Chinese ADC Developers Kelun-Biotech and Puzhong Discovery Secure Major Global Licensing Deals

　　【Pharmaceutical Network Industry DynamicsIn recent years, ADC has become one of the popular fields for pharmaceutical companies' R&D. As ADC technology continues to mature, the competitiveness and influence of China's innovative drug companies on the international stage will continue to grow.
 

Data shows that currently there are 519 projects in China for the research and development of domestically produced ADC new drugs, accounting for 43.8% of the global total; meanwhile, 155 domestically produced ADC projects have entered clinical trials, making up 41.1% of the global total. Chinese pharmaceutical companies have become core participants in global ADC research and development. At the same time, domestically produced ADC new drugs are increasingly going abroad. For instance, Kelun-Biotech and Puzhong Discovery Pharmaceutical Technology (Shanghai) Co., Ltd. have recently reached cooperation agreements with overseas pharmaceutical enterprises on ADC projects, achieving international expansion by leveraging external resources.
 

On August 20, Kelun Pharmaceutical disclosed the progress of the collaboration between its subsidiary Kelun-Biotech and Merck.
 

According to the announcement, Kelun-Biotech recently received a written notice from Merck stating that Merck will exercise its exclusive option for the SKB571 project and pay Kelun-Biotech US$37.5 million. Further milestone payments will be made to Kelun-Biotech upon achieving specific development and sales milestones, along with tiered royalties based on net sales once SKB571 is commercialized. Kelun-Biotech will retain the rights to develop, use, manufacture, and commercialize SKB571 in mainland China, Hong Kong, and Macao. Data shows that SKB571 is an innovative bispecific antibody-drug conjugate (ADC), primarily targeting various solid tumors such as lung cancer and gastrointestinal tumors. The product is expected to submit an IND application soon.
 

The announcement also revealed that while MSD exercises the option for SKB571, it will return to Kelun-Biotech the global rights for the development, use, manufacturing, and commercialization of the SKB315 project. According to the terms agreed upon in the contract signed by both parties, Kelun-Biotech is not required to refund the upfront payment and milestone payments already received from MSD for this project. Data shows that early clinical trials of SKB315 indicate positive efficacy in the field of CLDN18.2 overexpression in gastric cancer with good safety.
 

In addition, Kelun-Biotech also plans to submit IND applications for other preclinical ADC assets that have reached licensing cooperation with Merck in the near future, while continuing to explore new cooperation opportunities with Merck.
 

On the same day, Puzhong Discovery and Adcendo ApS jointly announced that they had reached a licensing agreement for AMT-754 (ADCE-T02), a novel, highly differentiated antibody-drug conjugate (ADC) targeting tissue factor (Anti-TF).
 

According to the agreement, Adcendo will obtain exclusive global development and commercialization rights outside of Greater China, while Puzhong Discovery will retain the development and commercialization rights in Greater China. Puzhong Discovery will receive tens of millions of US dollars as an upfront payment and is eligible to receive total milestone payments exceeding 1 billion US dollars upon achieving subsequent development, regulatory, and commercial milestones, along with tiered royalties in the single-digit to low double-digit percentage range based on net sales (excluding Greater China).
 

Data shows that ADCE-T02 is a novel, highly differentiated Anti-TF ADC. Its unique antibody design can reduce the impact on the coagulation pathway. Meanwhile, the T1000-exatecan linker-payload technology platform has been proven by research to enhance the "bystander effect," improve linker stability, and possess the potential to overcome drug resistance mechanisms. These differentiated characteristics are expected to translate into higher clinical response rates, longer duration of efficacy, and better safety, offering a superior therapeutic window. ADCE-T02 has been submitted for clinical trials in Australia and is expected to file for U.S. IND approval soon.
 

It is reported that Puzhong Discovery currently has multiple ADCs in clinical stages, targeting CDH6, FRα, HER3, MUC18, CD44v9, and others. The potent anti-melanoma efficacy of AMT-253, along with the high sensitivity of melanoma cells and tumor vasculature to exatecan, suggests that AMT-253 has the potential to become one of the effective ADC drugs for major melanoma subtypes. AMT-116 is a promising CD44v9-targeted antibody-drug conjugate (ADC) developed by Puzhong Discovery.
 

ADC drugs, following chemotherapy, targeted therapy, and immunotherapy, represent a new approach in the fight against malignant tumors. Due to their high targeting ability and wide therapeutic window, ADCs are ushering in a broad-spectrum anti-tumor mode. Industry experts indicate that ADC drugs, which combine the high specificity of antibodies with the potent anti-tumor activity of cytotoxins, offer more controllable safety, making them one of the hottest research directions in the field of cancer treatment. Data projections suggest a vast market potential for ADC drugs, with the global ADC market expected to grow from $7.9 billion in 2022 to $64.7 billion by 2030, at a compound annual growth rate (CAGR) as high as 30%.
 

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