Sertaly (trastuzumab botidotin) / Sichuan Kelun Pharma, Sorrento - LARVOL DELTA

Trastuzumab Botidotin Versus Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: A Phase III, Open-Label, Randomized Controlled Trial. (PubMed, J Clin Oncol) - P3 | "Among patients with HER2-positive advanced BC previously treated with trastuzumab and a taxane, trastuzumab botidotin resulted in significantly longer PFS than trastuzumab emtansine, with a distinct safety profile."

Journal • P3 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Identification of a Conserved Macrophage-Associated Inflammatory Program in Inflammatory Bowel Disease Through Cross-Disease Transcriptomic Analysis (ACG 2026) - "Differential expression analysis identified 16,620 significant genes in psoriasis, 12,588 in UC, and 6,267 in CD. Cross-disease integration yielded a 166-gene concordant signature, consisting of 149 upregulated and 17 downregulated genes shared across all three conditions. Enrichment analysis demonstrated significant activation of interferon-γ response, inflammatory response, TNFα/NF-κB signaling, interleukin signaling, and chemokine pathways."

Omic analysis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • CCL2 • CXCR4 • IL1B • PTPRC • STAT1

Safety, tolerability, pharmacokinetics, and antitumor activity of SHR-A1811 in HER2-expressing/mutated advanced solid tumors: A global phase 1, multi-center, first-in-human study (AACR 2023) - "Background: SHR-A1811 is an ADC comprised of a humanized anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a DNA topoisomerase I inhibitor payload. SHR-A1811 was well-tolerated and showed promising antitumor activity in heavily pretreated advanced solid tumors.Table 1. Subgroup analyses of ORRNo. of prior treatment lines in metastatic setting in all pts (N=250)HER2 positive BC (N=108)HER2-low BC (N=77)Other tumor types (N=65)≤381.8% (45/55)58.7% (27/46)36.7% (18/49)>381.1% (43/53)51.6% (16/31)31.3% (5/16)Prior anti-HER2 therapies in pts with BC (N=185)*HER2 positive BC (N=108)HER2-low BC (N=77)All BC (N=185)Any82.2% (88/107, 73.7-89.0)68.8% (11/16, 41.3-89.0)80.5% (99/123, 72.4-87.1)Trastuzumab81.9% (86/105, 73.2-88.7)75.0% (9/12, 42.8-94.5)81.2% (95/117, 72.9-87.8)Pertuzumab83.0% (39/47, 69.2-92.4)100% (5/5, 47.8-100)84.6% (44/52, 71.9-93.1)Pyrotinib86.9% (53/61, 75.8-94.1)71.4% (5/7, 29.0-96.3)85.3% (58/68, 74.6-92.7)Lapatinib80.0% (28/35,..."

Clinical • Metastases • P1 data • PK/PD data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Urothelial Cancer • HER-2

Trastuzumab botidotin vs trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer: Results from a randomized phase III study (ESMO 2025) - P3 | "Results A total of 365 pts were randomized (median age 55 years; 73.4% with visceral metastases; 53.4% received ≥2 prior anti-HER2 therapies; 55.9% had prior pyrotinib). Conclusions A166 demonstrated statistically significant and clinically meaningful improvement in PFS compared with T-DM1, with a manageable safety profile in pts with HER2+ unresectable or metastatic BC. These results position A166 as a potential new therapeutic option for HER2+ disease."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Results from Phase III Study of Trastuzumab Botidotin versus T-DM1 in HER2-Positive Breast Cancer Published in JCO (PRNewswire) - "Median PFS was significantly prolonged in the trastuzumab botidotin group compared with the T-DM1 group (11.1 months vs. 4.4 months; hazard ratio (HR) = 0.39) (Figure A), meeting the primary endpoint of the study; consistent PFS benefit was observed across all prespecified subgroups. Trastuzumab botidotin group demonstrated deeper and more durable tumor responses compared with T-DM1 group, with an ORR of 76.9% vs. 53.0% and a median DoR of 12.2 months vs. 5.7 months. OS data were not mature in both groups, but an OS benefit trend was observed in trastuzumab botidotin group, demonstrating a 38% reduction in the risk of death."

P3 data • HER2 Positive Breast Cancer

Kenaf-derived carbon quantum dots-modified BiVO4 thin film photoanodes for enhanced photoelectrochemical water splitting and hydrogen generation. (PubMed, RSC Adv) - "It also exhibited a 166.7% increment in photoconversion efficiency upon modification with kenaf-based CQDs (CB-14). An average hydrogen evolution of 10.83 µmol cm-2 h-1 was recorded by CB-14, which is 1.67 times higher compared to the unmodified BiVO4."

Journal

HER2 Therapies in Non-Small Cell Lung Cancer (NSCLC). (PubMed, Int J Mol Sci) - "Concerning treatment, in advanced HER2-positive, Non-Squamous NSCLC tumors, the first-line treatment is Platinum-based + Pemetrexed chemotherapy, with or without immunotherapy, because no HER2-targeted antibody therapy has yet been approved for initial treatment. After progression, HER2-targeted antibody-drug conjugates like Trastuzumab-Deruxtecan and Ado Trastuzumab-Emtansine may offer patients clinical benefits. New HER2-selective tyrosine kinase inhibitors, such as zongertinib and sevabertinib, have shown promising results, including patients previously treated with antibody-drug conjugates (ADCs). Recent advances, including next-generation ADCs such as SHR-A1811 and A166, and bispecific antibodies, such as zenocutuzumab for NRG1 fusion-positive disease, which are also expanding treatment options. Overall, advances in diagnostics and new targeted therapies are changing how HER2-altered NSCLC is treated and are helping to make care more personalized."

IO biomarker • Journal • Review • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NRG1

A Clinical Case of Treatment-Emergent Acinetobacter baumannii Non-Susceptibility to Sulbactam-Durlobactam. (PubMed, Clin Infect Dis) - "Treatment-emergent mutations in the AdeFGH efflux system were identified, accompanied by a 166-fold increase in adeG expression. Efflux pump inhibition restored sulbactam-durlobactam susceptibility."

Journal

Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene (clinicaltrials.gov) - P1/2; N=82; Recruiting; Sponsor: Klus Pharma Inc.; Trial completion date: May 2021 ➔ Dec 2021; Trial primary completion date: Oct 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Laryngeal Cancer • Lip Cancer • Liver Cancer • Lung Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Prostate Cancer • Rare Diseases • Renal Cell Carcinoma • Salivary Gland Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Tongue Carcinoma • Urethral Cancer • Urology • Urothelial Cancer • HER-2

Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene (clinicaltrials.gov) - P1/2; N=82; Recruiting; Sponsor: Klus Pharma Inc.; Trial completion date: Dec 2021 ➔ Dec 2022; Trial primary completion date: Apr 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colon Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genetic Disorders • Genito-urinary Cancer • Head and Neck Cancer • Hepatology • HER2 Breast Cancer • HER2 Positive Breast Cancer • Laryngeal Cancer • Lip Cancer • Liver Cancer • Lung Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Prostate Cancer • Rare Diseases • Renal Cell Carcinoma • Salivary Gland Cancer • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Tongue Carcinoma • Urethral Cancer • Urology • Urothelial Cancer • HER-2

GRAIN SIZE AND WEIGHT 3 affects rice grain size and weight through interaction with SR45a and its transcriptional efficiency. (PubMed, Plant Physiol) - "We previously identified the gene GSW3, derived from Oryza rufipogon, which negatively regulates rice grain size and weight; however, the regulatory mechanism remained unclear. GSW3 encodes two polypeptides of different lengths: a 147-aa peptide GSW3HY3 and a 166-aa peptide GSW3KJ01...GSW3 influences grain size and weight through its interaction with SR45a and the transcription efficiency of its promoter. Our studies elucidate a pathway for regulating rice grain size and weight."

Journal

Foliar application of Aloe vera and date palm extracts as natural biostimulants enhances yield, nutrient status and essential oil of cumin (Cuminum cyminum L.). (PubMed, Sci Rep) - "The ALE 4 ml L- 1 treatment resulted in a 166.66% increase in sulfur, while the ALE 4 ml L- 1 + PSE 4 g L- 1 combination resulted in a 0.239% phosphorus content compared to the control. There were 4 total compounds that were identified from both the 4 ml L-1 ALE treatment and the 4 g L-1 PSE treatment, 1,3-benzodioxole, 4,5-dimethoxy-6-(2-propenyl)-, carvone, D-limonene. These studies suggest that both ALE and PSE can enhance the growth of plants, yield from their harvest, physicochemical properties, and phytochemical profiles; Therefore, enhancing the growth and development of plants through a more sustainable approach to enhance their production and increasing bioactive compound production will be achieved by using environmentally friendly, low-input chemicals such as ALE and PSE."

Journal

Clinical Features of Corneal Adverse Events Associated with Trastuzumab Botidotin: Payload-Driven Epitheliopathy and Neuropathy. (PubMed, Am J Ophthalmol) - "Trastuzumab botidotin was associated with visual impairment, corneal epitheliopathy, and nerve damage. Close collaboration between ophthalmologists and oncologists is crucial for early detection of corneal AEs related to ADC therapy, thereby improving clinical outcomes and patient quality of life."

Adverse events • Journal • Dry Eye Disease • Oncology • Ophthalmology • Pain • Solid Tumor

Robustness of LLM-assisted network meta-analysis in second-line or later HER2-positive metastatic breast cancer: A cross-model validation study (ESMO-BC 2026) - "ChatGPT, Gemini, and Claude ranked trastuzumab rezetecan and trastuzumab botidotin highest, above trastuzumab deruxtecan. Concordant NMA results from independently created datasets support the robustness of LLM-assisted trial selection. Regimen rankings were stable across networks, with investigational ADCs above the current standard of care. Clinical interpretation of efficacy rankings should account for toxicity, data maturity and cross-trial comparison limitations."

Metastases • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

KL166-III-06: A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy (clinicaltrials.gov) - P3 | N=365 | Active, not recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Trial primary completion date: Nov 2025 ➔ Nov 2026

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Effect of Calafate (Berberis microphylla) Intake on Plasma Atherogenic Indices in Rats With High-Sucrose Diet-Induced Obesity. (PubMed, J Nutr Metab) - "Compared to controls, calafate-supplemented rats showed a significant increase in HDL-c and total cholesterol, with the latter showing a 166% elevation. Additionally, calafate intake was associated with a marked decrease in the atherogenic index and the glucose-triglyceride index, suggesting an improvement in cardiovascular risk markers. These findings support the potential cardioprotective and antithrombotic properties of calafate, reinforcing its relevance as a functional food."

Journal • Preclinical • Cardiovascular • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Obesity

A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Sichuan Kelun-Biotech Biopharmaceutical…announced the official China launch of trastuzumab botidotin, its innovative HER2‑targeted antibody‑drug conjugate (ADC), following NMPA approval on 17 Oct 2025 (flcube.com) - "Launch Date: 19 Nov 2025 (China market)....Indication: HER2‑positive unresectable or metastatic breast cancer (post‑trastuzumab + taxane)....Kelun‑Biotech plans to submit for National Reimbursement Drug List (NRDL) inclusion in 2026."

Launch non-US • Reimbursement • HER2 Positive Breast Cancer

KL166-I-01-CTP: A Study of A166 in Patients With Advanced Solid Malignant Tumors (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • HER-2

Trastuzumab Botidotin Demonstrates Superior Efficacy to T-DM1 in HER2-Positive Metastatic Breast Cancer: Results from ESMO 2025 (OncoDaily) - "The phase 3 trial achieved its primary endpoint, showing a significant efficacy advantage for trastuzumab botidotin (A166) over trastuzumab emtansine (T-DM1). With a median follow-up of nearly 15 months, the data demonstrated notable improvements in progression-free survival, objective response rate, and duration of response...Median PFS: 11.1 months with A166 vs 4.4 months with T-DM1 (HR 0.39; 95% CI 0.30–0.51; p < 0.0001)."

P3 data • HER2 Positive Breast Cancer

Kelun-Biotech’s Core product Trastuzumab Botidotin Approved for Marketing by NMPA for HER2-positive BC (PRNewswire) - "The approval is based on a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study that evaluates the efficacy and safety profile of trastuzumab botidotin versus T-DM1 in patients with HER2-positive unresectable or metastatic BC who have received prior trastuzumab and taxane-containing regimens."

China approval • HER2 Positive Breast Cancer

First-in-human study of BA1301, a novel CLDN18.2-targeting antibody-drug conjugate in advanced solid tumors (ESMO 2025) - P1 | "Hematologic and gastrointestinal toxicities were significantly lower than other CLDN18.2-targeting ADCs,and ocular toxicity was also substantially reduced compared to the ADC A166 with the same payload Duo-5. Encouraging antitumor activity was observed in heavily pre-treated Gastric Cancer, Cholangiocarcinoma and Pancreatic Cancer with CLDN18.2 medium or high expression. Based on the positive efficacy data and good long-term safety, further trials of BA1301 as monotherapy or in combination with nivolumab are being planned."

First-in-human • Metastases • P1 data • Biliary Cancer • Cholangiocarcinoma • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

First detection of two cycloviruses in cormorant fecal samples in China by high-throughput sequencing technology. (PubMed, Front Vet Sci) - "The Rep gene of Corcyclo-1 contained a 166-bp intron and shared >96.9% amino acid identity with human-, wild boar-, and chicken-derived cyclovirus strains (HaCV-8) from Vietnam and Madagascar, classifying it as a novel strain of HaCV-8...Cross-species surveillance detected Corcyclo-2 in chickens (25.8%, 16/62) and ducks (11.7%, 9/77), whereas Corcyclo-1 was absent in these hosts. This study represents the first report of cormorant-associated cycloviruses, highlighting their potential for cross-species transmission and providing new insights into the ecological diversity and evolutionary mechanisms of cyclovirus."

Journal

Respiration electron of pathogenic bacteria activated ZnO@Viologen-COF heterojunction to boost piezo-phototronic effect for microbiota regulation. (PubMed, Sci Bull (Beijing)) - "Concurrently, Re-ZVP exhibits a 166% increase in a higher rate of reactive oxygen species (ROS) generation than ZVP under the synergy of light and ultrasound...In an acne model in mice induced by C. acnes, ZVP demonstrates potent in vivo antibacterial activity against C. acnes and effectively attenuates pathogen-driven inflammation induced by C. acnes. By leveraging bacterial redox heterogeneity, this study pioneers a smart microbial regulation strategy through pathogen-activated piezo-photocatalysis, offering a novel means for targeted microbiota modulation."

Journal • Acne Vulgaris • Inflammation

Commercialization Accelerates: Sales & Market Access Expanding Footprint (PRNewswire) - "Sac- TMT, tagitanlimab and Cetuximab N01 have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin in the China market and file one NDA for A400 in the second half of 2025."

China filing • Launch non-US • Colorectal Cancer • HER2 Positive Breast Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Triple Negative Breast Cancer