Chinese ADC Drug Developers Make Strong Start in 2024: Hengrui’s SHR-A2009 Granted FDA Fast Track Designation, Yilien Bio Inks Global Deal with Roche

　　【Pharmaceutical Network Product Information】 In recent years, the antibody-drug conjugate (ADC) market has been booming, with multiple positive developments in the ADC field at the beginning of 2024.
 

As announced by Hengrui Pharma on January 1, 2024, the company received a certification letter from the U.S. Food and Drug Administration (FDA) stating that its project, SHR-A2009 for injection, has been granted Fast Track Designation (FTD) by the FDA. The proposed indication is for the treatment of metastatic non-small cell lung cancer with EGFR mutations whose disease has progressed after treatment with third-generation EGFR tyrosine kinase inhibitors and platinum-based chemotherapy.
 

In addition to Hengrui Pharma, on January 2, 2024, MediLink announced that it had reached a global collaboration and licensing agreement with the multinational pharmaceutical company Roche. The two parties will collaborate to develop the next-generation ADC candidate product YL211, which targets the mesenchymal-epithelial transition factor, for the treatment of solid tumors. According to the terms of the agreement, Roche will pay MediLink an upfront payment and near-term milestone payments totaling $50 million, along with potential development, regulatory, and commercialization milestone payments of nearly $1 billion. Additionally, tiered royalties based on global annual net sales will be paid in the future.
 

Data shows that SHR-A2009 for injection, independently developed by Hengrui Pharma, is an antibody-drug conjugate targeting HER3. It can specifically bind to HER3 on the surface of tumor cells, and is subsequently internalized into the cells and transported to lysosomes, where it releases free toxins through hydrolysis, thereby killing tumor cells.
 

SHR-A2009 entered clinical research in 2021 and has now advanced to Phase II clinical trials. Its international multicenter Phase I clinical study for the treatment of solid tumors is being conducted across 16 centers in China, Japan, and South Korea. Preliminary results of this study were presented at the 2023 ESMO Short Oral Session, demonstrating favorable anti-tumor activity, safety, and pharmacokinetic characteristics. No similar drugs have been approved for marketing globally so far. To date, Hengrui Pharma has invested approximately 49.92 million yuan in the development of SHR-A2009 for injection.
 

Data show that c-MET, a member of the receptor tyrosine kinase (RTK) family, is closely related to tumor formation, invasive growth, and metastasis, and serves as a key target for treating epithelial-mesenchymal transition. Although various c-MET-targeted therapies, including ADCs, have demonstrated efficacy in patients with solid tumors, there remains an opportunity globally to provide better treatment options to address significant unmet medical needs. MediLink stated that YL211 is currently in the clinical application stage, utilizing next-generation TMALIN ADC platform technology, and has shown promising efficacy and safety in multiple preclinical tumor models and safety evaluation tests.
 

Reportedly, in addition to MediLink, other Chinese pharmaceutical companies such as Beijing Purun'ao Biotechnology Co., Ltd., CHIATAI TIANQING, ShunJian Biotech, Hansoh Pharma, and Fujian Cosunter Pharmaceutical Co., Ltd. are also developing c-MET inhibitors. Last month, Fujian Cosunter announced that its highly selective c-Met targeted inhibitor, the innovative drug GST-HG161, had completed the dose-escalation phase of the Phase I clinical trial for all subjects, with observations showing good overall safety and tolerability. The drug is currently undergoing the multi-center expansion phase trial but will need to go through a series of clinical studies and receive approval before it can be manufactured and marketed.
 

The ADC drug market in China is currently booming. According to data statistics, the year 2023, which has just passed, was a "big year" for the overseas expansion of domestically produced ADC drugs. In 2023, Chinese pharmaceutical companies completed 26 disclosed innovative drug overseas transactions. In terms of product types, drug licensing exports were mainly concentrated in ADC products and small molecule drugs, reaching 12 and 9 cases respectively.
 

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