MedPath

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.

HBM Holdings Secures NMPA Approval to Begin COPD Drug Trials in China

• HBM Holdings has received regulatory clearance from China's National Medical Products Administration to commence clinical trials for HBM9378/SKB378, a novel COPD treatment. • The development is part of a global licensing agreement with Windward Bio AG, which could provide HBM Holdings with significant revenue through upfront payments, milestones, and royalties. • This strategic advancement strengthens HBM Holdings' position in respiratory therapeutics and builds upon their collaboration with Sichuan Kelun-Biotech Biopharmaceutical.

Kelun-Biotech Announces Exclusive License Agreement for SKB378/HBM9378, an Anti-TSLP Monoclonal Antibody

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has entered into an exclusive license agreement with Windward Bio AG for SKB378/HBM9378, an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody. The agreement grants Windward Bio exclusive rights for the research, development, manufacturing, and commercialization of SKB378/HBM9378 globally, excluding Greater China and several Southeast and West Asian countries. Kelun-Biotech and Harbour BioMed, the co-developers, are eligible to receive up to US$970 million in payments and royalties.

DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer

• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy. • The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months. • This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.

Sacituzumab Tirumotecan Shows Promising Activity in Pretreated Endometrial and Ovarian Cancers

• Sacituzumab tirumotecan (sac-TMT) demonstrates antitumor activity in patients with pretreated advanced endometrial and ovarian cancers, offering a potential new treatment option. • In endometrial cancer patients, sac-TMT achieved an objective response rate (ORR) of 34.1% and a disease control rate (DCR) of 75.0% at a median follow-up of 7.2 months. • Ovarian cancer patients treated with sac-TMT showed an ORR of 40.0% and a DCR of 75.0% at a median follow-up of 28.2 months, indicating durable responses. • The safety profile of sac-TMT was manageable, with common treatment-related adverse events being generally reversible with dose modifications and supportive care.

Kelun-Biotech's SKB571 Receives Green Light for Clinical Trials in Solid Tumors

• Sichuan Kelun-Biotech has been granted approval to commence clinical trials for SKB571, a novel drug targeting solid tumors, including lung and gastrointestinal cancers. • The company secured a $37.5 million payment from Merck & Co., with potential for future milestone payments and royalties, indicating significant industry interest. • Kelun-Biotech retains commercialization rights for SKB571 in China, Hong Kong, and Macau, positioning them strategically in the Asian market.

Kelun-Biotech's SKB535 Receives Approval for Clinical Trials in Advanced Solid Tumors

• Kelun-Biotech's SKB535, an innovative antibody-drug conjugate (ADC), has been approved by China's NMPA for clinical trials targeting advanced solid tumors. • The drug was developed using Kelun-Biotech’s OptiDC platform and has demonstrated promising preclinical results, warranting further clinical investigation. • Kelun-Biotech has partnered with Merck & Co., Inc. for the development of SKB535, potentially receiving milestone payments and royalties upon successful commercialization.

Kelun-Biotech's SKB571 Receives Green Light for Clinical Trials

• Sichuan Kelun-Biotech has received approval to proceed with clinical trials for its investigational drug, SKB571. • SKB571 represents a novel therapeutic approach, though specific details regarding its mechanism of action and target indications remain undisclosed. • The approval marks a significant milestone for Kelun-Biotech, potentially expanding its pipeline of innovative pharmaceutical products. • Further details regarding the trial design, patient population, and clinical endpoints are anticipated to be released as the study progresses.

Kelun-Biotech's SKB445 ADC Receives NMPA Approval for Advanced Solid Tumor Trials

• Kelun-Biotech's SKB445, a novel antibody-drug conjugate (ADC), has been approved by China's NMPA for clinical trials in advanced solid tumors. • SKB445 leverages Kelun-Biotech's OptiDC platform, demonstrating promising preclinical efficacy and a favorable safety profile. • The drug targets unmet medical needs in solid tumors, marking a significant step in Kelun-Biotech's globalized drug development strategy. • This approval underscores Kelun-Biotech's focus on innovative biological drugs and small molecule drugs for major disease areas.

Sacituzumab Tirumotecan (Sac-TMT) Approved in China for Advanced TNBC

• Kelun-Biotech's Sacituzumab tirumotecan (Sac-TMT) has received marketing approval in China for treating advanced or metastatic triple-negative breast cancer (TNBC). • The approval is based on the Phase III OptiTROP-Breast01 trial, which showed Sac-TMT significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. • Sac-TMT is the first domestically developed TROP2-directed antibody-drug conjugate (ADC) to be fully approved for marketing in China. • Kelun-Biotech is also pursuing approval for Sac-TMT as a monotherapy for EGFR-mutant non-small cell lung cancer (NSCLC) after EGFR-TKI therapy.

Kelun-Biotech's SKB264 (Sac-TMT) Demonstrates Promising Results Across Multiple Solid Tumors

• Sacituzumab tirumotecan (sac-TMT) significantly improved progression-free survival (PFS) and overall survival (OS) in patients with triple-negative breast cancer (TNBC) compared to chemotherapy. • In advanced non-small cell lung cancer (NSCLC), sac-TMT combined with KL-A167 showed high objective response rates (ORR) and promising PFS in treatment-naive patients. • Sac-TMT plus pembrolizumab demonstrated a high ORR and encouraging PFS in patients with recurrent or metastatic cervical cancer, including those pre-treated with anti-PD-1 therapy. • Sac-TMT showed clinically meaningful activity in heavily pre-treated patients with advanced endometrial and ovarian cancers, with notable ORRs and PFS, particularly in TROP2 high-expressing tumors.
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