On November 5, 2025 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported the completion of patient enrollment of SAFFRON, a global Phase III study of ORPATHYS (savolitinib) and TAGRISSO (osimertinib) for the treatment of patients with epidermal growth factor receptor ("EGFR")-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic non-small cell lung cancer ("NSCLC") following progression on treatment with TAGRISSO. The last patient was randomized on October 31, 2025.

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This combination represents a promising, chemotherapy-free, all-oral treatment option following progression on an EGFR tyrosine kinase inhibitor ("TKI"), and was granted approval in China in June 2025 based on the results of the SACHI randomized Phase III trial. ORPATHYS is an oral, potent and highly selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. TAGRISSO is a third-generation, irreversible EGFR TKI.

SAFFRON is a global Phase III, open-label, randomized, multicenter study to investigate the efficacy and safety of ORPATHYS administered orally in combination with TAGRISSO versus platinum-based doublet chemotherapy in participants with EGFR-mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on first- or second-line treatment with TAGRISSO as the most recent therapy. The primary endpoint of the study is progression free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST 1.1 criteria. Other endpoints include overall survival (OS), objective response rate ("ORR"), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. This study randomized 338 patients, screened from over 230 sites across 29 countries. Additional details may be found at clinicaltrials.gov, using identifier NCT05261399.

Topline results from the SAFFRON study are estimated to be reported in the first half of 2026, followed by submission of results for presentation at an appropriate medical congress. If favorable, the results could support global regulatory filings for the ORPATHYS and TAGRISSO combination.

About NSCLC and MET aberrations
Lung cancer is the leading cause of cancer death, accounting for about one-fifth of all cancer deaths.[1] Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.[2] The majority of NSCLC patients (approximately 75%) are diagnosed with advanced disease, and approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50% of patients in Asia have EGFR-mutated ("EGFRm") NSCLC.[3],[4],[5],[6],[7]

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is one of the mechanisms of de novo or acquired resistance to EGFR TKI for metastatic EGFRm NSCLC.[8],[9]

About ORPATHYS
ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China and is marketed by AstraZeneca for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, representing the first selective MET inhibitor approved in China. ORPATHYS is also approved in China for the treatment of patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC with MET amplification after disease progression on EGFR tyrosine kinase inhibitor therapy, in combination with TAGRISSO.

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines.

About TAGRISSO
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with ORPATHYS (savolitinib) in the SAFFRON Phase III trial and in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

About ORPATHYS and TAGRISSO Combination Development in EGFR-mutated NSCLC
This combination represents a promising chemotherapy-free oral treatment strategy to address mechanisms of resistance in this setting. Among patients who experience disease progression following treatment with a third-generation EGFR TKI, approximately 15-50% present with MET aberration, depending on the sample type, detection method and assay cut-off used. TAGRISSO is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases. Treatment with ORPATHYS in combination with TAGRISSO has been studied extensively in these patients in the TATTON study (NCT02143466) and the SAVANNAH single-arm Phase II study (NCT03778229). Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress (ELCC) demonstrated high, clinically meaningful and durable ORR, with consistent safety results. The encouraging results led to the initiation of several randomized Phase III trials in this setting including the SACHI trial in China (NCT05015608) and the global SAFFRON trial (NCT05261399), as well as the SANOVO trial in China (NCT05009836).

SACHI: This Phase III trial in China evaluated the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy for the treatment of patients with EGFRm, MET-amplified locally advanced or metastatic NSCLC following progression on treatment with an EGFR TKI. Results were presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The treatment combination received approval in China in June 2025.

SAFFRON: This ongoing global Phase III trial is to evaluate the combination of ORPATHYS and TAGRISSO compared to platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following progression on treatment with TAGRISSO. This received Fast Track Designation from the US Food and Drug Administration (FDA) and enrollment was completed in October 2025. We look forward to completing this trial to support potential US and other global registration filings.

SANOVO: This ongoing Phase III trial in China is to evaluate the combination of ORPATHYS and TAGRISSO compared to TAGRISSO monotherapy in previously untreated patients with locally advanced or metastatic NSCLC with EGFRm and MET overexpression. Enrollment was completed in August 2025.

(Press release, Hutchison China MediTech, NOV 5, 2025, https://www.hutch-med.com/saffron-global-phiii-enrollment-completion/ [SID1234659385])

On November 4, 2025 NEOK Bio, Inc., a biotechnology company focused on the development of novel antibody drug conjugates (ADCs) for improving outcomes for cancer patients, reported that it has emerged from stealth mode with $75 million in Series A financing. The company’s principal investor is ABL Bio, Inc., a leading Korean biotech company and a proven leader in antibody engineering. The funding will be used to advance two bispecific ADC programs into the clinic. The company aims to be a leading bispecific ADC company in the U.S.

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Leveraging ABL’s innovative ADC platform technology, NEOK is building a pipeline of bispecific ADCs by pursuing validated targets, while balancing high expression, selectivity, and target-related safety signals. NEOK utilizes a proprietary, linker-payload technology (SYNtecan E) that enables ADC generation with strong linker stability and superior biophysical properties. The company aims to overcome the efficacy and safety limitations of conventional ADCs through its bispecific approach which targets unique pairs of cancer targets.

"ADCs are a proven modality in treating select cancers, but historically have had limitations related to stability, selectivity, and therapeutic window. We believe our dual-targeting strategy has the potential to overcome drug resistance, target a wider range of tumors, increase internalization rates and cell killing, and improve the safety profile of ADCs by increasing selectivity and reducing off-tumor toxicity," said Mayank Gandhi, Chief Executive Officer of NEOK Bio. "The financing is a critical step in our journey to a clinical-stage company and enables the execution of a robust and efficient clinical development plan for our bispecific ADCs."

"Our investment in the formation of NEOK Bio underscores our commitment to deliver transformative therapeutic innovation to the dynamic and growing ADC landscape," said ABL Bio CEO Dr. Sang Hoon Lee. "We are excited to support an outstanding and experienced NEOK team as they aim to fulfill the significant untapped potential of bispecific ADCs to improve the lives of people with cancer."

The financing will support the initiation of clinical studies for NEOK’s two lead ADC candidates, which target proteins that are broadly expressed in multiple tumor types with significant unmet needs. They include NEOK001 (previously ABL206), a bispecific ADC targeting ROR1 and B7-H3, and NEOK002 (previously ABL209), a bispecific ADC targeting EGFR and MUC1 proteins. Both assets have the potential to demonstrate enhanced efficacy and safety over monovalent ADCs in large patient populations across thoracic, gastrointestinal, and gynecological cancers.

NEOK plans to file an Investigational New Drug (IND) application for both programs by early 2026 and initiate Phase 1 clinical trials in mid-2026 in the U.S. First data readouts from both programs are expected in 2027.

(Press release, Neok Bio, NOV 4, 2025, View Source [SID1234659407])

On November 4, 2025 Ensoma, an in vivo hematopoietic stem cell (HSC) engineering company with a mission to advance the future of medicine through one-time therapies, reported new preclinical data demonstrating proof-of-concept for its in vivo, HSC-derived CAR-M, NK, and T cell platform, including its potential to durably generate lineage-restricted CAR cells in solid tumors. The data will be presented in two poster sessions this week at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, taking place November 5-9 in National Harbor, Md.

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"While ex vivo CAR-T therapies have transformed treatment for blood cancers, use in solid tumors has been limited by multiple factors, including poor T cell infiltration and persistence in the immunosuppressive tumor microenvironment, as well as manufacturing cost and complexity," said Jim Burns, CEO of Ensoma. "By engineering HSCs in vivo, we can develop off-the-shelf therapies that turn the body into its own cell factory—capable of continuously producing multiple CAR immune cell types that work together against solid tumors. These data move us closer to realizing this vision as we advance toward our first in vivo, HSC-derived CAR-M, NK, and T development candidate early next year."

Ensoma SITC (Free SITC Whitepaper) poster presentations:

In vivo HSC engineering with Ensoma’s virus like particles (VLPs) generates lineage-restricted, multiplexed CAR-M, NK, and T cells to cooperatively mediate solid tumor control in pre-clinical models

Abstract Number: 302

Poster Presentation Time/Date: Saturday, November 8, 5:10-6:35 pm EST

Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

Presenter: Yiwen Zhao, Ph.D., Ensoma

This study in HER2-positive orthotopic tumor-bearing mouse models, validates proof-of-concept for anti-tumor activity driven by in vivo CAR therapy via HSC engineering. Administration of VLPs encoding lineage-specific HER2 CARs successfully generated durable CAR-expressing myeloid, NK, and T cells from HSCs that:

Exhibited tumor suppression in vivo and ex vivo
Remodeled the cold solid tumor microenvironment, marked by macrophage M1 polarization, increased lymphocyte recruitment, and production of inflammatory cytokines and chemokines.
Discovery of lineage specific regulatory elements for development of in vivo CAR immune cell therapy via hematopoietic stem cell engineering

Abstract Number: 1019

Poster Presentation Time/Date: Friday, November 7, 5:10-6:35 pm EST

Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC

Presenter: Alvin Pratama, Ph.D., Ensoma

This research supports the ability of the Ensoma platform to precisely identify and validate genetic regulatory elements that have the potential to drive robust lineage-restricted CAR expression in effector immune cells, potentially improving safety and functional control. Using Ensoma’s HSC-targeted VLPs to deliver lineage-restricted CAR payloads, the team achieved stable integration and selective CAR expression across myeloid, NK and T cells in human CD46 transgenic mouse models. The lineage-restricted CAR cells displayed potent, antigen-dependent cytotoxicity and cytokine production comparable to ubiquitous CAG-driven CARs, supporting the platform’s potential for precise, scalable and lineage-controlled in vivo CAR delivery.

(Press release, Ensoma, NOV 4, 2025, View Source [SID1234659406])

On November 4, 2025 Dispatch Bio, a biotechnology company developing a universal treatment for solid tumors, reported preclinical data supporting its first therapeutic program planned to enter the clinic, DISP-10, and its first-in-class Flare platform, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting.

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Immunotherapies have had limited success in solid tumors due to the lack of tumor-specific targets and a profoundly immunosuppressive microenvironment. Dispatch’s Flare platform addresses these barriers by systemically delivering a tumor-specific virus that paints a universal synthetic antigen (Flare) on tumor cells, enabling precise recognition by T cells, while reshaping the tumor microenvironment to support immune activity. Data presented at SITC (Free SITC Whitepaper) (Abstract 394) demonstrate strong and consistent tumor labeling, iterative viral amplification and tumor cell clearance across multiple epithelial tumor models.

"These data show that delivering engineered targets specifically to tumor cells allows us to control antigen specificity, while also reprogramming the tumor microenvironment," said Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer. "We are excited to start with CAR T as our first program, and because the Flare approach is modular and not restricted to CAR T cells, it can be extended across multiple immunotherapy modalities."

The company also presented preclinical findings from DISP-10, its first therapeutic candidate (Abstract 393). DISP-10 pairs DV-10, a tumor-targeted virus expressing a modified BCMA antigen (dBCMA) and the immune-stimulatory cytokine IL-18 and chemokine CXCL9, with a clinically validated BCMA-directed CAR T. The viral component installs the target and drives local immune activation, enabling robust CAR T function in solid tumors. DISP-10 demonstrated potent anti-tumor responses in numerous in vitro and in vivo models, with no activity observed in healthy cells. Dispatch plans to initiate a first-in-human Phase 1 study in 2026 to evaluate DISP-10 across multiple solid tumor types.

"DISP-10 creates the right biological context for CAR T cells to function in solid tumors," said Barbra Sasu, Ph.D., Chief Scientific Officer. "The consistency of activity seen with various BCMA-targeted therapies across tumor models gives us confidence in its clinical potential."

(Press release, Dispatch Bio, NOV 4, 2025, View Source [SID1234659405])

On November 4, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported a financial update and announced its cash position as of September 30, 2025.

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"MaaT Pharma is actively executing its financing strategy, building on the momentum of our outstanding Phase 3 results with Xervyteg in acute Graft-versus Host disease patients. With funding secured through February 2026, we are leveraging a balanced mix of dilutive and non-dilutive sources to support our development programs and preserve shareholder value. The recent partnership with Clinigen and the loan agreement with the European Investment Bank are key milestones in this strategy, providing capital-efficient solutions we intend to build upon to sustain our growth throughout 2026," said Eric Soyer, Chief Financial Officer of MaaT Pharma.

Corporate and Financing Update

In July 2025, the Company announced that it has secured a €37.5 million, 4-tranche loan financing from the European Investment Bank (EIB). The financing will support the advancement of its late-stage hemato-oncology clinical programs including the lead-asset Xervyteg, currently under regulatory review by the European Medicines Agency (EMA) for the treatment of acute Graft-versus-Host disease (aGvHD), and the second drug candidate, MaaT033, currently being evaluated in a Phase 2b randomized controlled trial in improving survival for patients receiving allo-HSCT.
The Company announces the successful drawdown in October 2025 of Tranche A for an amount of €3.5 million, together with the issuance, in accordance with the terms of the 24th resolution of the shareholders’ meeting held on June 20, 2025 and Articles L. 228-91 and seq. of the French Commercial Code, of 468,772 warrants to the EIB with an exercise price of 4.5898€, as per the Loan and Warrant agreements with the EIB. The Tranche A loan is payable over two years after a grace period of 4 years, and bears an interest rate of 7% per annum.
In July 2025, the Company announced the signature of an exclusive license and distribution agreement with Clinigen, the global pathfinder accelerating access to critical medicines and a leading European player in hospital distribution and market access, to support market access to Xervyteg for 3rd-line aGvHD patients across Europe, should the submission for Marketing Authorisation be successful. With this partnership, MaaT Pharma demonstrates its capability to supply products to pharmaceutical companies, including those specializing in rare diseases while ensuring commercial scale-up.
The Company received an upfront payment of €10.5 million in July 2025 and may receive up to an additional €18 million, including €12 million upon Marketing Authorization approval and €6 million in commercial milestones. The Company is also eligible for royalty payments on net sales, with a rate in the mid-thirties, as well as recurring cash flows under the supply agreement, with products being sold to the partner at a pre-agreed price.
In September 2025, MaaT Pharma has been awarded the Innovative Company label ("Entreprise Innovante") by Bpifrance.
Cash position1

As of September 30, 2025, total cash and cash equivalents were EUR 22.4 million, as compared to EUR 15.0 million as of June 30, 2025, and EUR 20.2 million as of December 31, 2024.
The Company believes it has sufficient cash to cover its current operating needs and development programs until the end of February 2026.
Revenues in Q3 20251

MaaT Pharma reported revenues from France from its Early Access Program of EUR 1.0 million for the quarter ended September 30, 2025, a 56% increase over the third quarter of 2024. Total revenues for the first nine months of 2025 amounted to EUR 3.4 million compared with EUR 2.3 million for the same period of 2024, a year-over-year increase of 45%1, reflecting the continued demand from the medical community for MaaT Pharma’s drug candidate Xervyteg(MaaT013).
Upcoming financial communication*

March 30th, 2026 – Q4 and Full year 2025 financial results
*Indicative calendar that may be subject to change.

Upcoming investor and medical conferences participation

November 5-9, 2025 – 40th Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in National Harbor, MD, USA
November 19-21, 2025 – Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) annual meeting in Geneva, Switzerland
November 25, 2025 – Investir Day event in Paris, France
December 6-9, 2025 – 67th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in Orlando, Fl, USA

(Press release, MaaT Pharma, NOV 4, 2025, View Source [SID1234659404])