On July 27, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, reported that initiation of Part 2 monotherapy expansion has been achieved in its Phase 1/2 clinical trial evaluating IDE892, a potential best-in-class methylthioadenosine (MTA)-cooperative inhibitor of PRMT5, in MTAP-deleted solid tumors, with a focus on non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). IDE892 Phase 1/2 monotherapy expansion has been initiated at projected efficacious target human exposures where 24-hours target EC90 coverage have been achieved. The IDE892 maximum tolerated dose (MTD) has not yet been reached in the ongoing dose escalation.

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"We are excited to initiate monotherapy expansion evaluating IDE892 in MTAP-deleted PDAC and NSCLC. We designed IDE892 to be a potential best-in-class PRMT5 inhibitor, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding, lack of brain penetrance, and favorable drug-like properties intended to maximize its therapeutic window as both a monotherapy agent and in combination. We are well positioned to have the industry’s deepest MTAP-deletion pipeline, with IDE892, MAT2A inhibitor IDE397 in Phase 2, and the potential first-in-class CDKN2A lead molecule advancing in preclinical toxicology studies for a target IND in the first half of 2027," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

Loss of MTAP leads to the accumulation of MTA and increased dependence on PRMT5 and MAT2A, two key enzymes involved in methylation and RNA splicing. In MTAP-deleted tumors, this biology establishes a robust synthetic lethal vulnerability that underpins the mechanistic rationale for combining IDE892 and IDE397, where the first-patient-in (FPI) was achieved in mid-2026. IDEAYA also entered into a clinical collaboration with Roche evaluating IDE892 in combination with RG6505, Roche’s Phase 1 pan-RAS inhibitor, in MTAP-deleted pancreatic ductal adenocarcinoma (PDAC) to target the genetic co-alterations of MTAP and KRAS in this indication. Next, IDEAYA is advancing a third proprietary and potential first-in-class program for MTAP-deleted solid tumors targeting CDKN2A, the most common co-alteration of MTAP-deletion, through ongoing preclinical toxicology studies to support an investigational new drug (IND) application in the first half of 2027. IDEAYA anticipates that rational combination doublets may be pursued with IDEAYA’s CDKN2A lead molecule and IDE892 to target the co-alterations of MTAP and CDKN2A, and pan-RAS inhibitors, as the key tumor suppressor gene CDKN2A has been reported to be deficient in approximately 70% of PDAC.

MTAP deletion is estimated to occur in approximately 15% of all solid tumors, including 15 to 20% of NSCLC and up to 40% of PDAC. There are no approved therapies for MTAP-deleted cancers, highlighting the significant unmet need and opportunity for new precision therapies for these patients.

IDE892 has potential best-in-class properties, including approximately 1,400-fold selective MTA-PRMT5 cooperative binding versus SAM-PRMT5 cooperative binding and lack of brain penetrance intended to maximize its therapeutic window, and favorable drug-like properties to enable rational combinations with IDE397, pan-RAS inhibitors, KRAS G12D therapies, and IDEAYA’s CDKN2A lead molecule. IDE892 has a CYP3A4 IC50 greater than 45 micromolar and did not show time dependent inhibition of any of the 7 major cytochrome P450s (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4) based on full kinetic CYP inactivation assays, positioning IDE892 as a potential best-in-class MTA-cooperative PRMT5 combination partner.

(Press release, Ideaya Biosciences, JUL 27, 2026, View Source [SID1234669438])

On July 27, 2026 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, reported that it has entered into a strategic collaboration with China National Pharmaceutical Group Co., Ltd. ("Sinopharm"). The two parties will establish the Sinopharm – Harbour BioMed Innovation Consortium (the "Innovation Consortium") to advance collaborative research and development of innovative biologics.

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Under the terms of the agreement, Harbour BioMed and Sinopharm will collaborate across the full research and development lifecycle of innovative biologics, with a strategic focus on oncology, immune-mediated inflammatory diseases and other therapeutic areas. Harbour BioMed will leverage its globally leading Harbour Mice fully human antibody technology platform and AI-enabled drug discovery capabilities to drive the discovery and optimization of antibody candidates together with Sinopharm. Sinopharm will contribute their expertise in clinical development, large-scale manufacturing and commercialization, and will be responsible for developing commercial-scale manufacturing processes, producing clinical trial materials, and commercializing products arising from the collaboration. The two parties will jointly fund the research and development activities and share product rights in accordance with mutually agreed terms.

"We are delighted to establish this strategic partnership with Sinopharm," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. "Harbour BioMed is committed to becoming a leading platform-driven biopharmaceutical group. Leveraging our globally differentiated Harbour Mice fully human antibody technology platform and continuously expanding AI-enabled antibody discovery capabilities, we have established strategic collaborations with leading global pharmaceutical companies, including AstraZeneca, Bristol Myers Squibb and Pfizer. This partnership with Sinopharm represents another important step in advancing our ‘platform + pipeline’ strategy in China. Sinopharm is a leading pharmaceutical and healthcare group that covers the entire industry chain—from R&D and manufacturing to distribution. With strong R&D capabilities, robust industrial-scale production capacity, proven commercial execution, and an extensive market network, we look forward to deeply integrating the strengths of our technology platform with Sinopharm’s full-industry-chain capabilities to jointly accelerate the R&D and accessibility of innovative medicines."

Sinopharm commented: "As the national team in the pharmaceutical and healthcare sector, Sinopharm has always placed scientific and technological innovation at the core of its development strategy and is accelerating the establishment of a new paradigm that synergizes independent innovation with open collaboration. Harbour BioMed is a world-leading platform-driven biopharmaceutical company, equipped with a rare fully human antibody technology platform and AI-powered antibody discovery capabilities that are at the forefront in China. The establishment of an innovation R&D consortium with Harbour BioMed represents a key move by Sinopharm to optimize resource allocation and enhance R&D efficiency. We look forward to both parties fully leveraging our respective strengths in technology, talent, platforms, and industrial chains to jointly advance the R&D and industrialization of innovative drugs, and to provide patients with more high-quality and affordable treatment options."

(Press release, Harbour BioMed, JUL 27, 2026, View Source [SID1234669439])

On July 27, 2026 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, reported that Ian Woo, President and Chief Financial Officer, will participate in the upcoming investor conferences.

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Morgan Stanley Biotech Without Borders Series
Date: Tuesday, July 28, 2026
Time: US: 10:00am – 10:30am ET / 10:00pm – 10:30pm HKT
Format: Fireside chat
Webcast: View Source;tp_key=ca5039df5f

2nd Annual Evercore China Biotech Summit
Date: Tuesday, August 18, 2026
Time: 11:00am HKT
Format: Presentation and Q&A
Location: The Ritz-Carlton Shanghai, Pudong

(Press release, Everest Medicines, JUL 27, 2026, View Source [SID1234669440])

On July 24, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the second quarter of fiscal year 2026.

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Core revenue of ¥663.3 billion (+14.7%), core operating profit of ¥329.1 billion (+21.0%), and core net income of ¥238.4 billion (+23.2%) were achieved (all changes year-on-year)
Strong growth in domestic and overseas sales, combined with a significant increase in other revenue driven by one-time income, and royalty income related to Hemlibra and NEMLUVIO, resulted in increased revenue and profit year-on-year
Achieved eight regulatory filings in Japan during the first half of the year, progressing steadily toward achieving the highest number of filings ever planned
R&D activities progressed steadily across both early- and late-stage development, including Chugai-originated projects
For NXT007, which is expected to become a next-generation growth driver, two Phase III studies were initiated
For AQUA07, the third macrocyclic peptide project, entry into the clinical stage was achieved, with dosing in a Phase I study in ALK-positive non-small cell lung cancer expected to start shortly
For Enspryng, developed using Chugai’s proprietary antibody engineering technologies, the U.S. FDA accepted the regulatory application for thyroid eye disease (TED) and granted Priority Review designation
Regarding products out-licensed to third parties, global market penetration of Chugai-originated new products advanced
Export sales and royalty income from NEMLUVIO (nemolizumab), a humanized anti-human IL-31 receptor A monoclonal antibody out-licensed to Galderma, drove revenue growth
As for Foundayo (orforglipron), an oral GLP-1 receptor agonist out-licensed to Eli Lilly, prescriptions were driven in the U.S. primarily by GLP-1 naïve patients, and the oral anti-obesity drug market is expanding. Chugai commenced recognition of royalty income from the product in the second quarter
Refer to the information below for details on the financial results:

Quarterly Reports / Finance Reports

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Presentation Materials

In addition to Chugai’s business and financial performance, these materials provide updates on our research and development pipeline. Videos and transcripts (including Q&A) will be made available at a later date.

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[2026 Second Quarter Results]

Core results (Billion JPY)
2026

Jan-Jun

2025

Jan-Jun

% change
Revenue

663.3

578.5 +14.7%
Domestic sales 237.9 223.3 +6.5%
Overseas sales 328.6 288.1 +14.1%
Other revenue 96.8 67.0 +44.5%
Operating profit 329.1 272.0 +21.0%
Net income 238.4 193.5 +23.2%

(Press release, Chugai, JUL 24, 2026, View Source [SID1234669414])

On July 24, 2026 AstraZeneca and Daiichi Sankyo reported Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 Phase III trial presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and subsequently published in The New England Journal of Medicine.1

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes. DESTINY-Breast09 sets a new benchmark with a median progression-free survival of more than three years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2-positive metastatic breast cancer."

John Tsai, Global Head, R&D, Daiichi Sankyo, said: "Enhertu in combination with pertuzumab improved progression-free survival by more than one year compared with the current first-line standard of care, representing a meaningful advantage early in the treatment of patients with metastatic HER2-positive disease. Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway."

In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% confidence interval [CI]: 0.44-0.71; p<0.00001) in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease. Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP. The PFS benefit was consistent across subgroups, including for the prespecified stratification factors of hormone receptor status, de novo or recurrent disease and PIK3CA mutation status.

The safety profile of Enhertu plus pertuzumab was consistent with the known profiles of each individual therapy with no new safety concerns identified.

Enhertu in combination with pertuzumab is approved in the US, Switzerland and other countries as a 1st-line treatment for patients with metastatic HER2-positive breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu is also under review in the EU for patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 trial.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Notes

HER2-positive metastatic breast cancer
Breast cancer is the most common cancer in women worldwide and the leading cause of cancer-related death among women.2 Approximately, 2.4 million breast cancer cases were diagnosed in 2024, with more than 690,000 deaths globally.2 In Europe, approximately 540,000 cases of breast cancer are diagnosed annually, with more than 140,000 deaths.3 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or whose disease has progressed to metastatic disease are expected to live five years following diagnosis.4

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer.5 HER2 protein overexpression may occur as a result of HER2 gene amplification.4 Approximately one in five cases of breast cancer is considered HER2-positive.5

HER2-positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer.6 While HER2-targeted therapies have improved outcomes, prognosis remains poor with most patients experiencing disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.6-8 Further, approximately one in three patients do not receive any treatment following first-line therapy due to disease progression or death.10,11

DESTINY-Breast09
DESTINY-Breast09 is a global, multicentre, randomised, open-label, Phase III trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) either alone or in combination with pertuzumab versus standard of care THP as first-line treatment in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than six months before the diagnosis of advanced or metastatic disease.

Patients were randomised 1:1:1 to receive either Enhertu monotherapy with a pertuzumab matching placebo; Enhertu in combination with pertuzumab; or THP. Randomisation was stratified by prior treatment (de novo metastatic disease versus progression from early-stage disease), hormone receptor (HR) status and PIK3CA mutation status.

The primary endpoint of DESTINY-Breast09 is PFS as assessed by BICR in both the Enhertu monotherapy and Enhertu combination arms. Secondary endpoints include investigator-assessed PFS, overall survival, ORR, duration of response, pharmacokinetics and safety. The investigational arm assessing Enhertu monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.

DESTINY-Breast09 enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) followed by THP is approved in the US, China and Singapore as a neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4mg/kg) is approved in the US as an adjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4mg/kg) in combination with pertuzumab is approved in the US, Switzerland, India, Israel, United Arab Emirates, Saudi Arabia, Korea and Singapore as a 1st-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally authorised test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu clinical development programme
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu as a monotherapy, in combination or sequentially with other cancer medicines across multiple HER2-targetable cancers.

(Press release, AstraZeneca, JUL 24, 2026, View Source [SID1234669415])