Professor Wang Shujun's Decade-Long Lymphatic Tracer Innovation: From Mitoxantrone to Isosulfan Blue

Image from the official website of Shenyang Pharmaceutical University

Recently, Shenyang Pharmaceutical University willA Patent for Isosulfan Blue InjectionTransfer to Shenyang Gerun Biotechnology Co., Ltd., price400,000。

Although the amount is not substantial, a review of inventor Wang Shujun’s track record reveals that this is hardly a new story. Her previous lymphatic tracing product, China’s first independently developed visual tracer, was approved for market launch in 2021, with a technology transfer value of RMB 25 million.

This time, the isothiocyanate blue is her second product line.

Wang ShujunShe is a Professor and Doctoral Supervisor at the School of Pharmacy, Shenyang Pharmaceutical University, a Distinguished Professor of Liaoning Province, and has been selected for the “Top 100” tier of Liaoning Province’s “Hundred, Thousand, and Ten Thousand Talents Project.” Her core research focus lies in lymph-targeted drug delivery systems, encompassing lymphatic tracing of tumor metastasis, immunotherapy, and imaging diagnosis.

The first-line treatment is mitoxantrone.

In 2021, her team’s Class II new drug, “Mitoxantrone Hydrochloride Injection for Tracing,” was approved for market launch. This is China’s first independently developed visible lymphatic tracer, which can be used for lymph node dissection in various tumors such as thyroid cancer, breast cancer, and gastric cancer. The team also won the Second Prize of the National Science and Technology Progress Award in 2023 for their related research.

The rationale behind mitoxantrone is"Integrated Diagnosis and Treatment"—Leverages the tracing properties of blue dye while exerting antitumor effects.

The second line is Evans blue.

Patent Blue V is another lymphatic tracer active ingredient widely used internationally, but there had been no domestic product available in China. It was not until the end of 2024 that Guangdong Hebo Pharmaceutical’s “Bolinlan® Patent Blue V Injection” received marketing approval, becoming the first domestically produced generic version in China.

Wang Shujun’s team filed a patent for their indocyanine green formulation in 2015, a full nine years before the market launch of Bolinlan®. During those nine years, she addressed the formulation challenges associated with traditional indocyanine green.

Current tracer protocols each have limitations:Radionuclide methods are expensive and require specialized equipment; carbon nanoparticle suspensions have large particle sizes, preventing them from reaching distant lymph nodes and posing a risk of capillary obstruction. Methylene blue is moderately priced and easy to administer, but its rapid diffusion and short duration hinder intraoperative localization.

Wang Shujun's team proposes a hyperosmolar adaptation strategy:By precisely controlling osmolarity (600–1200 mmol/kg, preferably 900 mmol/kg) and pH (6.0–8.0), Patent Blue V achieves blue staining of lymph nodes within 5 minutes after subcutaneous injection, maintains visible blue staining for 2 hours, and does not diffuse into the interstitial space.

Mouse Experimental Data:Staining begins 5 minutes after injection, reaches maximum intensity at 10 minutes, and stabilizes within 2 hours. When osmolality is controlled below 938 mmol/kg, local subcutaneous administration does not cause irritation.

This adjustment may appear simple, but it is underpinned by a systematic exploration of formulation and processing techniques.

TransfereeShenyang Green Biotechnology Co., Ltd.Established in 2003, the company specializes in the distribution of laboratory instruments and reagents, serving as the Liaoning regional distributor for brands such as Promega and Eppendorf.

Patent information indicates that the applicants and inventors of this isothiocyanate blue patent include “Shenyang Pharmaceutical University Shenyang Gerun Biotechnology Co., Ltd.,” demonstrating that Gerun was involved during the R&D phase and did not merely take over the project at a later stage.

For local enterprises like Gerun, shifting from distribution to in-house R&D represents a logical upgrade path. The price of RMB 400,000 is not expensive; in return, it secures a validated technological direction and ongoing support from an experienced university-based team.

By the end of 2024, Bolinlan® Indocyanine Green Injection was officially launched, with the market just beginning to be educated.

Bolinlan® has established market recognition, but as a mature ingredient, isothiocyanate blue offers more than one technological pathway. Wang Shujun’s team’s formulation falls within its own patented scope—Hyperosmolar Formulations and Osmolality Adjustment Technology. Entering the market when it has been validated but the competitive landscape has not yet solidified offers an opportunity to capture your share of the pie.

While RMB 400,000 may not constitute a major business deal, it represents a strategic move by a team that has been deeply engaged in the field of lymphatic tracing for ten years, marking their launch of a second product.