Domestic ADC Innovation Surge: Maiwei, Hansoh Among Chinese Biopharma Firms Reporting Major Advances

　　【Pharmaceutical Network Industry Dynamics】The global ADC drug market size is continuing to grow, expected to increase from USD 7.9 billion in 2022 to USD 64.7 billion by 2030, with a compound annual growth rate (CAGR) of 30.0%. Against this backdrop, China-produced innovative ADC drugs are experiencing a major boom. Recently, a large number of pharmaceutical companies, including Mabwell and Hansoh Pharma, have successively reported positive developments.
 

On August 23, Mabwell announced that the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has agreed to the protocol of "A Randomized, Open-label, Controlled, Multi-center Phase III Clinical Study of 9MW2821 versus Investigator’s Choice Chemotherapy for the Treatment of Recurrent or Metastatic Cervical Cancer Patients Who Have Failed Platinum-based Chemotherapy." The company will initiate a Phase III clinical study of 9MW2821 for the treatment of recurrent or metastatic cervical cancer patients who have failed platinum-based chemotherapy.
 

Cervical cancer is one of the most common tumors among women globally, posing a serious threat to women's health and lives. According to the "2022 Global Cancer Statistics Report" released by the International Agency for Research on Cancer (IARC), there were 661,000 new cases of cervical cancer worldwide in 2022. Data published in February 2024 by the National Cancer Center in the JNCC revealed that China reported 150,700 new cases of cervical cancer in 2022, showing a significant increase compared to 119,000 new cases in 2016 as reported in February 2022. Currently, there remains a substantial unmet treatment demand among cervical cancer patients.
 

9MW2821 is a novel定点偶联ADC drug developed by Mabwell that targets Nectin-4. It is the first-in-class drug in China to enter clinical trials for this target and also the only drug globally to disclose clinical efficacy data for indications including cervical cancer, esophageal cancer, and breast cancer. In 2024, it received multiple designations from the U.S. FDA: "Fast Track Designation" (FTD) for treating advanced, recurrent, or metastatic esophageal squamous cell carcinoma, recurrent or metastatic cervical cancer that has failed prior platinum-based chemotherapy, and locally advanced or metastatic Nectin-4 positive triple-negative breast cancer; "Orphan Drug Designation" (ODD) for the treatment of esophageal cancer. Additionally, it was included in the list of breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration.
 

According to reports, this variety achieves site-specific modification of antibodies through a proprietary linker technology and optimized ADC conjugation process. After 9MW2821 is injected into the body, it can bind to Nectin-4 on the surface of tumor cells and enter the cells. Through enzymatic cleavage, it selectively releases cytotoxins, thereby achieving precise tumor killing.
 

Relevant research results indicate that 9MW2821 has shown positive therapeutic effects in cervical cancer patients. The company is scientifically evaluating and advancing the clinical research for first-line combination therapy.
 

On August 20, Hansoh Pharma also announced good news: its partner GlaxoSmithKline (GSK) received the Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for HS-20093 (GSK5764227). This B7-H3-targeted antibody-drug conjugate (ADC) is being evaluated for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed during or after platinum-based chemotherapy (recurrent or refractory). The FDA's Breakthrough Therapy Designation was supported by data from the ongoing ARTEMIS-001 Phase I open-label, multicenter trial conducted by Hansoh Pharma. The trial results will be presented at the 2024 World Conference on Lung Cancer (WCLC) to be held in San Diego, California, USA, from September 7 to 10, 2024.
 

In addition, there have been frequent reports recently about China-produced ADCs going overseas. Among them, Puzhong Discovery has licensed the global development and commercialization rights outside of Greater China for ADCE-T02 (Puzhong Discovery's research and development code: AMT-754), a novel, highly differentiated antibody-drug conjugate (ADC) targeting tissue factor (Anti-TF), to Adcendo. The drug has already been submitted for clinical trial approval in Australia and is expected to file for U.S. IND approval soon.
 

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