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Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

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Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026
Business

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Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

2026-06-03 08:00 Last Updated At:08:25

CHENGDU, China, June 3, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, the first-in-human study results of the novel B7-H3 ADC SKB500 in patients with advanced solid tumors were presented as a rapid oral report by Professor Liu Haifeng from Jilin Provincial Cancer Hospital (Abstract #3011|Molecularly Targeted Agents and Tumor Biology).

SKB500 utilizes an antibody with high affinity, high hydrophilicity, and enhanced endocytosis, and has been engineered to silence Fc effector function in the constant region. Moreover, the antibody is conjugated to a payload with moderate toxicity via a cleavable hydrophilic AAA linker, with a drug-to-antibody ratio (DAR) of approximately 8.

The study was divided into three stages: dose escalation, dose expansion, and indication expansion, enrolling a total of 192 patients, including those with small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), neuroendocrine carcinoma (NEC), and other tumors. Patients received SKB500 at doses ranging from 2 to 18 mg/kg every three weeks (Q3W), with dose expansion and indication expansion conducted at 12 mg/kg and 16 mg/kg.

As of March 31, 2026, efficacy data showed:

  • Antitumor activities were observed across multiple solid tumor types, including SCLC, ESCC, HNSCC, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and nasopharyngeal carcinoma (NPC). Among 124 patients treated at 12 mg/kg with at least 6 weeks of follow-up, the objective response rate (ORR) was 42.7%, and the disease control rate (DCR) was 83.9%.
  • Among the treated SCLC patients (n=40), the ORR was 65.0% (95% CI: 48.3, 79.4), median progression-free survival (mPFS) was 7.2 months (95% CI: 4.3, NE), DCR was 95.0%, and mDOR was 5.8 months.
  • Among the treated ESCC patients (n=37), the ORR was 54.1%.

In terms of safety, compared to the 16 mg/kg group, the 12 mg/kg group demonstrated a more favorable safety profile, characterized by a lower incidence of grade ≥3 treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs), as well as a low rate of permanent discontinuation. In the 12 mg/kg group, the incidence of grade ≥3 TRAEs was 32.3%, most commonly hematologic events.

The study demonstrates that SKB500 exhibits broad-spectrum antitumor activity, with responses observed in multiple treated advanced solid tumors including SCLC, ESCC, HNSCC, and PDAC, with notable efficacy in SCLC patients. At the 12 mg/kg group, SKB500 showed a favorable safety profile, where there was a low incidence of permanent discontinuation and no treatment-related deaths.

Professor Liu Haifeng, Principal Investigator from Jilin Provincial Cancer Hospital, said: "The positive results from this first-in-human study of SKB500 not only preliminarily confirm its favorable efficacy and manageable safety profile as a novel B7-H3 ADC, but also suggest its therapeutic potential in multiple solid tumors—offering particular hope for SCLC, a disease that is highly aggressive and has limited later-line treatment options. These findings lay a solid foundation for further clinical development. We look forward to further validating its clinical value in subsequent trials."

About SKB500

SKB500 is a novel B7-H3-targeted ADC independently developed by the company using its OptiDC™ platform technology, featuring a site-specific cleavable linker and a potent topoisomerase I inhibitor. In the Phase I clinical study, SKB500 demonstrated robust efficacy and manageable safety profiles across multiple advanced solid tumors. Currently, a Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

CHENGDU, China, June 3, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA, the first-in-human study results of the novel B7-H3 ADC SKB500 in patients with advanced solid tumors were presented as a rapid oral report by Professor Liu Haifeng from Jilin Provincial Cancer Hospital (Abstract #3011|Molecularly Targeted Agents and Tumor Biology).

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Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

SKB500 utilizes an antibody with high affinity, high hydrophilicity, and enhanced endocytosis, and has been engineered to silence Fc effector function in the constant region. Moreover, the antibody is conjugated to a payload with moderate toxicity via a cleavable hydrophilic AAA linker, with a drug-to-antibody ratio (DAR) of approximately 8.

The study was divided into three stages: dose escalation, dose expansion, and indication expansion, enrolling a total of 192 patients, including those with small cell lung cancer (SCLC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), neuroendocrine carcinoma (NEC), and other tumors. Patients received SKB500 at doses ranging from 2 to 18 mg/kg every three weeks (Q3W), with dose expansion and indication expansion conducted at 12 mg/kg and 16 mg/kg.

As of March 31, 2026, efficacy data showed:

  • Antitumor activities were observed across multiple solid tumor types, including SCLC, ESCC, HNSCC, pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and nasopharyngeal carcinoma (NPC). Among 124 patients treated at 12 mg/kg with at least 6 weeks of follow-up, the objective response rate (ORR) was 42.7%, and the disease control rate (DCR) was 83.9%.
  • Among the treated SCLC patients (n=40), the ORR was 65.0% (95% CI: 48.3, 79.4), median progression-free survival (mPFS) was 7.2 months (95% CI: 4.3, NE), DCR was 95.0%, and mDOR was 5.8 months.
  • Among the treated ESCC patients (n=37), the ORR was 54.1%.

In terms of safety, compared to the 16 mg/kg group, the 12 mg/kg group demonstrated a more favorable safety profile, characterized by a lower incidence of grade ≥3 treatment-related adverse events (TRAEs) and treatment-related serious adverse events (TRSAEs), as well as a low rate of permanent discontinuation. In the 12 mg/kg group, the incidence of grade ≥3 TRAEs was 32.3%, most commonly hematologic events.

The study demonstrates that SKB500 exhibits broad-spectrum antitumor activity, with responses observed in multiple treated advanced solid tumors including SCLC, ESCC, HNSCC, and PDAC, with notable efficacy in SCLC patients. At the 12 mg/kg group, SKB500 showed a favorable safety profile, where there was a low incidence of permanent discontinuation and no treatment-related deaths.

Professor Liu Haifeng, Principal Investigator from Jilin Provincial Cancer Hospital, said: "The positive results from this first-in-human study of SKB500 not only preliminarily confirm its favorable efficacy and manageable safety profile as a novel B7-H3 ADC, but also suggest its therapeutic potential in multiple solid tumors—offering particular hope for SCLC, a disease that is highly aggressive and has limited later-line treatment options. These findings lay a solid foundation for further clinical development. We look forward to further validating its clinical value in subsequent trials."

About SKB500

SKB500 is a novel B7-H3-targeted ADC independently developed by the company using its OptiDC™ platform technology, featuring a site-specific cleavable linker and a potent topoisomerase I inhibitor. In the Phase I clinical study, SKB500 demonstrated robust efficacy and manageable safety profiles across multiple advanced solid tumors. Currently, a Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) is ongoing in China.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, 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. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world's leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

Kelun-Biotech Presents First-in-human Study Data for Its Novel B7-H3 ADC SKB500 at ASCO 2026

BEIJING, June 3, 2026 /PRNewswire/ -- Cheung Kong Graduate School of Business (CKGSB) today announced the opening of its first permanent campus in Beijing, marking a major milestone in the school's 23-year journey of developing leaders capable of shaping the future in an increasingly complex and uncertain world.  

Located in the heart of Beijing's Ciqikou, or "China's Gateway," the new campus sits at a rare geographical and symbolic intersection in Beijing. On one side stand the Forbidden City and the Temple of Heaven, symbols of China's rich history and civilization. On the other rises Beijing's CBD, reflecting the country's dynamism and innovation. Positioned between these two worlds, the campus embodies CKGSB's role as a bridge between China's past and future, and between China and the world. 

Founded in 2002, right after China entered the WTO, CKGSB has spent more than two decades advancing business education and management research, while helping leaders understand China's evolving role in the global economy. The new campus strengthens the school's ability to connect research with practice, deepen engagement with China's business ecosystem, and contribute to global dialogue from the nation's capital.

The 30,000-square-meter campus features a façade inspired by a vessel setting sail, reflecting CKGSB's commitment to helping leaders navigate uncertainty and discover new opportunities. At its center is a 17-meter high atrium inspired by the ancient Greek Agora—a dynamic learning hub where faculty, students, alumni, entrepreneurs, policymakers, and scholars come together to exchange ideas and translate insight into action.

As China's first privately-funded, research-driven business school, CKGSB focuses on developing decision makers with a global vision, social responsibility, and an innovative mindset. 95% of CKGSB's 25,000 alumni are comprised of business leaders who collectively run one fifth of China's most valuable brands. The new campus reflects the collective support of this community, whose contributions helped turn a long-held vision into reality.

Today, CKGSB also welcomed 275 new Executive MBA students of its Spring 2026 cohort to the new campus. 75% of these EMBA students are either chairmen or CEOs, more than half of whom run high-tech enterprises or hidden champions in China. Among them, two lead unicorn companies. 

In the coming months, the school will host lectures and conferences at the new Beijing campus exploring AI and innovation, leadership, China's economic outlook, and the future of global business.

BEIJING, June 3, 2026 /PRNewswire/ -- Cheung Kong Graduate School of Business (CKGSB) today announced the opening of its first permanent campus in Beijing, marking a major milestone in the school's 23-year journey of developing leaders capable of shaping the future in an increasingly complex and uncertain world.  

Located in the heart of Beijing's Ciqikou, or "China's Gateway," the new campus sits at a rare geographical and symbolic intersection in Beijing. On one side stand the Forbidden City and the Temple of Heaven, symbols of China's rich history and civilization. On the other rises Beijing's CBD, reflecting the country's dynamism and innovation. Positioned between these two worlds, the campus embodies CKGSB's role as a bridge between China's past and future, and between China and the world. 

Founded in 2002, right after China entered the WTO, CKGSB has spent more than two decades advancing business education and management research, while helping leaders understand China's evolving role in the global economy. The new campus strengthens the school's ability to connect research with practice, deepen engagement with China's business ecosystem, and contribute to global dialogue from the nation's capital.

The 30,000-square-meter campus features a façade inspired by a vessel setting sail, reflecting CKGSB's commitment to helping leaders navigate uncertainty and discover new opportunities. At its center is a 17-meter high atrium inspired by the ancient Greek Agora—a dynamic learning hub where faculty, students, alumni, entrepreneurs, policymakers, and scholars come together to exchange ideas and translate insight into action.

As China's first privately-funded, research-driven business school, CKGSB focuses on developing decision makers with a global vision, social responsibility, and an innovative mindset. 95% of CKGSB's 25,000 alumni are comprised of business leaders who collectively run one fifth of China's most valuable brands. The new campus reflects the collective support of this community, whose contributions helped turn a long-held vision into reality.

Today, CKGSB also welcomed 275 new Executive MBA students of its Spring 2026 cohort to the new campus. 75% of these EMBA students are either chairmen or CEOs, more than half of whom run high-tech enterprises or hidden champions in China. Among them, two lead unicorn companies. 

In the coming months, the school will host lectures and conferences at the new Beijing campus exploring AI and innovation, leadership, China's economic outlook, and the future of global business.

** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **

Cheung Kong Graduate School of Business Opens First Permanent Beijing Campus

Cheung Kong Graduate School of Business Opens First Permanent Beijing Campus

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