Phase II Study of the Combination of Sacituzumab Tirumotecan(SKB264)and Tagitanlimab (KL-A167) in the Treatment of Aggressive Variant Prostate Cancer (AVPC) and Neuroendocrine Prostate Cancer (NEPC)

This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and Tagitanlimab (KL-A167) in the treatment of AVPC (aggressive variant prostate cancer) and NEPC (neuroendocrine prostate cancer).

Start Date22 Sep 2025

Sponsor / Collaborator

Second Hospital of Tianjin Medical University

[+1]

NCT07153965

/ Not yet recruitingPhase 2IIT

An Open-label, Single-arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Tagitanlimab in Previously Treated PD-L1-positive Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

This is an open-label, single-arm, multicenter phase II study to evaluate the safety and efficacy of sac-TMT plus Tagitanlimab in patients with PD-L1-positive locally advanced or metastatic TNBC.

Start Date01 Sep 2025

Sponsor / Collaborator

Tianjin Medical University Cancer Institute and Hospital

NCT07109284

/ Not yet recruitingPhase 2IIT

A Single Arm, Multi-center Phase II Study of Neoadjuvant Therapy With Sacituzumab Tirumotecan (Sac-TMT) and KL-A167 for Early-stage, High-risk ER+/HER2- Breast Cancer (NeoSaciA)

This study aimed to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant therapy in early-stage high-risk ER+HER2- breast cancer patients.

Start Date01 Sep 2025

Sponsor / Collaborator

West China Hospital

100 Clinical Results associated with Tagitanlimab

100 Translational Medicine associated with Tagitanlimab

100 Patents (Medical) associated with Tagitanlimab

Literatures (Medical) associated with Tagitanlimab

01 Jun 2019·Plant diseaseQ2 · AGRICULTURAL & FORESTRY SCIENCE

Compatible Mixture of Bacterial Antagonists Developed to Protect Potato Tubers from Soft Rot Caused by Pectobacterium spp. and Dickeya spp.

Q2 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Krychowiak, Marta ; Czajkowski, Robert ; Krzyzanowska, Dorota M. ; Maciag, Tomasz ; Siwinska, Joanna ; Jafra, Sylwia

Possibilities to protect potato tubers from rotting caused by Soft Rot Pectobacteriaceae (SRP) under disease favoring conditions were investigated using compatible mixtures of bacterial antagonists and tested with a newly developed stepwise efficacy-based screening protocol. Twenty-two bacterial antagonists were evaluated against a combination of five Pectobacterium and Dickeya strains representing species and subspecies most often associated with potato soft rot in Europe. To enable potential synergistic activity, the antagonists were initially tested against the combination of pathogens in 15 random mixtures containing up to 5 antagonists each. Three mixtures (M2, M4, and M14) out of 15 tested reduced tuber tissue maceration due to soft rot. The individual antagonists derived from M2, M4, and M14 mixtures were tested on potato slices and whole tuber injection assays. These five strains (S. plymuthica strain A294, E. amnigenus strain A167, R. aquatilis strain H145, S. rubidaea strain H440, and S. rubidaea strain H469) were combined to develop a tailored biological control mixture against potato soft rot. The new mixture, designated the Great Five (GF), was tested on seed potato tubers vacuum infiltrated with antagonists and subsequently with the combination of five SRP pathogens. In these experiments, the GF mixture provided stable protection of inoculated potato tubers, reducing soft rot by 46% (P = 0.0016) under high disease pressure conditions. The A294, A167, H145, H440, and H469 antagonists were characterized for features important for viable commercial applications including growth at different temperatures, resistance to antibiotics, and potential toxicity toward Caenorhabditis elegans. The implications for control of soft rot caused by SRP with the use of the GF mixture of antagonists are discussed.

01 Nov 2014·Bioorganic & medicinal chemistry lettersQ4 · MEDICINE

From the covalent linkage of drugs to novel inhibitors of ribonucleotide reductase: Synthesis and biological evaluation of valproic esters of 3′-C-methyladenosine

Q4 · MEDICINE

Article

Author: Hofer, Anders ; Vodnala, Munender ; Meli, Maria ; Torquati, Ilaria ; Vita, Patrizia ; D'Alessandro, Natale ; Ferro, Arianna ; Grifantini, Mario ; Tolomeo, Manlio ; Franchetti, Palmarisa ; Jayaram, Hiremagalur N ; Kusumanchi, Praveen ; Petrelli, Riccardo ; Del Bello, Fabio ; Cappellacci, Loredana

We synthesized a series of serum-stable covalently linked drugs derived from 3'-C-methyladenosine (3'-Me-Ado) and valproic acid (VPA), which are ribonucleotide reductase (RR) and histone deacetylase (HDAC) inhibitors, respectively. While the combination of free VPA and 3'-Me-Ado resulted in a clear synergistic apoptotic effect, the conjugates had lost their HDAC inhibitory effect as well as the corresponding apoptotic activity. Two of the analogs, 2',5'-bis-O-valproyl-3'-C-methyladenosine (A160) and 5'-O-valproyl-3'-C-methyladenosine (A167), showed promising cytotoxic activities against human hematological and solid cancer cell lines. A167 was less potent than A160 but had interesting features as an RR inhibitor. It inhibited RR activity by competing with ATP as an allosteric effector and concomitantly reduced the intracellular deoxyribonucleoside triphosphate (dNTP) pools. A167 represents a novel lead compound, which in contrast to previously used RR nucleoside analogs does not require intracellular kinases for its activity and therefore holds promise against drug resistant tumors with downregulated nucleoside kinases.

01 Jan 1993·Biological & pharmaceutical bulletinQ4 · MEDICINE

Mitogenic Activity and Lethal Toxicity of Lipid A Analogs, Glucosamine-phosphate Carrying Aromatic Alkyl Groups, in Mice.

Q4 · MEDICINE

Article

Author: Yanagihara, Yasutake ; Iwamoto, Yoshihisa ; Nakamoto, Shinichi ; Achiwa, Kazuo ; Shimizu, Tadayori ; Itoh, Hajime

The mitogenicity and lethal toxicity of four synthetic lipid A analogs, glucosamine-4-phosphate with a 7-hydroxy-heptanoyl group (A-166), with a 7-phenyl-heptanoyl group (A-167), or with a 8-(1-phenyl-hexanoyl)-nonanoyl group (A-168), at the C-2 and C-3 positions, and glucosamine-6-phosphate with the same substituents as A-168 at C-2 and C-3 (A-169), were compared. The compound A-166 exhibited no mitogenic activity at various concentrations ranging from 3.13 to 50 micrograms/ml in the splenocytes of BALB/c mice, but A-167 exhibited weak mitogenic activity at concentrations of 12.5 and 25 micrograms/ml. A-168 and A-169, as well as A-103, glucosamine-4-phosphate carrying (R)-3-tetradecanoyl-oxytetradecanoyl groups, have remarkable mitogenic activity at concentrations ranging from 12.5 to 100 micrograms/ml; the activity of A-169 (6-phosphate) was stronger than that of A-168 (4-phosphate). Compound A-167 failed to cause death at doses of 25 and 50 micrograms/mouse in galactosamine-loaded C57BL/6 mice while A-166 and A-169 were toxic to 2 out of 6 mice at 50 micrograms/mouse; no deaths were observed at 25 micrograms/mouse. A-168 showed the highest toxicity of any of the compounds tested at 25 and 50 micrograms/mouse. The lethal effect of A-103 appeared to be somewhere between that of A-168 and A-169. These findings indicate that lipid A analogs, carrying an aromatic alkyl group as well as a hydroxyacyl group, are mitogenic and lethal when given to mice.

News (Medical) associated with Tagitanlimab

19 Aug 2025

·www.prnewswire.com

Nature Medicine Publishes Results of Phase II Study of Sacituzumab Tirumotecan Plus Tagitanlimab as First-Line Therapy for NSCLC

CHENGDU, China, Aug. 19, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) announced that clinical data from a Phase II study evaluating novel TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with PD-L1 monoclonal antibody (mAb) tagitanlimab for the first-line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) have been published in Nature Medicine (Impact Factor: 58.7). The publication highlighted initial findings from the Phase II OptiTROP-Lung01 study, evaluating the efficacy and safety results of sac-TMT in combination with tagitanlimab as a first-line treatment of advanced or metastatic NSCLC patients without actionable genomic alterations. The study was led by Prof. Zhang Li's team at the Center for Cancer Prevention and Control, Sun Yat-sen University, China. Patients in Cohort 1A received sac-TMT (5 mg/kg, Q3W) plus tagitanlimab (1200 mg, Q3W) in a three-week cycle, while patients in Cohort 1B were treated with sac-TMT (5 mg/kg, Q2W) plus tagitanlimab (900 mg, Q2W) in a four-week cycle. Patients received sac-TMT in combination with tagitanlimab in a non-randomized manner until disease progression or unacceptable toxicity. Median follow-ups for Cohort 1A and Cohort 1B were 19.3 months and 13.0 months, respectively (Data cutoff date: May 27, 2024). The study results demonstrated promising anti-tumor activity, and manageable safety of sac-TMT in combination with tagitanlimab as a first-line treatment for advanced or metastatic NSCLC patients. A total of 40 patients in Cohort 1A and 63 patients in Cohort 1B were included in the full analysis set (FAS) for efficacy assessment. In Cohort 1A and Cohort 1B, respectively, the confirmed objective response rates (ORRs) were 40.0% (95% CI: 24.9–56.7) and 66.7% (95% CI: 53.7–78.0), and the ORRs were: 44.4% and 64.7% among patients with non-squamous carcinoma, 36.4% and 69.0% with squamous carcinoma; 41.7% and 57.1% among patients with PD-L1 tumor proportion score (TPS) <1%; 38.5% and 63.2% for TPS 1–49%; 40.0% and 78.3% for TPS ≥50%. The median progression-free survival (mPFS) for Cohort 1A was 15.4 months (95% CI: 6.7–17.9) and not reached (95% CI: 9.6–NE) for Cohort 1B. The most common grade ≥3 treatment-related adverse events (TRAEs) for both Cohorts 1A and 1B were decreased neutrophil count, decreased white blood cell count and anemia. No treatment-related deaths were observed. Subgroup analyses showed consistent efficacy across PD-L1 and TROP2 expression levels, as well as in both squamous and non-squamous histological subtypes. Dr. Michael Ge, CEO of Kelun-Biotech, commented: "The OptiTROP-Lung01 study supports the promising efficacy and safety of sacituzumab tirumotecan in combination with tagitanlimab as a first-line treatment for patients with advanced NSCLC. The results were observed across PD-L1/TROP2 expression levels and histological subtypes and support the advancement potential of sac-TMT from later-line to front-line therapy. The publication of results from several studies in top-tier international journals reflects the recognition of our innovation-driven development strategy. We will continue to work to address critical clinical challenges and unmet medical needs, striving to deliver more therapeutic options and improve quality of life for patients." 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 among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor 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 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 (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with 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) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 ongoing Phase III global clinical studies of sac-TMT as a monotherapy or with pembrolizumab[1] or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit . Media: [email protected] SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Drug ApprovalPriority Review

18 Aug 2025

·www.prnewswire.com

KELUN-BIOTECH ANNOUNCES 2025 INTERIM RESULTS

Revenue reached approximately RMB950.4 million, with total commercial sales RMB309.8million, representing a significant increase in proportion Research and development expenses was approximately RMB611.5 million Loss for the period was RMB145.2 million; adjusted loss for the period[1] was RMB69.4 million Cash and cash equivalents[2] amounted to approximately RMB4527.8 million, reflecting ample cash reserves CHENGDU, China, Aug. 18, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. (" Kelun-Biotech" or the " Company", Stock Code: 6990.HK) announced its unaudited interim results for the six months ended 30 June 2025 (the " Reporting Period"). In the first half of 2025, China's biopharmaceutical industry reached an inflection point for high-quality growth, driven by accelerated innovation in drug research and development, the rollout of favorable policies, increasing momentum in industry collaboration and mergers and acquisitions. Kelun-Biotech capitalized on these opportunities by its proprietary technology platforms, innovation-led R&D, and a well-established commercialization infrastructure. These elements have worked together to enable the Company to establish a fully integrated model covering R&D, clinical development, manufacturing, and commercialization. Focusing on addressing significant unmet medical needs in both oncology (such as breast cancer (BC), non-small cell lung cancer (NSCLC), and gastrointestinal (GI) cancers including gastric cancer (GC) and colorectal cancer (CRC)) and non-oncology diseases, the Company has developed a rich and diverse pipeline of over 30 candidates. More than 10 of these candidates have already entered clinical stage. At the same time, the Company continues to invest in next-generation conjugation technologies and a diversified portfolio of assets, aiming to deliver innovative therapies for patients worldwide and contribute to the improvement of global healthcare. ADC & novel DC assets b reakthroughs are redefining the treatment landscape. sac-TMT (sacituzumab tirumotecan, SKB264/MK-2870, 佳泰萊 ® ) The first TROP2 ADC drug approved for marketing in LC globally. TNBC : Approved by the National Medical Products Administration ("NMPA") for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC. HR+/HER2- BC. In May 2025, the NDA for sac-TMT for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the NMPA, and was included in the priority review and approval process. A Phase 3 registrational study of sac-TMT versus investigator's choice of chemotherapy for treatment of patients with unresectable locally advanced, recurrent or metastatic HR+/HER2- BC who received prior endocrine therapy is in progress. EGFR-mutant NSCLC. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS compared with docetaxel. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress. EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT in combination with pembrolizumab are in progress. In June 2025, sac-TMT in combination with tagitanlimab was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of locally advanced or metastatic non-squamous NSCLC without actionable genomic alterations. Other indications. The Company is actively exploring the potential of sac-TMT both as a monotherapy and in combination with other therapies for treating other solid tumors, including GC, EC, CC, OC, UC, CRPC and HNSCC. Global clinical development . As of August 18, 2025, MSD is progressing 14 ongoing Phase 3 global, multi-center clinical studies for sac-TMT for several types of cancer including BC, LC, gynecological cancer and GI cancer. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing. Trastuzumab Botidotin (HER2 ADC, A166 , 舒泰萊 ® [1] ) In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ and advanced HER2+ BC based on results from the primary analysis, and the NDA has been submitted to the NMPA. The Company has initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase 1 inhibitor ADC. Other ADC Products SKB315 (CLDN18.2 ADC) : the company is conducting a Phase 1b clinical trial of SKB315 and have initiated the exploration in combination with immunotherapy for the treatment of GC/GEJC. Results of a Phase 1 study of SKB315 will be presented at 2025 ESMO Congress in October 2025. SKB410/MK-3120 (Nectin-4 ADC) : has shown promising Phase 1 clinical data. MSD, as the partner, has launched the global Phase 1/2 clinical trial of SKB410. SKB571/MK-2750 : a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 2 clinical trial in China is to be initiated. SKB518, SKB535/MK-6204 and SKB445 : novel ADC drugs with potential FIC targets. The Phase 2 clinical trial for SKB518 and the Phase 1 clinical trials for SKB535 and SKB445 are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535. SKB500 and SKB501 : novel ADC drugs with verified targets but differentiated payload-linker strategies. The company been received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA. SKB107 : a RDC drug jointly developed by the Company and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting bone metastases in solid tumors. In March 2025, an IND application for SKB107 was approved by the NMPA and the Phase 1 study is ongoing. Non-DC asset advancements are diversifying the innovation pipeline. Tagitanlimab (PD-L1 mAb ; A167 ; 科泰莱 ® ) : The first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. We have received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, we received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA. Cetuximab N01 (EGFR mAb; A140; 达泰莱 ® ) An EGFR mAb compared with Cetuximab Solution for Injection (Erbitux ® ) In February 2025, we received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC. A400/EP0031 (RET inhibitor) : The Company is currently conducting pivotal clinical studies for 1L & 2L+ advanced RET+ NSCLC as well as a Phase 1b/2 clinical study for RET+ MTC and solid tumor in China. Through the Company's collaboration and license agreement, Ellipses Pharma is progressing their phase 2 clinical study globally outside of China. SKB378/WIN378 (TSLP mAb): In January 2025, an IND application for SKB378 for the treatment of COPD was approved by the NMPA. The Company's collaboration partner, Windward Bio, has launched the Phase 2 POLARIS trial in patients with asthma. SKB336 (FXI/FXI a mAb): The Phase 1 clinical trial has been completed in China. A296 (STING agonist): A Phase 1 trial is being carried out in China. Commercialization Accelerates: Sales & Market Access Expanding Footprint Sac- TMT (佳泰莱®), tagitanlimab (科泰莱®) and Cetuximab N01 (达泰莱®) have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin (舒泰莱®) in the China market and file one NDA for A400 in the second half of 2025. Sales performance: The total commercial sales reached RMB309.8 million for the first half of 2025. Among them, the sales of sac-TMT (佳泰莱®) accounted for 97.6%. At the same time, all accounts receivables from sales of pharmaceutical products were collected within the payment period, ensuring efficient and stable cash flow. Market coverage and academic promotion: Currently, the company's businesses have covered 30 provinces, over 300 prefectures, and over 2,000 hospitals, where over 1,000 hospitals generated sales, and reached tens of thousands of healthcare professionals through various types of marketing campaigns to convey product and medical professional information. In addition, the company has obtained authoritative endorsement for its products from experts in clinical guidelines, providing further support for the commercialization process. Commercialization system: The Company has established a fully-fledged marketing team of over 350 people, with a departmental structure that includes marketing, sales, medical affairs, strategic planning and commercial excellence, among other departments, as well as marketing compliance and KA functions. Through the efficient execution of the marketing team, the company has established relationships with multiple leading commercial and distribution groups, including 60+ Tier 1 distributors and 400+ DTP pharmacies. A hierarchical management system for pharmacy retail has been adopted and trainings have been provided to around 4,500 pharmacists in the first half of 2025. By organizing nationwide pharmacy trainings, the company has significantly enhanced the professionalism of terminal services and improved the ability to provide patients with medication guidance. Market a ccess: In the first half of 2025, sac-TMT (佳泰莱®), tagitanlimab (科泰莱®) and Cetuximab N01 (达泰莱®) have been included in 29, 25 and 15 provincial networks, respectively, ensuring rapid market access through provincial procurement channels. Meanwhile, preparations for the National Reimburesement Drug List (國家醫保藥品目錄) access of marketed products are underway. Currently, sac-TMT (佳泰莱®), tagitanlimab (科泰莱®) and Cetuximab N01 (达泰莱®) have all passed the preliminary formal examination of National Reimbursement Drug List. Meanwhile, to further reduce the burden of patients and implement the concept of inclusive healthcare, the company been proactively facilitating the enrollment of sac-TMT (佳泰莱®) in provincial and prefecture city level Inclusive Insurance (惠民保). As at the end of the Reporting Period, sac-TMT (佳泰莱®) has been enrolled in more than 7 provinces and 20 cities. Global m arket : Globally, we will continue to pursue a flexible strategy to capture the commercial value in major international markets, through forging synergistic license and collaboration opportunities worldwide. Global Collaboration Network Expansion & Authoritative Industry Recognition In the first half of 2025, the Company continued to expand its global collaboration network and deepen partnerships. Working closely with collaborators, it is advancing clinical research worldwide with the goal of maximizing the global value of its pipeline, delivering high-quality medical solutions to patients, and strengthening its leading position in the biopharmaceutical sector. Collaboration with MSD : As of the date of this announcement, MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as monotherapy or in combination with pembrolizumab or other agents, for several types of cancer including BC, LC, gynecological cancer and GI cancer. In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios. Collaboration with Ellipses Pharma: The Company has deepened its collaboration with Ellipses Pharma on A400/EP0031, which has been cleared by the FDA to progress into Phase 2 clinical development. As of June 30, 2025, Ellipses Pharma had set up a total of 36 clinical sites in the United States, Europe and UAE for EP0031. Collaboration with Windward Bio : In January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). In the first half of 2025, the Company earned high recognition from professional institutions and industry associations for its outstanding corporate management, product innovation, and strong performance in the capital market. In May 2025, the Company received "Asia's Best Company" award from FinanceAsia (亞洲金融), as well as a series of awards from Extel, including "Most Honored Company", "Best Company Board", "Best CEO", "Best CFO", "Best ESG" and etc.. The Company was also awarded "IRM OF CHINESE LISTED COMPANIES" by Securities Times (證券時報). In July 2025, the Company was recognized with the "China Pharmaceutical Emerging Innovative Force Award" by the China National Pharmaceutical Industry Information Center (中國醫藥工業信息中心). Additionally, the Company continues to strengthen its ESG strategy and improve its ESG governance structure to support sustainable development. The Company has established a comprehensive three-tier ESG governance structure consisting of the Board of Directors, ESG Working Group and ESG Executive Body. Through the establishment and continuous improvement of the ESG governance structure, the Company comprehensively enhances ESG performance ability. Outlook In the second half of 2025, the Company will continue to advance its differentiated pipelines targeting indications with significant medical needs, innovate and optimize payload-linker strategies, novel DC designs and structures, and expand application to non-oncology diseases. Meanwhile, the Company will further enhance its end-to-end drug development capabilities, advance towards commercialization and actively expand global footprints and strategic partnerships to maximize the value of its pipelines. In addition, the Company will continuously optimize its operation system to become a leading global biopharmaceutical company. About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech" Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, production, commercialization, and international collaboration of innovative biotechnology and small-molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, inflammation, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 3 projects that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC development platform, OptiDCTM, with 1 ADC project approved for market launch, 1 ADC project at the NDA stage, and several ADC or novel ADC projects in clinical or preclinical development. For more information, please visit the official website: . For further information, please contact: Wonderful Sky Financial Group Ltd. Angie Li & Jason Lai Tel: (852) 6150 8598 / (852) 9798 0715 Email: [email protected] SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 2Phase 3Drug ApprovalLicense out/in

12 Jun 2025

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Kelun-Biotech's Novel CLDN18.2 ADC SKB315 IND in Combination with Tagolizumab Receives NMPA Approval for the First-Line Treatment of Gastric/Gastro-oesophageal Junction Cancer

CHENGDU, China, June 11, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") today announced that the Company has received a clinical trial notice approving the investigational new drug application for the its CLDN18.2-directed antibody-drug conjugate (ADC) SKB315 in combination of the anti-programmed death ligand 1 (PD-L1) monoclonal antibody (mAb) tagitanlimab for the first-line treatment of gastric cancer / gastro-oesophageal junction cancer (GC/GEJC) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). SKB315 is a novel CLDN18.2-directed ADC for advanced solid tumors, configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. Building upon ongoing monotherapy studies in CLDN-expressing tumors such as GC/GEJC and pancreatic ductal adenocarcinoma, the Company is also initiating clinical studies of its combination therapy with immunotherapy for the first-line treatment of CLDN-positive GC/GEJC. Tagitanlimab is the first PD-L1 mAb to receive authorization for the first-line treatment of nasopharyngeal carcinoma (NPC). It has been approved by the NMPA for marketing in China as a combination therapy with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic (R/M) NPC, as well as monotherapy for the treatment of patients with R/M NPC who have failed after prior 2L+ chemotherapy. Previously, tagitanlimab in combination with TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) granted Breakthrough Therapy Designation by the CDE of the NMPA of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Encouraging clinical development progress has been made in recent years with combination strategies based on PD-(L)1 antibodies. The innovative ADC SKB315 combined with the PD-L1 monoclonal antibody tagitanlimab is expected to generate synergistic effects through their distinct mechanisms of action, overcoming tumor heterogeneity among different patients and delivering greater survival benefits. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit . Media: [email protected] SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyADCBreakthrough TherapyINDDrug Approval

100 Deals associated with Tagitanlimab

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Nasopharyngeal Carcinoma	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	25 Dec 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	22 Sep 2025
Prostate Adenocarcinoma with Neuroendocrine Differentiation	Phase 2	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	22 Sep 2025
Prostate Cancer, Hereditary, 7	Phase 2	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	22 Sep 2025
Prostate Neuroendocrine Carcinoma	Phase 2	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	22 Sep 2025
HER2-negative breast cancer	Phase 2	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	17 Aug 2022
Refractory Classic Hodgkin Lymphoma	Phase 2	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	17 Jul 2018
Relapsing classical Hodgkin lymphoma	Phase 2	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	17 Jul 2018
Diffuse Large B-Cell Lymphoma	Phase 1	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	19 Sep 2018
Extranodal NK-T-Cell Lymphoma	Phase 1	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	19 Sep 2018
Advanced Malignant Solid Neoplasm	Phase 1	China	Sichuan Kelun Botai Biomedicine Co., Ltd.	28 Dec 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05351788 (OptiTROP-Lung01, Nat Med) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	103	sacituzumab tirumotecan+tagitanlimab (Cohort 1A)	whcwfknqcn(pwdajdbwdv) = ymfnsqqesz vaazpphlww (phteunhzhx ) View more	Positive	19 Aug 2025
				sacituzumab tirumotecan+tagitanlimab (Cohort 1B)	whcwfknqcn(pwdajdbwdv) = ewkckrdwxb vaazpphlww (phteunhzhx ) View more
NCT05351788 (OptiTROP-Lung01, Pubmed \| Nat Med)	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	103	Tagitanlimab 1,200 mg every 3 weeksvery 3 weeks + Tagitanlimab 1,200 mg every 3 weeks	nttfnykrvv(udjfmeyfgu) = zplzxlxoov pprosfxejq (rgzlpiftax ) View more	Positive	19 Aug 2025
				Sacituzumab tirumotecan 5 mg kg-1 every 2 weeks + Tagitanlimab 900 mg every 2 weeks	nttfnykrvv(udjfmeyfgu) = mvvufhuuxd pprosfxejq (rgzlpiftax ) View more
NCT05351788 (OptiTROP-Lung01, ASCO2025) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma First line	81	Sacituzumab tirumotecan (sac-TMT) + Tagitanlimab	cflsbdqsxz(bbgqjmrepz) = nptdnzptnv upgyxztfjj (wqpvytzsve ) View more	Positive	30 May 2025
NCT05294172 (KL167-Ⅲ-08, ASCO2025)	Phase 3	Nasopharyngeal Cancer, Recurrent First line PD-L1	295	Tagitanlimab + Gemcitabine and Cisplatin	roslgptjvc(hhvnbllzmy) = kfcpqmxbxy bhyyoaqxyo (tjvmoeurca, 10.9 - NE) View more	Positive	30 May 2025
				Placebo + Gemcitabine and Cisplatin	roslgptjvc(hhvnbllzmy) = hlxuesfumn bhyyoaqxyo (tjvmoeurca, 6.9 - 8.3) View more
CTR20220691 (NEWS) Manual	Phase 3	Nasopharyngeal Carcinoma	-	塔戈利单抗+顺铂+吉西他滨	myhytmmrjc(dtxnfrlzyi) = qynffgmett erkvbarypl (ykadxcbpar ) View more	Positive	21 Jan 2025
				安慰剂+顺铂+吉西他滨	myhytmmrjc(dtxnfrlzyi) = iytxotgiwd erkvbarypl (ykadxcbpar ) View more
NCT05351788 (OptiTROP-Lung01, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer First line	103	SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W	xdrcnrxdii(lczbyttcto) = tpwjddmhsc gakfcrsbvj (sifxuxtzgr ) View more	Positive	24 May 2024
				SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W	xdrcnrxdii(lczbyttcto) = tsphdjctzv gakfcrsbvj (sifxuxtzgr ) View more
NCT03848286 (KL167-2-05-CTP, Pubmed \| NEWS) Manual	Phase 2	Nasopharyngeal Carcinoma	153	KL-A167 900mg	qizyijosep(dwuerkoqzi) = uncieuebwm pqrgnompwz (kdkhanklsz, 19.2 - 34.9) View more	Positive	10 Oct 2022

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