On April 28, 2026 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.

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The NDA is supported by data from the Phase 2b part of the REZILIENT1 clinical trial of zipalertinib monotherapy in patients with NSCLC harboring EGFR ex20ins mutations who have received prior therapy. The study met its primary endpoint of objective response rate. Study results from REZILIENT1 were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in the Journal of Clinical Oncology.

"Zipalertinib was discovered at Taiho Pharmaceutical Co., Ltd., and has been developed with a focus on addressing the unmet needs of patients with EGFR exon 20 insertion-mutated non-small cell lung cancer," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "The FDA’s acceptance of the NDA for zipalertinib is an important milestone for this program, and we look forward to working with FDA during the review process."

"Zipalertinib is a compound created using Taiho Pharmaceutical’s proprietary drug discovery and development technologies, Cysteinomix, with the aim of delivering a new treatment option to address high unmet medical needs," said Takeshi Sagara, PhD, Executive Director, Board Member, Medical Affairs, Translational Development, Clinical Development, Discovery and Preclinical Research at Taiho Pharmaceutical. "The FDA’s acceptance of the NDA represents an important milestone, reflecting the scientific and clinical data accumulated to date. We will continue to work closely with Taiho Oncology, Cullinan Therapeutics and the FDA throughout the review process, with the shared goal of ultimately delivering a new treatment option to patients with non-small cell lung cancer EGFR exon 20 insertion mutations."

"FDA acceptance of the zipalertinib NDA is an important step toward making zipalertinib available for people living with non-small cell lung cancer with EGFR exon 20 insertion mutations, who continue to face limited treatment options," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "We are deeply grateful to the patients and families who have participated in the REZILIENT program, and to the investigators, study teams, and advocates whose collaboration made achievement of this milestone possible. We believe zipalertinib has the potential to help address a significant unmet need, and we look forward to working with our partners at Taiho with the goal of bringing zipalertinib to patients waiting for new treatment options."

Summary of Primary Study Results:

Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab.
The confirmed objective response rate (ORR) was 35%. Median duration of response (mDOR) was 8.8 months.
In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with a mDOR of 8.8 months.
In exploratory subgroup analyses:
Patients who had received prior amivantamab without other ex20ins-targeted therapy (n=30) showed a confirmed ORR of 30% and mDOR of 14.7 months.

Patients with brain metastases (n=68) showed a confirmed ORR of 31% and a mDOR of 8.3 months.
The safety profile of zipalertinib was manageable and consistent with previously reported data.¹ The most common treatment-emergent adverse events were paronychia, rash, anemia, dermatitis acneiform, diarrhea, dry skin, nausea and stomatitis. Most treatment-emergent adverse events were grade 1 or 2 per NCI-Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Zipalertinib is an oral EGFR tyrosine kinase inhibitor. Zipalertinib received Breakthrough Therapy Designation in 2021 for the treatment of patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations who have previously received platinum‑based systemic chemotherapy.

About REZILIENT1

REZILIENT1 (Researching Zipalertinib in EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in adult patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations who have received prior therapy. Patients were treated with oral zipalertinib 100 mg twice daily. The primary endpoints were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Adverse events were characterized and graded according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE v5.0).

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with ex20ins mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA for the treatment of patients with locally advanced or metastatic NSCLC harboring epidermal growth factor EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., and its parent company, Taiho Pharmaceutical Co., Ltd. worldwide, and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,2 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, APR 28, 2026, View Source [SID1234664874])

On April 28, 2026 Sapient, a leader in multi-omics data generation for biomarker discovery and clinical insight delivery, reported the launch of its Tumor Protein Mapping Platform as a suite of mass spectrometry-based discovery proteomics workflows designed to map functional tumor biology across four critical dimensions: the druggable cell surface proteome, phosphorylation-driven signaling pathways, the tumor immune microenvironment, and therapeutic resistance mechanisms. The platform is now available to biopharma sponsors and comprises four purpose-built workflows – SurfaceSeek, SignalingSeek, ImmuneSeek, and ResistanceSeek – each optimized for both fresh-frozen and FFPE human tumor samples.

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Central to the platform is SurfaceSeek, which directly measures proteins that are functionally deployed on the tumor cell surface to enable confident identification and validation of druggable targets for ADC, T-cell engager, and radioligand therapies. The workflow combines Sapient’s mass spectrometry-based discovery proteomics with selective enrichment of mature N-linked glycoproteins to preferentially identify proteins that have completed intracellular trafficking and are exposed on the extracellular surface. This enables direct characterization of surface target accessibility, density, and tumor selectivity, and brings peptide-level resolution to identify protein isoforms and post-translationally modified proteoforms bearing extracellular domains compatible with therapeutic binding.

The platform’s additional workflows complement and extend SurfaceSeek findings by mapping functional tumor biology that determines therapeutic outcome. SignalingSeek quantifies tumor signaling pathway activation via the measurement of phosphorylation events across critical oncogenic pathways, enabling direct assessment of on-target pathway modulation as well as identification of adaptive signaling and resistance pathways. ImmuneSeek measures functionally active tumor immune cells and the immune pathways that are driving therapeutic response, immune evasion, or suppression, while ResistanceSeek identifies the coordinated protein networks through which tumors adapt to therapeutic pressure across modalities.

"Building upon our next-generation FFPE Proteomics offering, we have developed specialized workflows that enable precise, multi-dimensional characterization of tumor biology at the protein level – and directly in human tumor tissue," said Jeramie Watrous, PhD, Co-Founder and Head of Analytical R&D at Sapient. "The key technical innovation is that these workflows – including SurfaceSeek’s selective glycoprotein enrichment and SignalingSeek’s deep phosphoproteomics – perform with exceptional concordance in both fresh-frozen and FFPE samples. This means we can apply them retrospectively to the vast biorepositories of archived tissue already collected, unlocking dimensions of functional tumor biology that were previously inaccessible in these samples."

"Tumors are not defined by a single biological dimension. They are complex and changing systems where surface target accessibility, signaling pathway activation, immune function, and resistance mechanisms all interact to determine therapeutic outcome," said Mo Jain, MD, PhD, Founder and Chief Scientific Officer at Sapient. "By mapping each of these dimensions directly at the protein level, we give drug development teams a comprehensive, unified view of what is actually governing drug response – moving oncology development beyond genomic inference alone, adding new layers of insight derived from the direct measurement of dynamic human tumor biology."

"This platform was shaped by many conversations with oncology leaders where we kept hearing the same thing: they were navigating some of the highest-stakes decisions in drug development, such as which targets to pursue, without the ability to directly measure those targets or the mechanisms that influence therapeutic outcome," added Jonathan Usuka, PhD, MBA, Chief Executive Officer at Sapient. "We designed the workflows to interrogate key dimensions of tumor biology that determine whether a drug will succeed, so our clients can advance their programs with direct evidence rather than inference."

All four workflows are available as standalone services or can be delivered in combination to provide integrated, multi-dimensional tumor characterization, and may be supported by Sapient’s DynamiQ Tumor-Tissue virtual biobank which offers streamlined access to annotated FFPE tumors and tissues.

(Press release, Sapient Discovery, APR 28, 2026, View Source [SID1234664873])

On April 28, 2026 Remepy, the pioneer of Hybrid Drugs, reported a collaboration with Merck KGaA, Darmstadt Germany, a leading science and technology company, to explore the development of Hybrid Drugs across multiple therapeutic areas.

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The collaboration will initially focus on some programs in the US in a rare tumor area, while potentially establishing a broader framework to explore additional Hybrid Drug opportunities across the therapeutic portfolio of Merck KGaA, Darmstadt, Germany, in the future.

Hybrid Drugs are an emerging therapeutic category that combine pharmacological treatments with personalized digital therapeutic protocols delivered through a mobile app. Research increasingly shows that the most effective care is multidisciplinary and integrative, combining medication with behavioral and therapeutic interventions. Hybrid Drugs integrate these evidence-based motor, physical, and cognitive interventions alongside medication to improve clinical outcomes1.

"We are excited about our collaboration with Merck KGaA, Darmstadt, Germany, that is a leading science and technology company," said Dr. Michal Tsur, Co-founder and Co-CEO at Remepy. "Remepy’s Hybrid Drug platform combines traditional drugs with evidence-based AI enabled digital interventions delivering personalized, adaptive integrative treatment. The new advances in regulatory frameworks, supporting the integration of software with drugs, enable the pharma industry to use the power of the digital world to differentiate drugs, enhance their efficacy and amplify their label. We are looking forward to accelerating the delivery of innovative and effective therapies to patients who need them most."

Recent developments, including the introduction of FDA Prescription Drug Use-Related Software (PDURS) guidance, and evolving SaMD-Drug combination pathways are creating clearer regulatory routes for integrating digital therapeutic components directly into pharmaceutical products. Advances in FDA digital health initiatives and guidance on AI for medical devices are opening the door to a new generation of innovative therapeutic solutions.

Hybrid Drugs introduce a new economic model for digital health. By combining a drug and a therapeutic application into a single prescription product, hybrid drugs shift digital health innovation into the established economics of pharmaceutical development, commercialization, and reimbursement.

(Press release, Merck KGaA, APR 28, 2026, View Source [SID1234664872])

On April 28, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that ivonescimab, the company’s first-in-class PD-1/VEGF bispecific antibody, has secured multiple authoritative updates and upgrades across first-line and later-line settings in the officially updated 2026 Chinese Society of Clinical Oncology (CSCO) Guideline for the Diagnosis and Treatment of Non-Small Cell Lung Cancer (NSCLC). These strong recommendations further solidify ivonescimab’s breakthrough clinical value and its position as a new standard of care (SOC), highlighting its leadership as a next-generation immunotherapy driving the IO 2.0 era.

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Key Highlights

In the Phase III HARMONi-2 study, ivonescimab monotherapy demonstrated superior progression-free survival compared with pembrolizumab in first-line PD-L1-positive (TPS ≥1%) NSCLC. Based on these results, ivonescimab has been upgraded to a Class I recommendation for first-line treatment of both squamous and non-squamous NSCLC with PD-L1 TPS ≥1%. This indication was previously approved in China and included in the National Reimbursement Drug List (NRDL). The upgrade strengthens its position as a preferred first-line option for PD-L1-positive advanced NSCLC.

In the Phase III HARMONi-6 study, ivonescimab plus chemotherapy showed positive results versus PD-1 inhibitor plus chemotherapy in first-line squamous NSCLC. This combination has received a new Class II recommendation for first-line treatment of squamous NSCLC. The supplemental application for this indication is currently under regulatory review.

Latest CSCO Guideline Recommendations for Ivonescimab

Post-resistance treatment in EGFR-mutant NSCLC: Ivonescimab plus chemotherapy maintains a Class I recommendation.
First-line treatment for advanced driver gene-negative squamous NSCLC with PD-L1 TPS ≥1%: Ivonescimab monotherapy upgraded to Class I recommendation.
First-line treatment for advanced driver gene-negative non-squamous NSCLC with PD-L1 TPS ≥1%: Ivonescimab monotherapy upgraded to Class I recommendation.
First-line treatment for advanced driver gene-negative squamous NSCLC: Ivonescimab plus chemotherapy newly added as Class II recommendation.
To date, the breakthrough clinical value of ivonescimab has been demonstrated in dozens of clinical trials and real-world experience involving more than 70,000 patients. It has gained wide acceptance among oncologists and patients, contributing to the ongoing advancement of immuno-oncology treatment paradigms globally.

(Press release, Akeso Biopharma, APR 28, 2026, View Source [SID1234664871])

On 28 April, Fosun Pharma ("the Company", stock code: 600196.SH; 02196.HK) reported its results for the first quarter of 2026 (the reporting period). During the reporting period, the Company achieved a total revenue of RMB 10,073 million, representing a year-on-year increase of 6.93%. Regarding R&D investment, the Company firmly implemented its innovation transformation strategy. During the reporting period, the R&D expenditure increased to RMB 897 million, increased by 1.59% YoY. While increasing the R&D intensity, the Company maintained a positive growth trend in profit. Net profit attributable to shareholders of the list company after deducting extraordinary gain or loss was RMB 501 million, up 21.96% year-on-year. Net profit attributable to shareholders of the listed company was RMB 871 million, increased by 13.87% YoY. Net cash flows generated from operating activities was RMB 1,149 million, up 8.8% YoY.

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In the first quarter of 2026, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma firmly continued to advance its innovation transformation, promoted the deep synergy between innovation and R&D and global operations, and further enhanced the foundation for high-quality development. Driven by the continuous increase in R&D investment, the Company’s transformation of innovative achievements continues to materialize. During the reporting period, the NDA for 4 Innovative Drugs were accepted by the NMPA or the U.S. FDA, and 14 clinical trials for Innovative Drugs (calculated by approval) were approved by domestic and overseas regulatory authorities, covering core therapeutic areas such as oncology. In the Pharma R&D Annual Review 2026 white paper released by the world-known consulting firm Citeline, Fosun Pharma ranked among the global top 20, gained international professional recognition for its innovative R&D strength and pipeline quality.

Deepening Core Technology Platforms to Consolidate Advantages in Oncology and Other Fields

Fosun Pharma has established an open-ended R&D system that combines in-house R&D, co-development, licensing, fund incubation, and industrial investment, also focused on strengthening core technology platforms such as antibodies/ADC, small molecules, and cell therapy, continuously consolidating its innovation moat in core therapeutic areas including oncology.

In the field of antibody/ADC technology platform, Shanghai Henlius, a subsidiary of Fosun Pharma, has steadily advanced the approvals and clinical progress of several self-developed biological drugs. Notably, denosumab injection (HLX14) secured approval in Canada in March 2026, covering all indications of the reference product approved locally, achieving a global commercialization breakthrough in areas such as osteoporosis, bone metastasis from tumors, and giant cell tumor of bone. The NDA for bevacizumab injection (HLX04) was accepted in the U.S., marking a new milestone in the Company’s international registration capabilities for biosimilars. HLX43, an antibody-drug conjugate targeting PD-L1, is expected to create synergy with HLX07 or serplulimab injection for the treatment of advanced colorectal cancer and other solid tumors. HLX3901, a tetraspecific antibody of DLL3×DLL3×CD3×CD28, received approval for clinical trial, demonstrating significant potential in refractory solid tumors through multi-target synergistic activation of immune cells.

In the field of small molecule innovative drug platform, in January 2026, the NDA for foritinib succinate capsules (SAF-189), Fosun Pharma’s Class 1 innovative drug, was accepted by the NMPA, intended for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), expected to provide a new option for precision treatment of lung cancer. In February 2026, the NDA for the self-developed MEK 1/2 inhibitor luvometinib tablets (Trade name in Chinese mainland: Fu Mai Ning) for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) have been accepted and granted in the priority review by the NMPA. This marks a critical step toward full-age coverage following its approval for pediatric and adolescent NF1 patients in May 2025, also brings new hope to a large number of adult NF1 patients in China who lack effective drug treatments. Additionally, the NDA for methoxyetomidate hydrochloride injection (ET-26), a Class 1 innovative drug self-developed by the subsidiary Avanc Pharma for anesthesia induction and short-term surgical anesthesia, was also accepted.

In the field of prospective layout of early-stage pipeline, several new molecules have been approved for the clinical trials: FXB0871, a PD-1-targeted IL-2 fusion protein, was approved for clinical trials in locally advanced or metastatic solid tumors. Based on the ATTENUKINE platform, FXB0871 is expected to achieve high efficacy and low toxicity. FXS0683, a next-generation Bcl-2 inhibitor, was approved for Phase I clinical trials in hematological malignancies. Innovative molecule including HLX97 (a KAT6A/B small molecule inhibitor) and HLX3901 (tetra specific antibody of DLL3×DLL3×CD3×CD28) were approved for clinical trials, widely covering refractory solid tumors such as breast cancer and small cell lung cancer. Meanwhile, HLX22 (anti-HER2 monoclonal antibody) entered phase II clinical trials for the first-line treatment of HER2-positive recurrent or metastatic breast cancer in combination with HLX87. HLX43 (PD-L1 ADC) in combination with HLX07 or serplulimab injection, and HLX701 (CD47 fusion protein), among others, have entered Phase I clinical trials, further enhancing the Company’s layout in the fields of tumor immunology and targeted therapy.

Expanding Global Commercialization Network and Enhancing Academic Influence

During the reporting period, Fosun Pharma’s global registration and commercialization network continued to expand. The overseas registration of products like denosumab and bevacizumab progressed steadily. The Company reached deep collaborations with global partners such as Eisai and Abbott to accelerate the market coverage of innovative products in Japan, Asia-Pacific, Middle East, Africa, and Eastern Europe.

In the academic field, several innovation achievements were presented at top international conferences such as AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper). The Phase III study data of luvometinib tablets for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) was selected for a rapid oral abstract session at 2026 ASCO (Free ASCO Whitepaper), the study results will be released for the first time during the meeting. At the 2026 AACR (Free AACR Whitepaper) Annual Meeting, Shanghai Henlius, a Fosun Pharma’s subsidiary, presented preclinical data for the novel trispecific T-cell engager HLX3902 and the tetraspecific antibody HLX3901, demonstrating best-in-class treatment potential, building a solid foundation for the future clinical development.

AI Embracement: Driving Digital Transformation via FoSTRAID

Fosun Pharma continues to deepen its digitalization and AI strategic layout, and systematically advances the platformisation, engineering and scaled implementation of AI capabilities focusing on core aspects such as new drug R&D, clinical research, products and services, and operation management. On this basis, the fully AI- embracing strategy centered on FoSTRAID (Fosun Pharma Strategic Transformation via AI & Data science) was further defined and steadily advanced. By integrating resources, a digital-intelligence architecture that promotes synergistic development across "foundation — platform — data — agent — scenario — mechanism" has been established.

The self-developed PharmAID Pharmaceutical Intelligence Platform deeply applies large language models, fine-tuned with professional medical corpora and R&D data. It integrates full-cycle of decision-making tools including competitor analysis, clinical competitive performance evaluation, NDA approval prediction, and peak sales estimation, comprehensively applied in key scenarios such as target discovery, molecular optimization, clinical writing, intelligence retrieval, and literature interpretation, providing systematic and data-driven support for drug R&D decision-making.

Looking ahead, Fosun Pharma will continue to adhere to the dual drivers of innovation and globalization, deepen its core technology platforms, promote the implementation of AI strategy and accelerate the transformation of its pipeline and global market access. The Company remains committed to providing high-quality healthcare products and services to patients worldwide, striving to become a leading global healthcare innovation integrator.

(Press release, Fosun Pharma, APR 28, 2026, View Source [SID1234664870])