On April 9, 2026 DualityBio ("DualityBio" or the "Company", Stock Code: 9606.HK) reported that the Biologics License Application (BLA) for the investigational antibody-drug conjugate ("ADC") trastuzumab pamirtecan ("T-Pam", also known as DB-1303 or BNT323), has been accepted for review by the China National Medical Products Administration (NMPA). With the BLA filing, DualityBio is seeking approval for trastuzumab pamirtecan as second-line treatment for patients with unresectable or metastatic HER2-positive breast cancer. The application is based on positive interim results from the pivotal Phase III clinical trial (Study DB-1303-O-3001).

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The DB-1303-O-3001 trial is a randomized, controlled, open-label, multicenter Phase III clinical trial conducted in China. It aims to evaluate the efficacy and safety of trastuzumab pamirtecan compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane chemotherapy. As assessed by the Independent Data Monitoring Committee (IDMC), the trial has met its primary endpoint of statistically significant improvement of progression-free survival (PFS, assessed by Blinded Independent Central Review, BICR) for trastuzumab pamirtecan compared to T-DM1 at a pre-specified interim analysis.

Dr. Hua Mu, Global Chief Medical Officer of DualityBio, stated: "China has over 350,000 new breast cancer cases annually [1], representing a high incidence rate and ranking as the second most common cancer among Chinese women. We are delighted to see that DB-1303/T-Pam has achieved a milestone in its commercialization progress, demonstrating its potential to provide an effective new treatment option for breast cancer patients. In the China market, we have entered into a collaboration with 3SBio to jointly advance the commercialization of multiple indications of DB-1303/T-Pam in Chinese mainland, Hong Kong and Macao. Globally, we will continue to deepen our global strategic partnership with BioNTech to further drive the global development of this product. DB-1303/T-Pam is a globally co-developed new drug with strong strategic partners in both China and global markets. We will work closely together to accelerate the product’s marketing approval process, maximize its global clinical value, present more treatment options to patients worldwide."

About trastuzumab pamirtecan (BNT323/DB-1303)

Trastuzumab pamirtecan ("T-Pam", also known as BNT323 or DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 which is being developed by BioNTech and DualityBio. Trastuzumab pamirtecan was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates ("DITAC") platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells, making it a potential target for innovative cancer therapeutics. The candidate has exhibited antitumor activity in both HER2-positive and HER2-low tumor models as well as in several solid tumor indications, including patients with breast and endometrial cancers, as well as other advanced solid tumors. Preclinical data and preliminary clinical data for trastuzumab pamirtecan indicate its potential to target HER2 receptors on solid tumors irrespective of expression level with a manageable safety profile and a potentially expanded therapeutic window. Trastuzumab pamirtecan is currently being evaluated in multiple solid tumor types and innovative treatment combinations, including two global pivotal clinical trials in first-line HER2-low, hormone receptor positive ("HR+") metastatic breast cancer (DYNASTY-Breast02; NCT06018337) and second-line endometrial cancer (BNT323-01; NCT06340568), a novel-novel combination Phase 1/2 clinical trial (BNT323-03; NCT06827236) evaluating trastuzumab pamirtecan in combination with pumitamig in HR-positive or –negative, HER2-low, -ultra-low, or -null advanced/metastatic breast cancer and a Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 Versus Investigator’s Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer (NCT06340568) .

The BNT323/DB-1303 program received the Fast Track designation and Breakthrough Therapy designation from the U.S. Food and Drug Administration ("FDA") for the treatment of endometrial cancer in 2023.

(Press release, DualityBio, APR 9, 2026, View Source [SID1234664281])

On April 9, 2026 Compugen Ltd. (NASDAQ: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that management will present at the 25th Annual Needham Virtual Healthcare Conference. The presentation will take place on Monday, April 13, 2026, at 8:45-9:25 AM ET.

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A live webcast will be accessible on the Investor Relations section of the Compugen website at www.cgen.com. A replay will also be available following the live event.

(Press release, Compugen, APR 9, 2026, View Source [SID1234664280])

On April 9, 2026 Deck Bio reported a multi-target approach designed to expand the reach of T cell engagers in solid tumors by addressing tumor heterogeneity and resistance. Founded by Jack Silberstein, Ph.D., a Stanford-trained protein engineer, Deck Bio is advancing differentiated T cell engagers (TCEs) designed to overcome key limitations of current immuno-oncology approaches and expand the impact of immunotherapy in solid tumors. Preclinical data will be presented by Johanna Kaufmann, Ph.D., Deck Bio’s Chief Scientific Officer, at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22 in San Diego, California.

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While immuno-oncology therapies have transformed cancer treatment, a significant unmet need remains for broader patient populations. TCEs have shown clinical efficacy in hematologic cancers, but their impact on solid tumors remains limited due to tumor heterogeneity, antigen escape, and limited availability of suitable targets.

To overcome these challenges, Deck Bio is developing first-in-class TCEs that target tumor-exclusive peptide–major histocompatibility complex (pMHC) proteins, enabling access to a broad range of cancer-driving targets inside the cell that are not reachable with conventional biologics. Unlike first-generation T cell engagers that rely on single antigen targets, the company’s therapeutic candidates are designed to recognize multiple tumor-specific targets through a single engineered binder. This approach is designed to improve tumor specificity, expand patient eligibility, and reduce the risk of resistance, without the complexity of multi-component therapeutic formats.

"Deck Bio was founded to tackle fundamental challenges in targeting cancer, including the limitations of single-antigen approaches and the difficulty of safely accessing intracellular targets," said Jack Silberstein, Ph.D., Founder & Chief Executive Officer of Deck Bio. "We believe a multi-target approach can help stack the odds in favor of patients, and we are taking a deliberate, capital-efficient approach to development, focusing from the outset on the attributes that matter most for patients and clinicians, including safety, patient access, and durability of response."

Underlying this approach is a proprietary platform that integrates a stabilized T cell receptor domain (dbTv) with a T cell engaging arm to create its T cell engager format (dbTCE), designed for antibody-like stability and manufacturability. This is complemented by a sequence-agnostic specificity profiling platform (dbSCOPE), which assesses off-target interactions and guides the design of highly selective therapies.

"Our goal is to expand the reach of T cell engagers in solid tumors, where patients continue to face significant unmet need," said Johanna Kaufmann, Ph.D., Chief Scientific Officer of Deck Bio. "By combining multi-target recognition with deep specificity profiling and improved molecular stability, we are building a platform designed to improve both efficacy and safety, while also enabling scalable manufacturing, all key factors for delivering meaningful patient benefit."

Since its founding in 2023, Deck Bio has raised approximately $3.1 million in funding from Mission BioCapital, the American Cancer Society’s venture arm BrightEdge, and Impact Ventures Partners Fund, and has received additional support from leading industry organizations. The company’s launch comes at a time of increasing industry focus on next-generation T cell engagers designed to overcome the limitations of earlier approaches in oncology and beyond.

The company’s lead program, DBXO-1, is a multi-target T cell engager being developed for solid tumor indications, including non-small cell lung cancer and gastroesophageal cancer. Additional details will be highlighted during the upcoming presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2026.

Conference Presentation Details:

Session Title: T Cell Engagers 1 (PO.IM01.16)
Abstract Title: Preclinical characterization of DBXO-1, a multi-pMHC targeted bispecific T cell engager for major solid tumors
Date: April 20, 2026
Time: 9:00 a.m. – 12:00 p.m. PST
Poster ID: 1632

(Press release, Deck Bio, APR 9, 2026, View Source [SID1234664279])

On April 9, 2026 Gan & Lee Pharmaceuticals (hereinafter referred to as "Gan & Lee", SSE: 603087) reported the signing of an exclusive licensing agreement with JW Pharmaceutical, a leading pharmaceutical company in South Korea. Under the agreement, the two parties will collaborate on the clinical development, regulatory filing, and commercialization in South Korea of Bofanglutide Injection, a bi-weekly (once every two weeks) Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) independently discovered and developed by Gan & Lee.

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Under the terms of the agreement, JW Pharmaceutical will be granted the exclusive rights to develop and commercialize Bofanglutide Injection in South Korea. Gan & Lee Pharmaceuticals will receive a one-time, non-refundable upfront payment of USD 5 million. Additionally, Gan & Lee is eligible to receive milestone payments totaling USD 76.1 million, contingent upon research and development progress, regulatory approvals, and commercialization achievements. Following the product’s commercial launch, Gan & Lee will also receive tiered royalties based on net sales. The total potential transaction value reaches up to USD 81.1 million (excluding royalties).

This collaboration marks the third overseas out-licensing deal for Gan & Lee’s Bofanglutide Injection, following previous partnerships in Latin America and India. According to data from Grand View Research, the GLP-1RA market in the Asia-Pacific region reached USD 5.47 billion in 2025 and is projected to grow to USD 16.95 billion by 2033, representing a compound annual growth rate (CAGR) of 14% [1], making it one of the fastest-growing regions globally. Currently, the treatment penetration rate of GLP-1 drugs remains extremely low, indicating massive growth potential. As a mature market in the Asia-Pacific region, South Korea’s GLP-1RA market size reached USD 526 million in 2025 and is expected to increase to USD 1.6 billion by 2033 [2]. With its high acceptance of innovative drugs and strong patient purchasing power, the South Korean market has become a strategic foothold for multinational pharmaceutical companies entering East Asia. This collaboration marks another key step in the rapid global expansion of Gan & Lee’s differentiated bi–weekly GLP–1RA, Bofanglutide.

Steady Progress in Global Phase III Clinical Trials; Bi-weekly Dosing Regimen Significantly Enhances Patient Compliance

Currently, as the world’s first bi-weekly GLP-1RA to enter Phase III clinical research, Bofanglutide has advanced into the critical Phase III stage of its global development for three proposed indications: obesity/overweight, type 2 diabetes mellitus (T2DM), and obstructive sleep apnea (OSA). Existing clinical data demonstrate that Bofanglutide can effectively reduce body weight and blood glucose levels while comprehensively improving other metabolic parameters, yielding overall metabolic benefits. Its safety and tolerability profiles are consistent with other GLP-1RA class therapies. The bi-weekly dosing regimen further reduces the annual number of injections by 50% compared to mainstream once-weekly GLP-1RAs. This is anticipated to substantially boost patient adherence, offering a more convenient treatment option for the long-term, effective management of metabolic diseases.

As the global burden of metabolic diseases continues to rise, GLP-1 therapies are encountering tremendous market opportunities. South Korea, as one of the world’s key pharmaceutical markets, exhibits a robust demand for innovative diabetes and weight-loss therapies. This collaboration will effectively address the clinical and commercial needs of the South Korean market for highly efficacious and convenient treatment regimens.

"This partnership with JW Pharmaceutical marks another pivotal step in the globalization strategy for Bofanglutide," stated Dr. Zhi Li, Chief Business Officer of Gan & Lee Pharmaceuticals. "GLP-1 therapies are reshaping the global treatment landscape for metabolic diseases. The convenience of Bofanglutide’s bi-weekly dosing and its compelling clinical benefits will help address the unmet medical needs of South Korean patients. With over 80 years of experience, JW brings deep development and commercial expertise in metabolic diseases—a key factor in our decision to partner with JW."

Young-sub Shin, CEO of JW Pharmaceutical, commented: "This agreement represents a significant milestone in expanding our product portfolio within the rapidly growing therapeutic area of metabolic diseases, particularly diabetes and obesity. JW Pharmaceutical will leverage its established expertise in clinical development and regulatory execution, remaining committed to advancing the development and commercialization of Gan & Lee’s Bofanglutide in South Korea, thereby bringing innovative treatment options to South Korean patients."

About Bofanglutide

Bofanglutide Injection (GZR18), independently developed by Gan & Lee Pharmaceuticals, is a bi-weekly administered GLP-1RA designed for the treatment of obesity/overweight, type 2 diabetes mellitus (T2DM), and other metabolic diseases. Clinical research data indicates that Bofanglutide can effectively reduce body weight and lower blood glucose levels, while comprehensively improving other metabolic parameters. With safety and tolerability profiles consistent with the GLP-1RA class of drugs, it is poised to potentially become the world’s first commercially available bi-weekly GLP-1RA. Currently, the global development of Bofanglutide Injection has entered the Phase III clinical research stage.

(Press release, Gan and Lee Pharmaceuticals, APR 9, 2026, View Source;lee-pharmaceuticals-signs-exclusive-license-agreement-with-jw-pharmaceutical-the-leading-south-korean-pharma-to-advance-the-global-commercialization-of-the-innovative-glp-1-receptor-agonist-bofanglutide-302738066.html [SID1234664278])

On April 9, 2026 Alpheus Medical, Inc., a private, clinical-stage biotechnology company, reported the initiation of its Phase 2b randomized controlled trial in newly diagnosed glioblastoma (nGBM) with 10 patients enrolled to date and additional clinical sites continuing to come online.

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Glioblastoma is a highly infiltrative brain tumor in which cancer cells extend beyond the visible tumor margins and spread throughout the brain hemisphere, limiting the effectiveness of surgery and localized therapies.

To address this challenge, the Alpheus study is evaluating an investigational therapy based on Porphyrin Metabolite Activation (PoMA), an approach previously described in the literature as Sonodynamic Therapy (SDT). This drug-centered approach leverages a molecule that preferentially accumulates in tumor cells, followed by activation using low-intensity ultrasound to enable localized pharmacologic effects. The treatment is designed to act within tumor cells throughout the affected hemisphere.

"Glioblastoma patients have few effective treatment options and poor long-term outcomes, highlighting the urgent need for innovation," said David Reardon, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, and Principal Investigator of the study. "Alpheus’ approach is designed to address the diffuse nature of the disease by enabling treatment across the affected hemisphere. We look forward to generating data to understand its potential role in patient care."

"The Phase 2b trial marks an important step forward in bringing our new therapeutic approach to patients with glioblastoma," said Vijay Agarwal, MD, FAANS, FCNS, Chief Executive Officer of Alpheus Medical. "We believe our drug-centered approach has the potential to address the diffuse nature of the disease in ways that localized treatment cannot. With strong early enrollment, we are focused on generating the randomized clinical data to advance this therapy."

About the Therapy and Trial
Alpheus Medical is developing a novel therapeutic approach based on Porphyrin Metabolite Activation (PoMA), a drug-centered strategy that leverages a molecule that preferentially accumulates in tumor cells, followed by activation using low-intensity, diffuse ultrasound designed to enable treatment across the affected hemisphere, achieving localized pharmacologic effects. Previously described in clinical literature as SDT, this non-invasive approach is intended to activate the molecule directly within tumor cells while minimizing systemic exposure.

The company’s Phase 2b study (NCT07225621) is a multi-center, randomized trial expected to enroll more than 100 newly diagnosed high-grade glioma patients at up to 15 U.S and European sites. Eligible patients have undergone resection and standard radiochemotherapy. The study compares standard of care alone to standard of care plus investigational therapy. The primary endpoint is progression-free survival (PFS) with key secondary endpoints including overall survival (OS), safety, and tolerability.

For patients and caregivers seeking more information about the study and enrolling sites, visit www.BrainCancerTrial.com.

(Press release, Alpheus Medical, APR 9, 2026, View Source [SID1234664277])