Hengrui’s Ruikang Trastuzumab Designated Breakthrough Therapy for HER2+ Cervical Cancer
By Thomas Yuan, Health and Biotechnology Correspondent

SHANGHAI — On the evening of March 19, Suzhou Shengdia Biopharmaceutical Co., Ltd., a subsidiary of Hengrui Medicine, announced that its investigational therapy Ruikang Trastuzumab for Injection (SHR-A1811) has once again been listed as a proposed breakthrough therapeutic variety by China’s Drug Review Center under the National Medical Products Administration — marking its eighth such designation.

SHR-A1811 is being developed for patients with recurrent or metastatic cervical cancer expressing HER2 (IHC ≥ 1+) who have progressed after platinum-based chemotherapy and immune checkpoint inhibitor therapy. This population, which faces limited second-line treatment options, represents a critical unmet need in women’s oncology.

Addressing an Urgent Clinical Gap

Cervical cancer remains a major public health concern in China and worldwide, ranking first among female reproductive system tumors and sixth in cancer-related deaths among Chinese women. In 2022 alone, China reported approximately 150,000 new cases and 56,000 deaths. While HPV vaccination and screening programs have curbed incidence, HER2-positive subtypes — found in roughly 20% of cervical cancers — are more aggressive, have shorter disease-free survival, and currently lack approved targeted therapies.

SHR-A1811 is designed as a HER2-targeting antibody-drug conjugate (ADC). It binds HER2-expressing tumor cells, is internalized, and then releases cytotoxic agents via protease cleavage in the tumor cell lysosomes, triggering cell cycle arrest and apoptosis. This mechanism mirrors that of leading global ADCs such as Kadcyla, Enhertu, and China’s Mingedix — therapies that collectively generated over $5.7 billion in global sales in 2023, according to EvaluatePharma.

Pipeline Progress and Strategic Positioning

To date, Hengrui has invested nearly RMB 941 million in the SHR-A1811 program. The company’s clinical strategy reflects its broader push to dominate high-barrier therapeutic areas like oncology, autoimmune disease, and endocrinology.

As of mid-2024, Hengrui boasts 14 self-developed innovative drugs and 2 co-developed therapies approved for market in China — a testament to its industry-leading R&D platform. Its integrated capabilities in drug discovery, clinical development, and commercialization position it as a key player in pharma B2B partnerships and global biopharmaceutical alliances.

With Ruikang Trastuzumab advancing in a space with no approved HER2-directed options for cervical cancer, the drug has potential not only to reshape treatment standards, but also to emerge as a high-value health product with strong international relevance.

Related Resource

Explore pharmaceutical formulations and drug R&D solutions on Drugdu.com.

https://finance.eastmoney.com/a/202503193350189124.html