End-of-Month Sprint! China's ADC Sector Sees Multiple Breakthroughs

China's antibody-drug conjugate (ADC) sector is surging toward the end of the second quarter, with a flurry of regulatory milestones and clinical breakthroughs signaling the sector's rapid ascent on the global stage. Over the past week alone, Hansoh Pharmaceutical, Sino Biopharmaceutical, MediLink-Therapeutics, Huadong Medicine, and Sichuan Biokin Pharmaceutical have each announced significant advances—underscoring how Chinese drugmakers are accelerating both domestic innovation and international ambitions.

ADC therapies, which combine the precision of targeted antibodies with the potency of cytotoxic payloads, have emerged as one of the most hotly contested areas in oncology. Through their ability to deliver drugs directly to cancer cells while sparing healthy tissue, these therapies are reshaping treatment paradigms—and attracting ever-greater investment from pharmaceutical companies worldwide.

Hansoh Pharmaceutical Pushes Into First-in-Class Territory

Shanghai Hansoh Biomedical Technology Co. and Changzhou Hengbang Pharmaceutical Co., a joint filing by entities linked to Hansoh Pharmaceutical Group Company Limited, have secured acceptance from China's Center for Drug Evaluation (CDE) for a new drug application for injectable HS-20110. The Class 1 novel drug is a potential first-in-class ADC designed by Hansoh's in-house research team. It consists of a humanized monoclonal antibody targeting cadherin-17 (CDH17) conjugated via a covalent bond to a topoisomerase inhibitor (TOPOi) payload—a mechanism aimed at delivering lethal cytotoxic agents directly to cancer cells expressing the CDH17 surface protein.

Huadong Medicine Expands ADC Pipeline Into Lymphoma

On June 24, Huadong Medicine Co., Ltd. announced that its wholly owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., had received approval from China's National Medical Products Administration (NMPA) to initiate a clinical trial for injectable HDM2005 in combination with a PD-1 inhibitor and AD (doxorubicin and dacarbazine) for the treatment of classical Hodgkin lymphoma.

HDM2005, an ADC independently developed by Huadong Medicine, first received regulatory clearance to begin clinical trials for advanced solid tumors in both China and the U.S. in June 2024. Since then, it has gone on to secure additional clinical trial approvals for diffuse large B-cell lymphoma and mantle cell lymphoma, among other indications—signaling the company's broad ambitions in hematologic malignancies.

Sino Biopharmaceutical's Lixin Unit Files for Drug Approval in Gastric Cancer

On June 23, Sino Biopharmaceutical Co., Ltd. disclosed that its wholly owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has submitted a new drug application (NDA) to the CDE for its innovative CLDN18.2-targeting ADC, vortetocotamab (also known as LM-302). The application, which has been accepted for review, seeks approval for the treatment of CLDN18.2-positive, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJ) in patients who have received at least two prior lines of systemic therapy.

The NDA submission is supported by positive results from a pivotal Phase III clinical study evaluating LM-302 as a monotherapy in the third-line setting and beyond for patients with CLDN18.2-positive, locally advanced or metastatic GC/GEJ, assessing both efficacy and safety.

MediLink's YL201 Wins FDA Breakthrough Therapy Designation for Lung Cancer

Also on June 23, MediLink announced that its self-developed B7-H3-targeting ADC, YL201, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer (SCLC). The designation was granted based on positive results from multiple clinical studies, with particularly strong efficacy signals observed in previously treated SCLC patients.

MediLink said it plans to initiate a pre-Biologics License Application (pre-BLA) meeting with the FDA within 2025, a key step toward accelerating the drug's global commercialization pathway.

Biokin's Bispecific ADC Wins Approval—Backed by $8.4 Billion BMS Deal

On June 22, Sichuan Biokin Pharmaceutical Co., Ltd. announced that its self-developed EGFR×HER3 bispecific ADC, izatabren (also known as BLB01D1), has been approved for marketing in China for the treatment of nasopharyngeal carcinoma in later-line settings.

The approval marks a major milestone for a drug that has already drawn global attention. In late 2023, Biokin licensed izatabren to Bristol-Myers Squibb (BMS) in a deal worth up to $8.4 billion in total value, with an upfront payment of $800 million—one of the largest ADC licensing agreements in China's pharmaceutical history.

Biokin has since launched more than 40 clinical trials worldwide for izatabren, spanning over 10 tumor types including lung cancer, breast cancer, gastrointestinal tumors, urological cancers, gynecological cancers, and head and neck cancers.

From Followers to Global Competitors

The recent wave of breakthroughs across China's ADC sector underscores a broader transformation: Chinese pharmaceutical companies have moved well beyond "follow-the-leader" research and are now competing on the global stage. With multiple drugs advancing through late-stage clinical trials, securing regulatory milestones from both Chinese and U.S. authorities, and striking blockbuster licensing deals with Western pharmaceutical giants, the country's ADC ecosystem is entering a new phase of maturity.

Looking ahead, the commercialization of innovative ADC products by Chinese drugmakers—and the continued evolution of their partnership models with global players—are expected to accelerate, further cementing China's position as a force in the rapidly expanding ADC market.