On May 27, 2026 NUCLIDIUM AG, a clinical-stage radiopharmaceutical company, reported the closing of an oversubscribed CHF 26 million (EUR 28.4 million) Series B extension, bringing the Series B total raised to CHF 105 million (approximately EUR 115 million). The financing was led by existing investors Kurma Growth Opportunities Fund, Angelini Ventures, together with EIB co-investment facility Aurea, Wellington Partners and Neva SGR (Intesa Sanpaolo Group), with participation from DeepTech & Climate Fonds (DTCF), Bayern Kapital, Vives Partners, NRW.BANK, and additional existing investors.

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„Emerging data from our Phase 1/2 diagnostics studies continue to generate strong momentum for NUCLIDIUM’S true radiotheranostics approach. We will build on our programs‘ best-in-class potential by initiating Phase 1/2a therapeutic studies for NU-101 and NU-201 later this year, demonstrating our direct conversion strategy from diagnosis to treatment. The Series B extension and support from our world-class investors further validate our strategy to advance next-generation copper-based radiotheranostics and unlock the full potential of the theranostic modality," said Leila Jaafar, PhD, CEO and Co-Founder of NUCLIDIUM .

Proceeds from the Series B extension will accelerate and expand the clinical development of NUCLIDIUM’S lead theranostic programs, NU101 in metastatic castration resistant prostate cancer (mCRPC) and NU201 in metastatic breast cancer (mBC), into advanced clinical trials. The financing will also support the continued buildout of its worldwide production and manufacturing network for diagnostics and therapeutics and expand novel target development for its preclinical programs to bring radiotheranostics to novel solid tumor indications.

„Radiopharmaceuticals are one of the most compelling growth opportunities in oncology today. NUCLIDIUM has established clear differentiation with its copper-based radiotheranostic approach, demonstrating clinical superiority to competing radioligands and ease-of-use that supports seamless integration into hospital workflow. We are proud to support NUCLIDIUM through this new phase of growth as it advances its pipeline toward additional clinical proof-of-concept data," said Regina Hodits, PhD, Managing Director at Angelini Ventures , Daniel Parera, MD, Partner at Kurma Partners and Mario Costantini, CEO and General Manager at Neva SGR (Intesa Sanpaolo Group) for all participating investors.

The Series B financing transaction was advised by VISCHER AG as legal counsel.

(Press release, NUCLIDIUM, MAY 27, 2026, View Source [SID1234666099])

On May 27, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that following review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), the company has received CDE endorsement to conduct the pivotal Phase III CLINCH-3 study of ATG-022, a Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The study is expected to be initiated in China first and is planned as a multi-regional clinical trial (MRCT).

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"Receiving CDE endorsement to conduct the pivotal Phase III CLINCH-3 study represents a defining milestone for Antengene." said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "This achievement underscores Antengene’s fully integrated R&D capabilities, from the design and discovery of novel molecules to clinical translation and registrational development. The Breakthrough Therapy Designation previously granted by CDE provided an important basis for our regulatory discussions on this pivotal study and enabled efficient feedback from CDE. We are highly encouraged by the potential of ATG-022 to address the significant unmet medical needs of patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma, and we look forward to working closely with investigators to advance this important study."

The CLINCH-3 study will be led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. As a pivotal registrational study, CLINCH-3 is intended to support a future marketing approval application for ATG-022 as monotherapy for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The primary endpoints of the study are progression-free survival as assessed by independent review committee (PFS by IRC) and overall survival (OS). Secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety, and other measures. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH study, which showed that ATG-022, as monotherapy, demonstrated a differentiated efficacy and safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of December 25, 2025, among patients whose tumors had CLDN18.2 expression of IHC 2+ >20%, ATG-022 achieved ORRs of 46.7% and 40.0% at 1.8 mg/kg and 2.4 mg/kg, respectively, with corresponding DCRs of 86.7% and 90.0%. Median PFS (mPFS) was 6.97 months and 5.09 months, respectively, while median OS (mOS) was not yet reached in the 1.8 mg/kg cohort and was 14.72 months in the 2.4 mg/kg cohort. In the 1.8 mg/kg cohort, the incidence of Grade 3 or higher treatment-related adverse events (TRAEs) was 19.4%, highlighting a highly differentiated safety profile for an ADC. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma.

"Advanced gastric and gastroesophageal junction adenocarcinoma remains one of the most difficult solid tumors to treat, and the challenge is particularly acute in the 3L setting, where current options, including chemotherapy, anti-angiogenic agents and immunotherapy, provide limited efficacy, low objective response rates and insufficient survival benefit," said Professor Lin Shen of Peking University Cancer Hospital, principal investigator of the CLINCH-3 study. "ATG-022 has shown a compelling clinical profile as monotherapy at 1.8 mg/kg, with strong anti-tumor activity, meaningful survival benefit and a favorable safety profile. The CDE endorsement to conduct this pivotal Phase III study represents an important step toward potentially transforming the treatment landscape for patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. I am pleased to lead CLINCH-3 and look forward to working with Antengene to bring this promising therapy to more patients."

Antengene will continue to advance a comprehensive clinical development strategy for ATG-022 across multiple settings, including its pivotal monotherapy study in advanced gastric or gastroesophageal junction adenocarcinoma, ongoing combination studies with anti-PD-1 therapy and chemotherapy in the 1L gastric cancer setting, and further exploration in other CLDN18.2+ solid tumors, including tumor types beyond the digestive system where encouraging efficacy signals with confirmed tumor responses, have been observed. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world.

(Press release, Antengene, MAY 27, 2026, View Source [SID1234666115])

On May 27, 2026 Palleon Pharmaceuticals, the first company to translate glycan editing science into clinical-stage therapeutics for immune modulation, reported the first patient has been dosed in a Phase 1 clinical trial of E-688/HLX316, a first-in-class B7-H3-targeted sialidase. The study is being conducted in China by strategic collaborator Shanghai Henlius Biotech in patients with tumors prone to B7-H3 overexpression and hypersialylation, with an initial focus on platinum-resistant ovarian cancer.

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This milestone marks the clinical translation of a fundamentally new mechanism — glycan editing for immune modulation — grounded in the pioneering glycobiology research of Nobel laureate Carolyn Bertozzi. Tumor hypersialylation, the upregulation of sialic acid-containing glycans on the surface of cancer cells, can suppress anti-tumor immunity by activating sialic acid-dependent immune regulatory pathways. This axis of immune evasion is present across many solid tumors and correlates with poor clinical outcomes in dozens of published studies.

"E-688/HLX316 is designed to enzymatically remove sialic acid from tumor cell surfaces at the site of B7-H3 overexpression, unmasking tumors to the immune system in a durable, mechanistically distinct way. This first-in-human trial is a critical step toward validating glycan editing for immune modulation as a new therapeutic paradigm across hypersialylated solid tumors," said Jim Broderick, M.D., Chief Executive Officer and Founder of Palleon. "The protocol includes a planned expansion into platinum-resistant ovarian cancer, where high B7-H3 expression and hypersialylation provide a compelling biological rationale for this approach."

About E-688/HLX316

E-688/HLX316 is generated from Palleon’s EAGLE (Enzyme-Antibody Glycan-Editing) platform and combines a human sialidase enzyme with a targeting arm directed at B7-H3, a tumor antigen broadly overexpressed across solid tumors and associated with aggressive disease biology and poor prognosis. By enzymatically removing sialic acid from tumor cell surfaces, E-688/HLX316 restores immune recognition through glycan-binding receptor pathways, disrupts the immunosuppressive tumor microenvironment, and is designed to generate durable anti-tumor immune responses — activating both innate and adaptive immunity through a mechanism distinct from existing checkpoint therapies.

In preclinical studies, E-688/HLX316 demonstrated tumor surface desialylation lasting more than seven days in vivo and showed improved anti-tumor activity relative to anti-PD-1 monotherapy in humanized tumor models.

Phase 1 Trial Design

The Phase 1 first-in-human trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, and preliminary anti-tumor activity of E-688/HLX316 monotherapy, comprising a Phase 1a dose escalation in B7-H3+ advanced solid tumors and Phase 1b dose expansion in platinum-resistant ovarian cancer. Palleon and Henlius intend to expand the program into additional solid tumor indications characterized by high B7-H3 expression and hypersialylation.

(Press release, Palleon Pharmaceuticals, MAY 27, 2026, View Source [SID1234666131])

On May 27, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will be participating in the following investor conferences in June:

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Jefferies Global Healthcare Conference – Participating in a fireside chat on Wednesday, June 3, 2026, at 11:40 a.m. ET. Management will also be participating in one-on-one meetings.
Goldman Sachs 47th Annual Global Healthcare Conference – Participating in a fireside chat on Tuesday, June 9, 2026, at 8:00 a.m. ET. Management will also be participating in one-on-one meetings.

Webcasts of the fireside chat discussions will be available through the investor section of the company’s website at www.oricpharma.com. Replays of the webcasts will be available for 90 days following the event.

(Press release, ORIC Pharmaceuticals, MAY 27, 2026, View Source [SID1234666100])

On May 27, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of oncology and hematological diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for ZEGFROVY (sunvozertinib) 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).

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ZEGFROVY was granted accelerated approval previously by China’s CDE and the U.S. Food and Drug Administration (FDA). The new sNDA is based on the results of WU-KONG28 study, a confirmatory, multinational, randomized phase 3 study evaluating ZEGFROVY versus platinum-containing chemo doublet as first-line treatment in advanced NSCLC patients with EGFR exon20ins. The study met its primary endpoint with statistically significant and clinically meaningful improvement in Progression Free Survival (PFS). The detailed data will be presented as a Late-Breaking Abstract (LBA) oral presentation at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

"The NDA acceptance and priority review designation for ZEGFROVY in first-line EGFR exon20ins NSCLC is an important step forward for us to make the drug available to our patients globally," said Dr. Xiaolin Zhang, CEO of Dizal. "Supported by positive results from WU-KONG28, we believe ZEGFROVY has the potential to be a practice-changing drug for this underserved patient population. We are working very hard to submit NDAs to other regulatory agencies globally as soon as possible."

Lung cancer with EGFR exon20ins are particularly challenging to treat due to its high heterogeneity. Currently, the first-line treatment for EGFR exon20ins NSCLC largely relies on chemotherapy-based regimens. There remains an unmet need for effective, chemotherapy-free, oral targeted therapies for newly diagnosed patients.

Globally, no oral targeted therapies have been approved for the first-line treatment of EGFR exon20ins NSCLC. ZEGFROVY monotherapy has received Breakthrough Therapy Designations (BTDs) from both the U.S. FDA and China’s CDE for this treatment-naïve patient population.

About ZEGFROVY(sunvozertinib)
ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists 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.

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 event) were Grade 1/2 in nature and clinically manageable.

WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals including Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.

(Press release, Dizal Pharma, MAY 27, 2026, View Source [SID1234666116])