On May 8, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company") reported that the sNDA (the "Application") for the Company’s TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. The application is for sac-TMT in combination with MSD’s[1] anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA[2]) as first‑line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS) ≥1% and are EGFR-negative and ALK-negative. This acceptance is based on the positive results from the OptiTROP-Lung05 registrational Phase III study, and the application is the fifth indication application for sac-TMT that has been accepted by the NMPA.

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The OptiTROP-Lung05 is a randomized, open-label, multicenter, Phase III clinical study that evaluates the efficacy and safety profile of sac-TMT in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment for PD-L1-positive locally advanced or metastatic NSCLC. At a pre-specified interim analysis, the study has met its primary endpoint of progression-free survival (PFS) and demonstrated a statistically significant and clinically meaningful improvement as concluded by the Independent Data Monitoring Committee (IDMC). A positive trend in overall survival (OS) was also observed. Notably, the OptiTROP-Lung05 study is the first Phase III study of an immunotherapy and ADC combination to meet its primary endpoint in first-line NSCLC treatment. The study has been selected for an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract number #8506, Lung Cancer –Non-Small Cell Metastatic).

Previously, sac-TMT in combination with intravenous and subcutaneous pembrolizumab for the first-line treatment of patients with locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and ALK-negative was granted Breakthrough Therapy Designation (BTD) by the NMPA. On April 9, 2026, the CDE’s official website announced that the Application has entered the priority review and approval process. This marks the fifth sac-TMT indication to enter the CDE’s priority review and approval process. Through this process, the review time will be significantly shortened, potentially expediting its approval pathways.

Dr. Michael Ge, CEO of Kelun-Biotech said, "We are delighted to see the acceptance of the fifth indication application for sac-TMT. Compared to immunotherapy alone, the ADC combination with KEYTRUDA as first-line treatment for PD-L1-positive NSCLC has achieved not only positive results in PFS, but also a trend toward benefit in OS. This achievement holds significant importance for improving current treatment regimens for lung cancer. We will continue to collaborate with our partners to advance the clinical development and commercialization of sac-TMT, to help more patients with lung cancer and enhance their survival outcomes."

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors and genitourinary tumors, among others. Sac-TMT is developed with a unique, bifunctional linker that maximizes payload delivery to tumor cells both through its irreversible connection with the anti-TROP2 monoclonal antibody sacituzumab and its pH-sensitive cleavage from a belotecan-derivative topoisomerase I inhibitor payload in the lysosome, with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc, Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).

To date, four indications for sac-TMT have been approved and marketed in China for: 1) unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting); 2) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy; 3) EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy; 4) unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) BC who have received prior ET and at least one line of chemotherapy in advanced setting. The first two indications above have been included in China’s National Reimbursement Drug List (NRDL). This inclusion is expected to bring clinically meaningful benefits to a greater number of patients with BC and NSCLC. Additionally, sac-TMT has been granted six Breakthrough Therapy Designations (BTDs) by the NMPA.

Sac-TMT is the world’s first TROP2 ADC drug approved for marketing in lung cancer. A new indication application for sac-TMT in combination with pembrolizumab (KEYTRUDA) as first‑line treatment for locally advanced or metastatic NSCLC who have PD-L1 TPS≥1% and are EGFR-negative and ALK-negative has been accepted for review by the NMPA, and has entered the priority review and approval process. As of today, Kelun-Biotech has initiated 9 registrational clinical studies in China. MSD has initiated 17 ongoing global Phase III clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, MAY 8, 2026, View Source [SID1234665395])

On May 8, 2026 Day One Biopharmaceuticals, Inc., now part of Servier Group, reported that it has completed enrollment in the FIREFLY-2 clinical trial, which is evaluating the efficacy, safety and tolerability of tovorafenib vs standard of care chemotherapy in the front-line setting of therapy for patients aged 6 months to 25 years with low-grade glioma. The trial is being conducted in collaboration with the European Society for Paediatric Oncology (SIOPe) Brain Tumor Group LOGGIC Consortium (LOGGIC). Tovorafenib, known as OJEMDATM, is currently indicated for treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

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"Reaching full enrollment in this trial is a critical step toward our goal of establishing OJEMDA as standard of care across all lines of therapy for individuals with BRAF-altered pLGG. By moving earlier in the treatment journey, we aim to intervene when we can have the greatest impact on the burden of this challenging cancer," said Elly Barry, M.D., Chief Medical Officer at Day One, now part of Servier Group. "Success in this study would not only further validate the efficacy and safety profile of OJEMDA, but also fundamentally evolve the pLGG treatment paradigm, and potentially establish a new standard of care for patients newly diagnosed with pLGG, the most common brain tumor afflicting children."

FIREFLY-2 is a Phase 3, global, randomized, multicenter, open-label study to evaluate the efficacy, safety, and tolerability of monotherapy tovorafenib, an oral, Type II RAF inhibitor, in patients ages 6 months to 25 years with RAF-altered pLGG requiring first-line systemic therapy. It is being conducted at approximately 140 sites across the U.S., Canada, Europe, Australia, South America, Middle East and Asia, and in just over three years has enrolled approximately 400 participants who are receiving either tovorafenib once weekly or one of four standard of care (SoC) chemotherapy regimens.

"Completing enrollment in FIREFLY-2 is a powerful early signal of momentum. It reflects what’s possible when we bring together deep scientific expertise, a patient-first culture, and the scale to execute globally," said David K. Lee, CEO of Servier Pharmaceuticals. "So soon after Servier’s acquisition of Day One, this milestone reinforces our conviction that joining forces was the right decision for patients and for our oncology strategy. As we aim to accelerate the development of targeted medicines and advance them with the rigor, speed and reach needed to make a meaningful difference, we hope this study helps unlock the potential to improve outcomes for children living with pediatric low-grade glioma."

The primary endpoint of the trial is overall response rate (ORR), including duration of response (DOR), based upon Response Assessment in Pediatric Neuro-Oncology Low-Grade Glioma (RAPNO-LGG) criteria, with key secondary endpoints including progression-free survival (PFS) and event-free survival (EFS) per RAPNO-LGG, time to next treatment (TTNT), overall survival (OS) and other measures, including patient-reported outcomes. The primary analysis is expected to occur approximately 12 months after the last patient is enrolled; preliminary insights are expected to be available in 2027. More information on the trial can be found at The FIREFLY-2 Trial – Day One Clinical Trials or View Source

About tovorafenib
Tovorafenib (known as OJEMDATM in the U.S.) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases. Tovorafenib is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based, in part, on response rate and duration of response according to multiple response assessment criteria: Response Assessment in Neuro-Oncology High-Grade Glioma (RANO-HGG) criteria, Response Assessment in Pediatric Neuro-Oncology Low-Grade Glioma (RAPNO LGG) criteria, and Response Assessment for Neuro-Oncology Low-Grade Glioma (RANO LGG) criteria. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

Please see full prescribing information including important safety information about OJEMDA at www.OJEMDA.com.

About Pediatric Low-Grade Glioma
Pediatric low-grade gliomas (pLGG) are the most common brain tumor with an estimated US incidence of 1,100 and Europe incidence of 700 children per year who are eligible for front-line systemic therapy.i, ii BRAF is the gene most commonly altered in pLGG, which includes two primary types of BRAF alterations – a BRAF gene fusion and BRAF point mutation. These BRAF alterations account for >50% of pLGG cases worldwide and prior to the introduction of OJEMDA, there were no approved treatments for people with pLGG driven by BRAF fusions.i, iii

Pediatric low-grade gliomas can be chronic and relentless, with patients suffering profound side effects from both the tumor and the treatment, which may include chemotherapy and radiation. These side effects can impact their life over the long term, and may include motor deficiencies, vision loss, hormone deficiency and alterations in growth and development. Most children with pLGG will survive their cancer, but for the majority of those in whom a complete surgical resection is not possible, these tumors tend to recur frequently throughout childhood, necessitating multiple treatments. The cumulative toxicity of numerous therapies, along with the damage caused by multiple episodes of tumor progression, take a significant toll on the children and their families.

(Press release, Day One, MAY 8, 2026, View Source [SID1234665394])

On May 8, 2026 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapeutics for oncology and rare diseases, reported that it will host a live webcast presentation on Monday, May 11, 2026 at 5:30 a.m. Pacific Time to provide interim results from the randomized, first-line Phase 2 portion of the HexAgon study, which is evaluating the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC).

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Investors may join via the web: View Source or may listen to the call by dialing (1-888-880-3330). Please refer to Inhibrx or the conference ID 1841482 when calling in. Following the webcast, the presentation may be accessed through a link on the "Events and Presentations" section of Inhibrx’s website. The webcast will be available for 60 days following the event. Following the presentation, Inhibrx will also update its corporate presentation within the "Investors" section of its website at www.inhibrx.com.

About INBRX-106

INBRX-106 is a hexavalent agonist targeting OX40 (CD134), a costimulatory receptor on T-cells. Utilizing Inhibrx’s proprietary single-domain antibody (sdAb) platform, INBRX-106 is designed to achieve the high-order receptor clustering necessary for robust T-cell activation and survival, a feat that has eluded traditional bivalent antibody approaches.

(Press release, Inhibrx, MAY 8, 2026, View Source [SID1234665393])

On May 8, 2026 Zhejiang Wenda Pharmaceutical Technology Co., Ltd., reported that its novel oral BET inhibitor NHWD-870 HCI officially received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the proposed indication of advanced thoracic midline (NUT) carcinoma in patients who have failed prior chemotherapy. This milestone progress brings new targeted therapy hope to NUT carcinoma patients, a disease with extremely high malignancy and a very poor prognosis.

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NUT carcinoma is a rare, poorly differentiated carcinoma characterized by NUTM1 gene rearrangement. The disease progresses rapidly, with a median survival of only approximately 6.5 months. It commonly occurs in the lungs, head, and neck regions, and the median age of onset is only 23.6 years. Due to the lack of specificity in clinical manifestations and insufficient awareness among the public, the rates of misdiagnosis and missed diagnosis are extremely high, and most patients are already at an advanced stage at the time of diagnosis. Currently, no effective targeted drug for NUT carcinoma has been approved globally, and the treatment landscape is extremely dire.

The granting of Breakthrough Therapy Designation to NHWD-870 HCI is primarily based on the significant efficacy and survival benefits demonstrated in its Phase II clinical study. As of December 27, 2025, a total of 40 evaluable subjects with advanced NUT carcinoma were enrolled in the study. The data showed that the drug exhibited positive anti-tumor activity across different lesion sites: the objective response rate (ORR) in 20 patients with advanced thoracic NUT carcinoma reached as high as 45.00%; the median overall survival (mOS) for advanced thoracic NUT carcinoma patients and for all subjects both reached 9.33 months, representing a significant extension compared with standard chemotherapy regimens. Currently, some patients are still receiving ongoing treatment and close follow-up. In addition, preliminary safety data showed that the drug was generally well tolerated and held high potential for clinical application.

This Breakthrough Therapy Designation is of great significance for NUT carcinoma patients and represents a leapfrog advance in the field. For patients, it means that the regulatory review process for NHWD-870 HCI will be accelerated and the drug will reach the market sooner, enabling patients with advanced NUT carcinoma to receive targeted therapy earlier and escape the dilemma of having no effective drug, thereby significantly prolonging survival and improving quality of life. On the clinical level, the development and designation of this drug fill the gap in targeted treatment for NUT carcinoma and provide clinicians with a completely new treatment option. This not only drives the transformation of NUT carcinoma treatment from "symptomatic treatment" to "precision targeted therapy" but also provides valuable clinical experience for the future development of similar drugs.

Mr. Nenghui Wang, Founder of Wenda Pharma, stated: "We are delighted that our product has received Breakthrough Therapy Designation. This progress highlights China’s growing capabilities in innovative drug development for rare cancers. NHWD-870 not only brings hope to NUT carcinoma patients but also offers new avenues for exploring treatments for other rare malignancies."

Professor YIN Mingzhu, Director of the Midline (NUT) Carcinoma Specialty at the Affiliated Three Gorges Hospital of Chongqing University, noted, "NUT carcinoma once plunged countless patients and doctors into despair. The Breakthrough Therapy Designation for NHWD-870 is an important achievement integrating medical research and clinical practice. In the future, with the accelerated market entry of this drug, the treatment landscape of NUT carcinoma is expected to be completely transformed, injecting new momentum into the cause of rare disease diagnosis and treatment in our country."

(Press release, Wenda Pharma, MAY 8, 2026, View Source [SID1234665392])

On May 8, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor—reported that CEO Thomas Jensen has been invited to participate as a speaker at Precision Medicine Forum Europe 2026, taking place May 11–12, 2026, in Stockholm, Sweden.

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Presentation Details:

Event: Precision Medicine Forum Europe 2026
Presentation Title: Dual Inhibition of PARP and WNT: A Novel Drug-Biomarker Combination in Clinical Trials
Track: Oncology
Date: Monday, May 11, 2026
Time: 10:20–10:40 CEST

Mr. Jensen will discuss stenoparib’s dual mechanism of action and Allarity’s predictive biomarker, the Stenoparib DRP, based on a 414-mRNA gene expression signature, which is designed to identify patients who may be more likely to benefit from stenoparib, as well as the Company’s ongoing Phase 2 trials.

Mr. Jensen will be available for individual meetings during the conference to discuss Allarity’s clinical development strategy and potential business development opportunities.

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in Ovarian Cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is intended to support future pivotal development and eventual regulatory review. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple U.S. Veterans Administration (VA) sites.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

(Press release, Allarity Therapeutics, MAY 8, 2026, View Source [SID1234665391])