Hengrui's Anti-HER2 Injection Approved for Colorectal Cancer; SHR0302 Tablets Add Fifth Indication
Hengrui Pharmaceuticals said its subsidiary Suzhou Shengdiya Biomedical received National Medical Products Administration approval for a third indication of Ruikang trastuzumab for injection, making it China's first anti-HER2 product approved for colorectal cancer. The company also received approval for a fifth indication of its independently developed Class 1 innovative drug SHR0302 tablets, for adults with active non-radiographic axial spondyloarthritis who have inadequate response or intolerance to NSAIDs and show objective signs of inflammation. The JAK inhibitor's approval extends the company's presence in autoimmune disease treatment.
Hengrui Pharmaceuticals announced that its subsidiary Suzhou Shengdiya Biomedical Co. , Ltd. recently received a notice from the National Medical Products Administration (NMPA) approving a third indication for Ruikang trastuzumab for injection, making it the first anti-HER2 product approved for colorectal cancer in China. The product had previously received approval for other indications, and this new approval further expands its clinical application scope.
Separately, the company received an NMPA notice approving a fifth indication for its independently developed Class 1 innovative drug SHR0302 tablets, for adult patients with active non-radiographic axial spondyloarthritis who have inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) and present objective signs of inflammation. The drug is a JAK inhibitor, and this approval represents further progress in the autoimmune disease field.
Why this event matters
The event has a measured impact on 2 industrys. The strongest current signal is positive for Biotechnology, with intensity 60/100 and 75% confidence over a short term horizon.
Biotechnology
- Direction
- positive
- Intensity
- 60
- Confidence
- 75%
- Horizon
- Short term
Pharmaceuticals
- Direction
- positive
- Intensity
- 50
- Confidence
- 70%
- Horizon
- Short term
Impact figures are analytical estimates that combine direction, intensity, confidence and event importance. They are not investment advice.