On July 14, 2026 Dizal reported that it has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy.

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Zegfrovy is approved in China and the U.S. for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Dizal recently announced results of the multinational Phase III WU-KONG28 study of Zegfrovy in first line NSCLC with EGFR exon20ins mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine. Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the China’s Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA). The China’s CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

Approximately 80-85% of lung cancer patients globally have NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR mutations as a disease driver. Roughly one in four patients with an EGFR-mutated NSCLC mutation has a tumor with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited.

Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: "Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the US and China for patients following prior systemic therapy." As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe."

Financial considerations

AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy.

The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances.

About Zegfrovy

Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of Zegfrovy in the same indication. The sNDA for previously untreated NSCLC with EGFR exon20ins has been submitted to China Center for Drug Evaluation (CDE) and US Food and Drug Administration (FDA), supported by WU-KONG28 study results. The China’s CDE and US FDA have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting.

In addition, Zegfrovy also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse events) were Grade 1/2 in nature and clinically manageable.

(Press release, Dizal Pharma, JUL 14, 2026, View Source [SID1234669213])

On July 14, 2026 HUYABIO International reported statistically significant and clinically meaningful topline results from its global Phase 3 clinical trial evaluating HBI-8000 in combination with nivolumab for patients with advanced melanoma, bringing the company one step closer to a potential new frontline treatment option for one of the deadliest forms of skin cancer.

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The study met its primary endpoint, with patients receiving HBI-8000 in combination with nivolumab achieving a median progression-free survival of 11.7 months, compared with 7.4 months for patients receiving nivolumab plus placebo, a statistically significant improvement in progression-free survival of 58%. Further statistical analysis is in progress to identify in detail the strong efficacy advantage of HBI-8000.

The randomized global Phase 3 trial enrolled 404 patients across 15 countries, representing HUYABIO’s largest oncology study to date. HBI-8000 is an oral drug that has received regulatory approval for lymphoma in China and Japan. It has been prescribed to over 90,000 patients and so has a well established safety record.

"These results represent an exciting milestone for patients and the future of melanoma treatment," Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said. "Although immunotherapy has dramatically improved outcomes, many patients still need better options. We believe HBI-8000 will become an important addition to the standard of care, helping physicians improve outcomes while bringing new hope to patients and their families."

Data from HBI-8000-303 will be presented at future medical meetings.

(Press release, HUYA Bioscience, JUL 14, 2026, View Source [SID1234669212])

On July 14, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) reported that the Independent Data Monitoring Committee (IDMC) concluded that the Phase III clinical study (OptiTROP-Lung06) of its trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱), in combination with MSD’s[1] anti-programmed cell death protein 1 (PD-1) therapy KEYTRUDA[2] (pembrolizumab) as a first-line treatment for programmed death-ligand 1 (PD-L1)-negative locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) has met its primary endpoint of progression‑free survival (PFS) at a prespecified interim analysis. This is the world’s first Phase III clinical study of an ADC combined with an immune checkpoint inhibitor to meet its primary endpoint in the first-line treatment of driver gene‑negative and PD‑L1‑negative non-squamous NSCLC.

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OptiTROP-Lung06 is a randomized, open‑label, multicenter Phase III clinical study evaluating the efficacy and safety of sac-TMT in combination with pembrolizumab versus chemotherapy in combination with pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-squamous NSCLC who have PD-L1 tumor proportion score (TPS) <1%. The primary endpoint of the study was PFS assessed by blinded independent central review (BICR); secondary endpoints included overall survival (OS), safety and others. At a pre-specified interim analysis, the sac-TMT combined with pembrolizumab demonstrated a statistically significant and clinically meaningful improvement in PFS compared with pembrolizumab combined with pemetrexed and platinum-based chemotherapy, and a positive trend in OS was also observed. The safety profile of sac-TMT combined with pembrolizumab was consistent with that observed in previously reported studies, and no new safety signals were observed. The Company plans to communicate with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China based on the results of this sac‑TMT study.

Previously, the Phase III registrational OptiTROP-Lung05 study of sac-TMT in combination with pembrolizumab as first-line treatment for PD-L1-positive NSCLC had successfully met its primary endpoint, supporting the submission of a new indication application to the CDE. The findings of the OptiTROP-Lung05 study were presented as an oral report at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The Lancet. The positive results from the OptiTROP-Lung06 study mark the further expansion of sac-TMT plus immunotherapy into the PD-L1-negative population in first-line non-squamous NSCLC, providing clinical support for this combination strategy to cover a broader first-line NSCLC population and are expected to drive the optimization of first-line treatment landscape for driver gene-negative non-squamous NSCLC.

Professor Caicun Zhou, National Lead Principal Investigator from Shanghai East Hospital, Tongji University, said: "For patients with driver gene‑negative and PD‑L1‑negative NSCLC, immunotherapy combined with chemotherapy remains the current standard first-line treatment and has improved patient outcomes to some extent. However, long-term survival benefit remains limited. The achievement of positive results in the Phase III OptiTROP-Lung06 study represents an important breakthrough in the first-line treatment of PD-L1-negative NSCLC. These results not only provide robust clinical evidence supporting the ‘ADC plus immunotherapy’ strategy of sac-TMT in combination with pembrolizumab, but also have the potential to offer these patients a new first-line treatment option beyond the current standard of care, with the promise of improved survival outcomes."

Dr. Michael GE, CEO of Kelun-Biotech, stated: "We are delighted to see that sac-TMT combined with pembrolizumab has achieved exciting positive results compared with immunotherapy plus chemotherapy in the first-line treatment of patients with PD-L1-negative NSCLC. This ADC plus immunotherapy regimen has previously demonstrated superior efficacy over immunotherapy monotherapy in patients with PD-L1-positive NSCLC. The positive results of both the OptiTROP-Lung05 and OptiTROP-Lung06 studies confirm the strong synergetic effect of sac-TMT combined with pembrolizumab, supporting the potential of this combination regimen to benefit the broad first-line NSCLC population and bringing new treatment opportunities to patients with different PD-L1 expression levels."

Sac-TMT is currently being evaluated in ten registrational studies in lung cancer, including five registrational studies in China and five global multicenter Phase III studies.

About sac-TMT(佳泰莱)
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic triple‑negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy and platinum-based chemotherapy; 3) epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) (Immunohistochemistry (IHC) 0, IHC 1+ or IHC 2+/In Situ Hybridization (ISH)-) BC who have received prior endocrine therapy and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and anaplastic lymphoma kinase (ALK)-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, JUL 14, 2026, View Source [SID1234669211])

On July 14, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), today highlights its approaches to overcoming target limitations in radioligand therapy (RLT) through Radio-DARPins, in a presentation at the Gordon Research Conference Radionuclide Theranostics for the Management of Cancer in Newry, Maine, US.

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Title: Appropriate Targets for RLT? High selectivity vs high expression
Presenter: Daniel Steiner, Ph.D.
Time: Wednesday July 15 at 11:10-11:30 ET

The presentation outlines the ability of DARPins to match the biological characteristics of both the target and the disease, by optimizing their binding properties, systemic half-life, and biodistribution. To address tumor heterogeneity, Molecular Partners is also developing multispecific Radio-DARPins that can engage multiple tumor targets simultaneously, improving precision and therapeutic efficacy.

"Our multispecific Radio-DARPin approaches reflect Molecular Partners’ ambition to push the boundaries of radiotheranostics and address the complexity and heterogeneity of cancer. By combining the versatility of DARPins with our deep expertise in designing multispecific medicines, we are exploring innovative approaches that have the potential to broaden patient reach and improve outcomes. This work represents an important step toward the next generation of radiopharmaceuticals," said Daniel Steiner, Ph.D., SVP of Targeted Radio Therapeutics at Molecular Partners.

Building on the success of its first "mono"-targeting Radio-DARPins, the Company is highlighting the ability to expand its impact in the field of RLT through multispecific DARPins. These can be formatted either as a bispecific (two DARPins each binding an individual target) or as a 2-in-1 DuoDARPin (one DARPin able to bind two tumor targets in an either/or manner).

The Company’s multispecific approaches enable the design of radiopharmaceuticals for effective treatment of highly heterogenous cancers, with target expression variability across tumor lesions and patients. Such bispecific radiopharmaceuticals could allow to treat cancer indications in which two targets are co-expressed solely on tumor tissues, creating tumor-specific solutions for patients with limited therapeutic options today.

Molecular Partners’ lead Radio-DARPin candidate MP0712, co-developed with Orano Med and targeting delta-like ligand 3 (DLL3), is in a multicenter US Phase 1/2a trial, building on the successful generation of first imaging and dosimetry data from a compassionate care program. The second candidate MP0726, targeting mesothelin MSLN, is differentiated by its ability to selectively bind membrane-bound MSLN, and work towards first human imaging is expected this year. Molecular Partners expects to announce a third Radio-DARPin program, targeting a different tumor target, in 2026.

Following today’s presentation, a copy of the presentation from the Gordon Research Conference will be available on Molecular Partners website, under Scientific Documents.

On July 14, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported the initiation of the Himalayas-1 global Phase 3 registrational trial in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone and announced a clinical trial collaboration and supply agreement with Bayer AG ("Bayer").

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Himalayas-1 Global Phase 3 Registrational Trial Initiation
ORIC previously presented dose optimization data for rinzimetostat in combination with darolutamide and selected 400 mg once daily rinzimetostat as the recommended Phase 3 dose (RP3D). Following End-of-Phase 1 interactions with the FDA and other global health authorities, ORIC finalized the trial protocol and has initiated the Himalayas-1 global Phase 3 registrational trial.

The Himalayas-1 trial is expected to enroll approximately 600 patients from over 250 sites in 25 countries, randomized 1:1 to receive the RP3D of 400 mg once daily rinzimetostat (with or without food) in combination with darolutamide versus physician’s choice of an androgen receptor (AR) inhibitor or docetaxel. The primary endpoint is radiographic progression-free survival, the key secondary endpoint is overall survival, and additional secondary endpoints include PSA response rate, objective response rate and patient reported outcomes.

Clinical Trial Collaboration and Supply Agreement with Bayer
Under the terms of the agreement, ORIC will conduct and sponsor the Himalayas-1 trial and Bayer will provide their AR inhibitor, NUBEQA (darolutamide), at no cost for use in the trial in combination with rinzimetostat. This agreement does not grant Bayer any license, option, or other rights to rinzimetostat and ORIC retains full global development and commercial rights to rinzimetostat.

"Given the significant unmet need in prostate cancer and the potential best-in-disease clinical profile that rinzimetostat has continued to demonstrate, the initiation of our Himalayas-1 Phase 3 trial represents an important milestone toward establishing rinzimetostat as a potentially practice-changing therapy for patients," said Jacob M. Chacko, M.D., president and chief executive officer. "This collaboration with Bayer strengthens our global operational readiness by securing access to darolutamide for Himalayas-1 and underscores our shared interest in evaluating this regimen for patients with prostate cancer."

(Press release, ORIC Pharmaceuticals, JUL 14, 2026, View Source [SID1234669209])