabwell’s TCE technology platform and features a "2+1" asymmetric molecular structure. It simultaneously targets LILRB4 and CD3, forming an immunological synapse by bridging tumor cells and T cells, thereby activating T cells to efficiently kill tumors. The molecule incorporates a unique steric hindrance design. This structure significantly reduces the binding activity of the CD3 antibody to T cells in the absence of tumor cells. T cells are specifically activated only when tumor cells are present, which substantially enhances safety while improving anti-tumor efficacy.

In vitro studies have demonstrated that 6MW5311 exhibits potent cytotoxic activity across multiple tumor cell lines and patient-derived samples. In vivo pharmacodynamic studies have shown that 6MW5311 achieves significant tumor inhibition in both LILRB4-high and LILRB4-low expressing AML tumor models. Notably, it achieved complete tumor clearance in high-expression models. Furthermore, 6MW5311 demonstrated a favorable safety profile in cynomolgus monkey safety evaluation models.

As a key technological approach for directly mobilizing T cells to kill tumors, TCE has shown significant clinical value in various lymphoma indications, with multiple products successfully launched. However, current treatments for AML and CMML primarily remain primarily limited to chemotherapy, hematopoietic stem cell transplantation, and targeted therapies for specific mutations; no TCE products have been approved for these indications to date.

About Acute Myeloid Leukemia (AML)

AML is a group of clonal malignant disorders originating from myeloid stem cells, characterized by high heterogeneity and mortality. Globally, approximately 172.4 thousand new cases of AML were diagnosed in 2022, with the number projected to reach 221.4 thousand by 2035, representing a compound annual growth rate (CAGR) of 1.94%. In China, approximately 30.8 thousand new AML cases were diagnosed in 2022, accounting for approximately 17.9% of the global total. The number is expected to reach 36.7 thousand by 2035, representing approximately 16.6% of the global total, with a CAGR of 1.36%.

About Chronic Myelomonocytic Leukemia (CMML)

CMML is a clonal hematopoietic stem cell disorder that shares overlapping features with both myelodysplastic syndrome (MDS) and Myeloproliferative Neoplasm (MPN). It is characterized by significant monocytosis in peripheral blood and carries an inherent risk of transformation to AML (approximately 15-20% within 3-5 years). CMML is a rare disease with an annual incidence of approximately 3-4 per 100,000, and currently lacks effective treatment options.

About Multiple Myeloma (MM)

MM is a clonal plasma cell malignancy characterized by the uncontrolled proliferation of monoclonal plasma cells in the bone marrow. This leads to the overproduction of abnormal immunoglobulins and subsequent end-organ damage, manifested as hypercalcemia, renal impairment, anemia, and bone lesions (collectively known as CRAB features). Globally, MM accounts for approximately 1%-2% of all cancers and about 10% of hematologic malignancies. The median age at diagnosis is approximately 69 years, with higher incidence rates observed in males and individuals of African descent. Over the past two decades, patient survival rates have significantly improved thanks to the application of proteasome inhibitors, immunomodulatory drugs, and monoclonal antibodies. However, MM remains largely incurable, and most patients experience multiple relapses during the course of the disease.

(Press release, Mabwell Biotech, JUN 23, 2026, View Source [SID1234668915])

Abbisko Therapeutics Deepens R&D Collaboration with Lilly

On June 23, 2026 Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) reported that it has entered into a strategic research collaboration and license agreement with Eli Lilly and Company ("Lilly"), a leading global pharmaceutical company. Under the agreement, the two companies will collaborate on the discovery and development of innovative medicines across multiple targets, advancing novel drug candidates with global potential.

By leveraging their respective strengths in drug discovery, research and development, and global drug development, Abbisko and Lilly aim to accelerate the advancement of innovative therapeutic programs and bring new treatment options to patients worldwide.

Under the terms of this agreement, Abbisko will utilize its early-stage drug discovery platform, innovative R&D ecosystem, and extensive development expertise to conduct discovery and early development activities for novel drug programs directed against disease targets selected by Lilly. Abbisko will receive an upfront payment and is eligible to receive development, regulatory and commercial milestone payments totaling up to approximately US$1.9 billion. In addition, Abbisko will be eligible to receive tiered royalties based on annual net sales of products arising from this collaboration.

In 2022, Abbisko and Lilly entered into a global collaboration and exclusive license agreement to collaborate on the discovery, development, and potential commercialization of a novel small-molecule therapeutic.

Supported by its continually evolving drug discovery platform, extensive R&D experience and proven execution capabilities, Abbisko has continued to expand its global partnership network and accelerate the translation of scientific innovation into therapeutic advances. This collaboration with Lilly is expected to advance multiple innovative programs and further strengthen Abbisko’s global innovation strategy and long-term value creation potential.

(Press release, Abbisko Therapeutics, JUN 23, 2026, View Source [SID1234668914])

Orion Pharma’s ODM-212 Granted Orphan Designation for the Treatment of Malignant Mesothelioma by the European Commission

On June 23, 2026 Orion Corporation (Orion Pharma) reported that its investigational drug ODM-212 has received Orphan Designation from the European Commission, based on the recommendation from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP), for the treatment of malignant mesothelioma, which is a rare and difficult to treat cancer. The US Food and Drug Administration (FDA) has previously granted Orphan Drug Designation to ODM-212 for the treatment of mesothelioma.

ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor being tested in a Phase 2 clinical study (TEADES) for the treatment of malignant pleural mesothelioma (MPM), epithelioid hemangioendothelioma (EHE) and other solid tumors with dysfunction in Hippo pathway. The trial includes patients who have progressed after receiving standard treatments and have no further treatment options. This is a global trial conducted at leading oncology centers in the US and Europe. For more information on the TEADES Phase 2 clinical study, please visit ClinicalTrials.gov and reference identifier NCT06725758.

"The Orphan Designation for ODM-212 is an important milestone for Orion Pharma. It highlights the need for new treatments in mesothelioma and reinforces our commitment to developing innovative therapies for patients with rare cancers," said Praveen Aanur, MD, MPH, MBA, Chief Medical Officer, Oncology Therapy Area, Orion Pharma.

About Orphan Designation in the EU
The EMA grants Orphan Designation to medicines intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating rare diseases, defined as having a prevalence of no more than 5 in 10,000 in the EU. Additionally, for a medicine to be granted Orphan Designation there should be no satisfactory method of diagnosis, prevention or treatment of the condition concerned, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.

With this designation for ODM-212, Orion Pharma, the sponsor, is now qualified for incentives including protocol assistance, fee reductions for certain regulatory activities, and eligibility for a 10-year period of market exclusivity following approval. Orphan Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

About ODM-212
ODM-212 is an oral small-molecule pan-TEAD (Transcriptional Enhanced Associate Domain) inhibitor developed by Orion Pharma. It targets the Hippo signaling pathway, which regulates cell growth and organ size. Dysregulation of this pathway—particularly through YAP/TAZ activation—can lead to uncontrolled tumor growth and resistance to cancer therapies. ODM-212 works by blocking TEAD transcription factors, disrupting YAP-TEAD protein-protein interactions, and inhibiting TEAD auto-palmitoylation, which is essential for TEAD activity.

(Press release, Orion, JUN 23, 2026, View Source [SID1234668913])

GENFIT: Positive Phase 1b Data with GNS561 in Combination Therapy in Heavily Pretreated Patients with Cholangiocarcinoma

On June 23, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported positive Phase 1b results for GNS561 in combination therapy in patients with heavily pretreated cholangiocarcinoma, demonstrating a favorable safety and tolerability profile and early signs of antitumor activity.

Clinical trial context and objective
CCA is a rare and aggressive bile duct cancer, often diagnosed at an advanced stage. It is associated with a high unmet medical need, driven by limited treatment options and poor prognosis. GNS561 is an investigational small molecule targeting PPT1, leading to autophagy inhibition and lysosomal dysfunction, thereby disrupting cancer cell survival mechanisms. By blocking autophagy, GNS561 aims to promote cancer cell death and may enhance sensitivity to other treatments. Its combination with a MEK inhibitor is intended to unlock synergistic potential by simultaneously targeting autophagy and MAPK signaling pathways. In the Phase 1b study, patients with advanced KRAS mutated CCA, who have previously failed one or two lines of prior standard of care therapies, were enrolled to evaluate the safety and tolerability of GNS561 when given in combination with trametinib, a MEKi.

Clinical results and next steps
The initial part of the Phase 1b study has been completed as planned, with 19 patients enrolled across four cohorts evaluating increasing doses of GNS561. A favorable safety and tolerability profile was observed, with no dose-limiting toxicities (DLT) reported, supporting continued clinical development. Continued signals of antitumor activity were also noted in this heavily pretreated population, with approximately half of patients achieving Stable Disease (SD) at Week 6, including one patient maintaining this status up to Week 30. While based on a limited dataset, these findings contribute to shaping the emerging clinical profile of the combination. On this basis, GENFIT has decided to expand the Phase 1b study with additional cohorts at higher dose levels. This expansion, intended to further strengthen the clinical dataset, does not alter the planned transition to Phase 2, which remains on track for initiation in the second half of 2026. The recommended Phase 2 dose and study design are expected to be finalized over the summer.

Dr. Mark Yarchoan, Associate Professor of Oncology at Johns Hopkins Medicine (Baltimore, MD, USA), principal investigator of the program, commented: "Advanced KRAS-mutated cholangiocarcinoma remains an area of high unmet medical need, particularly in patients who have progressed after prior therapies. What is notable in these data is the consistency of the signal as additional patients have been treated, which helps reinforce the initial findings. Combined with a favorable safety and tolerability profile and signs of activity, these results support continued clinical investigation of this combination strategy targeting autophagy and MAPK signaling pathways."

Details available on ClinicalTrials.gov (NCT05874414) cover both the Phase 1b and planned Phase 2 components of this open-label, multicenter study, and will be updated upon initiation of Phase 2.

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ABOUT CHOLANGIOCARCINOMA

Biliary tract cancer (BTC) is the second most common primary liver malignancy diagnosed globally. Cholangiocarcinoma (CCA) is a type of BTC and represents approximately 15% of all primary liver tumors and 3% of gastrointestinal cancers. Based on its anatomical origin, CCA is best classified anatomically as intrahepatic (iCCA) or extrahepatic (eCCA), which is comprised of perihilar (pCCA) and distal (dCCA) CCA. Early diagnosis is a major challenge as most patients with early-stage disease do not have symptoms due to limited biliary obstruction. Rather, patients characteristically manifest symptoms related to their underlying cirrhosis, a condition present in some patients with CCA. Taken together, the majority of patients with CCA are diagnosed with advanced disease, often precluding potentially curative therapies. There are limited therapeutic options for this aggressive disease. The 5-year survival rates drop to 5-15% in the advanced and unresectable settings. The only potentially curative treatment remains surgical resection. Unfortunately, at the time of first diagnosis, only about 25% of the patients are eligible for surgery. Moreover, even after curative intent surgery, the clinical outcomes are disappointing, with 5-year survival rates of 7% to 20%.

ABOUT GNS561

GNS561 is a first-in-class investigational lysosomotropic agent with a novel mechanism of action. When combined with Mitogen-Activated Protein Kinase Kinase (MEK) inhibitors, GNS561 targets complementary pathways critical for cancer cell survival and proliferation, resulting in potent antitumor activity. The combination is being developed as a potential breakthrough therapy for patients with advanced solid tumors. In December 2021, we licensed the exclusive rights from Genoscience Pharma to develop and commercialize the investigational treatment GNS561 in CCA in the United States, Canada and Europe, including the United Kingdom and Switzerland. In early 2025, GENFIT completed the acquisition of the full intellectual property rights for GNS561 from Genoscience Pharma, expanding upon the limited rights initially obtained through the 2021 license.

(Press release, Genfit, JUN 23, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-positive-phase-1b-data-gns561-combination-therapy-heavily [SID1234668912])