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

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

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

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

The 2025 European Society for Medical Oncology (ESMO) Congress…will present results from multiple clinical studies at the congress, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT), HER2 ADC A166 (trastuzumab botidotin), and CLDN18.2 ADC SKB315. (PRNewswire) - "Among these, two Phase III clinical studies of sac-TMT were selected for the Latest Breakthrough Abstracts (LBA) and presented as oral reports, including one featured in the Presidential Symposium; one Phase III clinical study of A166 was selected for LBA and presented as oral report."

Clinical data • Late-breaking abstract • Castration-Resistant Prostate Cancer • Cervical Cancer • Endometrial Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer

Microalgae enhance cadmium accumulation in Perilla frutescens: root structural adaptation and secretion-mediated detoxification. (PubMed, Front Plant Sci) - "Microalgae treatment also promoted Cd retention in root cell walls, with hemicellulose I showing a 166.37% increase in Cd binding (p < 0.05)...These findings indicate that microalgae enhanced Cd phytoextraction in Perilla frutescens through modulation of root structural and metabolic traits, leading to enhanced Cd accumulation and tolerance. Microalgae-assisted phytoremediation may thus provide a viable strategy for remediating Cd-contaminated environments."

Journal

Mitochondria-immobilized fluorescent probes for viscosity and cellular imaging. (PubMed, Spectrochim Acta A Mol Biomol Spectrosc) - "In high-viscosity media, Mito-CDM exhibits a 166-fold fluorescence enhancement at 586 nm. It is crucial to note that the benzyl chloride group has the ability to react with highly reactive thiols on mitochondrial proteins, which enables Mito-CDM to be immobilized on mitochondria for extended periods. Additionally, Mito-CDM was successfully used to monitor mitochondrial viscosity changes during nystatin and lipopolysaccharide-induced inflammation in HeLa cells."

Journal • Inflammation

Structural insights into the nirmatrelvir-resistant SARS-CoV-2 Mpro L50F/E166A/L167F triple mutant-inhibitor-complex reveal strategies for next generation coronaviral inhibitor design. (PubMed, RSC Med Chem) - "One such variant harbors a triple mutation in Mpro, L50F/E166A/L167F, that displays decreased potency for nirmatrelvir (IC50 ∼ 850-1600 nM) and ibuzatrelvir while viral replication remained similar to that of the wildtype (WT) virus. A co-crystal structure reveals tight inhibitor binding that is stabilized by a network of hydrogen bonds formed by the mutated residues A166 and F167. This study provides the groundwork for optimized Mpro inhibitors against potential emerging variants of SARS-CoV-2, as well as strategies for broad-spectrum inhibitor design against variants of Mpro."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Case Report: Two children with factor XII deficiency caused by novel F12 compound heterozygous variants. (PubMed, Front Pediatr) - "In vivo RT-PCR assays demonstrated c.800+1G>C intron mutation resulted to a 166-bp deletion (exon 8 skipping) for patient 1...We presented two pediatric cases with FXII deficiency caused by novel F12 compound heterozygous variants. Pediatricians should raise awareness of this rare and underdiagnosed disorder and improve diagnostic and intervention strategies."

Journal • Cough • Hematological Disorders • Infectious Disease • Pediatrics • Pneumonia • Respiratory Diseases

HER2 alterations in non-small cell lung cancer (NSCLC): from biology and testing to advances in treatment modalities. (PubMed, Front Oncol) - "Furthermore, we present updated clinical trial data for published HER2-targeted agents and explore ongoing clinical trials examining combinatorial therapies and next-generation HER2-targeted agents such as zongertinib, A166, ARX788, SHRA1811, and others. Given the rapid evolution in this field, our review offers a timely and comprehensive synthesis of the current state and future directions for HER2-altered NSCLC."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2 • TYK2

Whole-Cell Biosynthesis of Branched Human Milk Hexasaccharide Lacto-N-neohexaose. (PubMed, J Agric Food Chem) - "The production of LNnH was further increased to 173.21 mg/L in a 5 L bioreactor, representing a 166.5-fold increase over the starting engineered strain. This whole-cell biosynthetic strategy not only paves the way for accessing abundant branched HMOs but also enhances the field of HMO glycomics, opening new avenues for biological applications."

Journal

Characterization of Anti-Acinetobacter Phages Isolated from Wastewater Sludge (ASM Microbe 2025) - "Genomic analysis revealed that Ac_SuMae contains a 166,858 bp double-stranded DNA genome- It closely resembles a previously isolated phage AB1I1M-1, obtained from the same wastewater facility one year earlier...These findings lay the basis for the potential use of Ac_SuMae in combating multidrug-resistant Acinetobacter infections. Ab_MuGnat may offer insights into genes necessary for potent lytic activity in anti-Acinetobacter phages."

Infectious Disease

Continuous-time digital twin with analog memristive neural ordinary differential equation solver. (PubMed, Sci Adv) - "We experimentally validate our solver on digital twins of HP variable-resistor model and Lorenz96 dynamics, demonstrating a 166.5-fold/369.3-fold speedup and a 499.0-fold/673.9-fold improvement in energy efficiency, respectively. This work paves the way to future digital twins for Industry 4.0."

Journal • Developmental Disorders

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.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Inseguridad alimentaria y consumo de agua en migrantes en tránsito por México durante la pandemia por Covid-19. (PubMed, Salud Publica Mex) - "Es necesario trabajar en soluciones que mejoren el acceso al agua y la alimentación de la población en tránsito como parte de sus derechos universales."

Journal • Infectious Disease • Novel Coronavirus Disease

Process-Focused Approach to Reduce Central Line Bloodstream Infections in the Pediatric Population. (PubMed, J Healthc Qual) - "A multifaceted approach with unit focus allowed our institution to decrease the number of CLABSIs in the pediatric and neonatal units."

Journal • Infectious Disease • Pediatrics

Cloning and functional characterization of the caffeine oxidase gene CsCDH from Camellia sinensis. (PubMed, Int J Biol Macromol) - "We successfully isolated the full-length CsCDH cDNA, which contains a 501-bp open reading frame (ORF) encoding a 166-amino-acid protein with a calculated molecular weight of 18.7 kDa...Finally, antisense oligonucleotide (asODN) interference experiments confirmed that CsCDH exhibits caffeine oxidase activity in tea plants. This study lays the groundwork for unraveling the theacrine biosynthesis pathway and offers new insights into breeding low-caffeine or high-theacrine tea cultivars."

Journal

Antibodies to watch in 2025. (PubMed, MAbs) - "In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key..."

Journal • Review • Oncology

NEW DRUG APPLICATION FOR CORE PRODUCT TRASTUZUMAB BOTIDOTIN ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews) - "The board...of directors ('Directors') of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...is pleased to announce that the new drug application (NDA) (the 'Application') for human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) trastuzumab botidotin (formerly A166) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with HER2 positive unresectable or metastatic breast cancer (BC) who have received at least one prior anti-HER2 therapy....The approval is based on a multi-center, randomized, open-label, controlled, phase III KL166-III-06 study that evaluates the efficacy and safety results of trastuzumab botidotin monotherapy versus T-DM1 in patients with HER2 positive unresectable or metastatic BC who have received prior trastuzumab and Taxane-containing regimens."

China filing • HER2 Positive Breast Cancer

Transforming waste wood into pure L-(+)-lactic acid: Efficient use of mixed sugar media through cell-recycled continuous fermentation. (PubMed, Bioresour Technol) - "Work on synthetic media enabled process durations of up to 188 h, providing further insights into the process behavior and offering cues for further optimization. Employing inhibitor compound tolerant H. coagulans A166 at optimal initial dilution rate, cell-recycled continuous fermentation is a promising approach to enhance lactic acid production from lignocellulose media."

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