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SKB BIO-B

🇨🇳China
Ownership
-
Established
2016-11-22
Employees
1.5K
Market Cap
-
Website
http://www.kelun-biotech.com
Introduction

Sichuan Kolumbotai Biopharmaceutical Co., Ltd. (hereinafter referred to as “Colombotai” or the “Company”) is a biomedical company focusing on R&D, manufacturing and commercialization of innovative drugs. Since its establishment in 2016, it has always been committed to solving the medical needs of China and the world at large. With integrated drug development capabilities and comprehensive management mechanisms covering all key business functions, Kolumbotai is committed to developing differentiated treatments in-house to support the improvement of existing healthcare standards. As one of the pioneers and leading developers of antibody drug conjugates (ADC), Kolumbotai has accumulated more than ten years of experience in ADC development, and is one of the first biopharmaceutical companies in China and one of the few biopharmaceutical companies in the world to establish an integrated ADC research and development platform, OptiDC.

The company uses a systematic, adaptation-oriented approach to the world's most common or difficult to treat cancers and other diseases and conditions with large numbers of patients and unmet medical needs. After many years, the company has established integrated capabilities covering all major drug development functions, including R&D, production, quality control and commercialization, and can strategically and rapidly advance 33 differentiated and clinically valuable asset pipelines, 14 of which are in the clinical stage. With the support of three independently developed technology platforms, Colombotel already has proprietary technology in ADC, macromolecules (monoclonal antibodies (monoclonal antibodies), bispecific antibodies (dual antibodies), and small molecule drugs, etc., and has been verified by many of the company's clinical-stage drug candidates. The company has built a strong pipeline that is diverse and can exert synergistic effects in terms of drug modalities, mechanisms and indication coverage.

Decades of experience, industry relationships and extensive networks of the controlling shareholder Colon Pharmaceuticals have created favorable conditions for Klen Botai to expand its commercial infrastructure and market channels. At the same time, the clinical value of Clumbotai's pipeline and drug development capabilities have also been recognized by strategic partners around the world. To date, the company has signed nine external licensing agreements, including three licensing and cooperation agreements with MerckSharp & DohmelLC (together with its affiliate, “MSD”) to develop up to nine ADC assets for cancer treatment, with upfront and milestone payments totaling US$11.8 billion. These strategic partnerships not only prove the company's R&D and business development capabilities, but are also a key driving force for continuous innovation to build global influence and long-term growth.

Looking forward to the future, Colombotai will strive to promote the commercialization of the pipeline and enhance integrated drug development capabilities, continue to lead the development and clinical activities of drug candidates, and also strive to optimize R&D platforms and develop new technologies to support the development of innovative drugs. Colon Botai will also continue to expand cGMP production and quality control facilities and enhance internal commercialization capabilities to support future pipeline assets and achieve the goal of becoming a leading global biopharmaceutical company.

Clinical Trials

10

Active:2
Completed:2

Trial Phases

4 Phases

Phase 1:3
Phase 2:3
Phase 3:3
+1 more phases

Drug Approvals

3

NMPA:3

Drug Approvals

Cetuximab N01 Injection

Product Name
西妥昔单抗N01注射液
Approval Number
国药准字S20250006
Approval Date
Jan 24, 2025
NMPA

Tagitanlimab Injection

Product Name
科泰莱
Approval Number
国药准字S20240058
Approval Date
Dec 25, 2024
NMPA

Sacituzumab Tirumotecan for Injection

Product Name
佳泰莱
Approval Number
国药准字S20240052
Approval Date
Nov 22, 2024
NMPA

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 1
3 (30.0%)
Phase 2
3 (30.0%)
Phase 3
3 (30.0%)
Not Applicable
1 (10.0%)

A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy

Not Applicable
Recruiting
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2025-07-17
Last Posted Date
2025-08-14
Lead Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Target Recruit Count
430
Registration Number
NCT07071337
Locations
🇨🇳

The Fifth Medical Center of the Chinese PLA General Hospital, Beijing, Beijing, China

🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

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

Phase 3
Active, not recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2025-05-13
Last Posted Date
2025-05-13
Lead Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Target Recruit Count
365
Registration Number
NCT06968585
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants with Advanced Solid Tumors

Phase 1
Recruiting
Conditions
Advanced Solid Tumors
Interventions
Drug: MK-6204 (SKB535) for Injection
First Posted Date
2024-12-10
Last Posted Date
2025-03-13
Lead Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Target Recruit Count
90
Registration Number
NCT06726369
Locations
🇨🇳

Beijing Cancer Hospital, Beijing, China

🇨🇳

Hunan Cancer Hospital, Changsha, China

🇨🇳

West China Hospital of Sichuan University, Chengdu, China

and more 4 locations

A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Phase 3
Recruiting
Conditions
Triple Negative Breast Cancer
Interventions
First Posted Date
2024-02-28
Last Posted Date
2024-06-26
Lead Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Target Recruit Count
524
Registration Number
NCT06279364
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer

Phase 2
Recruiting
Conditions
Triple-negative Breast Cancer and HR+/HER2- BC
Interventions
First Posted Date
2022-07-06
Last Posted Date
2023-10-23
Lead Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Target Recruit Count
175
Registration Number
NCT05445908
Locations
🇨🇳

Hunan Cancer Hospital, Changsha, Hunan, China

🇨🇳

Jiangsu Province Hospital, Nanjing, Jiangsu, China

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News

Kelun-Biotech Raises $250 Million in Largest Hong Kong Biopharma Follow-On Offering in 12 Months

Kelun-Biotech successfully completed a $250 million share placement on June 5, 2025, representing the largest follow-on offering in Hong Kong's biopharma sector over the past 12 months.

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