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Among the various methods of tumor treatment, there is one called targeted drugs – finding the “target” of the tumor and developing the corresponding drug to “eliminate the tumor”
But in clinical practice, how can it be known that the drug matches the tumor “target”? The answer lies in genetic testing
Recently, Shihe Gene, an enterprise in the new district, has brought good news: its independently developed “NTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit” for pan-solid tumors has been approved for marketing by the National Medical Products Administration for use in the companion diagnosis of Luoshengquan ® (entrectinib Capsules).
In the future, when doctors determine whether cancer patients can use this tumor-targeted drug, they only need to conduct tests with Pandekang ™ first, and then they can obtain scientific and authoritative medication basis.
What can this test reagent detect? How important is it to the industry?
The therapeutic logic of targeted drugs is like one key opening one lock. The specific gene mutations on cancer cells are the “locks”, and targeted drugs are the exclusive “keys”. If the corresponding “lock” cannot be found, no matter how good the “key” is, it will not work.
The core mission of Pandekang ™ is to precisely identify the special keyhole named “NTRK Gene Fusion”. Although the overall incidence of this mutation is less than 1%, it is an important therapeutic target in solid tumors. Once a patient is detected to carry this mutation, treatment with corresponding NTRK inhibitors, such as entrectinib, often yields very significant results.
Therefore, accurately detecting whether a patient carries NTRK gene family variations is of great significance for clinical medication determination. It can prevent the blind attempt of multiple treatment options without molecular diagnosis, thereby reducing unnecessary economic burdens and the risk of delaying the best treatment opportunity.
However, a fact is that despite the significant clinical significance of NTRK gene fusions, their detection faces challenges: they are distributed across hundreds of types of cancer, and the fusion forms are complex and diverse, making it difficult for traditional detection methods to capture them comprehensively.
Pandekang ™, launched by Shihe Gene, was precisely created to address this industry pain point. As the first domestic NTRK companion diagnostic kit for pan-solid tumors based on high-throughput sequencing technology (NGS), it has demonstrated powerful technical advantages:
01
The universal clinical trial covered 7 clinical central hospitals and 33 types of solid tumors, with over 2,400 cases enrolled, demonstrating its cross-cancer detection capability.
02
The accuracy has been verified in over 200 NTRK gene family fusion sites in large-scale clinical trials of the product, and it can handle complex and diverse fusion forms with ease.
03
Pharmacodynamic research data on effectiveness show that for patients who tested positive for Pandekang ™, the objective response rate after using entrectinib capsules was as high as 71%. This means that over 70% of the positive patients saw their tumors significantly shrink after taking the medication, bringing hope of survival to patients in the advanced stage.
The approval of Pandekang ™ not only fills the gap in China in the field of precise detection of rare and complex genetic targets, but also marks the official opening of a new era of “comprehensive solid tumor and all cancer types” detection in tumor NGS companion diagnostics.
Its leading position in the industry is also reflected in its authoritative status as an “original research companion diagnostic device”. Companion diagnostics, that is, the “officially designated test” for a drug. Public information on the approval of the product shows that this product is used for the companion diagnosis of Roche Pharmaceuticals’ Roche Shengquan ® (entrectinib Capsules).
At the same time, it is also the original research companion diagnostic reagent of Zai Lab’s Oukailuo ® (Repuritinib) and Weikailuo’s Anretretinib (VC004), both of which are currently under registration. The fact that it has been recognized by multiple top pharmaceutical companies simultaneously demonstrates the solid strength of Shihe Gene’s technology platform.
In the field of biomedicine, innovation is the “ceiling” for measuring an enterprise’s value. Shihua Gene’s innovative pace has never ceased: In 2018, it launched the first batch of approved tumor NGS companion diagnostic kits, Yishengkang ™, in China.
In 2023, the first domestic tumor NGS large Panel kit, Shihe No.1 ®, was approved.
In August 2024, Shihe-1 ® was approved by the US FDA for all indications, becoming the world’s first and only high-throughput sequencing large Panel product for tumors to simultaneously obtain the three major international authoritative certifications of China’s NMPA, the US FDA, and the EU CE.
From a single target to full coverage of all cancer types, from following to leading globally, Shihe Gene is moving towards a series of breakthroughs. We look forward to more “Pandekang ™” being born in the new district
