China NMPA approves Foresee's Camcevi 42 mg six-month injection for advanced prostate cancer
China's NMPA has approved Foresee Pharmaceuticals' Camcevi 42 mg, a ready-to-use six-month leuprolide injection for adults with advanced prostate cancer.
The approval authorises Camcevi (leuprolide mesylate) as a six-month subcutaneous depot injection in China, expanding the product's regulatory reach beyond existing approvals in the United States and Europe.
Changchun GeneScience Pharmaceutical holds exclusive commercialisation rights in China, positioning the long-acting formulation as an additional treatment option for adults with advanced prostate cancer.
Field | Content |
Article Type | Approvals |
Drug Name | Camcevi |
Generic Name | Leuprolide mesylate |
Company | Foresee Pharmaceuticals |
Commercialisation Partner | Changchun GeneScience Pharmaceutical |
Regulatory Authority | China National Medical Products Administration (NMPA) |
Approval Type | Marketing authorisation in China |
Indication | Advanced prostate cancer |
Patient Population | Adults with advanced prostate cancer |
Therapy Area | Oncology; urology; prostate cancer |
Technology/Modality | Ready-to-use long-acting subcutaneous depot formulation |
Drug Class | Gonadotropin-releasing hormone (GnRH) agonist |
Approved Strength | 42 mg |
Administration | Subcutaneous injection every six months |
Dosing Frequency | Once every six months |
Commercialisation Rights | Changchun GeneScience Pharmaceutical holds exclusive commercialisation rights in China |
Geography | China |
Existing Regulatory Footprint | Previously approved in the United States and Europe |
What Happened | China's NMPA approved Camcevi 42 mg for the treatment of adults with advanced prostate cancer. |
Why It Matters | The approval expands access to a ready-to-use six-month leuprolide depot formulation in China and extends Camcevi's international regulatory footprint. |
Supporting Context | Camcevi is a long-acting leuprolide mesylate formulation administered by subcutaneous injection every six months. |
Potential Impact | The approval could broaden treatment options for eligible patients with advanced prostate cancer while reducing injection frequency to twice yearly. |
Key Takeaway | Foresee Pharmaceuticals has secured Chinese marketing authorisation for Camcevi 42 mg, with Changchun GeneScience Pharmaceutical responsible for commercialisation in China. |
What to Watch | Commercial launch timing in China, pricing and reimbursement, physician adoption, market access and future geographic expansion. |
Primary Source | Foresee Pharmaceuticals |
Relevant Date | 12 October 2026 |
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