On April 14, 2026 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that 18F-FD4 (R&D code: SST001), an α-synuclein (α-syn) targeted PET tracer independently developed by its incubated company SynuSight Biotech, has recently been approved by the National Medical Products Administration (NMPA) to initiate a Phase I clinical trial.

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The clinical trial to be initiated is a non-randomized, open-label study to be conducted at Huashan Hospital, Fudan University and the Affiliated Hospital of Jiangnan University. The study plans to enroll healthy volunteers, patients with multiple system atrophy (MSA), and patients with Parkinson’s disease (PD). The primary objectives are to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001, thereby supporting subsequent clinical development.

Abnormal aggregation and deposition of α-syn protein are key pathological features of α-synucleinopathies such as PD and MSA. However, current clinical diagnosis still relies mainly on clinical symptom assessment and indirect functional imaging biomarkers. As an α-syn-specific PET molecular tracer validated through IIT (Investigator-Initiated Trial) studies, SST001 enables in vivo, real‑time, qualitative, and quantitative detection. It is expected to provide more objective and quantifiable imaging evidence for early diagnosis and disease subtyping of PD and MSA, as well as potential imaging support for subject screening and efficacy evaluation in clinical trials of related therapeutic drugs.

According to data from the Global Burden of Disease (GBD) Study 1990–2021, there were approximately 11.8 million PD patients worldwide in 2021, of which Chinese patients accounted for more than 40%. In China, the number of PD patients increased significantly from 651,800 in 1990 to 5.077 million in 2021, driven mainly by population aging. Although MSA is a rare disease, it progresses more rapidly and has a poorer prognosis, with a median survival of only 6 to 10 years, resulting in a significant disease burden.

Previously, SST001, partnering with XingImaging, has received high recognition from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and obtained a research grant of US$3.84 million, which will be specifically used to support its clinical research advancement in the United States. In January this year, SST001 received a Research IND clearance from the U.S. FDA, and clinical studies have been successfully initiated with the first subject dosed. Relevant data are being continuously collected. SST001 has now entered clinical stage in both China and the United States, entering a new phase of global development.

(Press release, Mabwell Biotech, APR 14, 2026, View Source;syn-pet-tracer-from-mabwells-incubated-company-synusight-biotech-received-nmpa-approval-to-initiate-a-clinical-trial-302741808.html [SID1234664366])

On April 14, 2026 CrossBridge Bio, Inc., a pre-clinical biotechnology company pioneering the development of next-generation dual-payload antibody-drug conjugates (ADCs) reported a definitive agreement to be acquired by Eli Lilly and Company ("Lilly").

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CrossBridge Bio, a Houston-based biotechnology firm founded in 2023, is developing a new dual-payload ADC technology originally created by Kyoji Tsuchikama at the University of Texas Health Science Center at Houston (UTHealth Houston). The company is focused on advancing next-generation ADCs with the potential to transform clinical practice. Its lead candidate, CBB-120, is a TROP2-targeting TOP1i/ATRi dual-payload ADC for cancer treatment. It is designed to enhance the therapeutic index and generate more durable responses compared to current TROP2-targeting ADCs, while also addressing key resistance mechanisms. U.S. Food and Drug Administration Investigational New Drug application for CBB-120 is anticipated in 2026.

"We look forward to seeing how Lilly advances our new generation of dual-payload antibody-drug conjugates, including CBB-120, with the potential to meaningfully improve outcomes for patients with limited treatment options. At CrossBridge Bio, we believe our dual-payload ADC platform is uniquely positioned to be transformative in oncology. I’m proud of how well our team has executed and advanced our platform in such a short time since the company’s founding. By becoming a part of Lilly, a leader in patient-focused therapeutic development, we are well-positioned to further accelerate the clinical potential of this approach," said Dr. Michael Torres, Co-Founder and CEO.

Under the terms of the agreement, Lilly will acquire CrossBridge Bio, and CrossBridge Bio shareholders could receive up to $300 million in cash, inclusive of an upfront payment and a subsequent payment upon achieving a specified development milestone.

Cooley LLP is serving as legal counsel to CrossBridge Bio, and Zwick Advisory, LLC acts as a strategic advisor to the Company’s Board of Directors.

(Press release, CrossBridge Bio, APR 14, 2026, View Source [SID1234664381])

On April 14, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported the signing of a Commercial Manufacturing Agreement for 64Cu-SAR-bisPSMA with Nucleus Radiopharma, an innovative contract development and manufacturing organisation (CDMO) in the radiopharmaceutical industry, dedicated to the development and manufacturing of targeted radiotherapies.

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The Agreement relates to Nucleus RadioPharma’s state-of-the-art facility in Rochester, Minnesota, which is capable of manufacturing around 50,000 patient doses per year, and future production in Spring House, Pennsylvania. The Spring House facility is a 47,000 square foot site that is planned to open in 2028, enabling broad coverage across the northeast of the US with up to 600,000 doses of 64Cu-SAR-bisPSMA per year. Together, these two facilities in Minnesota and Pennsylvania will provide access to key commercial markets with manufacturing and distribution to all 50 states in the US and select international sites, including Europe.

The Commercial Manufacturing Agreement further builds on Clarity’s existing partnership with Nucleus RadioPharma with a Master Services Agreement and 67Cu-SAR-bisPSMA Clinical Supply Agreement in place from November 20241, covering the existing site in Rochester with additional facilities in Pennsylvania2 and future strategic sites to expand patient access.

This Agreement represents an important step in Clarity’s continued build out of its manufacturing capabilities ahead of 64Cu-SAR-bisPSMA’s anticipated commercial launch upon successful completion of Phase III registrational trials with this product, AMPLIFY3 and CLARIFY4, and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval.

Geoffrey Johnson, MD, PhD, Chief Scientific Officer of Nucleus RadioPharma, commented, "Nucleus RadioPharma is excited to produce a next-generation diagnostic imaging agent, 64Cu-SAR-bisPSMA, that data shows is capable of visualising tiny prostate cancer lesions that the current standard of care prostate specific membrane antigen (PSMA) positron emission tomography (PET) fails to detect. Earlier cancer detection and better cancer staging directly affects patient management and treatment outcomes and I firmly believe that seeing is saving. At Nucleus RadioPharma, we are proud to be driving demonstrable advances at the cutting edge of theranostics."

Stephen Hahn, MD, Chief Executive Officer of Nucleus RadioPharma, commented, "We are pleased to continue growing our partnership with Clarity through this new Commercial Manufacturing Agreement. At Nucleus RadioPharma, we share Clarity’s goal of improving treatment outcomes for patients with cancer and look forward to delivering novel products to people in need of better diagnostic and therapeutic options. 64Cu-SAR-bisPSMA is now quickly approaching its market launch, and with recently released data highlighting its detection benefits in comparison to standard of care PSMA PET, we could not be more excited about being part of the change in shaping the future of prostate cancer diagnostics."

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "Clarity is building a strong foundation with its supply and manufacturing strategy to support a large-scale commercial rollout of 64Cu-SAR-bisPSMA from day one, with capability to supply not only the entire existing PSMA PET market, but a larger pool of patients that could benefit from our optimised product, given the promising data we have seen in the clinic to date. With large-scale drug product manufacturing, reinforced by large-scale copper-64 production, we will be able to provide 64Cu-SAR-bisPSMA on demand through centralised manufacturing and distribution, broadly with sites servicing the entirety of the US and beyond, including sites close to areas of high demand. The half-life of copper-64 gives us the freedom to deliver a number of models in order to meet the future demand for our products.

"Together with Clarity’s existing copper-64 supply agreements with SpectronRx, Nusano and Theragenics, as well as a 64Cu-SAR-bisPSMA commercial manufacturing agreement with SpectronRx, the new Agreement with Nucleus RadioPharma further enhances Clarity’s broad network of high-volume production in distinct US geographies, building a tiered approach with regional distribution. The network is designed to support commercial-scale demand with secure, seamless and abundant supply and manufacturing.

"Nucleus RadioPharma is a trusted partner with extensive expertise in radiopharmaceuticals across not only the supply and manufacturing side, but also with a unique insight into the impact that radiopharmaceuticals can have on the healthcare system, treating clinicians and their patients. We look forward to continuing to work with their team as we continue to deliver on our promise of improving treatment outcomes for patients with cancer."

The Commercial Manufacturing Supply Agreement is effective as of 14 April 2026. Cancellation and extension provisions are aligned with industry standard rates.

(Press release, Clarity Pharmaceuticals, APR 14, 2026, View Source [SID1234664315])

On April 14, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported a new clinical case study illustrating how CyPath Lung, the Company’s noninvasive sputum-based diagnostic test, helped determine next steps for a high-risk patient with a suspicious pulmonary nodule where imaging and risk models suggested a high likelihood of cancer, but the physician suspected possible inflammation.

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The patient, a 70-year-old female with a 50 pack-year smoking history and smoking-related emphysema, presented with increased symptoms including cough, sputum production and shortness of breath. A low-dose CT scan identified a suspicious 30-millimeter (mm) lesion in the lower right lung with nearby enlarged lymph nodes, findings that can be associated with lung cancer. PET imaging suggested a high likelihood of malignancy. Lung cancer risk calculators estimated the probability of cancer as high on the Mayo and Herder models and intermediate on the Brock model.

"In this case, imaging findings and risk calculators suggested a very high probability of lung cancer, and we scheduled her for biopsy," said Daya Nadarajah, MD, the treating pulmonologist. "I routinely use CyPath Lung in my practice and ordered the test for her. She received a negative result, ‘Unlikely Malignancy,’ which prompted another scan before we moved forward with the biopsy."

A follow-up CT scan showed that the concerning 30-mm nodule had completely resolved, confirming the physician’s acumen that the abnormality was due to a reversible inflammatory process rather than lung cancer.

"In patients with underlying lung disease, like emphysema, or other comorbidities like cardiovascular disease, biopsy can carry significant risks. Physicians must weigh the risks against the potential benefits," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "Adding CyPath Lung to the diagnostic pathway for indeterminate nodules provides additional objective data that can be very valuable when assessing patients with complicating health conditions. In this patient’s case, CyPath Lung supported additional imaging before biopsy which resulted in saving the patient from a risky, costly and unnecessary procedure."

This case highlights how CyPath Lung can assist physicians with pulmonary nodule management by helping physicians confidently defer unnecessary – and often risky – invasive procedures. This case study is illustrative of a single patient experience and does not establish generalized clinical utility.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. CyPath Lung is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, APR 14, 2026, View Source [SID1234664349])

On April 14, 2026 Partner Therapeutics, Inc. (PTx), a private, fully integrated biotechnology company, reported the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for BIZENGRI (zenocutuzumab-zbco), seeking approval for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion. Cholangiocarcinoma is a rare, aggressive malignancy of the bile ducts with few effective treatment options. There are no approved therapies specifically targeting cholangiocarcinoma harboring NRG1 gene fusions.

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"This submission marks an important step in advancing BIZENGRI for patients with NRG1 fusion positive cholangiocarcinoma, a population with limited treatment options, and historically poor outcomes. Cholangiocarcinoma remains a challenging and aggressive disease, and we believe these data support the potential of BIZENGRI to address a critical unmet need for patients whose tumors are driven by NRG1 gene fusions. Tissue‑based RNA testing is essential to identify rare oncogenic fusions such as NRG1 and ensure patients with these actionable alterations are not overlooked," said Pritesh J. Gandhi, Chief Development Officer, Partner Therapeutics.

The sBLA is supported by data from the eNRGy study evaluating zenocutuzumab-zbco in patients with NRG1 fusion-positive cancers, including cholangiocarcinoma. In the cholangiocarcinoma cohort, BIZENGRI demonstrated an overall response rate (ORR) of 36.8% (95% CI: 16.3, 61.6%) and a median duration of response (DOR) of 12.9 months, as assessed by blinded independent central review (BICR). Treatment was generally well tolerated, and no patients discontinued therapy due to adverse events.

Based on these data, National Comprehensive Cancer Network (NCCN) added zenocutuzumab‑zbco to the Oncology Clinical Practice Guidelines for biliary tract cancers as a Category 2A subsequent‑line therapy and as a Category 2B recommendation for front‑line treatment of NRG1 fusion–positive cholangiocarcinoma.

"Cholangiocarcinoma remains a devastating disease, particularly in the advanced setting. The identification of NRG1 gene fusions has highlighted an actionable biomarker, and the eNRGy study data suggest that targeted inhibition with zenocutuzumab may represent a meaningful treatment approach for these patients" said Dr. James Cleary, Dana-Farber Cancer Institute.

BIZENGRI received U.S. Food and Drug Administration accelerated approval for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer and pancreatic adenocarcinoma harboring NRG1 gene fusions with disease progression on or after prior systemic therapy.

For more information on the eNRGy trial and zenocutuzumab-zbco, please visit www.partnertx.com.

National Comprehensive Cancer Network

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

About NRG1 Gene Fusions

NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). The chimeric ligands bind to HER3, triggering HER2/HER3 heterodimerization and activate downstream signaling pathways that cause cancer cells to grow and proliferate. Zenocutuzumab-zbco is a bispecific antibody that blocks HER2/HER3 dimerization and NRG1 fusion interactions with HER3, resulting in the suppression of these pathways. Comprehensive molecular testing, notably the combination of tissue-based DNA and RNA next generation sequencing, is essential to identify rare and actionable gene fusions like NRG1.

About BIZENGRI (zenocutuzumab-zbco)

INDICATIONS
BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

BIZENGRI is indicated for the treatment of adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

Embryo-Fetal Toxicity: Exposure to BIZENGRI during pregnancy can cause embryo-fetal harm. Advise patients of this risk and the need for effective contraception.

WARNINGS AND PRECUATIONS

Infusion-Related Reactions/Hypersensitivity/Anaphylactic Reactions
BIZENGRI can cause serious and life-threatening infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions. Signs and symptoms of IRR may include chills, nausea, fever, and cough.

In the eNRGy study, 13% of patients experienced IRRs, all were Grade 1 or 2; 91% occurred during the first infusion.

Administer BIZENGRI in a setting with emergency resuscitation equipment and staff who are trained to monitor for IRRs and to administer emergency medications. Monitor patients closely for signs and symptoms of infusion reactions during infusion and for at least 1 hour following completion of first BIZENGRI infusion and as clinically indicated. Interrupt BIZENGRI infusion in patients with ≤ Grade 3 IRRs and administer symptomatic treatment as needed. Resume infusion at a reduced rate after resolution of symptoms. Immediately stop the infusion and permanently discontinue BIZENGRI for Grade 4 or life-threatening IRR or hypersensitivity/anaphylaxis reactions.

Interstitial Lung Disease/Pneumonitis
BIZENGRI can cause serious and life-threatening interstitial lung disease (ILD)/pneumonitis.
In the eNRGy study, ILD/pneumonitis occurred in 2 (1.1%) patients treated with BIZENGRI. Grade 2 ILD/pneumonitis (Grade 2) resulting in permanent discontinuation of BIZENGRI occurred in 1 (0.6%) patient. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold BIZENGRI in patients with suspected ILD/pneumonitis and administer corticosteroids as clinically indicated.
Permanently discontinue BIZENGRI if ILD/pneumonitis ≥ Grade 2 is confirmed.

Left Ventricular Dysfunction
BIZENGRI can cause left ventricular dysfunction.
Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including BIZENGRI. Treatment with BIZENGRI has not been studied in patients with a history of clinically significant cardiac disease or LVEF less than 50% prior to initiation of treatment.
In the eNRGy study, Grade 2 LVEF decrease (40%-50%; 10 – 19% drop from baseline) occurred in 2% of evaluable patients. Cardiac failure without LVEF decrease occurred in 1.7% of patients, including 1 (0.6%) fatal event.
Before initiating BIZENGRI, evaluate LVEF and monitor at regular intervals during treatment as clinically indicated. For LVEF of less than 45% or less than 50% with absolute decrease from baseline of 10% or greater which is confirmed, or in patients with symptomatic congestive heart failure (CHF), permanently discontinue BIZENGRI.

Embryo-Fetal Toxicity
Based on its mechanism of action, BIZENGRI can cause fetal harm when administered to a pregnant woman. No animal reproduction studies were conducted with BIZENGRI. In post marketing reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios manifesting as fatal pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In animal models, studies have demonstrated that inhibition of HER2 and/or HER3 results in impaired embryo-fetal development, including effects on cardiac, vascular and neuronal development, and embryolethality. Advise patients of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of BIZENGRI. Advise females of reproductive potential to use effective contraception during treatment with BIZENGRI and for 2 months after the last dose.

ADVERSE REACTIONS
NRG1 Gene Fusion Positive Unresectable or Metastatic NSCLC
Serious adverse reactions occurred in 25% of patients with NRG1 gene fusion positive NSCLC who received BIZENGRI. Serious adverse reactions in ≥ 2% of patients included pneumonia (n=4) dyspnea and fatigue (n=2 each). Fatal adverse reactions occurred in 3 (3%) patients and included respiratory failure (n=2), and cardiac failure (n=1). Permanent discontinuation of BIZENGRI due to an adverse reaction occurred in 3% of patients. Adverse reactions resulting in permanent discontinuation of BIZENGRI included dyspnea, pneumonitis and sepsis (n=1 each).
In patients with NRG1 gene fusion positive NSCLC who received BIZENGRI, the most common (>20%) adverse reactions, including laboratory abnormalities, were decreased hemoglobin (35%), increased alanine aminotransferase (30%), decreased magnesium (28%), increased alkaline phosphatase (27), decreased phosphate (26%), diarrhea (25%), musculoskeletal pain (23%), increased gamma-glutamyl transpeptidase (23%), increased aspartate aminotransferase (22%), and decreased potassium (21%).
NRG1 Gene Fusion Positive Unresectable or Metastatic Pancreatic Adenocarcinoma
Serious adverse reactions occurred in 23% of patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI.

There were 2 fatal adverse reactions, one due to COVID-19 and one due to respiratory failure.
In patients with NRG1 gene fusion positive pancreatic adenocarcinoma who received BIZENGRI the most common (≥20%) adverse reactions, including laboratory abnormalities, were increased alanine aminotransferase (51%), diarrhea (36%), increased aspartate aminotransferase (31%), increased bilirubin (31%), decreased phosphate (31%), increased alkaline phosphatase (28%), decreased sodium (28%), musculoskeletal pain (28%), decreased albumin (26%), decreased potassium (26%), decreased platelets (26%), decreased magnesium (24%), increased gamma-glutamyl transpeptidase (23%), decreased hemoglobin (23%), vomiting (23%), nausea (23%), decreased leukocytes (21%), and fatigue (21%).

(Press release, Partner Therapeutics, APR 14, 2026, View Source [SID1234664367])