YiJanuary 23, 2025
Tag: bispecific ADC , out-licensing , ADC
Antibody-drug conjugate (ADC) is a hot field in drug R&D and has achieved tremendous success to date, with 16 approved products globally and a market size exceeding USD 10 billion in 2023.
Chinese pharmaceutical companies are increasingly shining in the field of ADCs, with 2 products already approved for marketing, and in 2024, multiple innovated ADC products made in China and technical platforms have garnered the favor of foreign pharmaceutical companies:
In January 2024, MediLink Therapeutics and Roche reached a global cooperation and license agreement, granting Roche the exclusive rights to develop, manufacture, and commercialize YL211 worldwide. The total transaction amount reached USD 1.05 billion. YL211 is a c-MET-targeting ADC currently in Phase I clinical stage.
In January 2024, Biocytogen entered into an exclusive option and licensing agreement with Radiance. According to the agreement, Radiance has the right to opt in to obtain the global development, production, and commercialization rights for a first-in-class fully human HER2/TROP2-targeting ADC from Biocytogen.
In May 2024, MediLink Therapeutics and BioNtech reached an ADC technology licensing agreement, involving several targets, with a potential total cooperation amount of USD 1.825 billion.
In June 2024, Alphamab Oncology and Arrivent entered into a cooperation agreement to discover and develop innovative ADC drugs using Alphamab Oncology's proprietary linker-payload platform and site-specific glycosylation conjugation platform. According to the agreement, Alphamab Oncology retains rights in Greater China, while Arrivent holds overseas rights, with a total agreement amount of up to USD 615.5 million.
In July 2024, Biocytogen and IDEAYA Biosciences reached an option and license agreement for a first-in-class B7H3/PTK7-targeting ADC project, with a potential total transaction amount of USD 406.5 million.
In July 2024, Foreseen Biotech and Ipsen entered into an exclusive global license agreement for FS001. According to the agreement, Ipsen will obtain the exclusive rights to develop, manufacture, and commercialize FS001 globally, with a total transaction amount of up to USD 1.03 billion. FS001 is a potential first-in-class ADC developed by Foreseen Biotech through its proprietary high-throughput, integrated translational proteomics, and artificial intelligence (AI)-driven screening platform, targeting a novel tumor-associated antigen and currently in the preclinical stage.
In July 2024, Escugen and US-based Sidewinder Therapeutics reached an ADC platform technology licensing collaboration. According to the agreement, Escugen granted Sidewinder an exclusive global license to use its ADC technical platform EZWi-Fit® for the development of ADC products targeting specific Sidewinder targets.
In August 2024, Multitude Therapeutics and Adcendo reached a licensing agreement for ADCE-T02 (AMT-754). According to the agreement, Adcendo will obtain the exclusive global development and commercialization rights for AMT-754 outside of Greater China, with a total transaction amount exceeding USD 1 billion. AMT-754 is a novel, highly differentiated TF-targeting ADC currently in Phase I clinical stage.
In August 2024, Kelun Biotech provided an update on its cooperation progress with MSD. MSD exercised its option for the global rights (excluding Greater China) to the bispecific ADC product SKB571, paying Kelun Biotech USD 37.5 million, with additional milestone payments and tiered royalties upon achieving specific development and sales milestones. SKB571 is an innovative bispecific ADC primarily targeting various solid tumors such as lung cancer and gastrointestinal cancer, currently in Phase I clinical stage.
In December 2024, Duality Biologics (DualityBio) and GSK reached an exclusive licensing agreement for DB-1324. According to the agreement, GSK will obtain exclusive global rights (excluding Chinese Mainland, Hong Kong, and Macau) to advance the R&D and commercialization of DB-1324, with a total transaction amount exceeding USD 1 billion. DB-1324 is an innovative ADC developed based on DualityBio's proprietary and clinically validated Duality Immune Toxin Antibody Conjugates (DITAC) platform, targeting an undisclosed antigen and currently in the preclinical stage.
In December 2024, Hengrui Pharmaceuticals granted exclusive rights to IDEAYA Biosciences in the United States for the global development, production, and commercialization of SHR-4849 outside of Greater China, with a potential total transaction amount of USD 1.045 billion. SHR-4849 is a DLL3-targeting ADC self-developed by Hengrui Pharmaceuticals, currently in Phase I clinical stage.
According to incomplete statistics, 11 out-licensing transactions for ADCs have been reached in 2024, with 7 focusing on specific ADC projects and 3 on ADC technologies or platforms. Most of the 7 out-licensed ADC projects are in the preclinical stage and target novel antigens. Notably, 3 of these are bispecific ADCs, representing a new direction in ADC development. In addition to specific ADC projects, ADC technologies/platforms from Chinese pharmaceutical companies, including those from MediLink Therapeutics, Alphamab Oncology, and Escugen, have also gained favor from foreign pharmaceutical companies.
In terms of transaction value, 5 of these 11 transactions have exceeded USD 1 billion. Foreign companies' willingness to invest heavily in early-stage ADC projects or technical platforms from China reflects the significant strength of Chinese pharmaceutical companies in ADC development.
From the perspective of the companies involved in the transactions, 4 of these 11 transactions were reached with large multinational corporations (MNCs), with Biocytogen securing two out-licensing agreements and IDEAYA Biosciences acquiring two ADC projects. This demonstrates the considerable R&D capabilities of small biotech companies in ADCs and their strong commitment to this field, positioning them as potential future leaders in the ADC race.
Out-licensing not only provides financial support for the subsequent R&D efforts of Chinese pharmaceutical companies but also accelerates the internationalization of China's innovative ADCs. We look forward to more ADCs made in China being approved for marketing and making their mark on the global stage.
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