Shandong Xinbo assists Qingdao Weineng Biotech in obtaining clinical approval for its innovative stem cell drug, tackling two major challenges: AIDS and diabetic kidney disease!
2025/11/11
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 Key Research and Development Programs during the 13th and 14th Five-Year Plans, stem cell-based innovative drugs provide critical assistance in treating AIDS and diabetic kidney disease. Among the nearly 40 million AIDS patients worldwide, 15%-30% still face immune challenges such as difficulty in restoring CD4+ T-cell counts despite antiretroviral therapy. In China, there are 233 million diabetic patients, approximately 40% of whom progress to diabetic kidney disease, with traditional treatments being limited in efficacy or unable to reverse the condition.
This stem cell drug, with complete independent intellectual property rights, leverages "subpluripotent stem cell" technology. For AIDS, it can bidirectionally regulate immunity and help patients restore immune function, filling the domestic treatment gap. For diabetic kidney disease, it improves insulin levels and renal function through multiple mechanisms including anti-inflammatory, immune modulation, and tissue repair. As a collaborative innovation achievement in industry, academia, and research, this drug breaks through the limitations of traditional single-target treatments, offering new hope for patients with these two major diseases and advancing the treatment technology for serious illnesses in China.
Empower industrial upgrading! Shandong Xinbo showcases local responsibility
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.
Xinbo's hardcore strength: From the laboratory to the approved "safety escort" Shandong Xinbo Energy deeply participated in this milestone project, stemming 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.
Industrial synergy: the "innovation ecosystem" in the cell industry park
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.
