A downloadable PDF version of the content of this chapter can be downloaded from Shanghai Quansheng Company Listing and Financing Exchange Network - Latest News _20210801.pdf

October 2021 - Quansheng completed the preclinical study of a series of new drug co-formulations, and submitted IND applications for new drugs consecutively

On the 31st of this month, Shanghai Quansheng Co., Ltd. submitted an online application for the preIND meeting of the "Exploratory Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Burn Injuries" to the CDE of the State Food and Drug Administration. The project has been studied in human clinical studies by the National Health Commission in Shanghai Changhai Hospital, and the data is good so far. So far, Shanghai Quansheng Company has entered the stage of submitting 1~2 national first-class new drug declarations every month. In the next step, Shanghai Quansheng plans to submit an application for the multiple sclerosis (orphan drug) project and the preIND meeting of the State Food and Drug Administration.

Screenshots of the 4 PreIND application CDE websites .jpg

September 2021 - Quansheng completed the preclinical study of a series of new drug co-preparations and submitted IND applications for new drugs

At nearly midnight on the evening of the 13th of this month, Shanghai Quansheng Company submitted an application for the preIND meeting of "Exploratory Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Mild to Moderate Acute Respiratory Distress Syndrome" to the CDE of the State Food and Drug Administration. At about 19 o'clock on the evening of the 30th of this month, Shanghai Quansheng Company submitted an application for the preIND meeting of "Exploratory Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Chronic Ischemic Stroke" to the CDE of the State Food and Drug Administration. So far, Shanghai Quansheng Company has entered the stage of submitting 1~2 national first-class new drug declarations every month. In October, Shanghai Quansheng Company plans to submit two applications for burns and hepatitis B cirrhosis.

August 2021 - Quansheng completed a series of preclinical studies of new drug co-preparations, and submitted IND applications for new drugs consecutively

As of this month, Shanghai Quansheng Company's aStem-M-UC-allo-f®™ human allogeneic umbilical cord mesenchymal stem cell Off-The-helf off-the-spot liquid nitrogen freezing preparation ("ready-to-use; no in-hospital resuscitation re-culture; long futures shelf life; long-distance transportation "liquid nitrogen frozen type)" has: (1) completed CMC production quality control research and development (preclinical pharmaceutical research) (2) Completed safety evaluation animal experiments (preclinical toxicology studies) ;(3) Completed animal experiments for more than 10 indications

The preparation (sharing CMC data and toxicology safety assessment data with the preparation) for two different indications (acute lung injury and ischemic stroke) will be submitted to the China Food and Drug Administration PreIND meeting in September this year (2021), followed by more indications (new drugs) submitted applications consecutively. It is expected that starting from the end of this year, Shanghai Quansheng Company will submit about 1-2 IND applications for different indications (new drugs) to the China Food and Drug Administration every month to enter the phase I human clinical trials of the China Food and Drug Administration.

August 2021 - Quansheng successfully completed the preclinical toxicology test of the same preparation

Shanghai Quansheng Co., Ltd. successfully completed the "Preclinical Toxicology and Pharmacokinetic Study (Safety Evaluation) of Human Umbilical Cord Mesenchymal Stem Cell Injection of a Class I New Drug" at the Shanghai Drug Safety Evaluation Center of the State Food and Drug Administration, including more than a dozen independent tests such as repeated dosing tests of rhesus macaques and rats, in vivo distribution tests, and tumorigenicity in vivo. The data for all outcomes were good. A formal report will be issued at the same time.

July 2021 - Report the latest R&D progress to shareholders (WeChat group).

︎ Shanghai Quansheng Co., Ltd. conducted an exploratory clinical study on the safety and tolerability of single administration of umbilical cord mesenchymal stem cell injection in patients with second-degree burns in patients with second-degree burns, which was conducted by Shanghai Quansheng Company in Shanghai Changhai Hospital (academician Xia Zhaofan is the PI), and the first subject has been enrolled. It is expected that the clinical trial treatment of all subjects will be completed by the end of 2021 and the interim clinical trial report will be obtained.

︎ Shanghai Quansheng Company conducted a human clinical study (= phase I human clinical trial of the State Food and Drug Administration) in the treatment of end-stage liver cirrhosis after hepatitis B by umbilical cord mesenchymal stem cell transplantation (hepatic arterial infusion) conducted by Shanghai Quansheng Company in Sichuan Provincial People's Hospital (Professor Huang Xiaolun is PI), and recently began to recruit subjects. It is expected that all 30 subjects will be treated in the clinical trial in October 2021 and the interim clinical trial report will be obtained.

Shanghai Quansheng Company was founded by Professor Qi Nianmin, a professor/doctoral supervisor of the School of Pharmacy of Shanghai Jiao Tong University, the PI of the "Medicine and Cell" research group, and an expert of the national "Thousand Talents Program". The company focuses on business: preclinical and clinical trials of stem cell preparations and IND/NDA (clinical approval/new drug certificate) declaration.

Important nodes of Quansheng's new drug research and development:

1) In November 2021, submit the first new drug IND application to the State Food and Drug Administration, and then submit a new drug IND application every month (same toxicology/different indication efficacy of the same preparation);

2) Combined stem cell clinical research data (such as the above two clinical studies), a number of new drugs have entered phase II clinical trials of the State Food and Drug Administration, and it is expected that in August 2022, five new stem cell drugs will enter the phase II clinical trials of the State Food and Drug Administration.

Shanghai Quansheng Company plans to IPO on the main board of the Hong Kong Stock Exchange 18A in 2022, welcome to learn about investment!

Note: Chapter 18A listing requirements on the Main Board of the Hong Kong Stock Exchange - No revenue, no profit, at least one product has completed Phase I clinical trials.

June 10, 2021 - Shanghai Quansheng Co., Ltd. successfully completed the on-site supervision and verification of the State Food and Drug Administration, the National Health Commission and the China Pharmaceutical Biotechnology Association

This is the on-site supervision and verification of human clinical research on stem cells for projects and institutions that have completed the filing and licensing of human clinical research before the second quarter of 2021. Shanghai Quansheng Company successfully passed the verification and was highly praised by the verification experts. In particular, Shanghai Quansheng Company made a detailed report to the leaders and experts on the plan to build four 15,000-square-meter "CHINA NMPA, US FDA, EU EMA international cGMP certified medical grade cell preparation production facilities" in four major transportation hubs across the country, and received praise and enthusiastic guidance.

On the afternoon of May 10, 2021 - The kick-off meeting of the project "Exploratory Clinical Study on the Open, Dose Escalation Safety and Tolerability of aStem-M-UC™ Umbilical Cord Mesenchymal Stem Cell Injection in Patients With Second-Degree Burns" was successfully held

https://mp.weixin.qq.com/s/CvDRcXztW_h2NBZRg3Orpw

The kick-off meeting of the project "Exploratory Clinical Study on the Open, Dose Escalation Safety and Tolerability of Single Administration of aStem-M-UC™ Umbilical Cord Mesenchymal Stem Cell Injection in Patients with Second-Degree Burns" approved by the Health Bureau of the Logistics Support Department of the Central Military Commission and Shanghai Changhai Hospital was successfully held in the conference room on the fifth floor of the emergency building of Shanghai Changhai Hospital.

More than 10 experts from Shanghai Changhai Hospital, including PI Academician Xia Zhaofan, Professor Zhu Feng and Professor Wang Yue, the main clinical investigators of the project, Professor Qi Nianmin/Chairman of Asian Stem Cells, Professor Wang Hao and relevant personnel of clinical CRO companies attended the meeting.

December 2020 - Shanghai Quansheng submitted 4 IND (Human Clinical Studies) applications to the National Health Commission at one time

Project 1 "Single-center, prospective clinical study of umbilical cord mesenchymal stem cell transplantation in the treatment of decompensated hepatitis B cirrhosis", cooperative hospital: Haikou People's Hospital;

Project 2 "Exploratory Clinical Study of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Diabetic Foot", Cooperative Hospital: Affiliated Hospital of Zunyi Medical College;

Project 3 "Single-center, prospective clinical study of umbilical cord mesenchymal stem cell transplantation in the treatment of end-stage liver cirrhosis after hepatitis B", cooperative hospitals: Sichuan Provincial People's Hospital;

Project 4 "Single-group, non-randomized, open-label clinical study of collagen scaffold loaded with human umbilical cord mesenchymal stem cells in the treatment of Asherman (endometrial injury) syndrome", cooperative hospital: Shanghai First People's Hospital.

--- Latest news: A total of 97 human clinical research projects (new stem cell drugs) of the National Health Commission have been declared in the country, 13 of which have been approved, and 3 of us have been approved or need simple supplementary information.

September 2020 - Shanghai Quansheng Company's new crown pneumonia project was approved by the Provincial Department of Science and Technology for clinical research

Shanghai Quansheng and the Affiliated Hospital of Zunyi Medical University jointly carried out the "Research on the Application of Human Umbilical Cord Mesenchymal Stem Cell Preparation in the Treatment of Novel Coronavirus Pneumonia" and was approved

Remark:

After the approval of the clinical research record of the National Health Commission (equivalent to the IND clinical approval of the State Food and Drug Administration), human clinical studies (equivalent to phase I/IIa human clinical trials of the State Food and Drug Administration) will be carried out ---> obtained from human clinical data----> and the production and quality control CMC data, toxicology and safety evaluation animal experiment data, Pharmacodynamic animal experimental data, apply to enter the phase II clinical trial of the State Food and Drug Administration (see the regulations and excerpt PPT below).

The fifth listing requirement of the SSE STAR Market stipulates that no revenue and no profit but at least one drug under development must enter the Phase II clinical trial of the Food and Drug Administration, and the listing requirement of Chapter 18A of the Main Board of the Hong Kong Stock Exchange: no revenue and no profit but at least one drug under development must complete the Phase I clinical trial of the Food and Drug Administration. The NASDAQ in the United States does not have specific formal requirements, but it attaches great importance to substance, that is, animal experimental data and human clinical data that have been obtained.

For the application for direct or early entry into the phase II clinical trial of the NMPA after the completion of the human clinical trial (equivalent to the phase I and IIa human clinical trials of the NMPA), please refer to the Technical Guidelines for Clinical Trials of Human Stem Cells and Their Derived Cell Therapy Products (Draft for Comments) .pdf. On July 19, 2019, the National Health Commission held the second phase of the Lanzhou Stem Cell Clinical Research Management Training and Experience Exchange Meeting - Wang Jinqian, Director of the National Health Commission, and Gao Jianchao of CDE PPT excerpts:

Gao Jianchao of the State Food and Drug Administration:

Wang Jinqian (Deputy Director of the Regulation and Evaluation Division of the Department of Science and Education of the National Health Commission):