End-of-Month Surge: Domestic ADC Sector Achieves Multiple Breakthroughs

　　【Pharmaceutical Network | Industry Trends] In recent years, ADC therapy has been continuously reshaping the treatment landscape through its precise mechanisms and synergy with immunotherapy and chemotherapy, attracting increasing attention and investment from pharmaceutical companies. It is reported that since 2026, the domestic antibody-drug conjugate (ADC) sector has seen concentrated breakthroughs, with industrial innovation and globalization accelerating in tandem. For instance, in the past week alone, Hansoh Pharma, Sino Biopharm, and MediLink have all announced positive developments.
 

Recently, the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration showed that the Class 1 new drug HS-20110 for injection, jointly submitted by Shanghai Hansoh Biomedical Technology Co., Ltd. and Changzhou Hengbang Pharmaceutical Co., Ltd., has been accepted.
 

HS-20110 is a novel, potential first-in-class antibody-drug conjugate (ADC) independently developed by Hansoh Pharma. It consists of a humanized monoclonal antibody targeting cadherin-17 (CDH17) covalently linked to a topoisomerase inhibitor (TOPOi) payload.
 

On June 24, Huadong Medicine announced that the clinical trial application submitted by its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., for the use of HDM2005 for Injection in combination with a PD-1 monoclonal antibody and AD (doxorubicin and dacarbazine) in the treatment of classical Hodgkin’s lymphoma was approved by the NMPA.
 

HDM2005 is an antibody-drug conjugate (ADC) independently developed by Huadong Medicine. It received approval in June 2024 from China and the United States to initiate clinical trials for advanced malignant tumors, and has subsequently obtained approvals for clinical trials in indications including diffuse large B-cell lymphoma and mantle cell lymphoma.
 

On June 23, Sino Biopharm announced that its wholly-owned subsidiary, Lixin Pharmaceutical, had submitted and received acceptance from the Center for Drug Evaluation (CDE) for a New Drug Application (NDA) for its independently developed innovative drug, Vitacotamab (“CLDN18.2 ADC”). The application is for the treatment of CLDN18.2-positive locally advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) adenocarcinoma in patients who have received at least two prior systemic therapies.
 

This drug is an antibody-drug conjugate (ADC) targeting CLDN18.2. The acceptance of its marketing application is based on the positive results from a pivotal Phase III clinical study. This study evaluated the efficacy and safety of LM-302 monotherapy in patients with CLDN18.2-positive locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (GC/GEJ) who had received three or more prior lines of therapy.
 

On June 23, MediLink Biopharma announced that its independently developed B7-H3-targeting antibody-drug conjugate (ADC), YL201, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of small cell lung cancer (SCLC).
 

The approval of YL201 is based on positive results from multiple clinical studies, with particularly impressive performance in previously treated small cell lung cancer patients. MediLink plans to initiate a pre-Biologics License Application (pre-BLA) meeting with the FDA in 2025 to accelerate its global commercialization process.
 

On June 22, Biokin announced that its self-developed EGFR×HER3 bispecific antibody-drug conjugate (ADC), lunkangyilongtuomab (BLB01D1/iza-bren), has been approved for marketing for the treatment of later-line nasopharyngeal carcinoma.
 

It is reported that Biokin has currently launched over 40 clinical trials globally for lunkangyilongtuomab, covering more than 10 tumor types. These trials address various oncology indications, including lung cancer, breast cancer, gastrointestinal tumors, urological tumors, gynecological tumors, and head and neck cancers. Notably, this innovative drug was licensed to BMS in late 2023, with an upfront payment of $800 million and a total transaction value of $8.4 billion.
 

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Overall, the recent series of breakthroughs in China’s ADC sector clearly demonstrate that the Chinese ADC industry has transitioned from “follow-on R&D” to a new stage of “global competition.” Looking ahead, the commercialization of innovative domestic pharmaceutical products in this field, along with the upgrading of collaboration models, is expected to accelerate.
 

　　Disclaimer: Under no circumstances shall the information contained herein or the opinions expressed constitute investment advice for any person.