Shandong Xinbo helped Qingdao micro energy biological stem cell innovative drug to be approved clinically, with indications of AIDS and diabetes nephropathy!
2025/11/11
According to the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration and public sources, Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as "Shandong Xinbo") has contributed to the clinical trial approvals of two stem cell innovation drugs developed by Weineng Life Science Group Co., Ltd. (hereinafter referred to as "Weineng Life")—"VPD/FC01002 Injection" (subpluripotent stem cells, acceptance numbers: CXSL2500234, CXSL2500652). These drugs target two refractory fields: AIDS and diabetic nephropathy. This marks the first stem cell therapy for AIDS approved for clinical trials in China, as well as the first stem cell therapy for diabetes-related diseases approved in Shandong Province.
With the support of the national "13th Five Year Plan" and "14th Five Year Plan" key research and development plan, innovative stem cell drugs provide key support for the treatment of AIDS and diabetes nephropathy. Of the nearly 40 million AIDS patients worldwide, 15% -30% still face the immune dilemma of CD4+T cell count recovery after antiretroviral treatment; There are 233 million patients with diabetes in China, and about 40% will progress to diabetes nephropathy. Traditional treatment has limited effect or can not reverse the disease.
The drug uses pluripotent stem cell technology, bringing new hope to patients with two major diseases and promoting the upgrading of treatment technology for major diseases in China.
Shandong Xinbo participated in the preclinical evaluation of the project
The IND approval of Weineng Life Technology Group Co., Ltd. is not only a major breakthrough in the field of stem cell therapy, but also a microcosm of the high-quality development of Shandong's biopharmaceutical industry. Shandong Xinbo has taken this cooperation as an opportunity to further improve the full process service system of stem cell innovative drugs, providing solid support for local enterprise innovation and injecting strong impetus into Shandong's efforts to build a national stem cell therapy innovation highland.
The implementation of this new achievement further establishes its leading position in the field of innovative stem cell drugs. As a landmark breakthrough in the field of stem cell therapy in Shandong Province, the successful development of this drug demonstrates significant progress in stem cell engineering technology in China, breaking through core technological bottlenecks such as in vitro isolation, amplification, and reinfusion of stem cells.
Shandong Xinbo will undertake the following tasks in this project:
Shandong Xinbo Energy's deep involvement in this milestone project stems from its profound accumulation in the field of cell therapy evaluation:
✅ Professional qualifications: fully recognized by AAALAC, obtained national GLP certification in July, covering key experimental qualifications such as immunogenicity and toxicokinetics, and experimental data recognized by global regulatory agencies;
✅ Customized technical support: Based on the organ chip platform and the cell therapy safety evaluation system, provide technical support for cell efficacy and safety evaluation;
It is worth noting that the Lishan International Cell Medicine Industrial Park, where Shandong Xinbo Pharmaceutical Technology Co., Ltd. (Jinan Laboratory) has settled, is becoming an "accelerator" for biopharmaceutical innovation, providing key basis for drugs to quickly pass the evaluation and demonstrating the strong momentum of the "industry university research application" model.
As a key partner in the R&D process, Shandong Xinbo strictly adheres to the guidelines of the NMPA and ICH. Leveraging its extensive project experience and mature technical platform, the company undertook the preclinical efficacy studies and safety evaluations of the drug, facilitating the partner's smooth approval for clinical trials.
With the support of the national "13th Five Year Plan" and "14th Five Year Plan" key research and development plan, innovative stem cell drugs provide key support for the treatment of AIDS and diabetes nephropathy. Of the nearly 40 million AIDS patients worldwide, 15% -30% still face the immune dilemma of CD4+T cell count recovery after antiretroviral treatment; There are 233 million patients with diabetes in China, and about 40% will progress to diabetes nephropathy. Traditional treatment has limited effect or can not reverse the disease.
The drug uses pluripotent stem cell technology, bringing new hope to patients with two major diseases and promoting the upgrading of treatment technology for major diseases in China.
——Content reference“ https://mp.weixin.qq.com/s/p7x8-n5kQ_Zsfe5JxnfaeQ ”
Shandong Xinbo participated in the preclinical evaluation of the project
The IND approval of Weineng Life Technology Group Co., Ltd. is not only a major breakthrough in the field of stem cell therapy, but also a microcosm of the high-quality development of Shandong's biopharmaceutical industry. Shandong Xinbo has taken this cooperation as an opportunity to further improve the full process service system of stem cell innovative drugs, providing solid support for local enterprise innovation and injecting strong impetus into Shandong's efforts to build a national stem cell therapy innovation highland.
The implementation of this new achievement further establishes its leading position in the field of innovative stem cell drugs. As a landmark breakthrough in the field of stem cell therapy in Shandong Province, the successful development of this drug demonstrates significant progress in stem cell engineering technology in China, breaking through core technological bottlenecks such as in vitro isolation, amplification, and reinfusion of stem cells.
Shandong Xinbo will undertake the following tasks in this project:
Shandong Xinbo Energy's deep involvement in this milestone project stems from its profound accumulation in the field of cell therapy evaluation:
✅ Professional qualifications: fully recognized by AAALAC, obtained national GLP certification in July, covering key experimental qualifications such as immunogenicity and toxicokinetics, and experimental data recognized by global regulatory agencies;
✅ Customized technical support: Based on the organ chip platform and the cell therapy safety evaluation system, provide technical support for cell efficacy and safety evaluation;
✅ Rich practical experience: More than 400 innovative drug evaluations have been completed, helping more than 30 biological products to be approved for clinical use. Previously, it successfully supported the first iNKT cell liver cancer drug in China to enter the experimental stage.
It is worth noting that the Lishan International Cell Medicine Industrial Park, where Shandong Xinbo Pharmaceutical Technology Co., Ltd. (Jinan Laboratory) has settled, is becoming an "accelerator" for biopharmaceutical innovation, providing key basis for drugs to quickly pass the evaluation and demonstrating the strong momentum of the "industry university research application" model.
