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GenFleet Therapeutics Announces GFH375 Granted with First Breakthrough Therapy Designation in China for a KRAS G12D Inhibitor Treating Non-small Cell Lung Cancer

On March 2, 2026 GenFleet Therapeutics reported that oral KRAS G12D (ON/OFF) inhibitor GFH375 has been granted with the Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), for treatment of KRAS G12D-mutant non-small cell lung cancer (NSCLC) patients who have received at least one prior systemic therapy.

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This designation is supported by the phase I/II data from the GFH375X1101 study, demonstrating GFH375’s best‑in‑class monotherapy efficacy and manageable safety/tolerability for NSCLC in the global KRAS G12D inhibitor landscape. The preliminary data from GFH375 monotherapy treating KRAS G12D-mutant patients with solid tumors and NSCLC were featured in late-breaking abstract (LBA) and oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 2025 World Conference on Lung Cancer. More updated study data are expected to be published at global academic events later this year.

"GenFleet has established its integrated R&D capabilities in the program of fulzerasib, a marketed KRAS G12C inhibitor. Globally, no targeted therapies for KRAS G12D mutation have yet been approved, representing a significant unmet medical need across major tumor types carrying the G12D mutation. Within the global landscape of KRAS G12D inhibitor clinical development, GFH375 is progressing at the fastest pace for NSCLC treatment, showing encouraging efficacy and a manageable safety profile. Given its favorable monotherapy druggability and efficacy, GFH375 holds promising clinical potential as a single agent and in combination regimens. "Prof. Shun Lu, stated Shanghai Chest Hospital.

"We are deeply impressed by the urgent need for targeted therapies among patients harboring KRAS G12D mutation. We are encouraged by GFH375’s robust efficacy in the study and hope the BTD granted by CDE helps to accelerate the development and the ultimate launch of GFH375 to benefit patients. The extensive clinical program for GFH375/VS‑7375, in China by GenFleet and outside of China by its partner Verastem Oncology, underscores its broad therapeutic potential across multiple major tumor types. We look forward to presenting updated data for GFH375 in various indications at global academic events later this year." stated Yu Wang, MD, Ph.D., Chief Medical Officer of GenFleet.

GFH375 obtained clinical trial approval for a phase I/II study in China in June 2024. Currently, GFH375 monotherapy for metastatic pancreatic cancer has advanced into the world’s first phase III trial of an oral KRAS G12D inhibitor; besides, GFH375/VS-7375 has been granted with the US FDA Fast Track Designation for the treatment of metastatic KRAS G12D-mutated pancreatic ductal adenocarcinoma (PDAC) across all lines of therapy. Multiple monotherapy and combination trials of GFH375/VS-7375 for different tumor types are advancing smoothly, including the GenFleet-initiated phase Ib/II trial of GFH375 combined with chemotherapy (AG) as first-line treatment for PDAC.

(Press release, GenFleet Therapeutics, MAR 2, 2026, http://www.genfleet.com/en/press_release-102 [SID1234666092])

NovaBridge to Present at the Leerink Partners 2026 Global Healthcare Conference

On March 2, 2026 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, reported that NovaBridge’s management team will participate in the upcoming Leerink Partners 2026 Global Healthcare Conference being held on March 8-11, 2026.

Conference details are as follows:

Leerink Partners Global Healthcare Conference
Format: Fireside Chat
Date: Wednesday, March 11, 2026
Time: 8:00 AM ET
Webcast Link: Here

The webcast of the company presentation will be accessible on the News & Events page of the NovaBridge website for 90 days.

(Press release, NovaBridge Biosciences, MAR 2, 2026, View Source [SID1234663205])

Royalty Pharma and Zymeworks Enter Into $250 Million Royalty-Backed Note Financing

On March 2, 2026 Royalty Pharma plc (Nasdaq: RPRX) and Zymeworks Inc. (Nasdaq: ZYME) reported an agreement for $250 million in funding from Royalty Pharma in the form of a non-recourse royalty-backed note with repayments due from 30% of worldwide tiered royalties on Ziihera (zanidatamab-hrii) owed to Zymeworks from Jazz Pharmaceuticals (Jazz) and BeOne Medicines (BeOne).

"We are delighted to enter into this royalty funding agreement with Zymeworks on royalties from Ziihera, a therapy with the potential to meaningfully change the treatment landscape for patients with HER2‑positive gastric and biliary tract cancers," said Pablo Legorreta, Chief Executive Officer and Chairman of the Board of Royalty Pharma. "The recent clinical results from HERIZON-GEA-01 for Ziihera in first-line metastatic gastroesophageal adenocarcinoma (mGEA) underscore its potential to prolong survival in a disease with poor prognosis and urgent need of new treatment options. This transaction enables us to participate in the long-term value of this important therapy while providing Zymeworks capital to achieve their strategic and financial goals."

"This strategic funding provides non-dilutive capital that enhances our flexibility to continue repurchasing shares at current prices, which we believe represents a compelling discount to our estimate of intrinsic value," said Kenneth Galbraith, Chair, Chief Executive Officer and Acting Chief Financial Officer. "It also gives us additional capacity to pursue strategic acquisitions that meet our rigorous risk-adjusted return criteria and fund our cash runway beyond 2028. We believe this disciplined capital allocation strategy will increase the underlying value of the business, while thoughtfully reducing our share count over time, setting us up for higher long-term shareholder value."

Transaction Terms

Under the terms of the agreement, Zymeworks will receive $250 million from Royalty Pharma through the issuance of a non-recourse royalty-backed note. Repayment of the note will be secured by 30% of future royalties from the global sales of Ziihera, generated under collaboration agreements with partners Jazz and BeOne, equating to an approximately low to mid-single digit upward tiering royalty up to a pre-specified repayment limit. Royalty Pharma will cease receiving any such royalties when it receives cumulative payments of either 1.65x the note amount by December 31, 2033, or 1.925x the note amount at any time thereafter, at which time no further repayments will be owed with respect to the note.

Under the collaboration agreement with Jazz, Zymeworks is eligible to receive tiered royalties of 10% to high teens on global (outside of Asia (other than Japan), Australia and New Zealand) annual sales of Ziihera up to $2.0 billion and 20% on annual net sales above $2.0 billion.

Under the collaboration agreement with BeOne, Zymeworks is eligible to receive tiered royalties of mid-single to mid-double digits on annual net sales of Ziihera up to $1.0 billion and 19.5% on annual net sales above $1.0 billion. BeOne holds marketing rights to Ziihera in Asia (excluding Japan), Australia and New Zealand.

Zymeworks will retain 70% of royalties on Ziihera sales during the note repayment period, with full royalty rights reverting to Zymeworks once the royalty payments to Royalty Pharma have ceased. All earned regulatory and commercial milestone payments under its agreements with Jazz and BeOne will be retained by Zymeworks, including up to $440.0 million in near-term milestone payments tied to future regulatory approvals of Ziihera in mGEA, $89.0 million regulatory milestones for third indications, beyond biliary tract cancer and mGEA, and up to $977.5 million in potential commercial milestone payments, for total potential remaining payments of up to $1.5 billion.

Advisors

TD Cowen served as the financial advisor to Zymeworks on the transaction and Gibson Dunn served as its legal advisor. Covington & Burling, Choate and Maiwald acted as legal advisors to Royalty Pharma.

About Ziihera (zanidatamab-hrii)

Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. The U.S. FDA granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule.

The FDA granted two Breakthrough Therapy designations for zanidatamab’s development: one for patients with previously treated HER2 gene-amplified BTC, and one for patients with locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for first-line GEA. Additionally, zanidatamab has received Orphan Drug designations from the FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.

The full U.S. Prescribing Information for Ziihera, including BOXED Warning, is available at: View Source

(Press release, Zymeworks, MAR 2, 2026, View Source [SID1234663204])

Gyre Therapeutics Enters into Agreement to Acquire Cullgen to Gain Targeted Protein Degradation Platform and Pipeline

On March 2, 2026 Gyre Therapeutics, Inc. (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic diseases, reported its agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, in an all-stock transaction valued at approximately $300 million. Following the closure of the acquisition, the new combined entity will be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas including inflammatory diseases, cancers, and pain.

Under the terms of the definitive agreement, Cullgen will become a wholly owned subsidiary of Gyre. Upon the completion of the acquisition, the interim Chief Executive Officer and Executive Chairman of Gyre, Ping Zhang, will remain as the Executive Chairman. The current Chief Executive Officer of Cullgen, Dr. Ying Luo, is expected to become the President and Chief Executive Officer and a member of the board of directors of Gyre.

Dr. Luo, the expected President and Chief Executive Officer of Gyre, commented, "We are thrilled about the synergistic coalescing of our companies. Cullgen brings strong drug discovery capabilities and a solid preclinical and clinical pipeline to complement Gyre’s existing and highly efficient China-based manufacturing capabilities and sales team. Gyre is already a commercial-stage company with ETUARY on the market in China for the treatment of lung fibrosis and a second product for liver fibrosis, Hydronidone (F351), nearing New Drug Application (NDA), submission in China. Gyre is also exploring the expansion of F351’s development in ex-China territories. Following the acquisition, we will have a fully integrated biopharmaceutical company that will be capable of leveraging emerging drug discovery capabilities in China and strong clinical development in the United States to address unmet medical needs worldwide. I am excited for the potential of TPDs and DACs to drive this Company’s future growth globally."

Mr. Zhang, Chairman of Gyre, commented, "Recently, Gyre, through its majority owned subsidiary, Gyre Pharmaceuticals, had a pre-NDA meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) which supported a conditional approval and priority review eligibility filing for Gyre Pharmaceuticals’ first-in-class anti-liver fibrosis candidate, Hydronidone, subject to formal approval. As a result, Gyre Pharmaceuticals plans to submit an NDA for Hydronidone for conditional approval in the first half of 2026 and conduct a Phase 3c confirmatory trial to support full approval in China. The addition of Cullgen’s TPD/DAC platform and pipeline is expected to enhance our long-term growth prospects. We are excited to have Cullgen colleagues join our team in both the United States and China."

The transaction is expected to close early in the second quarter of 2026, subject to customary closing conditions, including necessary regulatory approvals in the United States.

Prior to entering into this transaction, Cullgen’s proposed merger with Pulmatrix was terminated.

(Press release, Gyre Therapeutics, MAR 2, 2026, View Source [SID1234663203])

Egle Therapeutics and Consortium Partners Awarded €8 Million Grant from Horizon Europe to Advance Clinical Development of EGL-001 in Neoadjuvant Head and Neck Cancer

On March 2, 2026 Egle Therapeutics SAS (Egle), a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer, reported it was awarded approximately €8 million in grant funding by Horizon Europe, the European Commission’s key funding program for research and innovation. This funding from the European Union will support an Egle-led initiative in partnership with a consortium of four leading European scientific institutions to advance the clinical development of EGL-001, a novel anti-CTLA-4 x IL-2m fusion protein, and to facilitate a comprehensive translational research program to de-risk later-stage clinical development.

"This Horizon Europe funding strengthens our ability to advance EGL-001’s clinical development and significantly expand the translational research needed to guide patient selection alongside several leading European partners. The grant enables the evaluation of EGL-001 by studying therapy-naïve patients in the neoadjuvant setting and focusing on head and neck squamous cell carcinoma as a single, well-defined indication," said John Celebi, CEO of Egle Therapeutics. "In parallel, we are advancing our ongoing Phase 1/2 study of EGL-001, where it has been well tolerated with early signs of single-agent activity in PD-(L)1-resistant disease. We remain on track to report top-line data from this study in the second half of this year and look forward to bringing our Treg-focused product candidates closer to patients in need."

As part of this initiative, Egle will collaborate with University College London (United Kingdom), Vall d’Hebron Institute of Oncology (VHIO) (Spain), Gustave Roussy (France), and Technical University of Dresden (Germany) to conduct a multicenter, randomized, open-label Phase 1/2 neoadjuvant clinical trial in patients with head and neck squamous cell carcinoma (HNSCC), a high-incidence, high-mortality cancer with limited benefit from current immunotherapies. This trial will evaluate the safety, tolerability, and early efficacy of EGL-001 in combination with pembrolizumab in these patients.

This initiative also integrates a comprehensive translational research program, including multi-omics profiling, immune monitoring, and AI-driven pathomics modeling, to deliver predictive biomarkers for patient stratification, ultimately supporting regulatory alignment and de-risking later-stage development. The consortium also provides cutting-edge expertise in immunology, genomics, pathology, and computational biology, alongside established clinical trial capacity across EU member states.

"EGL-001 represents a highly differentiated, Treg-based approach to cancer treatment that is designed to selectively disarm and remove regulatory T cells inside tumors, making tumor types with prominent Treg-driven immune suppression, including HNSCC, compelling settings for clinical evaluation," said Prof. Aurélien Marabelle, M.D., Ph.D., Gustave Roussy Cancer Center. "In addition, this project incorporates a rigorous, clinically actionable framework to evaluate a novel approach to tumor-driven immune suppression and to rapidly generate translational insights that can inform future development and patient selection. On behalf of the consortium partners, we are excited to partner with Egle to advance this work and generate the clinical and translational evidence needed to bring new options like EGL-001 to patients."

About EGL-001
EGL-001 is an investigational anti-CTLA-4-IL-2m fusion protein designed to selectively disarm and remove regulatory T cells (Tregs) in the tumor microenvironment and to block CTLA-4 to help restore effector T-cell priming and function. This dual-target approach is intended to induce tumor-selective Treg apoptosis through an Fc receptor-independent mechanism, with the goal of strengthening anti-tumor immunity while supporting tolerability and use in combination regimens, including with PD-(L)1 inhibitors. EGL-001 is currently being evaluated in an ongoing multicenter, open-label, first-in-human Phase 1/2 clinical trial (NCT06622486) in patients with selected advanced and/or metastatic solid tumors, with dose escalation underway both as a single agent and in combination with an anti-PD-(L)1 therapy to assess safety, tolerability, and preliminary anti-tumor activity and to identify recommended doses for expansion.

(Press release, Egle Therapeutics, MAR 2, 2026, View Source [SID1234663202])