Fosun Pharma Advances HLX17 and SAF-189: Strengthening Global and Domestic Oncology Footprints
hanghai Fosun Pharmaceutical is making strides in oncology with FDA approval for phase 1 trials of HLX17, a PD-1 biosimilar, and NMPA approval for phase 3 trials of SAF-189, an ALK/ROS1 inhibitor.
Shanghai Fosun Pharmaceutical has advanced its oncology pipeline with two recent regulatory approvals, signaling both domestic and international progress. Its controlled subsidiaries have received the U.S. FDA’s green light to initiate Phase 1 trials of the PD-1 biosimilar HLX17 in patients with multiple resected solid tumors, alongside NMPA approval for SAF-189, a novel ALK/ROS1-targeted small molecule, to enter Phase III trials in China. These milestones reflect Fosun’s strategic dual-track approach, expanding its presence in the global immuno-oncology arena while strengthening its innovative therapy portfolio in China.
HLX17: Aiming at the Global PD-1 Market
HLX17 is a recombinant humanized anti-PD-1 monoclonal antibody injection developed entirely in-house by Henlius Biotech, a Fosun subsidiary. It is a biosimilar of pembrolizumab, which has become a cornerstone immunotherapy for multiple cancers, including non-small cell lung cancer (NSCLC), melanoma, gastric cancer, and triple-negative breast cancer. HLX17’s FDA approval for a Phase 1 study in the U.S. positions Fosun among the few Chinese companies advancing PD-1 biosimilars in international clinical trials.
Pembrolizumab achieved $32.06 billion in global sales in 2024, according to IQVIA MIDAS™, underscoring the market potential for biosimilars. While competition and pricing pressure are expected, early entry into U.S. multi-center trials provides Fosun with opportunities to demonstrate clinical credibility and regulatory compliance internationally. Mechanistically, HLX17 blocks PD-1 receptor interactions with PD-L1 and PD-L2, restoring T-cell–mediated anti-tumor immunity—a pathway clinically validated by multiple checkpoint inhibitors.
As of July 2025, Fosun’s cumulative R&D investment in HLX17 totaled approximately RMB 176 million (unaudited), highlighting a significant commitment to biosimilar development with global ambitions.
SAF-189: Addressing Unmet Needs in Chinese NSCLC Patients
SAF-189 is a novel small-molecule tyrosine kinase inhibitor designed to target ALK-positive and ROS1-positive NSCLC. Fosun Wanbang (Jiangsu) Pharmaceutical Group, a Fosun subsidiary, received NMPA approval to conduct Phase III trials in China for patients who have undergone curative surgery.
Early clinical data suggest SAF-189 has robust activity against CNS metastases—a critical unmet need in ALK/ROS1-positive NSCLC. The drug was jointly developed with Chongqing Fuchuang Pharmaceutical Research and the Shanghai Institute of Materia Medica (Chinese Academy of Sciences). Fosun holds exclusive rights for clinical development and commercialization in China. The company has invested approximately RMB 453 million in SAF-189 R&D through July 2025 (unaudited).
According to IQVIA CHPA, ALK-targeted therapies generated roughly RMB 3.16 billion in sales in China in 2024, reflecting a market with significant commercial potential for therapies that combine efficacy with CNS penetration. SAF-189 could potentially differentiate itself from competitors such as alectinib, brigatinib, and lorlatinib.
Strategic Implications
These dual approvals reflect Fosun’s broader strategy:
- Global expansion through biosimilars – HLX17 targets a high-revenue biologics market, leveraging China’s growing capabilities in clinical development and manufacturing.
- Domestic innovation in precision oncology – SAF-189 addresses genetically defined NSCLC subpopulations, focusing on unmet needs such as CNS metastases, while strengthening Fosun’s presence in China’s competitive targeted therapy landscape.
Both programs remain at early clinical stages. Regulatory review, clinical trial outcomes, and safety/efficacy data will ultimately determine commercial success. Nonetheless, Fosun’s integrated approach—combining biosimilar development with original small-molecule innovation—positions it as a rising player in both Chinese and international oncology markets.
Conclusion
The FDA and NMPA approvals of HLX17 and SAF-189 underscore Fosun Pharma’s maturation as an R&D-driven company capable of bridging global and domestic markets. These developments highlight the company’s dual focus on leveraging proven immunotherapy pathways for global expansion while innovating targeted therapies for Chinese patients, marking Fosun as a significant emerging player in the oncology space.
References
- Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Announcement on FDA Approval of HLX17 Clinical Trial; Shanghai Stock Exchange, 2025.
- Shanghai Fosun Pharmaceutical (Group) Co., Ltd. Announcement on NMPA Approval of SAF-189 Clinical Trial; Shanghai Stock Exchange, 2025.
- Shanghai Henlius Biotech, Inc. Voluntary Announcement: Investigational New Drug Application of HLX17 Approved by FDA; Hong Kong Stock Exchange, 2025.
- IQVIA MIDAS™ Database. Global Oncology Market Sales Data, 2024.
- IQVIA CHPA Database. China Hospital Pharmaceutical Market Sales, 2024.