China's RET Inhibitor Sector Rises as Kelun-Biotech, SYHA Pharma, and Hansoh Pharma File NDAs for Novel RET-Targeted Therapies

　　【Pharmaceutical Network Industry DynamicsIn recent years, RET inhibitors produced in China have been emerging. In addition to Innovent Bio and CStone Pharmaceuticals' authorized introduction of Selpercatinib and Pralsetinib, which have already been approved for marketing, several other products have successively applied for market approval in China. These include Kelun-Biotech's Lorbirenib (A400/EP0031), SHOUYAO HOLDINGS’ Zotiratinib (SY-5007), and Hansoh Pharma’s Ruicentanib (HS-10365). The indications applied for are all RET fusion-positive locally advanced or metastatic adult non-small cell lung cancer (NSCLC).
 

Among them, according to the data, Lunbotinib is a second-generation small molecule selective RET inhibitor independently developed by Kelun-Biotech. It exhibits broad activity against common RET gene fusions and mutations. As a novel next-generation selective RET inhibitor, this drug is positioned as a precision treatment for NSCLC, medullary thyroid carcinoma (MTC), and other solid tumors with high prevalence of RET alterations. On September 22, 2025, the product's New Drug Application (NDA) was accepted by the National Medical Products Administration for the treatment of adult patients with RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
 

Preclinical study data show that Lumbotinib exhibits good inhibitory activity against major RET kinases both in vitro and in vivo, and demonstrates excellent blood-brain barrier penetration in animal models, providing a theoretical basis for treating patients with brain metastases. Notably, the drug has the potential to overcome resistance to first-generation RET inhibitors, offering a new solution for clinical treatment.
 

Sotetinib tablets are a highly selective small-molecule RET tyrosine kinase inhibitor independently developed by SHOUYAO HOLDINGS. As a highly selective RET inhibitor, Sotetinib precisely inhibits RET kinase activity, blocks downstream signal transduction, and effectively suppresses the growth of various tumor cells with RET gene abnormalities. Compared with traditional non-selective inhibitors, Sotetinib offers more significant efficacy, lower toxicity and side effects, and better patient tolerance.
 

The pivotal Phase II and Phase III clinical trials of the drug have both met their primary endpoints, demonstrating efficacy characteristics of "rapid onset, high response rate, and long duration" in both treatment-naïve and previously treated patients. Safety data show that adverse reactions are within clinically tolerable ranges, and high-grade adverse reactions can be effectively managed through dose adjustments and symptomatic treatment. On October 23, 2025, SHOUYAO HOLDINGS announced that the New Drug Application (NDA) for Sotetrectinib Tablets for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for rearranged during transfection (RET) gene fusion has been officially accepted by the National Medical Products Administration.
 

Resonretinib, a Class 1 innovative drug independently developed by Hansoh Pharma, is a small-molecule, highly selective RET receptor tyrosine kinase inhibitor. It directly targets intracellular protein tyrosine kinases, competitively binding with ATP to inhibit tyrosine kinase phosphorylation, thereby effectively controlling tumor growth. In October 2025, the product's New Drug Application (NDA) was accepted by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for RET gene fusion.
 

Recently, Hansoh Pharma also announced that Ruisentini has demonstrated significant anti-tumor effects and good tolerability in treating patients with RET gene fusion-positive locally advanced or metastatic non-small cell lung cancer. This research finding was presented at the 2025 European Society for Medical Oncology Asia Congress (ESMO ASIA).
 

In addition to the above products, there are multiple selective RET inhibitors under research and development in China. Among them, BYS10 is a highly selective RET inhibitor independently developed by Baiyunshan Pharmaceutical General Factory; HEC169096 is a highly selective RET inhibitor independently developed by Dongyangguang Pharmaceutical; APS03118 is a second-generation highly selective RET inhibitor independently developed by Zhijian Jinrui.
 

As multiple drugs advance steadily, China's innovative power is reshaping the treatment landscape for RET-positive tumors. Industry experts note that the development of China-produced RET inhibitors is accelerating, breaking the market monopoly of imported drugs. By precisely targeting clinical needs and optimizing drug structure design, these inhibitors offer more tailored and accessible treatment options for Chinese patients with RET fusion-positive NSCLC. As more China-produced RET inhibitors gain approval and advance in development, China’s independent innovation capabilities in precision oncology will continue to improve, bringing longer survival and better quality of life to cancer patients while driving the high-quality growth of China’s biopharmaceutical industry.
 

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