Hyderabad News Desk

Frost & Sullivan, in collaboration with one of the top domestic industry research institutions – LeadLeo, released the report of “2023 China EPC Drugs Industry Overview”. The study explored the role and therapeutic potentials of EPC, as well as the market status, industrial chain, development environment, and challenges of EPC drugs.

On April 26th 2022, the Chinese National Medical Products Administration (NMPA) granted the world’s first iPSC-derived EPC cell therapy IND, ALF201 to Allife Medicine. ALF201 injection, a product for the treatment of acute ischemic stroke, is currently in Phase I clinical trials and has demonstrated safety and efficacy in preclinical studies. In November 2023, ALF202 the EPC Injection from Allife Medicine for the treatment of severe Peripheral Limb Ischemia was approved for Investigational New Drug (IND) through the Chinese NMPA, which shows the further expansion of the therapeutic scope of EPC drugs for ischemic diseases.

Due to the increasing prevalence and mortality rates of cardiovascular and cerebrovascular diseases in China, there is a growing demand for more effective medications. Endothelial progenitor cells (EPCs) can promote the regeneration and repair of blood vessels and nerves, which extends their broader clinical application prospects, especially in the research and treatment of ischemic diseases.

EPCs are derived from peripheral blood, umbilical cord blood, or bone marrow. They mobilize from the bone marrow to the peripheral blood under physiological or pathological stimuli. They repair damaged vascular endothelium and promote angiogenesis, thus restoring vascular integrity and remodeling. They recruit neural stem/progenitor cells and oligodendrocytes, along with immune modulation, to promote neural repair and regeneration. They also improve brain micro-environment inflammation and offer neuroprotection.

In the clinical research field of EPC cell therapy, the market demands for cardiovascular and cerebrovascular diseases are enormous, necessitating the development and scaled-up production of universal EPC drugs. The preparation for EPCs mainly includes direct extraction and separation from peripheral blood or bone marrow, and iPSC-directed induction and differentiation. The iPSC-derived EPCs exploit the differentiation potential and unlimited in vitro replicate capacity of iPSCs.

Firstly, the iPSC technology platform uses iPSCs as the starting material for EPC drug development. iPSCs have ESC-like characteristics in morphology, properties, and functions, with strong self-renewal and differentiation abilities. Theoretically, they can differentiate into almost all functional cells and tissue types of the human body. This wide applicability enhances the platform’s innovative capacity, laying the foundation for developing various new cell therapies.

Secondly, iPSCs possess the ability for unlimited replication under suitable in vitro conditions, with consistent and unrestricted cell line numbers. This is helpful in meeting the latest regulatory requirements and significantly enhances the efficiency and functionality of iPSC-differentiated tumour immune cells and regenerative medicine-related cells.

Thirdly, iPSC development platforms use adult cells from rigorously selected or fixed donors, ensuring traceable and consistent sources. Due to the strong expansion capability and differentiation potential of iPSCs, repeated sampling is unnecessary. The EPCs differentiated from them have relatively stable batch characteristics. The platforms can effectively ensure the quality control of drugs and prevent inconsistent clinical efficacy.

EPCs are a type of circulating angiogenic cells that affect both vessels and nerves, aiding in the repair of damaged vessels, nerves, and myelin, promoting regeneration, and reducing brain inflammation. iPSC-derived endothelial progenitor cells are expected to become the ideal choice for treating ischemic diseases, especially irreversible acute conditions.

EPCs contribute to post-stroke spontaneous vasculogenesis. They can recruit neural stem/progenitor cells and oligodendrocytes, along with immunomodulation, to promote neural and myelin repair. EPCs can also help neural regeneration, improve brain microenvironment inflammation, and offer neuroprotection. Additionally, EPCs can further differentiate into mature endothelial cells. They have strong autocrine and paracrine abilities, participating in the treatment of a range of cardiovascular and cerebrovascular diseases, peripheral vascular diseases, and wound healing.

ALF201, independently developed by Allife Medicine as the world’s first iPSC-derived allogeneic EPC cell therapy product, is currently in Phase I clinical trials. It provides rapid access to ample and more effective treatments for patients with acute ischemic stroke (AIS). The advantages include compliant and traceable sample sources, strong cell expansion capability, and potent differentiation potential, ensuring batch consistency and therapeutic efficacy in mass production. Based on these features, the ALF201 product has huge commercial potentials.

ALF202, for severe lower limb ischemia, has received clinical trial permission approved by the Chinese National Medical Products Administration (NMPA) in November 2023. As iEPCs research in ischemic diseases progresses, the range of indications will expand, covering atherosclerosis, pulmonary hypertension, coronary heart disease, cerebral small vessel disease, male erectile dysfunction, and more.

The competitive barriers in China’s EPC drugs industry mainly include preparation technology, large-scale production, and the first-mover advantage of leading companies.

Stable, healthy donor sources and efficient in vitro expansion and differentiation technologies are the key to enhancing large scale production capabilities. The development of universal drugs is one of the main future trends in the EPC drugs research field.

Current clinical research suggests that EPC drugs have a positive impact on both vessels and nerves. They aid in the repair of damaged vessels, nerves, and myelin, promote regeneration, and reduce brain inflammation. EPC drugs offer significant advantages in treating cardiovascular and cerebrovascular diseases, providing better treatment options for more patients, particularly for AIS. EPCs are currently the only option for AIS’s acute phase, with clinical studies indicating that EPCs can effectively extend the administration window to 96 hours. Compared to traditional AIS treatments like intravenous thrombolysis and mechanical thrombectomy, EPC drugs offer a longer administration window and effectively reduce disability, mortality, and recurrence rates. The ongoing Phase I clinical study of ALF201 for stroke treatment allows for treatment within 7 days of stroke onset. With the smooth development of ALF201 clinical trials, the advantages of EPC drugs will be further revealed. In the future, EPC drugs may become the ideal drug of choice for AIS after they are approved for marketing and enter large-scale commercial production.

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