Farewell to the old and welcome the new | Item 5! Quansheng Biological's "Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Chronic Obstructive Pulmonary Disease" has obtained clinical implied permission from the National Medical Products Administration!

On February 7, 2024, on the occasion of bidding farewell to the old year and ushering in the new year and celebrating the New Year of the the Year of the Loong, Zhejiang Quansheng Biotechnology Co., Ltd. (referred to as "Quansheng Biotechnology") independently developed a new biological class 1 drug "Human Umbilical Cord Mesenchymal Stem Cell Injection" (acceptance number: CXSL2300795), which was officially approved by the Drug Evaluation Center (CDE) of the State Food and Drug Administration as the fifth clinical stem cell trial project approved by CDE.

CDE official website: Quansheng Biotechnology has obtained implied permission for clinical trials

The implied permission for the fifth clinical trial not only recognized Quansheng Biotechnology's research and technological capabilities by the National Medical Products Administration, but also established Quansheng Biotechnology's leading position in the field of stem cell new drug research and development. In the biopharmaceutical industry, experiencing the cold wind of capital in 2023, Quansheng Biotechnology is developing at a surprising speed, but also facing more difficulties and challenges. In the future, we hope that Quansheng Biotechnology will not only achieve more brilliant achievements in the field of stem cell therapy, but also continue to explore new industry standards and heights in fields such as iPSC and immune cells.

About chronic obstructive pulmonary disease

01 Chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum), which are sustained (often progressive) airflow obstruction caused by airway abnormalities (bronchitis, bronchiolitis) and/or alveolar abnormalities (emphysema). The diagnostic criteria for COPD are that there is still airflow restriction after inhaling bronchodilators, that is, the forced expiratory volume (FEV1)/forced vital capacity (FVC) ratio in the first second after inhaling bronchodilators is less than 0.7 or lower than the lower limit of the normal expected value, and other diseases that may cause airflow restriction are excluded.

COPD is the most common chronic respiratory disease in China, with a high incidence and heavy disease burden. In 2018, the results of the "Chinese Adult Pulmonary Health Research" led by Academician Wang Chen showed that the incidence rate of chronic obstructive pulmonary disease in adults aged 20 and above in China was 8.6%, and the incidence rate among people aged 40 and above was as high as 13.7%. It is estimated that the number of patients in China is nearly 100 million, indicating that the incidence of chronic obstructive pulmonary disease in China is still showing a high trend. The World Health Organization (WHO) predicts that the incidence of chronic obstructive pulmonary disease (COPD) will continue to rise in the next 40 years, with over 5.4 million deaths from COPD and related diseases predicted to occur annually by 2060.

Risk factors and pathogenesis of COPD caused by 02

The risk factors for COPD have diverse characteristics, which can be summarized as individual susceptibility factors and environmental factors working together: ① Individual factors, including genetic factors, age and gender, lung growth and development, bronchial asthma, and airway hyperresponsiveness. COPD has genetic susceptibility, α Severe deficiency of anti trypsin is associated with the formation of emphysema in non-smokers. Age is a risk factor for COPD, and the older one is, the higher the incidence of COPD Environmental factors, including tobacco, fuel smoke, air pollution, occupational dust, infection, and chronic bronchitis. Smoking is the most important environmental pathogenic factor for COPD. Respiratory infections are an important factor in the onset and exacerbation of COPD, and viral and/or bacterial infections are common causes of acute exacerbation of COPD

The pathogenesis of COPD is complex and not yet fully understood. Inhaling harmful particles or gases such as tobacco smoke can cause airway oxidative stress, inflammatory response, and protease/anti protease imbalance, among other pathways involved in the pathogenesis of chronic obstructive pulmonary disease. Multiple inflammatory cells are involved in the airway inflammation of COPD, including macrophages, neutrophils, as well as Tc1, Th1, Th17, and ILC3 lymphocytes. In addition, autoimmune regulatory mechanisms, genetic risk factors, and lung development related factors may also play important roles in the occurrence and development of COPD.

03 Current main treatment methods and deficiencies for COPD

The treatment of COPD mainly includes the following three aspects: ① reducing the stimulation of smoking, inhaling toxic gases or dust, etc.; ② Drug therapy: Bronchodilators are the basic first-line treatment drugs for chronic obstructive pulmonary disease, and inhalation therapy is often preferred. On the basis of using one or two long-acting bronchodilators, combined inhalation of glucocorticoids can be considered for treatment Non drug therapy: Non drug intervention and drug therapy have a synergistic effect and are an important component of stable COPD treatment, including respiratory rehabilitation therapy, home oxygen therapy, surgical treatment (lung transplantation, surgical lung volume reduction surgery), etc.

Although current treatment methods can alleviate COPD symptoms and improve patient quality of life, they cannot prevent the progression of COPD, repair damaged lung tissue and function, and reverse the deterioration of lung function. Therefore, there is an urgent need to develop new and effective COPD treatment strategies.

04 Stem cell therapy for COPD

Multiple preclinical studies have confirmed that stem cells (mainly concentrated in bone marrow mesenchymal stem cells, adipose mesenchymal stem cells, and umbilical cord mesenchymal stem cells) have good therapeutic effects in COPD animal models. At present, multiple clinical trials of stem cell therapy for COPD have explored the safety and effectiveness of mesenchymal stem cell therapy for COPD, providing a good research foundation for subsequent stem cell therapy for COPD.

The main mechanism of stem cell therapy for COPD:

Inhibition of inflammatory response: Chronic obstructive pulmonary disease is a chronic inflammatory response disease in which multiple cells and factors participate. Mesenchymal stem cells can reduce the level of inflammatory factors, reduce the occurrence of inflammatory reactions, and the mechanism may be through paracrine mechanisms.

Correcting the imbalance between protease and anti protease: Mesenchymal stem cells may correct the imbalance between protease and anti protease by activating the positive feedback pathway of inflammatory response and inhibiting protease release.

Inhibition of cell apoptosis: Mesenchymal stem cells can inhibit cell apoptosis through various pathways.

Inhibition of oxidative stress: Oxidative stress plays a very important role in the occurrence and development of chronic obstructive pulmonary disease. Mesenchymal stem cells can reduce oxidative stress levels and have a protective effect on cells. They can differentiate into alveolar epithelial cells through the activation of the Wnt signaling pathway.

Future prospects of stem cell therapy

Quansheng Biotechnology has independently developed a Class 1 biological drug, "Human Umbilical Cord Mesenchymal Stem Cell Injection," which has completed preclinical pharmaceutical and pharmacological toxicology research in accordance with the requirements of Class 1 therapeutic biological products. From the aspects of clinical needs, quality controllability, non clinical efficacy and safety, and past clinical safety, it supports its entry into clinical trials. According to the clinical trial data of stem cells conducted by Quansheng Biotechnology, stem cells have good safety and demonstrate certain uniqueness and superiority in the treatment of related diseases.

Quansheng Biotechnology will always start from the needs of patients, adhere to the development of new drugs, strictly follow the requirements of the National Medical Products Administration, GMP, and GCP to further improve related research, promote high-quality clinical research of stem cell products, ensure and continuously improve product safety, stability, and effectiveness, and make positive contributions to ensuring the health and well-being of the public and improving the quality of life.