Yingen Bio's HER2 ADC DB-1303 Receives Marketing Approval Acceptance in China for Breast Cancer Treatment
核心洞察
Yingen Bio's core HER2 (搜索) antibody-drug conjugate DB-1303 (Trastuzumab Pamirtecan) has received official acceptance from China's NMPA for marketing authorization to treat unresectable or metastatic HER2-positive breast cancer in adults.
The Biologics License Application is based on positive Phase III study results demonstrating statistically and clinically significant improvements in progression-free survival compared to control agent T-DM1.
DB-1303 has also received FDA Fast Track and Breakthrough Therapy designations, with the company planning to submit a marketing application to the FDA for endometrial cancer treatment in 2026.
Yingen Bio-B announced that China's National Medical Products Administration (NMPA) has officially accepted the Biologics License Application (BLA) for its core HER2 (搜索) antibody-drug conjugate DB-1303 (Trastuzumab Pamirtecan) for the treatment of unresectable or metastatic HER2-positive breast cancer in adults. This milestone marks the company's first ADC product to submit a BLA and represents a significant step toward commercialization of its lead therapeutic candidate.
Regulatory Progress and Clinical Data
The marketing application is supported by positive results from a Phase III clinical study, which demonstrated statistically and clinically significant improvements in progression-free survival (PFS) compared with the control agent T-DM1. The company has not disclosed specific numerical data from the trial, but the results were sufficient to support the regulatory submission.
At the international level, DB-1303 has received both Fast Track Eligibility and Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), highlighting its potential clinical value and recognition of unmet medical needs in HER2 (搜索)-positive cancers.
Expanding Therapeutic Applications
Beyond breast cancer, DB-1303 has shown promising results in other indications. The company's Phase III clinical trial in China for second-line and later treatment of HER2 (搜索)-positive advanced endometrial cancer has successfully met its primary endpoint, with a marketing application already submitted to the NMPA.
In collaboration with BioNTech, DB-1303 has yielded positive results in a Phase II study for endometrial cancer treatment, achieving a confirmed objective response rate (ORR) of 49.3%. The company plans to submit a marketing application for this indication to the FDA in 2026.
Pipeline Development and Financial Strategy
Yingen Bio's broader pipeline continues to advance, with DB-1311 demonstrating a median progression-free survival of 11.3 months in prostate cancer trials. This product has already received FDA Fast Track designation, with a global Phase III clinical trial expected to commence in 2026. Another investigational drug, DB-1310, has also received two FDA Fast Track designations.
The company's Board of Directors has approved a proposal to issue RMB-denominated shares (A-shares) and list on the Shanghai Stock Exchange's STAR Market. The plan involves issuing up to approximately 15.78 million RMB-denominated shares, representing 15% of total share capital after issuance, with an over-allotment option of no more than 15%. Total proceeds are expected not to exceed RMB 6.75 billion, with approximately 85% allocated to new drug R&D projects and the remaining 15% used to replenish working capital.
Financial Performance and Market Response
For the year ended December 31, 2025, Yingen Bio reported revenue of RMB 1.85 billion, down 4.6% year-on-year. The loss attributable to shareholders widened to RMB 2.59 billion, primarily due to changes in fair value of financial liabilities. The adjusted loss amounted to RMB 389 million, while cash and bank balances stood at RMB 3.33 billion.
The company announced senior management changes effective March 23, 2026, with Dr. Hua Haiqing appointed as Executive Director and Mr. Zhang Shaoren as Chief Financial Officer.
Haitong International has maintained an "Outperform" rating on Yingen Bio-B, noting that the commercialization of its core pipeline is imminent and serves as a key catalyst for market attention. The stock has shown positive momentum, with shares trading above key moving averages and forming technical indicators suggesting strengthened short-term momentum.