3D Medicines’ Envafolimab NDA for First-Line Biliary Tract Cancer Accepted by China’s NMPA

3D Medicines, Inc. ( (HK:1244) ) has shared an update.

3D Medicines Inc. announced that China’s National Medical Products Administration has accepted its new drug application for Envafolimab (KN035) in combination with the GEMOX regimen as a first-line treatment for unresectable or metastatic biliary tract cancer, supported by data from a Phase III randomized, multicenter trial in Chinese patients. The move, if ultimately approved, would expand Envafolimab’s use beyond its current indication in MSI-H/dMMR advanced solid tumors, strengthening 3D Medicines’ position in the immuno-oncology market and potentially broadening the commercial prospects of its partnerships with Alphamab and regional licensees, though regulatory success is not assured.

The most recent analyst rating on (HK:1244) stock is a Hold with a HK$4.50 price target. To see the full list of analyst forecasts on 3D Medicines, Inc. stock, see the HK:1244 Stock Forecast page.

More about 3D Medicines, Inc.

3D Medicines Inc. is a biopharmaceutical company focused on oncology, co-developing innovative cancer therapies such as Envafolimab (KN035), a subcutaneous PD-L1 inhibitor originally invented by Alphamab Oncology. Through collaboration and licensing agreements, the company is building a commercial footprint in mainland China via Jiangsu Simcere and expanding internationally via Glenmark across India, parts of Asia Pacific, the Middle East, Africa, Russia, CIS and Latin America.

Average Trading Volume: 321,481

Technical Sentiment Signal: Sell

Current Market Cap: HK$1.33B

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