/To overcome the problem of stem cell industrialization, NanHua Bio-medicine CO., Ltd. attaches great importance to original innovation and strengthens in-depth exploration.

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To overcome the problem of stem cell industrialization, NanHua Bio-medicine CO., Ltd. attaches great importance to original innovation and strengthens in-depth exploration.

NanHua Bio-medicine CO.,Ltd

2021/05/13

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Release time: 2021-05-13 17:08
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Category: News
Author:
Source:
Release time: 2021-05-13 17:08
Number of visits:

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(21st Century Business Herald reporter: Weng Rongtao) On May 8, the China Biomedical Technology Innovation Summit Forum and Xiangjiang Academician Forum (Second Phase) event was held in Changsha. Chen Runsheng, academician of the Chinese Academy of Sciences, Zhang Hongxiang, secretary-general of the Chinese Society for Bioengineering, and many other experts and scholars, as well as You Changqiao, general manager of NanHua Bio-medicine CO., Ltd., attended the meeting.

Stem cells are multifunctional cells that can self-renew, differentiate and regenerate. They are also known as "universal cells" in the medical community. They have broad prospects, but their commercialization is still in the exploratory stage. Many scholars and experts put forward their own opinions on the development prospects of the stem cell industry.

Chen Runsheng told Southern Finance’s all-media reporters, “The stem cell industry is cutting-edge science and a large pool with countless opportunities. However, from an academic perspective, there are still many technical problems in application, and future development opportunities are reserved for those who can see the technical problems and gradually solve them.”

When interviewed, You Changqiao said, “The stem cell industry is at the forefront of the industry. It is a capital-intensive and technology-intensive industry and is still in the scientific research stage. Currently, relevant companies must balance R&D investment and revenue and profits. It is expected that the industry may usher in an explosive period in the next 3-5 years.

Academician Chen Runsheng’s speech

Chen Runsheng: The cell industry must pay attention to original innovation

Stem cells are a type of pluripotent cells with the ability to replicate themselves. Under certain conditions, it can differentiate into progenitor cells of various tissues and organs.

This differentiation ability can be used by humans, such as for anti-aging and tissue and organ damage repair. For example, bone marrow mesenchymal stem cells can differentiate into various tissue cells such as fat and cartilage under specific induction conditions in vivo or in vitro.

In January this year, the Ministry of Science and Technology issued the "2021 Project Application Guidelines for the "Stem Cell Research and Organ Repair" Key Special Project of the "14th Five-Year Plan" National Key Research and Development Plan (Draft for Comments)", which clarified that my country will focus on key scientific issues of stem cell development and organ regeneration, carry out cutting-edge exploration such as organ regeneration regulation drugs, and provide innovative theories and technologies for the repair and replacement of important tissues and organs and the diagnosis and treatment of major diseases.

You Changqiao pointed out, “There is broad consensus around the world about the therapeutic application prospects of stem cells, which can be used to repair tissue damage and treat diseases. But it cannot cure all diseases. The types of cells that an adult stem cell can differentiate into are very limited and cannot be used to treat multiple types of diseases. For example, research on stem cell preparations for diabetes, even if successfully developed, will only be effective in treating diabetes. "According to a report by Transparency Market Research, the global stem cell market is expected to reach US$270.5 billion by the end of 2025, and the global stem cell market's compound annual growth rate in the past eight years is expected to reach 13.8%.

Currently, the stem cell clinical research projects registered around the world are mainly adult stem cell clinical trials, involving hematological diseases, tumors, neurological diseases, heart diseases, immune system diseases and other fields. The United States maintains an absolute leading position, followed by China, Germany, France and other countries. In Asia, China, South Korea and Japan are hot spots for stem cell research.

Since the State Food and Drug Administration accepted new clinical registration applications for stem cell therapy in 2018, in the past two years, the new drug approval system of "60-day clinical trial implicit permission" has provided new development opportunities for the research and development and application of new stem cell drugs in my country.

The research report pointed out that as of July 2020, 21 stem cell drugs have been approved for marketing internationally, and 14 domestic stem cell products have been approved for clinical trials. Domestic stem cell treatments lag behind developed countries, and the registration of new stem cell drugs has ushered in a new development situation.

However, Chen Runsheng also expressed his doubts, “As a cutting-edge field, the stem cell industry is prone to a rush. For example, in the past two years, in the field of genetic code sequencing, thousands of sequencing start-up companies suddenly emerged across the country, but most of them were eliminated one after another. The stem cell industry is the direction of future development, but it is not yet mature. Relevant enterprises and scientific research institutions must also realize that there are still many technical problems and must pay attention to original innovation. "

As a frontier field, the stem cell industry not only has weak penetration among the public, but also faces many technical difficulties in the field of scientific research.

In order to strengthen its research and development capabilities, NanHua Bio-medicine CO., Ltd. has joined forces with 10 units including Hunan Normal University, Hunan Pharmaceutical Industry Association and Hunan Aerospace Hospital to initiate and prepare for the establishment of the Hunan Life Sciences and Medical Collaborative Innovation Consortium.

Stem cell midstream and downstream industries are not yet mature

The industrial development direction of stem cells includes upstream stem cell collection and storage, midstream preparation production research, and downstream clinical treatment.

Relevant companies and businesses in my country are mainly concentrated in the upstream. Representative companies include NanHua Bio-medicine CO., Ltd., Zhongyuan Xiehe, China Stem Cell Group, etc., while most of the midstream and downstream businesses are currently in the clinical trial stage or market trial stage.

According to the "Market Prospects and Investment Potential Analysis Report of China's Stem Cell Therapy Technology Industry" released by the Qianzhan Industry Research Institute, it is estimated that the global stem cell therapy market will exceed US$100 billion in 2021. It is worth noting that downstream stem cell therapy accounts for more than 50% of the global stem cell industry market share, while in China, this field is still a blank market.

In February 2016, NanHua Bio-medicine CO., Ltd. launched an asset restructuring and transformation, aiming at the stem cell storage industry. Due to the characteristics of the biomedical industry, the stem cell industry also has problems such as large initial investments and long return cycles, and slow penetration of market awareness. The company has also faced short-term operating difficulties in the past.

Taking NanHua Bio-medicine CO., Ltd. as an example, it mainly focuses on cell storage and cell detection business. In 2020, the company's operating income was 176 million yuan, a year-on-year increase of 30.86%; after deducting non-recurring gains and losses, the net profit attributable to the parent company was 5.6546 million yuan, achieving a turnaround from losses to profits.

You Changqiao told reporters, "The profit of more than 5 million yuan may not seem like much, but it is of great significance to NanHua Bio-medicine CO., Ltd. The pharmaceutical industry has a large initial investment and a long return cycle. Many companies often lose hundreds of millions of yuan. NanHua Bio-medicine CO., Ltd. has also invested a lot in research and development in recent years. It is rare to be able to make profits in just a few years."

Judging from the current domestic stem cell storage status, the gap between my country's stem cell storage and developed countries is still large. The current stem cell storage rate in Shandong, Beijing, Tianjin and other provinces and cities is 10-20%, and the stem cell storage rate in Hunan Province is less than 1%. Domestic stem cell storage contains huge market space.

The company has carried out stem cell storage business in 14 prefectures, cities and states in Hunan Province. It currently has more than 340 front-line salesmen, 228 cooperative hospitals, and 120 formally contracted hospitals. In addition to carrying out stem cell storage business, NanHua Bio-medicine CO., Ltd. has also carried out basic and clinical scientific research cooperation with famous hospitals in the province.

In 2020, the company's cell storage and testing service revenue increased by more than 49% compared with 2019. This business accounted for 19.75%, 38.31%, and 43.82% of operating revenue from 2018 to 2020, respectively. Its gross profit margin level also increased by 4.77 percentage points, reaching 90.16%.

Although the profits from stem cell storage are considerable, stem cell preparations and clinical treatments have larger profit margins and higher technical barriers. Due to policy reasons, there is currently a large gap in the domestic market.

Before 2011, my country's clinical research in the field of cells actually experienced a small climax earlier than Europe and the United States. When these products first entered the country, they were defined as Class III biological products and did not need to be subject to drug approval. Subsequent policy restrictions have chilled the development of the domestic cell sector, but once the suppressed mid- and downstream markets can be loosened, they cannot be underestimated.

In terms of clinical research, in September 2020, the State Council issued the "Notice on Issuing the Overall Plan for the Beijing, Hunan, and Anhui Free Trade Pilot Zones and the Expansion Regional Plan for the Zhejiang Pilot Free Trade Zone", clarifying that clinical medical research such as cross-border telemedicine can be carried out in the free trade zone, and clinical cutting-edge medical technology research projects such as immune cells and stem cells can be supported.

In the next strategic plan, NanHua Bio-medicine CO., Ltd will also focus on the research and development of stem cells and immune cell preparations, the research and development of stem cell drugs, as well as the research and development of clinical-grade cell preparation and related equipment.

Dig deep into products vertically and start a battle to defend profits

For companies in the field of stem cells, in addition to the existing stem cell storage and testing business, how to extend product lines and create more revenue, thereby feeding back research and development that requires large amounts of funds, is a common problem faced.

Chen Runsheng pointed out, "Stem cells are undoubtedly cutting-edge science. Because everyone is sensitive to new things, companies in this area are developing rapidly. However, it is important to avoid lack of positioning and rush to the market. How companies achieve sustainable development is also very important. They need to find a breakthrough and come up with one or two competitive products."

Wang Xiujie, a researcher at the Chinese Academy of Sciences, believes, “In the field of stem cells, there are still many basic research problems that have not yet been solved in the short term. If companies engage in pure scientific research, it will indeed consume a lot of energy and money. If companies want to maintain their own profits and long-term development, they need to launch some suitable products as soon as possible.”

Wei Dongqing, a professor at Shanghai Jiao Tong University, pointed out, "Stem cells have broad application prospects in anti-aging. In addition to the field of cells, related pharmaceutical companies can also focus on small molecule drugs, which also work through cells. Small molecule drugs can be declared for food and cosmetics, and can generate economic benefits faster. Medical beauty fields such as anti-aging are also a relatively important business sector."

You Changqiao said that in the future, NanHua Bio-medicine CO., Ltd. will focus on developing competitive products and adhere to the combination of scientific research and profits, the combination of long-term and short-term, and the combination of platforms and projects.

Specifically, it includes having 2-3 world-leading stem cell or immune cell pharmaceutical products or medical technologies in scientific research; maintaining a certain revenue scale and profit at the same time to support the healthy development of listed companies; having both long-term layout and short-term breakthroughs; deeply cultivating the main business, and at the same time giving full play to the platform functions of listed companies' financing and industry integration.

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