Multiple New Drugs from Qilu Pharma, Junshi Biosciences, Lemei Pharma, and Gan & Lee Receive Clinical Trial Approvals

　　【Pharmaceutical Network Product Information] In the past week (May 12-May 17), several drugs have announced the good news of being approved for clinical trials, involving products from Qilu Pharmaceutical, Junshi Biosciences, Lai Mei Pharmaceuticals and other companies.
 

　　Wuzhou Zhongheng Subsidiary: "Nanocarbon Iron Suspension Injection" Approved for Clinical Trials
 

Wuzhou Zhongheng announced on May 17 that the "Nano Carbon Iron Suspension Injection" submitted by Yingrui Medicine, a subsidiary of its holding subsidiary Chongqing Lemei Pharmaceutical, to the National Medical Products Administration had obtained tacit approval for clinical trials and received the "Drug Clinical Trial Approval Notice."
 

The announcement shows that the Carbon Nanoparticles Iron Suspension Injection (hereinafter referred to as "Carbon Nanoparticles Iron") is a new generation of nanomedicine developed based on the company's product, Carbon Nanoparticles Suspension Injection. Carbon Nanoparticles Iron is an anticancer drug with a novel mechanism. When used in combination with relevant chemotherapy drugs, it is expected to maximize each drug’s anticancer advantages while keeping toxic side effects within a controllable range, further enhancing the efficacy of combination cancer therapy.
 

It is reported that the clinical research of nanocarbon iron has been initiated, with the intended indications being various solid cancers, such as pancreatic cancer, colorectal cancer, etc. According to the policy regulations of the Center for Drug Evaluation, the subjects of Phase I clinical trials are patients with advanced solid cancers who have failed standard treatments or for whom no standard treatment exists.
 

Currently, there are no similar products to nanocarbon iron on the market or in the late stages of research and development. To date, the total R&D investment in nanocarbon iron has reached 36.18 million yuan (data unaudited).
 

　　Junshi Biosciences: FCN-159 Tablets Approved for Clinical Trials
 

On May 13, Fosun Pharma announced that FCN-159 tablets, developed by its subsidiary Fosun Pharma Industry for the treatment of histiocytic tumors, have been approved for clinical trials. Fosun Pharma Industry plans to initiate a Phase II clinical trial for this indication in China (excluding Hong Kong, Macao, and Taiwan) once conditions are met.
 

The announcement shows that FCN-159 tablets, an innovative small-molecule chemical drug independently developed by Fosun Pharma, are selective MEK1/2 inhibitors, mainly intended for the treatment of advanced solid tumors, Type I neurofibromatosis, and histiocytic tumors.
 

Currently, FCN-159 tablets for the treatment of malignant melanoma are in Phase I clinical trials in China; for the treatment of Type I neurofibromatosis, they are in Phase II clinical trials in China and Phase I clinical trials in the United States.
 

　　Qilu Pharmaceutical: Injectable QLS31904 Approved for Clinical Trials
 

Information from the Center for Drug Evaluation of the National Medical Products Administration shows that Qilu Pharmaceutical's injectable QLS31904 has been approved for clinical trials, intended for the treatment of various advanced solid tumors, including small cell lung cancer.
 

Small cell lung cancer is a highly aggressive, fatal, and widely metastatic type of lung cancer, for which there remains a significant unmet treatment need among the vast patient population.
 

QLS31904 for injection is a Class 1 biological new drug independently developed by Qilu Pharmaceutical, targeting DLL3/CD3. Studies have shown that QLS31904 can recognize specific antigens on the surface of tumor cells while activating the body's own immune cells to specifically kill tumor antigen-positive cells, achieving the therapeutic purpose. If the development proceeds smoothly, the product is expected to benefit a large number of patients after its market launch.
 

　　Gan&Lee Pharmaceuticals: GZR101 Approved for Clinical Trials
 

On May 12, Gan&Lee Pharmaceuticals announced that the company had recently received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for its investigational drug GZR101.
 

GZR101 is a dual insulin compound formulation developed by Gan & Lee Pharmaceuticals, consisting of the long-acting basal insulin GZR33 and rapid-acting aspart insulin. It is intended for the treatment of diabetes. Currently, the only dual insulin product available globally is Novo Nordisk's Insulin Degludec and Aspart injection, which was approved for marketing in China in May 2019.
 

As of March 31, 2022, Gan&Lee Pharmaceuticals had cumulatively invested 14.16 million yuan in R&D for the GZR101 project.