Haoyue Capital | China's First Stem Cell Therapy for Diabetic ED Lands in Beidaihe: AStem-101 Achieves Triple Regulatory Milestones

Among the three pathways, the CDE Phase I trial and the 818 filing provide dual assurance of drug registration and technical compliance for the same clinical study, while the Beidaihe technology transfer independently establishes a pioneering channel for patient access—the former generating R&D evidence, the latter delivering clinical services, with both operating in parallel without conflict.

In March 2026, Astem-101 completed public disclosure on the Drug Clinical Trial Registration Platform (Registration No.CTR20260724). This is a non-randomized, open-label, single-arm exploratory study—Three dose groups, single administration, planned enrollment of 18 subjects. The principal investigator is Professor Lu Mujun from Renji Hospital, with participating centers including Peking University First Hospital and Jiangsu Provincial Hospital of Traditional Chinese Medicine. The trial focuses on patients with type 2 diabetes mellitus complicated by moderate-to-severe erectile dysfunction (ED) who have failed standardized treatment with phosphodiesterase type 5 inhibitors (PDE5i), evaluating the safety and tolerability of stem cell therapy.

Image source: Drug Clinical Trial Registration and Information Publicity Platform

On June 23, the China National Center for Biotechnology Development announced the third batch of completed filing list, with Astem-101 officially included (filing numberMR-N-31-2026-000017). This marks the completion of regulatory filing for the project under the framework of State Council Decree No. 818, ensuring that the clinical research operates in a standardized manner within the legal track. The sponsor is Ancestor Stem Cell, and the clinical research institution is Renji Hospital.

Image source: Official website of the China National Center for Biotechnology Development

On April 30, the Beidaihe Life Health Industry Innovation Demonstration Zone was officially approved, with conditional approval granted to Qinhuangdao Beidaihe New Area.Lejie HospitalImplementation of the technological translation and application of Astem-101, indicated for type 2 diabetes mellitus complicated by moderate to severe erectile dysfunction (ED). The dosing regimen is clearly defined—Inject 1×10⁷ cells into each corpus cavernosum of the penis (totaling 2×10⁷ cells bilaterally) per administration, with dosing intervals of 2–4 weeks, for a total of 3 administrations.. The formulation was provided by Ancestor Stem Cell. This is the first stem cell technology translation project approved in the pilot zone nationwide for the treatment of diabetes complicated with ED.

In the first half of 2026, Beidaihe approved multiple cell therapy technology translation projects, covering areas such as systemic lupus erythematosus, type 2 diabetes, and knee osteoarthritis. HoweverIn the field of "Type 2 Diabetes Complicated with ED," Astem-101 is the first.。

The overall prevalence of erectile dysfunction (ED) in male patients with diabetes is as high as 52.5%. For a significant proportion of these patients, phosphodiesterase type 5 inhibitors (PDE5i) have limited efficacy or are even ineffective—chronic hyperglycemia has already damaged the cavernous vascular endothelium and nerves, and conventional drugs can only temporarily dilate blood vessels without repairing the damaged tissue. Stem cell therapy operates on a different logic: it repairs vascular endothelium through regenerative effects, protects the corpus cavernosum via anti-apoptotic mechanisms, and suppresses local inflammation through immunomodulation—Not merely alleviating symptoms, but repairing damage。

Ancestor Stem Cell has selected erectile dysfunction (ED) as its initial breakthrough focus, targeting clinical gaps unaddressed by existing therapies. In this therapeutic area that still lacks effective options,First-Mover Advantage Is Itself a Barrier。