Health · Pharma & Biotech · 2 hrs ago
China accepts Junshi application for toripalimab injection in bladder cancer
China's drug regulator accepted Junshi Biosciences' application for a subcutaneous form of toripalimab.
The proposed treatment combines it with disitamab vedotin for first-line treatment of advanced urothelial cancer that expresses HER2.
Urothelial cancer affects the urinary tract, and the application covers locally advanced or metastatic disease.
HER2 expression in this application includes test results rated 1+, 2+ or 3+.
Toripalimab is already marketed as an intravenous injection, and the new formulation is given under the skin.
Acceptance means the application can be reviewed, not that the treatment is approved for this use.
Junshi says applications for the subcutaneous formulation covering all 13 approved uses of intravenous toripalimab have been accepted; the next step is a regulatory decision.
China’s National Medical Products Administration has accepted Junshi Biosciences’ supplemental application for toripalimab subcutaneous injection.
The application seeks approval to use the drug with disitamab vedotin as a first-line treatment for HER2-expressing urothelial carcinoma.
The proposed treatment is for locally advanced or metastatic disease.
The company defines HER2 expression as immunohistochemistry results of 1+, 2+ or 3+.
Junshi said applications for the subcutaneous formulation covering all 13 approved indications of intravenous toripalimab had been accepted.
- Who
- Shanghai Junshi Biosciences Co., Ltd. submitted the application.
- What
- China accepted a supplemental drug application for toripalimab subcutaneous injection in combination with disitamab vedotin.
- When
- The announcement was made on October 28, 2026; the application had recently been accepted.
- Where
- China.
- Why
- The application seeks use as a first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma.
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- Company
- Shanghai Junshi Biosciences Co., Ltd.
- Drug formulation
- Toripalimab injection, subcutaneous formulation; code JS001sc
- Combination drug
- Disitamab vedotin
- Target disease
- HER2-expressing locally advanced or metastatic urothelial carcinoma
- HER2 definition
- Immunohistochemistry results of 1+, 2+ or 3+
- Existing indications
- Applications for JS001sc covering all 13 approved intravenous toripalimab indications had been accepted.