On June 30, 2026 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, and Eli Lilly and Company (NYSE: LLY) reported that they have entered into a distribution and promotion agreement regarding Lilly’s CDK4 & 6 inhibitor Verzenios (abemaciclib) in mainland China:

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Innovent will be responsible for the importation, marketing, distribution and promotion of Verzenios (abemaciclib) in mainland China;
Lilly will continue to be responsible for manufacturing, supply, and development for the product.
Verzenios (abemaciclib), developed by Lilly, is a CDK4 & 6 inhibitor that has been approved in China for multiple indications, including:

(1) Early Breast Cancer: in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence.
(2) Locally Advanced or Metastatic Breast Cancer:
a) For the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer:

In combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.
In combination with fulvestrant for patients who have experienced disease progression following prior endocrine therapy.
b) In combination with imlunestrant: for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer who have previously received endocrine therapy.

The product was included in the National Reimbursement Drug List (NRDL) Class B in 2021, becoming the first CDK4 & 6 inhibitor covered by national reimbursement in China. In 2025, it successfully renewed its NRDL listing, achieving full coverage across both early and advanced breast cancer indications.

Under the agreement, Innovent will hold sole commercialization rights for Verzenios (abemaciclib) in mainland China, while Lilly, as the Marketing Authorization Holder (MAH), will continue to be responsible for manufacturing, supply, and ongoing product development. This collaboration combines Innovent’s experienced oncology commercialization team and extensive market reach in China with Lilly’s expertise in innovative medicine development and lifecycle management, further enhancing access to this important therapy and benefiting more breast cancer patients across the country.

Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We are delighted to further deepen our strategic partnership with Lilly through this eighth collaboration, bringing the number of our partnered, on-market products in China to seven. This also marks the 19th product in Innovent’s portfolio. Enhancing patient access to high-quality, innovative medicines has always been at the core of Innovent’s mission. Leveraging our established commercial infrastructure and strong market presence in China, we remain focused on addressing critical unmet needs in major oncology indications. Breast cancer, one of the most prevalent and life–threatening malignancies among women, is a strategic priority within Innovent’s oncology portfolio. Through this commercial collaboration with Lilly on Verzenios (abemaciclib) – backed by its robust clinical efficacy, comprehensive labeled indications and national reimbursement coverage – we are expanding our presence in this area, laying a solid foundation for our pipeline development and market expansion deliver lasting benefits to patients in breast cancer."

Huzur Devletsah, Lilly Group Vice President and China General Manager, said: "For 150 years, Lilly has remained committed to putting health above all, advancing human health through scientific innovation and expanding access through collaboration. This agreement for Verzenios (abemaciclib) is an important step in strengthening patient access in China, combining Lilly’s global R&D expertise with Innovent’s commercialization capabilities in China. Looking ahead, Lilly will continue to advance its oncology efforts in China. Since the beginning of this year, we have secured approvals for one new medicine (with two indications) and two new additional indications for on market products in China, including Inluriyo, which has become the first and currently only approved precision therapy in China only targeting ESR1-mutated advanced breast cancer, accelerating the introduction of globally innovative therapies and addressing unmet medical needs."

(Press release, Innovent Biologics, JUN 30, 2026, View Source [SID1234669020])

On June 30, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported positive topline results from the Phase 3 MANGROVE study (BGB-3111-306; NCT04002297) evaluating foundational BTK inhibitor BRUKINSA (zanubrutinib) plus rituximab versus bendamustine plus rituximab (BR) in adult patients with previously untreated mantle cell lymphoma (MCL). MANGROVE is the first Phase 3, global, randomized trial to evaluate a BTK inhibitor-based chemotherapy-free regimen against standard chemoimmunotherapy in this setting. This pivotal Phase 3 trial builds on the established clinical evidence for BRUKINSA in MCL.

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Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
"For patients with newly diagnosed MCL, chemotherapy is currently the default. MANGROVE demonstrates for the first time that BRUKINSA plus rituximab, a chemotherapy-free regimen, can deliver unprecedented improvements in progression-free survival, potentially redefining the treatment paradigm globally. We believe it would be very meaningful for patients to be free from the burden of frequent infusions. This is what it means to state that BRUKINSA is foundational: another study where it anchors frontline therapy and extends its leadership across B-cell malignancies."

Topline results with practice-changing potential

For this prespecified interim analysis, MANGROVE met its primary endpoint of progression-free survival (PFS), demonstrating a highly statistically significant and clinically meaningful improvement for BRUKINSA plus rituximab versus BR, as assessed by an independent review committee (IRC). This is the first Phase 3 study of its kind to employ a chemotherapy-free, rituximab maintenance-free approach in first-line MCL, sparing patients approximately two years of infusions. This BRUKINSA-based, chemotherapy-free regimen led to a 43% reduction in the risk of progression or death (HR=0.57; [95% CI, 0.43, 0.76]; p<0.0001). The safety profile of BRUKINSA plus rituximab was consistent with the known safety profile of both medicines, with no new safety signals identified. Overall survival (OS), a key secondary endpoint, was immature at the time of this analysis; however, a strong trend in favor of BRUKINSA plus rituximab was observed. OS will be tested as part of the final analysis.

Full results from MANGROVE will be shared at an upcoming medical meeting. The Company is in discussions with global regulatory authorities with planned submissions in 2H 2026.

Why a chemotherapy-free approach is needed in MCL

Mantle cell lymphoma is a rare and typically aggressive (fast-growing) type of B-cell non-Hodgkin lymphoma.1 It predominantly affects older adults, who often have comorbidities that can influence treatment decisions and how well they can tolerate therapies.2 Frontline care has long relied on chemoimmunotherapy such as BR.3

Chemoimmunotherapy carries well-documented burdens, including myelosuppression, prolonged immune suppression and heightened infection risk, and cumulative toxicity that can be especially difficult for older patients.4

Efforts to improve frontline outcomes in MCL with BTK inhibitors have largely focused on adding them to chemotherapy rather than replacing it.5 MANGROVE takes a different approach, by evaluating whether a chemotherapy-free regimen of BRUKINSA plus rituximab can deliver durable disease control while sparing patients the burden of upfront chemotherapy. This approach seeks to advance longstanding efficacy and tolerability limitations of first-line care.

About MANGROVE

MANGROVE is a global, randomized, open-label Phase 3 trial evaluating BRUKINSA plus rituximab versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma. The trial enrolled 510 patients across 176 sites worldwide.

In the experimental arm, patients received BRUKINSA at 160 mg orally twice daily plus rituximab during the initial treatment period, followed by BRUKINSA monotherapy until disease progression or intolerance. In the control arm, patients received bendamustine plus rituximab for six cycles. The primary endpoint is PFS assessed by IRC. Overall survival is a key secondary endpoint for the study. Other secondary endpoints include investigator-assessed PFS, overall response rate (ORR), duration of response (DOR), patient-reported outcomes, and safety.

About BRUKINSA (zanubrutinib)

BRUKINSA is a next-generation Bruton tyrosine kinase (BTK) inhibitor designed to deliver complete and sustained BTK inhibition, enabled by optimized pharmacokinetics, including bioavailability, half-life, and selectivity, resulting in consistent target coverage in disease-relevant tissues.

BRUKINSA is the foundational BTK inhibitor and the first and only to demonstrate progression-free survival superiority over another BTK inhibitor in a Phase 3 study, setting a new benchmark for efficacy in the class. With the broadest label globally, it is also the only BTK inhibitor that offers the convenience of once- or twice-daily dosing to support individualized treatment.

The global BRUKINSA clinical development program spans more than 8,000 patients across over 45 trials in 30+ countries and regions. Approved in more than 80 markets, BRUKINSA has been used to treat over 290,000 patients worldwide, reflecting its rapidly expanding role as a standard of care across B-cell malignancies.

Select Important Safety Information for BRUKINSA

Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury).

In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Please see full U.S. Prescribing Information including U.S. Patient Information.

(Press release, BeOne Medicines, JUN 30, 2026, View Source [SID1234669018])

On June 30, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported that the United States Patent and Trademark Office (USPTO) has granted the key U.S. patent covering its proprietary stenoparib-specific Drug Response Predictor (DRP) companion diagnostic. The newly granted patent has a term extending into April 2042. The patent grant follows the USPTO’s Notice of Allowance for the stenoparib DRP companion diagnostic formerly announced by Allarity in April 2026.

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"This is a critical step for Allarity. With this U.S. patent now granted and providing protection into 2042, we have established an important long-term intellectual property foundation for stenoparib and our DRP companion diagnostic," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics. "Looking ahead, our goal is to use the stenoparib DRP to help identify the patients most likely to benefit from treatment. This patent provides the foundation for advancing a more precise, patient-selection-driven approach to ovarian cancer and accelerating stenoparib toward FDA approval."

The granted patent covers methods for predicting clinical benefit from stenoparib based on gene-expression profiles derived from tumor samples, as well as methods for selecting patients most likely to benefit from stenoparib treatment using the stenoparib DRP test. The patent protects Allarity’s long-term commercial strategy, allowing exclusivity for stenoparib when used in concert with the stenoparib DRP companion diagnostic in the United States into April 2042.

Allarity has also secured patent protection for the stenoparib DRP in Europe and Australia into 2039, with related applications pending in several additional international markets.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers, especially drug-resistant cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, small cell lung cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has completed its first Phase 2 trial for stenoparib in advanced ovarian cancer patients. That trial showed promising and durable clinical benefit in ovarian cancer patients who had 2+ lines of therapy and were given stenoparib twice daily. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in ovarian cancer in September 2025. Note that analyses may change as the study fully matures. A new protocol was designed expressly to capitalize on this emerging clinical experience with stenoparib in platinum resistant patients and began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites in the US.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, JUN 30, 2026, View Source [SID1234669017])

On June 30, 2026 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, reported the initiation of the global pivotal phase 3 AURORA trial (NCT07660094), evaluating aglatimagene besadenovec (aglatimagene or CAN-2409) plus valacyclovir in combination with continued pembrolizumab in patients with metastatic non-squamous NSCLC whose disease has progressed despite treatment with pembrolizumab and platinum-based chemotherapy.

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The global, randomized, open-label AURORA trial is expected to enroll patients with metastatic Stage IV non-squamous NSCLC across approximately 150 sites worldwide, randomized 1:1 to receive either aglatimagene plus valacyclovir for two injection courses with continued pembrolizumab, or standard-of-care docetaxel chemotherapy. The first trial site is activated and open to enrollment. The study’s primary endpoint is overall survival, with secondary endpoints including safety and quality-of-life assessments (NSCLC-SAQ and EORTC QLQ-30). The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation to aglatimagene for the treatment of NSCLC.

To support the efficient global execution of this pivotal trial, Candel has engaged Parexel International, a leading global clinical research organization with extensive experience in oncology and a global network of nearly 2,500 sites. Parexel will provide clinical operations support across the trial’s global sites.

"Patients whose lung cancer progresses despite immune checkpoint inhibitor therapy have limited treatment options, and outcomes with standard chemotherapy remain poor," said Roy Herbst, M.D., Deputy Director and Chief of Medical Oncology and Hematology at Yale Cancer Center and co-Principal Investigator of AURORA. "The survival results observed with aglatimagene in the phase 2 trial are particularly encouraging and support advancing the program into the pivotal phase 3 AURORA trial."

"The initiation of this first global phase 3 trial of a viral immunotherapy at NYU Langone Health marks an important milestone in advancing aglatimagene as a potentially first-in-class immunotherapy for patients with NSCLC," said Daniel Sterman, M.D., Thomas and Suzanne Murphy Professor of Medicine and Cardiothoracic Surgery at NYU Langone Health and co-Principal Investigator. Charu Aggarwal, M.D., M.P.H., Leslye M. Heisler Professor of Medicine at the University of Pennsylvania’s Perelman School of Medicine; Section Chief, Thoracic and Head & Neck Cancer; and Director of the Penn Center for Cancer Care Innovation at the University of Pennsylvania is also a co-Principal Investigator on AURORA.

The phase 3 AURORA trial builds on encouraging results from the Company’s phase 2 clinical trial (NCT04495153), which demonstrated extended long-term survival in patients with advanced NSCLC who had shown an inadequate response to immune checkpoint inhibitors (ICI). In that trial, 50% of 46 per-protocol patients survived beyond 24 months despite prior inadequate response to ICI and multiple adverse baseline prognostic factors. Among evaluable patients with non-squamous histology and progressive disease at baseline despite prior ICI (intended patient population of the phase 3 trial), median overall survival was 25.4 months.

"This is a pivotal moment for Candel and, most importantly, for the patients we aim to serve," said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. "Disease progression following ICI therapy remains associated with poor survival outcomes and a substantial unmet medical need. Building on our completed phase 2 clinical trial, we have refined the target patient population by integrating clinical and biomarker insights to maximize the likelihood of success of the phase 3 trial. Our data suggest that aglatimagene may offer a novel approach by inducing an individualized, systemic anti-tumor immune response in patients who have very limited therapeutic options."

Lung cancer is the leading cause of cancer death in the United States, and NSCLC represents approximately 77% of all lung cancer cases.1 Despite widespread use of ICI as first-line treatment for patients without actionable mutations, approximately 60% of patients experience disease progression within one year.2 These patients face limited therapeutic options, with docetaxel remaining the current standard of care and delivering a median overall survival of just 9.8 to 11.8 months.3,4

About aglatimagene besadenovec (CAN-2409)

Aglatimagene besadenovec, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the FDA or any other regulatory authority for any use.

(Press release, Candel Therapeutics, JUN 30, 2026, View Source [SID1234669016])

On June 30, 2026 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported it has been awarded a $1.5 million non-dilutive research grant from the Andy Hill Cancer Research Endowment (CARE) Fund under its Implementation and Outcomes Research program to support investigational new drug (IND)-enabling work for APVO451, Aptevo’s novel trispecific antibody-like immunotherapy candidate for solid tumors.

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Aptevo believes that obtaining this competitive award, reviewed by subject matter experts and awarded based on merit, provides external validation of APVO451’s tumor-directed trispecific design and supports Aptevo’s ongoing work around nectin-4-targeted therapies. Trispecific immunotherapies represent what Aptevo believes is the next generation of immuno-oncology therapies and are a strategic pipeline priority for Aptevo, with APVO451 advancing toward development candidate selection by year-end 2026 and initiation of IND-enabling studies in the first quarter of 2027. APVO451 is a strategic pipeline priority which reflects Aptevo’s broader effort to extend its controlled immune-activation platform into solid tumors.

"Solid tumors continue to present significant challenges for immunotherapy, particularly because the tumor microenvironment can limit effective immune activation," said Michelle Nelson, Ph.D., Senior Director at Aptevo and Principal Investigator of the study. "This award supports the generation of additional APVO451 preclinical data to further evaluate how its tumor-directed trispecific design may leverage CD40-mediated immune activation while bringing together T-cell engagement in a coordinated anti-tumor response and subsequently advancing it toward IND-enabling development."

CARE Fund grants promote cancer research led by public and private entities conducting cancer research in Washington State. Through research grants and strategic partnerships, CARE Fund improves health outcomes by advancing transformational research across the cancer research continuum. The grant will support IND-enabling activities for APVO451, including preclinical studies and development work intended to advance the program toward development candidate selection and future regulatory-enabling studies. The study will be led by Michelle Nelson, who brings deep scientific leadership and execution experience to the project with her background in immunobiology, solid tumor immunotherapy, and IND-enabling development.

"APVO451 reflects what we believe trispecific immunotherapies can uniquely do: bring complementary immune mechanisms together in a coordinated, tumor-directed way," said Mary Janatpour, Ph.D., Senior Vice President and Chief Scientific Officer of Aptevo Therapeutics. "By combining nectin-4-targeting with CD40 and CD3 engagement, APVO451 is designed to activate both antigen-presenting cells and T cells within the tumor microenvironment. We are grateful to the Andy Hill CARE Fund for supporting this program and for recognizing the promise of this approach as we work to advance new treatment options for patients with difficult-to-treat cancers."

About the APVO451 Program

APVO451 is designed to address a central challenge in solid tumor immunotherapy: the tumor microenvironment can suppress immune activity and limit the body’s ability to recognize and attack cancer cells. APVO451 brings together three functions in a single molecule: targeting nectin-4, a tumor-associated marker expressed in multiple solid tumors; activating CD40 on antigen-presenting cells to engage innate immunity in the tumor milieu; and engaging CD3 on T-cells to direct tumor-cell killing.

Together, these mechanisms are intended to concentrate immune activation within the tumor microenvironment, stimulate T-cell activity and broader immune engagement, and support an amplified attack against solid tumors. Unlike approaches that broadly activate the immune system, APVO451 is designed so that its CD3 and CD40 activity depend on binding to nectin-4, helping focus immune activation where it is needed and reduce the risk of systemic immune activation. APVO451 also incorporates Aptevo’s CRIS-7-derived CD3 binding domain, the same CD3 platform approach used in mipletamig, Aptevo’s lead clinical program. Aptevo’s CD3 strategy is designed to engage T cells while reducing the risk of excessive cytokine release, a key limitation that has historically challenged the development of T-cell-engaging therapies, particularly in solid tumors.

APVO451 is part of Aptevo’s broader pipeline of multispecific immunotherapies designed to control immune activation with precision. The program builds on Aptevo’s experience developing antibody-based candidates that seek to balance anti-tumor activity with tolerability while expanding the Company’s platform opportunity into next-generation trispecific approaches for solid tumors.

(Press release, Aptevo Therapeutics, JUN 30, 2026, View Source [SID1234669015])