Chinese Innovative ADCs Surge Overseas as Multinational Pharma Scrambles for Assets

　　【Pharmaceutical Network Industry Dynamics】As policy support continues to grow, the pharmaceuticals industry is accelerating its recovery in 2023. Notably, China-produced innovative drugs are experiencing a major boom in "going global." 2023 is hailed as the "first year" for Chinese pharmaceutical companies expanding overseas. While the scale of outbound licensing cooperation for innovative drugs hits record highs, multiple new drugs have successfully entered and been approved in European and American markets.
 

In the ADC drug field, according to relevant data statistics, multinational pharmaceutical companies have aggressively acquired ADC assets this year, with more than half of the targets coming from Chinese pharmaceutical enterprises.
 

On December 15, Harbour BioMed's wholly-owned subsidiary, Harbour BioMed (Suzhou) Co., Ltd (Nona Biologics), entered into an exclusive licensing agreement with Pfizer for the global clinical development and commercialization of the antibody-drug conjugate (ADC) HBM9033 targeting human mesothelin (MSLN). According to the announcement, Nona Biologics will receive a $53 million upfront and near-term payment, along with potential milestone payments of up to $1.05 billion. Additionally, Nona Biologics is eligible to receive tiered royalties ranging from high single-digit to high double-digit percentages on net sales.
 

Data show that HBM9033 specifically targets MSLN (mesothelin), a tumor-associated antigen (TAA) upregulated in various solid tumors. Therefore, HBM9033 can be used to treat MSLN-positive solid tumors. In August this year, the product received approval from the U.S. Food and Drug Administration (FDA) to commence clinical trials.
 

On December 12, Biokin announced that its wholly-owned subsidiary, SystImmune Inc. (hereinafter referred to as "SystImmune"), and Bristol-Myers Squibb (hereinafter referred to as "BMS", NYSE: BMY) had reached an exclusive licensing and cooperation agreement for SystImmune’s BL-B01D1. Both parties will jointly develop and commercialize BL-B01D1 in the United States. After the agreement takes effect, BMS will pay SystImmune an upfront payment of 800 million US dollars, with a potential total transaction value of up to 8.4 billion US dollars, breaking the record for China's innovative drug exports.
 

Data show that BL-B01D1 is an ADC based on a bispecific topoisomerase inhibitor, which can simultaneously target both epidermal growth factor receptor and human epidermal growth factor receptor 3 (EGFR x HER3). A global multicenter Phase I clinical study (BL-B01D1-LUNG101) is currently underway to evaluate its safety and efficacy in patients with metastatic or unresectable non-small cell lung cancer (NSCLC).
 

In addition, the multinational pharmaceutical company GSK has reached two transaction collaborations with Hansoh Pharma on ADC projects this year. The total amount of the two transactions is 3.28 billion US dollars, and the collaborative ADC projects are HS-20093 and HS-20089 developed by Hansoh Pharma.
 

Among them, HS-20093 is a novel B7-H3-targeted ADC drug, covalently linked by a fully humanized B7-H3 monoclonal antibody and a topoisomerase inhibitor (TOPOi) payload. It is currently undergoing multiple Phase I and Phase II clinical studies in China for the treatment of lung cancer, sarcoma, head and neck cancer, and other solid tumors. HS-20089 is composed of a humanized lgG1 anti-B7-H4 monoclonal antibody connected via a cleavable linker to a topoisomerase I inhibitor payload, with a DAR value of 6.
 

Experts in the industry indicate that ADC drugs, which combine the targeted precision of targeted therapies with the potent effects of chemotherapy, are known as "magic bullets" in anti-tumor treatment. The ADC field has become another key area of focus for multinational pharmaceutical companies in 2023, aside from the "weight-loss wonder drug" GLP-1 medications. Notably, Chinese innovative pharmaceutical companies have been actively involved in significant ADC transactions. According to research reports, since 2023, there have been more than 10 overseas licensing deals for ADC drugs produced in China. In addition to the aforementioned companies' deals, BioNTech has reached three licensing agreements with Duality Biologics and Alkyn Biologics, involving four ADC drugs.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice to any person.