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.
相关临床试验
159
56 进行中
药物批准
5
批准总数
监管机构
1
监管机构数
成立时间
2016
进行中（未招募）
43
27.0%
已完成
12
7.5%
尚未招募
13
8.2%
招募中
75
47.2%
终止
3
1.9%
Unknown
13
8.2%
- Kelun-Biotech's HER2-directed ADC trastuzumab botidotin extended median progression-free survival to 11.1 months versus 4.4 months with T-DM1 (HR, 0.39; 95% CI, 0.30-0.51; nominal P <.0001). - The phase III KL166-III-06 trial randomized 365 patients with HER2-positive unresectable or metastatic breast cancer after prior trastuzumab and taxane therapy, and results were published in the Journal of Clinical Oncology. - Trastuzumab botidotin produced an objective response rate of 76.9% versus 53.0% and a median duration of response of 12.2 months versus 5.7 months, with immature overall survival data favoring the ADC. - Ocular toxicity was the most common treatment-related adverse event with trastuzumab botidotin, while hematologic, hepatic and gastrointestinal toxicities, serious adverse events and discontinuations were lower than with T-DM1.
- Lunbotinib fumarate demonstrated high objective response rates of 81.3% in treatment-naïve patients and 87.1% in pre-treated patients with RET fusion-positive NSCLC. - The next-generation selective RET inhibitor showed remarkable intracranial efficacy with a 30% complete response rate in patients with CNS metastases. - The drug exhibited a manageable safety profile with predominantly Grade 1-2 adverse events and only 1.2% permanent discontinuation rate. - China's NMPA has accepted the New Drug Application for lunbotinib fumarate based on these pivotal Phase II study results.
- Kelun-Biotech and Crescent Biopharma announced a strategic partnership to develop CR-001, a PD-1 x VEGF bispecific antibody, and SKB105, an integrin beta-6-directed ADC with topoisomerase payload. - The collaboration grants Kelun-Biotech exclusive rights to CR-001 in Greater China while Crescent receives exclusive rights to SKB105 in the US, Europe and other global markets. - Both therapeutic candidates are expected to enter Phase 1/2 monotherapy clinical trials in Q1 2026, with combination studies to follow. - Crescent secured $185 million in private placement financing to support clinical development through multiple data readouts beginning in Q1 2027.
- Multitude Therapeutics announced interim Phase I/II results for AMT-116, a first-in-class CD44v9-directed antibody-drug conjugate, showing promising efficacy in heavily pretreated EGFR wild-type non-small cell lung cancer patients. - The study demonstrated an 80% overall response rate and 100% disease control rate in EGFR wild-type NSCLC patients treated at the highest dose of 5.0 mg/kg, with activity observed regardless of CD44v9 expression status. - AMT-116 showed a favorable safety profile with manageable hematologic toxicities and notably reduced mucosal and skin toxicities compared to other topoisomerase I inhibitor-based ADCs. - The multicenter trial across Australia, US, and China enrolled 164 patients with various advanced solid tumors, with the company planning to expand efficacious dose cohorts for further evaluation.
- Sichuan Kelun-Biotech announced that China's NMPA accepted its New Drug Application for A400/EP0031, a next-generation selective RET inhibitor for treating RET-fusion positive non-small cell lung cancer. - The acceptance is based on positive Phase 2 results from the KL400-I/II-01 study, which demonstrated favorable efficacy in both treatment-naïve and pretreated NSCLC patients, including those with brain metastases. - A400/EP0031 previously received FDA Fast Track designation in March 2024 and is being developed globally through a partnership with Ellipses Pharma for markets outside Greater China. - The drug addresses an unmet medical need for RET-fusion positive NSCLC patients, who represent 1.4% to 2.5% of Chinese NSCLC cases and derive limited benefit from conventional treatments.
- 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. - The offering was multiple times oversubscribed with strong participation from global institutional investors, leading to an upsize from the initially targeted $200 million. - Proceeds will fund R&D, clinical trials, manufacturing and commercialization of the company's innovative drug pipeline, which includes over 30 ongoing projects and a leading ADC platform. - The company focuses on solid tumors, autoimmune, inflammatory and metabolic diseases, with 3 approved products, 1 in NDA stage, and over 10 in clinical development.
